Kanada - anglų - Health Canada

j. strickland & co. - hydroquinone - cream - 2% - hydroquinone 2% - depigmenting agents

Kanada - anglų - Health Canada

nadinola inc. - hydroquinone - cream - 2% - hydroquinone 2% - depigmenting agents

Kanada - anglų - Health Canada

kiwi brands inc. - hydroquinone - cream - 2% - hydroquinone 2% - depigmenting agents

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

abbvie inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab 40 mg in 0.8 ml - humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. humira can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards).  humira is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. humira can be used alone or in combination with methotrexate. humira is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. humira can be used alone or in combination with non-biologic dmards. humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. humira is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. humira is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. limitations of use the effectiveness of humira has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies ( 14.7 , 14.8 )] . humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions ( 5 ) ] . humira is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. humira is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby humira pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd). registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data ) . adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations ) . in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data ) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data ) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to humira in utero  [see use in specific populations ( 8.4 ) ] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with humira, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of humira was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 µg/ml in cord blood, 4.28-17.7 µg/ml in infant serum, and 0-16.1 µg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 µg/ml), 7 weeks (1.31 µg/ml), 8 weeks (0.93 µg/ml), and 11 weeks (0.53 µg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for humira and any potential adverse effects on the breastfed child from humira or from the underlying maternal condition. the safety and effectiveness of humira have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn’s disease in pediatric patients 6 years of age and older. - the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. - the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. - the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older. due to its inhibition of tnfα, humira administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to humira in utero suggest adalimumab crosses the placenta [see use in specific populations ( 8.1 )] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including humira [see warnings and precautions ( 5.2 ) ] . juvenile idiopathic arthritis in study jia-i, humira was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies ( 14.2 ) ] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions ( 6.1 ) ] . humira has not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of humira in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions ( 6.1 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of humira for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of humira for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of humira in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.2 , 12.3 ), clinical studies ( 14.6 ) ] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of humira have not been established in pediatric patients with crohn’s disease less than 6 years of age. pediatric ulcerative colitis the safety and effectiveness of humira for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients 5 years of age and older. use of humira for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of humira in 93 pediatric patients (5 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.3 ) , clinical studies ( 14.8 ) ] . the adverse reaction profile in patients 5 years to 17 years of age was similar to adults. the effectiveness of humira has not been established in patients who have lost response or were intolerant to tnf blockers. the safety and effectiveness of humira have not been established in pediatric patients with ulcerative colitis less than 5 years of age. pediatric uveitis the safety and effectiveness of humira for the treatment of non-infectious uveitis have been established in pediatric patients 2 years of age and older. the use of humira is supported by evidence from adequate and well-controlled studies of humira in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients [see clinical studies ( 14.12 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with uveitis less than 2 years of age. hidradenitis suppurativa use of humira in pediatric patients 12 years of age and older for hs is supported by evidence from adequate and well-controlled studies of humira in adult hs patients. additional population pharmacokinetic modeling and simulation predicted that weight-based dosing of humira in pediatric patients 12 years of age and older can provide generally similar exposure to adult hs patients. the course of hs is sufficiently similar in adult and adolescent patients to allow extrapolation of data from adult to adolescent patients. the recommended dosage in pediatric patients 12 years of age or older is based on body weight [see dosage and administration ( 2.6 ) , clinical pharmacology ( 12.3 ) , and clinical studies ( 14.10 ) ] . the safety and effectiveness of humira have not been established in patients less than 12 years of age with hs. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received humira in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among humira treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of humira in patients 65 years of age and older. in patients treated with humira, closely monitor for the development of infection or malignancy [see warnings and precautions ( 5.1 , 5.2 )] . instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml single-dose pen do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira.  important: - do not use humira if frozen, even if it has been thawed. - the humira pen contains glass. do not drop or crush the pen because the glass inside may break. - each humira pen has 2 caps on it. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) until right before your injection. - when the plum-colored button on the humira pen is pressed to give your dose of humira, you will hear a loud “click” sound. you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. the loud click sound means the start of the injection. you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. - you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. - the loud click sound means the start of the injection. - you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. see the section below called “prepar ing the humira pen” . gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. 1 alcohol swab 1 cotton ball or gauze pad (not included in your humira carton) 1 humira pen (see figure a) puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. - 1 alcohol swab - 1 cotton ball or gauze pad (not included in your humira carton) - 1 humira pen (see figure a) - puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. if more comfortable, take your humira pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what the humira pen looks like. see figure a. figure a check the carton, dose tray, and humira pen . 1. make sure the name humira appears on the carton, dose tray, and humira pen label. 2. do not use and do call your doctor or pharmacist if: - you drop or crush your humira pen. - the seals on the top or bottom of the carton are broken or missing. - the expiration date on the carton, dose tray, and pen has passed. - the humira pen has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). see the “how should i store humira?” section at the end of this instructions for use. 3. hold the pen with the gray cap (cap # 1) pointed down. 4. make sure the amount of liquid in the pen is at the fill line or close to the fill line seen through the window. this is the full dose of humira that you will inject. see figure b. 5. if the pen does not have the full amount of liquid, do not use that pen . call your pharmacist. figure b 6. turn the pen over and hold the pen with the gray cap (cap # 1) pointed up. see figure c. 7. check the solution through the windows on the side of the pen to make sure the liquid is clear and colorless. do not use your humira pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. call your pharmacist. it is normal to see one or more bubbles in the window. figure c choose the injection site 8. wash and dry your hands well. 9. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure d. figure d - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject humira into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 10. wipe the injection site with an alcohol prep (swab) using a circular motion. - do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. preparing the humira pen 11. do not remove the gray cap (cap # 1) or the plum-colored cap (cap # 2) until right before your injection. 12. hold the middle of the pen (gray body) with one hand so that you are not touching the gray cap (cap # 1) or the plum-colored cap (cap # 2). turn the pen so that the gray cap (cap # 1) is pointing up. see figure e. figure e 13. with your other hand, pull the gray cap (cap # 1) straight off (do not twist the cap). make sure the small needle cover of the syringe has come off with the gray cap (cap # 1). see figure f. 14. throw away the gray cap (cap # 1). figure f - do not put the gray cap (cap # 1) back on the pen. putting the gray cap (cap # 1) back on may damage the needle. - the white needle sleeve, which covers the needle, can now be seen. - do not touch the needle with your fingers or let the needle touch anything. - you may see a few drops of liquid come out of the needle. this is normal. 15. remove the plum-colored cap (cap # 2) from the bottom of the pen by pulling it straight off (do not twist the cap). the pen is now activated. throw away the plum-colored cap (cap # 2). - do not put the plum-colored cap (cap # 2) back on the pen because it could cause medicine to come out of the syringe. the plum-colored activator button: - turn the pen so the plum-colored activator button is pointed up. see figure g. figure g - do not press the plum-colored activator button until you are ready to inject humira. pressing the plum-colored activator button will release the medicine from the pen. - hold the pen so that you can see the window. see figure h. it is normal to see one or more bubbles in the window. figure h position the pen and inject humira 16. position the pen: - squeeze the area of the cleaned skin and hold it firmly until the injection is complete. see figure i. you will inject into this raised area of skin. figure i 17. place the white end of the pen straight (at a 90º angle ) and flat against the raised area of your skin that you are squeezing. place the pen so that it will not inject the needle into your fingers that are holding the raised skin. see figure j. figure j 18. inject humira - it is important that you firmly push the pen down all the way against the injection site before starting the injection. - keep pushing down to prevent the pen from moving away from the skin during the injection. - press the plum-colored activator button with your thumb to begin the injection. try not to cover the window. see figure k. figure k - you will hear a loud ‘click’ when you press the plum-colored activator button. the loud click means the start of the injection. - keep pressing the plum-colored activator button and continue to push the pen against your squeezed, raised skin until all the medicine is injected. this can take up to 10 seconds, so count slowly to ten. keep pushing the pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine. - you will know that the injection has finished when the yellow indicator fully appears in the window view and stops moving. see figure l. figure l 19. when the injection is finished, slowly pull the pen from your skin. the white needle sleeve will move to cover the needle tip. see figure m. - do not touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure m - there may be a small amount of liquid on the injection site. this is normal. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 20. throw away (dispose of) your used humira pen in a sharps disposal container right away after use. see the section “how should i dispose of the used humira pen?” 21. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) the used humira pen? - put your pen in a fda-cleared sharps disposal container right away after use. see figure n. do not throw away the pen in your household trash.   - do not try to touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure n - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, never re-use your humira pens. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container.   - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a pen if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066944 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - if you do not have a fda cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 10 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 15 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml, 20 mg/0.4 ml and 10 mg/0.2 ml single-dose prefilled syringe do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira. gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. ● 1 alcohol swab ● 1 cotton ball or gauze pad (not included in your humira carton) ● 1 humira prefilled syringe (see figure a) ● puncture-resistant sharps disposal container for humira prefilled syringe disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used prefilled syringes and needles?” section at the end of this instructions for use. if more comfortable, take your humira prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the needle cover while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what a prefilled syringe looks like. see figure a. figure a check the carton, dose tray, and prefilled syringe 1. make sure the name humira appears on the dose tray and prefilled syringe label. 2. do not use and do call your doctor or pharmacist if: - the seals on top or bottom of the carton are broken or missing. - the humira labeling has an expired date. check the expiration date on your humira carton and do not use if the date has passed. - the prefilled syringe has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). - the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. make sure the liquid is clear and colorless. see the “how should i store humira?” section at the end of this instructions for use. choose the injection site 3. wash and dry your hands well. 4. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure b. figure b - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 5. wipe the injection site with an alcohol prep (swab) using a circular motion. 6. do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. prepare the syringe and needle 7. check the fluid level in the syringe: - hold the syringe with the covered needle pointing down. see figure c. figure c - hold the syringe at eye level. look closely to make sure that the amount of liquid in the syringe is the same or close to the: 0.8 ml line for the 40 mg prefilled syringe. see figure d. 0.4 ml line for the 20 mg prefilled syringe. see figure d. 0.2 ml line for the 10 mg prefilled syringe. see figure d. - 0.8 ml line for the 40 mg prefilled syringe. see figure d. - 0.4 ml line for the 20 mg prefilled syringe. see figure d. - 0.2 ml line for the 10 mg prefilled syringe. see figure d. figure d 8. the top of the liquid may be curved. if the syringe does not have the correct amount of liquid, do not use that syringe . call your pharmacist. 9. remove the needle cover: - hold the syringe in one hand. with the other hand gently remove the needle cover. see figure e. - throw away the needle cover. figure e - do not touch the needle with your fingers or let the needle touch anything. 10. turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. using your other hand, slowly push the plunger in to push the air out through the needle. see figure f. figure f - you may see a drop of liquid at the end of the needle. this is normal. position the prefilled syringe and inject humira position the syringe 11. hold the body of the prefilled syringe in one hand between the thumb and index finger. hold the syringe in your hand like a pencil. see figure g. figure g - do not pull back on the plunger at any time. - with your other hand, gently squeeze the area of the cleaned skin and hold it firmly. see figure h. figure h inject humira 12. using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle . see figure i. figure i - after the needle is in, let go of the skin. pull back gently on the plunger. if blood appears in the syringe: - it means that you have entered a blood vessel. - do not inject humira. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. see figure j. figure j - do not use the same syringe and needle again. throw away the needle and syringe in your sharps container. - do not rub the injection site. you may have slight bleeding. this is normal. - repeat steps 1 through 12 with a new prefilled syringe. if no blood appears in the syringe: - slowly push the plunger all the way in until all the liquid is injected and the syringe is empty. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 13. throw away the used prefilled syringe and needle in a sharps disposal container right away after use. see “how should i throw away ( dispose of ) used prefilled syringes and needles?” 14. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) used prefilled syringes and needles? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. see figure k. do not throw away (dispose of) loose needles and syringes in your household trash.   - do not try to touch the needle. figure k - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. the prefilled syringe is glass. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066947 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the prefilled syringe has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the needle cover while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the prefilled syringe if liquid has been frozen (even if thawed) - 1 single-dose prefilled syringe and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your prefilled syringe - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - throw the needle cover away - do not touch the needle with your fingers or let the needle touch anything - hold the prefilled syringe at eye level with one hand so you can see the air in the prefilled syringe - using your other hand, slowly push the plunger in to push the air out through the needle. - you may see a drop of liquid at the end of the needle. this is normal. - after the needle is in, let go of the skin. - do not rub - slight bleeding at the injection site is normal - put your used needles, syringes, and sharps in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in the household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: ○ made of a heavy-duty plastic, ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, ○ upright and stable during use, ○ leak-resistant, and ○ properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epipen and epipen jr are indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. epipen and epipen jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. epipen and epipen jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. none there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. in animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. during pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. epipen or epipen jr may be administered to pediatric patients at a dosage appropriate to body weight [ see dosage and administration (2.1) ] . clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from epipen and epipen jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, epipen should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see warnings and precautions (5.5), overdosage (10) ]. epipen ® [/epeepen/] (epinephrine injection, usp) auto-injector 0.3 mg epipen ® = one dose of 0.3 mg epinephrine, usp 0.3 mg/0.3 ml epipen jr ® [/epeepen/ /joonyer/] (epinephrine injection, usp) auto-injector 0.15 mg epipen jr ® = one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml for allergic emergencies (anaphylaxis) patient information read this patient information leaflet carefully before using the epipen ® or epipen jr ® auto-injector and each time you get a refill. there may be new information. anyone who may be able to administer the epipen or epipen jr auto-injector should know how to use it before you have an allergic emergency. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. what is the most important information i should know about epipen and epipen jr? - epipen and epipen jr are single-dose automatic injection devices (auto-injectors) that contain epinephrine. epinephrine is a medicine used to treat allergic emergencies (anaphylaxis). anaphylaxis can be life threatening and can happen within minutes. if untreated, anaphylaxis can lead to death. this allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. symptoms of anaphylaxis may include: - trouble breathing - wheezing - hoarseness (changes in the way your voice sounds) - hives (raised reddened rash that may itch) - severe itching - swelling of your face, lips, mouth, or tongue - skin rash, redness, or swelling - fast heartbeat - weak pulse - feeling very anxious - confusion - stomach pain - losing control of urine or bowel movements (incontinence) - diarrhea or stomach cramps - dizziness, fainting, or “passing out” (unconsciousness) - always carry 2 epipen or 2 epipen jr auto-injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care. you also need to always carry 2 auto-injectors with you if the first auto-injector is activated before the dose can be given. a device that has been activated by accident cannot be used in an allergic emergency (anaphylaxis). note: the epipen or epipen jr auto-injector has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked. you may not know when anaphylaxis will happen. talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. if you use 1 epipen or 1 epipen jr to treat an emergency allergic reaction, be sure to replace it so you always carry 2 auto-injectors. tell your family members, caregivers, and others where you keep your epipen or epipen jr auto-injectors. make sure they know how to use it before you need it. you may be unable to speak in an allergic emergency. - when you have an allergic emergency (anaphylaxis) use your epipen or epipen jr auto-injector right away. get emergency medical help right away even if you have used the epipen or epipen jr auto-injector. you can use a second epipen or epipen jr auto-injector if symptoms continue or come back or if the first auto-injector is activated before the dose can be given. for this reason, you should carry 2 epipen or 2 epipen jr auto-injectors with you at all times. if you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider. what are epipen and epipen jr auto-injectors? - epipen and epipen jr auto-injectors are disposable, prefilled auto-injectors used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. each device contains one dose of epinephrine. - epipen and epipen jr auto-injectors are for immediate administration by you or your caregiver. they do not take the place of emergency medical care. you should get emergency help right away after using your epipen or epipen jr auto-injector. - epipen and epipen jr auto-injectors are for people who have been prescribed this medicine by their healthcare provider. - the epipen (0.3 mg) auto-injector is for people who weigh 66 pounds or more (30 kilograms or more). - the epipen jr (0.15 mg) auto-injector is for people who weigh about 33 to 66 pounds (15 to 30 kilograms). - it is not known if epipen and epipen jr are safe and effective in children who weigh less than 33 pounds (15 kilograms). what should i tell my healthcare provider before using epipen or epipen jr? before you use your epipen or epipen jr auto-injector, tell your healthcare provider about all your medical conditions. your healthcare provider may give you more instructions about when and how to use epipen or epipen jr if you have the following: - heart problems or high blood pressure - diabetes - thyroid problems - asthma - a history of depression - parkinson’s disease you may also receive more instructions if you: - are pregnant or plan to become pregnant. it is not known if epinephrine will harm your unborn baby. - are breastfeeding or plan to breastfeed. it is not known if epinephrine passes into your breast milk. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. tell your healthcare provider about all of your known allergies. especially tell your healthcare provider if you take certain asthma medicines. epipen or epipen jr and other medicines may affect each other, causing side effects. epipen or epipen jr may affect the way other medicines work. other medicines may affect how epipen or epipen jr works. know the medicines you take. keep a list of all your medicines, including over-the-counter medicines, vitamins and herbal supplements to show your healthcare provider and pharmacist when you get a new medicine. use your epipen or epipen jr auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take. how should i use the epipen or epipen jr auto-injector? - use your single-dose epipen or epipen jr auto-injector exactly as your healthcare provider tells you to use it. you may need to use a second epipen or epipen jr auto-injector if symptoms continue or come back while you wait for emergency help or if the first auto-injector is activated before the dose can be given. if you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses must be administered by a healthcare provider. - epipen or epipen jr should be injected into the middle of your outer thigh (upper leg). it can be injected through your clothing if needed. do not inject into a vein or into the buttocks, fingers, toes, hands or feet. - read and make sure you understand the instructions for use at the end of this patient information leaflet to learn the right way to use the epipen and epipen jr auto-injector. - your healthcare provider will show you how to safely use the epipen or epipen jr auto-injector. - it is very important that you hold the epipen or epipen jr auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. if you do not hold it in place long enough, the epipen or epipen jr auto-injector might not have time to deliver the correct dose of medicine. - caution: never put your thumb, fingers or hand over the orange needle end. never press or push the orange needle end with your thumb, fingers or hand. the needle comes out of the orange needle end. accidental injection into fingers, hands or feet may cause a loss of blood flow to these areas. if an accidental injection happens, go immediately to the nearest emergency room. - warning: do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top. this may cause the device to activate by accident: a “pop” is heard, the orange needle end is extended and the medicine viewing window is blocked. a device that has been activated by accident cannot be used in an emergency. if this happens, replace it with a new epipen or epipen jr. - when you are ready to inject, pull the blue safety top straight up and away from the auto-injector. - your epipen and epipen jr auto-injector may come in a package with a gray trainer and separate trainer instructions for use. the gray trainer contains no medicine and no needle. keep the trainer and the real epipen and epipen jr auto-injectors away from young children. the real epipen and epipen jr auto-injectors and trainer are not toys. for young children, use of the trainer and the real epipen and epipen jr auto-injectors should be supervised by an adult. regularly practice with your gray trainer in non-emergency situations to make sure you can safely use the real epipen or epipen jr auto-injector in an emergency. always carry your 2 real epipen or epipen jr auto-injectors with you in case of an allergic emergency. additional training information is available at www.epipen.com . - do not drop the protective case, epipen auto-injector or epipen jr auto-injector. if the protective case or auto-injector is dropped, check for damage and leakage. if damage or leakage is noticed or suspected, throw away (dispose of) the epipen or epipen jr auto-injector and protective case and replace it. what are the possible side effects of epipen or epipen jr? epipen and epipen jr may cause serious side effects. - epipen or epipen jr should only be injected into the middle of your outer thigh (upper leg). do not inject epipen or epipen jr into your: veins buttocks fingers, toes, hands or feet if you accidentally inject epipen or epipen jr into any place other than the middle of your outer thigh, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - veins - buttocks - fingers, toes, hands or feet if you accidentally inject epipen or epipen jr into any place other than the middle of your outer thigh, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - rarely, people who have used the epipen or epipen jr auto-injector may get infections at the injection site within a few days of an injection. some of these infections can be serious. call your healthcare provider right away if you see any of the following at an injection site: redness that does not go away swelling tenderness the area feels warm to the touch - redness that does not go away - swelling - tenderness - the area feels warm to the touch - cuts on the skin, bent needles and needles that remain in the skin after the injection can happen when young children kick or move during an injection. if you inject a young child with an epipen or epipen jr auto-injector, hold their leg firmly in place before and during the 3 second injection to prevent injuries. follow the instructions for use at the end of this patient information leaflet. ask your healthcare provider to show you how to: hold the young child firmly in place (restrain). with one hand, grip the auto-injector with the orange needle end pointing down. with the other hand, pull the blue safety top straight up and away from the auto-injector. - hold the young child firmly in place (restrain). - with one hand, grip the auto-injector with the orange needle end pointing down. - with the other hand, pull the blue safety top straight up and away from the auto-injector. - if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your epipen or epipen jr auto-injector. talk to your healthcare provider about all your medical conditions. common side effects of epipen and epipen jr include: - fast, irregular or “pounding” heartbeat - sweating - headache - weakness - shakiness - paleness - feelings of over excitement, nervousness or anxiety - dizziness - nausea or vomiting - breathing problems these side effects may go away with rest. tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of epipen or epipen jr. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store epipen or epipen jr auto-injectors? - store epipen and epipen jr auto-injectors at room temperature between 68° f to 77° f (20° c to 25° c). - keep this medicine out of the sight and reach of young children. - keep protective case in the outer carton to protect from light. when exposed to air or light epinephrine changes quickly to a pinkish or brown color and should not be used. - do not expose to extreme cold or heat. for example, do not store in your vehicle’s glove box or trunk. do not store in the refrigerator or freezer. - examine the contents in the medicine viewing window of your epipen or epipen jr auto-injector regularly. the medicine should be clear. if the medicine is discolored (pinkish or brown color) or contains solid particles, replace the auto-injector. - always keep your 2 epipen or 2 epipen jr auto-injectors in the protective cases to prevent damage to the device. the protective case is not waterproof. - the blue safety top helps to prevent accidental injection. keep the blue safety top in place until you need to use the epipen or epipen jr auto-injector. after the auto-injector is used, throw away the blue safety top as this may pose a choking hazard for small children. disposing of an expired, unused or used epipen or epipen jr auto-injector your epipen or epipen jr auto-injector has an expiration date. replace the pack of auto-injectors before the expiration date. throw away (dispose of) expired, unwanted, or unused epipen and epipen jr auto-injectors in an fda-cleared sharps disposal container right away after use. do not throw away the epipen or epipen jr in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal visit the fda’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away unused, unwanted or expired medicines. after using your epipen or epipen jr auto-injector in an allergic emergency, get emergency medical help right away. take your used epipen or epipen jr auto-injector with you to give to your healthcare provider for disposal. general information about the safe and effective use of epipen and epipen jr auto-injectors. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use the epipen or epipen jr auto-injector for a condition for which it was not prescribed. do not give your epipen or epipen jr auto-injector to other people. this patient information leaflet summarizes the most important information about the epipen and epipen jr auto-injectors. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about epipen and epipen jr auto-injectors that is written for health professionals. what are the ingredients in epipen and epipen jr? active ingredients: epinephrine inactive ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water important information - the epipen auto-injector has a yellow colored label. - the epipen jr auto-injector has a green colored label. - your epipen or epipen jr auto-injector is designed to work through clothing. - when receiving an epipen or epipen jr auto-injector and before you need to use the epipen or epipen jr auto-injector, remove the auto-injector from the protective case and check the auto-injector to make sure the blue safety top is not raised (see figure d in the instructions for use). if the blue safety top is raised, the auto-injector should not be used because the device could activate by accident. do not try to push the blue safety top back down. put the auto-injector back in the protective case and replace it with a new epipen or epipen jr. - choking hazard : the blue safety top is a small part that may become a choking hazard for children. throw away the blue safety top immediately after using the epipen or epipen jr auto-injector. - it is very important that you hold the epipen or epipen jr auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. if you do not hold it in place long enough, the epipen or epipen jr auto-injector might not deliver the correct dose of medicine. - if an accidental injection happens, get emergency medical help right away. - do not place patient information or any other foreign objects in the protective case with the epipen or epipen jr auto-injector, as this may prevent you from removing the auto-injector for use. - each epipen or epipen jr auto-injector can be used only 1 time (single-use). the auto-injectors deliver a fixed dose of epinephrine and cannot be reused. do not try to reuse epipen or epipen jr after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle end is extended to cover the needle and the medicine viewing window is blocked. - incorrect use and correct use of epipen and epipen jr incorrect use correct use and important reminders storage outside the protective case or storage of the epipen or epipen jr auto-injector in extreme cold or heat. always keep your epipen or epipen jr stored in the protective case and at room temperature. keep protective case in the outer carton to protect from light. wrong storage may stop the epipen or epipen jr from working. if the device has been in extreme cold or heat, the epipen or epipen jr should be replaced. failing to remove the auto-injector from the protective case before use. the epipen or epipen jr auto-injector must be removed from the protective case it comes in before use. failing to remove the blue safety top before use. remove the blue safety top before use. epipen or epipen jr will not activate with the blue safety top in place. activating the auto-injector upside down which will cause an injection into the hand. the needle exits from the orange end of the epipen and epipen jr auto-injector, which should be in contact with the outer thigh (upper leg) at a 90˚angle (perpendicular) to the thigh before and during activation. the orange needle end will extend to cover the needle after activation. if you can still see the needle, do not try to reuse the auto-injector. failing to apply enough force to activate the epipen or epipen jr auto-injector. epipen and epipen jr should be administered by swinging and pushing the auto-injector firmly against the outer thigh. epipen and epipen jr auto-injectors make a distinct pop sound when pushed against the thigh. the pop sound signals that the injection has started. the correct dose has been administered if the orange needle end is extended and the window is blocked. administering at an injection site other than the outer thigh. administer epipen or epipen jr in the outer thigh only. failing to hold the auto-injector in place for a full 3 seconds. hold the epipen or epipen jr auto-injector in place for a full 3 seconds following activation (count slowly 1, 2, 3). for more information and video instructions on the use of epipen and epipen jr auto-injectors, go to www.epipen.com or call 1-800-395-3376. instructions for use epipen ® [/epeepen/] (epinephrine injection, usp) auto-injector 0.3 mg epipen ® = one dose of 0.3 mg epinephrine, usp 0.3 mg/0.3 ml for intramuscular and subcutaneous use epipen jr ® [/epeepen/ /joonyer/] (epinephrine injection, usp) auto-injector 0.15 mg epipen jr ® = one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml for intramuscular and subcutaneous use this instructions for use contains information on how to administer the epipen and epipen jr auto-injector. important information you need to know before administering the epipen and epipen jr auto-injector - the single-dose epipen or epipen jr auto-injector is for allergic emergency (anaphylaxis) and should be used right away. you can use a second epipen or epipen jr auto-injector if symptoms continue or symptoms come back. - before you need to use your epipen or epipen jr auto-injector, make sure your healthcare provider shows you the right way to use it. anyone who may be able to administer the epipen or epipen jr auto-injector should also understand how to use it. - carefully read the instructions for use in a non-emergency situation and make sure you understand them before using your epipen or epipen jr auto-injector. - if you have any questions, ask your healthcare provider. - it is very important that you hold the epipen or epipen jr auto-injector down for at least 3 full seconds. if you do not hold it in place long enough, the epipen or epipen jr auto-injector might not have time to deliver the correct dose of medicine. - make sure to always carry 2 epipen or 2 epipen jr auto-injectors. one dose may not be enough. - inject epipen or epipen jr into the muscle (intramuscular) or under the skin (subcutaneous) in the middle of the outer thigh (see figure b ). do not inject epipen or epipen jr into any other part of the body. - the injection can be given through clothes. - each epipen or epipen jr auto-injector can be used only 1 time (single-use). it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle end is extended to cover the needle and the medicine viewing window is blocked. - warning: do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top. this may cause the device to activate by accident: a “pop” is heard, the orange needle end is extended and the medicine viewing window is blocked. a device that has been activated by accident cannot be used in an emergency. if this happens, replace it with a new epipen or epipen jr. - do not take the epipen or epipen jr auto-injector apart. - keep the blue safety top in place until you are ready to inject. - always point the orange needle end down (see figure c ). keep your fingers, thumb and hand away from the orange needle end. accidental injection in the fingers, thumb or feet may cause loss of blood flow to these areas. checking the blue safety top when receiving an epipen or epipen jr auto-injector and before you need to use the epipen or epipen jr auto-injector, do the following: - remove the epipen or epipen jr auto-injector from the protective case and check the auto-injector to make sure the blue safety top is not raised (see figure d ). if the blue safety top is not raised, the auto-injector is okay to use. put the auto-injector back in the protective case so that it is ready to be used in an allergic emergency. - if the blue safety top is raised (see figure e ) , the auto-injector should not be used because the device could activate by accident. do not try to push the blue safety top back down. put the auto-injector back in the protective case and replace it with a new epipen or epipen jr. preparing to inject epipen or epipen jr note the following while preparing to inject epipen or epipen jr: - remove anything in or around the injection site that blocks you from giving the injection. - check the auto-injector before use. if the auto-injector appears damaged, throw it away (dispose of) and do not use. - the gray trainer contains no medicine and no needle. practice with the gray trainer before an allergic emergency happens to make sure you can safely use the real epipen in an emergency. - keep the trainer and the real epipen and epipen jr auto-injectors away from young children. the epipen and epipen jr auto-injectors and trainer are not toys. use by young children should be supervised by an adult. - while preparing to inject, make sure you know where to inject (see figure b ) and how to hold the epipen and epipen jr auto-injector (see figure c ). - epipen and epipen jr auto-injectors have a never-see-needle ® that covers the needle before and after you inject (see figure g ). you should never see a needle. if you can see a needle, do not use the epipen or epipen jr auto-injector. make sure the epipen or epipen jr auto-injector has not been used. if an epipen or epipen jr auto-injector has been used: - the orange needle end will be extended (see step 4 ), - the medicine viewing window will be blocked, and - the epipen or epipen jr auto-injector will no longer fit in the protective case. preparing to inject a child - if you are giving epipen or epipen jr to a young child, first hold the child firmly in place (restrain) and then use both hands to remove the blue safety top as shown (see figure j ). use one hand to hold the auto-injector with the orange needle end pointing down and your other hand to remove the blue safety top to activate the auto-injector. then, inject in the middle of the outer thigh (see figure l ). remember to hold the leg firmly in place before and during the 3 second injection to avoid needlestick injuries including cuts to the thigh. - keep the trainer and the real epipen and epipen jr auto-injectors away from young children. the real epipen and epipen jr auto-injectors and trainer are not toys. use by young children should be supervised by an adult. checking the medicine color examine the liquid in the medicine viewing window of your epipen or epipen jr auto-injector regularly. see the information below: medicine color: - the medicine can be seen through the medicine viewing window located near the middle of the epipen or epipen jr auto-injector. to check the medicine color, hold the auto-injector in front of a white background in a well-lit area and look through the medicine viewing window. figure h. medicine viewing window - use the medicine if it is clear and colorless. do not use the medicine if it is discolored (pinkish or brown color) or if the medicine has particles floating in it. throw it away (dispose of) and use a new epipen or epipen jr auto-injector (see the section “ disposing of an expired, unused or used epipen or epipen jr auto-injector ” on the patient information side of this leaflet). injecting epipen or epipen jr step 1 slide the epipen or epipen jr auto-injector out of the case (figure i) remove the auto-injector from the protective case. step 2 pull off the blue safety top (figure j) grip the epipen or epipen jr auto-injector with one hand and with the orange needle end pointing down. use the other hand to remove the blue safety top. pull it straight up and away . note: do not twist or bend the blue safety top. failure to pull out the blue safety top correctly (straight up and away) can cause accidental activation. note: to avoid an accidental injection, never put your thumb, fingers or hand over the orange needle end. if an accidental injection happens, get emergency medical help right away. step 3 inject the medicine by self (figure k) or caregiver (figure l) administration place the orange needle end against the outer thigh, through clothing if needed. push down firmly and hold in place for 3 seconds. note: epipen and epipen jr auto-injectors make a distinct pop sound when pushed against the thigh. this is normal and means that the epipen or epipen jr auto-injector is working. after the pop, continue to press the epipen or epipen jr auto-injector down firmly on the outer thigh for 3 seconds to make sure that the medicine is given. step 4 check if used (figure m) lift the auto-injector straight out from the thigh. the orange needle end will extend to cover the needle. if the needle is visible, do not reuse it. use a new auto-injector. throw away the blue safety top. step 5 get emergency medical help after injecting epipen or epipen jr, get emergency medical help right away. you can use a second epipen or epipen jr auto-injector if symptoms continue or come back. - take your used epipen or epipen jr auto-injector to your healthcare provider. - epipen and epipen jr are single-dose auto-injectors and cannot be reused. - if the needle is visible, do not try to reuse it. storing epipen and epipen jr auto-injectors store the epipen and epipen jr auto-injectors at room temperature between 68˚ f to 77˚ f (20˚ c to 25˚ c). keep protective case in the outer carton to protect from light. when exposed to air or light, the medicine in the epipen and epipen jr auto-injector changes rapidly to a pinkish or brown color and should not be used. disposing of epipen and epipen jr auto-injectors after using your epipen or epipen jr auto-injector, get emergency medical help right away. take your used auto-injector with you to give to your healthcare provider for disposal. important: the blue safety top is a small part that may become a choking hazard for children. throw away the blue safety top immediately after using the epipen or epipen jr auto-injector. your epipen or epipen jr auto-injector has an expiration date. replace it before the expiration date. for more information on how to throw away (dispose of) your expired epipen or epipen jr auto-injector, see the section “ disposing of an expired, unused or used epipen or epipen jr auto-injector ” on the patient information side of this leaflet. (epinephrine injection, usp) auto-injector 0.15 mg epipen jr ® = one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml for more information about epipen or epipen jr auto-injectors and proper use of the product, call mylan at 1-877-446-3679 or visit www.epipen.com for an instructional video. epipen trainer instructions for use in an emergency: do not use the gray trainer. use your real yellow epipen® or real green epipen jr® auto-injector. important information - the trainer label has a gray color. - the trainer contains no medicine and no needle. the orange end of the trainer is the needle end of the real yellow epipen or real green epipen jr auto-injector. - regularly practice with the gray trainer in non-emergency situations to make sure you are able to safely use the real yellow epipen or real green epipen jr auto-injector in an emergency situation. - always carry your 2 real yellow epipen or real green epipen jr auto-injectors in case of an allergic emergency. - in an actual emergency, you need to use your real yellow epipen or real green epipen jr auto-injector immediately. you should get emergency medical help right away after using your real yellow epipen or real green epipen jr auto-injector. - when receiving the real yellow epipen or real green epipen jr auto-injector and before you need to use the real yellow epipen or real green epipen jr auto-injector, check the auto-injector to make sure the blue safety top is not raised (see patient information leaflet ). if the blue safety top is raised, the auto-injector should not be used because the device could activate by accident. do not try to push the blue safety top back down. put the auto-injector back in the protective case and replace it with a new real yellow epipen or real green epipen jr. - choking hazard: the blue safety top is a small part that may become a choking hazard for children. put the blue safety top back on the trainer and reset it immediately after practicing. - keep the gray trainer away from young children. the trainer is not a toy. children should only practice with the trainer under adult supervision. - carefully read the instructions for use for the real yellow epipen and real green epipen jr auto-injector in a non-emergency situation and make sure you understand them before using the real yellow epipen or the real green epipen jr. the epipen trainer familiarize yourself with this gray trainer. practice until you are comfortable using it. your gray trainer: caution: know the difference between the trainer and your real yellow epipen and real green epipen jr auto-injector important differences between the trainer and your real yellow epipen or real green epipen jr auto-injector trainer (gray) epipen (yellow) epipen jr (green) contains medicine? no yes yes has needle? no yes yes comes in protective case? no yes yes color of label? gray yellow green has expiration date? no yes yes can be reused? yes no (use only one time) no (use only one time) okay to remove and replace blue safety top? yes no (remove just one time before use) no (remove just one time before use) pressure needed to hold against thigh? moderate strong strong practice instructions using the trainer step 1 pull off the blue safety top (figure b) grip the gray trainer with one hand and with the orange end pointing down. use the other hand to remove the blue safety top. pull it straight up and away. note: do not twist or bend the blue safety top. warning: do not flip the blue safety top off using a thumb or by pulling it sideways or by bending and twisting the blue safety top. this may cause the real yellow epipen or real green epipen jr auto-injector to accidentally activate. an epipen or epipen jr auto-injector that has been activated by accident cannot be used for a patient in an emergency and must be replaced. step 2 trainer injection simulation by self (figure c) or caregiver (figure d) administration place the orange end against the outer thigh, over clothing if needed. push down firmly and hold in place for 3 seconds. if practicing an injection on a young child, first hold the child firmly (restrain) and then use one hand to hold the trainer with the orange end pointing down and your other hand to remove the blue safety top. hold the leg firmly in place before and during the 3 second practice injection to prevent injuries. note: the trainer makes a distinct pop sound when pushed against the thigh. this is normal and means that the auto-injector is working. after the pop, continue to press the trainer down firmly on the outer thigh for 3 seconds. step 3 check if used (figure e) lift the trainer straight out from the thigh. inspect: the trainer was activated correctly if the orange end is extended. if the orange end is not extended, repeat step 1 and step 2. step 4 reset the trainer (figure f) put the blue safety top back on the trainer immediately. place the orange end on a hard surface. squeeze the sides of the orange end and push down on the trainer with the other hand. note: this resetting step should never be used with a real yellow epipen or real green epipen jr auto-injector as this may result in injury. never put your thumb, other fingers, or hand over the orange (needle) end of the real yellow epipen or real green epipen jr auto-injector. practice session information in case of an allergic emergency, use the real yellow epipen or real green epipen jr auto-injector and not the gray trainer. follow instructions above. repeat as often as needed until you are able to inject quickly and correctly. regularly practice with the trainer to make sure that you are able to use the real yellow epipen or real green epipen jr auto-injector in an emergency situation. reread: - the trainer instructions for use - the “patient information” leaflet that comes with your epipen or epipen jr auto-injector train others who could help you in an emergency: - anyone who may be able to administer the epipen or epipen jr auto-injector should know how to help you during an allergic emergency. before an emergency occurs, have them: regularly practice preparing the trainer for injection and simulating an injection read the trainer instructions for use and the “patient information” leaflet - regularly practice preparing the trainer for injection and simulating an injection - read the trainer instructions for use and the “patient information” leaflet for more information about the epipen and epipen jr auto-injector and the proper use of the products, go to www.epipen.com . repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-8762

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - auvi-q® is indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. auvi-q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. auvi-q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. none. 8.1 pregnancy teratogenic effects: pregnancy category c. there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. epinephrine was teratogenic in rabbits, mice and hamsters. epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both). epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). these effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). 8.3 nursing mothers it is not known whether epinephrine is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when auvi-q is administered to a nursing woman. 8.4 pediatric use auvi-q may be administered to pediatric patients at a dosage appropriate to body weight [see dosage and administration ( 22)]. clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from auvi-q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary. 8.5 geriatric use clinical studies of auvi-q did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. epinephrine should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see warnings and precautions 5-(5.5), overdosage ( 10)]. auvi-q® (epinephrine injection) auto-injector for allergic emergencies (anaphylaxis) read this patient information leaflet before you have to use auvi-q and each time you get a refill. there may be new information. you should know how to use auvi-q before you have an allergic emergency. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. what is the most important information i should know about auvi-q? always carry auvi-q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. talk to your doctor if you need additional units to keep at work, school, etc. an anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. follow your healthcare provider’s instructions on when to use auvi-q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below: trouble breathing wheezing hoarseness (changes in the way your voice sounds) hives (raised reddened rash that may itch) severe itching swelling of your face, lips, mouth or tongue skin rash, redness, or swelling fast heartbeat weak pulse feeling very anxious confusion stomach pain losing control of urine or bowel movements dizziness or fainting tell your family members and others where you keep auvi-q and how to use it before you need it. you may be unable to speak in an allergic emergency. get medical attention immediately after using auvi-q. if you have a serious allergic reaction, you may need more medicine. what is auvi-q? auvi-q is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in people who are at risk for or have a history of serious allergic reactions. auvi-q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. you should get emergency medical help right away after using auvi-q. it is not known if auvi-q is safe and effective in children who weigh less than 16.5 pounds (7.5 kg). what should i tell my healthcare provider before using auvi-q? before you use auvi-q, tell your healthcare provider if you: have heart problems or high blood pressure have diabetes have thyroid problems have history of depression have parkinson’s disease have any other medical conditions are pregnant or plan to become pregnant. it is not known if auvi-q will harm your unborn baby. are breastfeeding or plan to breastfeed. it is not known if auvi-q passes into your breast milk. tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. auvi-q and other medicines may affect each other, causing side effects. auvi-q may affect the way other medicines work, and other medicines may affect how auvi-q works. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. how should i use auvi-q? each auvi-q contains only 1 dose of medicine. auvi-q should only be injected into the muscle of your outer thigh. it can be injected through your clothing, if needed. read the instructions for use at the end of this patient information leaflet for information about the right way to use auvi-q. use auvi-q exactly as your healthcare provider tells you to use it. a trainer for auvi-q with a separate trainer instructions for use leaflet is included with auvi-q. additional training resources are available at www.auvi-q.com. practice with the trainer for auvi-q before an allergic emergency happens to make sure you are able to safely use the real auvi-q in an emergency. the trainer for auvi-q does not contain a needle or medicine and can be reused to practice your injection. what are the possible side effects of auvi-q? auvi-q may cause serious side effects. auvi-q should only be injected into your outer thigh. do not inject auvi-q into your: veins buttocks fingers, toes, hands or feet if you accidentally inject auvi-q into any other part of your body, go to the nearest hospital emergency room right away. tell the healthcare provider where on your body you received the accidental injection. rarely, patients who use auvi-q may develop infections at the injection site within a few days of an injection. some of these infections can be serious. call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away swelling tenderness the area feels warm to the touch if you inject a young child or infant with auvi-q, hold their leg firmly in place before and during the injection to prevent injuries. ask your healthcare provider to show you how to properly hold the leg of a young child or infant during an injection. if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use auvi-q. talk to your healthcare provider about all your medical conditions. common side effects of auvi-q include: fast, irregular, or ‘pounding’ heart beat sweating shakiness headache paleness feelings of over excitement, nervousness, or anxiety weakness dizziness nausea and vomiting breathing problems tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all of the possible side effects of auvi-q. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store auvi-q? store auvi-q at 68° to 77°f (20° to 25°c). do not expose to extreme heat or cold. for example, do not store in your vehicle’s glove box. do not store auvi-q in the refrigerator or freeze. examine contents in the viewing window periodically. solution should be clear. if the solution is discolored (pinkish color or darker than slightly yellow), cloudy or contains solid particles, replace the unit. your auvi-q has an expiration date. replace it before the expiration date. keep auvi-q in the outer case it comes in to protect it from light. keep auvi-q and all medicines out of the reach of children. general information about the safe and effective use of auvi-q: medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use auvi-q for a condition for which it was not prescribed. do not give auvi-q to other people, even if they have an allergic reaction or the same symptoms that you have. it may harm them. this patient information leaflet summarizes the most important information about auvi-q. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about auvi-q that is written for health professionals. for more information and video instructions on the use of auvi-q, go to www.auvi-q.com or call 1-844-828-8472. what are the ingredients in auvi-q? active ingredient: epinephrine. inactive ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water. auvi-q does not contain latex. instructions for use read these instructions for use carefully before you need to use your auvi-q. before you use auvi-q, make sure your healthcare provider shows you the right way to use it. if you have any questions, ask your healthcare provider. if you are administering auvi-q to a young child or infant, hold the leg firmly in place and limit movement prior to and while administering an injection. automated voice instructions auvi-q contains an electronic voice instruction system to help guide you through each step of your injection. if the voice instructions do not work for any reason, use auvi-q as instructed in these instructions for use. it will still work during an allergic reaction emergency. how to use your auvi-q figure a. 1. pull auvi-q up from the outer case. see figure b. do not go to step 2 until you are ready to use auvi-q. if you are not ready to use auvi-q, put it back in the outer case. figure b. 2. pull red safety guard down and off of auvi-q. see figure c. to reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. if an accidental injection happens, get medical help right away. note: the red safety guard is made to fit tight. pull firmly to remove. figure c. 3. place black end of auvi-q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. see figure d. only inject into the middle of the outer thigh. do not inject into any other part of the body. if you are administering auvi-q to a young child or infant, hold the leg firmly in place while administering an injection see figure e. figure d. (for auvi-q 0.3 mg and auvi-q 0.15 mg) figure e. (for auvi-q 0.1 mg) note: auvi-q makes a distinct sound (click and hiss) when you push it against your outer thigh. this is normal and indicates auvi-q is working correctly. do not pull auvi-q away from your leg when you hear the click and hiss sound. the needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. auvi-q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete, and to seek emergency medical attention, auvi-q will beep, and the lights will blink red. 4. get emergency medical help right away. replace the outer case and talk to your healthcare provider about the right way to throw away your auvi-q. ask your healthcare provider for an auvi-q prescription refill. after the use of auvi-q: the black base will lock into place. the voice instruction system will say “seek emergency medical attention”, say “this auvi-q has been used…”, and the lights will blink red. the red safety guard cannot be replaced. the viewing window will no longer be clear. it is normal for some medicine to remain in your auvi-q after you have received your dose of medicine. talk to your healthcare provider about the right way to throw away your auvi-q. auvi-q is a single-use auto-injector and cannot be reused. until you throw away your used auvi-q, the electronic voice instruction system will remind you that it has been used when the outer case is removed. if you will be administering auvi-q to a young child or infant, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose. this patient information has been approved by the u.s. food and drug administration. rev nov 2017 manufactured for: kaleo, inc. richmond, va 23219 usa this product may be covered by one or more u.s. patents or pending patent applications. see www.kaleopharma.com/pat for details. *for california only: this product uses batteries containing perchlorate material – special handling may apply. see www.dtsc.ca.gov/hazardouswaste/perchlorate important: the trainer for auvi-q does not contain a needle or medicine. in case of an allergic emergency, use the real auvi-q and not the gray trainer. always carry your real auvi-q with you in case of an allergic emergency. important information about the trainer for auvi-q: inside your trainer for auvi-q are: batteries a speaker that will make a beeping sound and that produces electronic voice instructions red and green blinking lights the trainer for auvi-q batteries are made to last long enough for you to practice 1 time each day for 2 years. if your trainer for auvi-q does not work properly call your healthcare provider for a new trainer. storage: store the trainer for auvi-q at room temperature; the trainer for auvi-q should not be used at temperatures less than 50°f (10°c) or greater than 104°f (40°c). store the trainer for auvi-q in its outer case. keep the trainer for auvi-q away from dirt, chemicals, and water. disposal: the trainer for auvi-q contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. follow your state and local environmental regulations for disposal. for california only: this product uses batteries containing perchlorate material - special handling may apply. see www.dtsc.ca.gov/hazardouswaste/perchlorate manufactured for: kaleo, inc. richmond, va 23219 usa this product may be covered by one or more u.s. patents or pending patent applications. see www.kaleopharma.com/pat for details. rev nov 2017

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. none risk summary there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. in animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk: during pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. data animal data: in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). risk summary there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may be administered to pediatric patients at a dosage appropriate to body weight [ see dosage and administration ( 2.1) ] . clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, epinephrine injection, 0.3 mg should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see warnings and precautions ( 5.5), overdosage ( 10) ]. epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml for allergic emergencies (anaphylaxis) patient information read this patient information leaflet carefully before using the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) and each time you get a refill. there may be new information. you, your parent, caregiver, or others who may be in a position to administer epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector), should know how to use it before you have an allergic emergency. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. what is the most important information i should know about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? 1. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are single-dose automatic injection devices (auto-injectors) that contain epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. symptoms of anaphylaxis may include: - trouble breathing - wheezing - hoarseness (changes in the way your voice sounds) - hives (raised reddened rash that may itch) - severe itching - swelling of your face, lips, mouth, or tongue - skin rash, redness, or swelling - fast heartbeat - weak pulse - feeling very anxious - confusion - stomach pain - losing control of urine or bowel movements (incontinence) - diarrhea or stomach cramps - dizziness, fainting, or “passing out” (unconsciousness) 2. always carry your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg with you because you may not know when anaphylaxis may happen. talk to your healthcare provider if you need additional units to keep at work, school, or other locations. tell your family members, caregivers, and others where you keep your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg and how to use it before you need it. you may be unable to speak in an allergic emergency. 3. when you have an allergic emergency (anaphylaxis) - use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg right away. - get emergency medical help right away. you may need further medical attention. you may need to use a second epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if symptoms continue or recur. only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. what are epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are disposable, pre-filled auto-injectors used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. each device contains a single dose of epinephrine. - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are for immediate self (or caregiver) administration and do not take the place of emergency medical care. you should get emergency help right away after using epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg. - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are for people who have been prescribed this medicine by their healthcare provider. - the epinephrine injection, 0.3 mg (auto-injector) is for patients who weigh 66 pounds or more (30 kilograms or more). - the epinephrine injection, 0.15 mg (auto-injector) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms). - it is not known if epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are safe and effective in children who weigh less than 33 pounds (15 kilograms). what should i tell my healthcare provider before using the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg? before you use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg, tell your healthcare provider about all your medical conditions, but especially if you: - have heart problems or high blood pressure. - have diabetes. - have thyroid problems. - have asthma. - have a history of depression. - have parkinson’s disease. - are pregnant or plan to become pregnant. it is not known if epinephrine will harm your unborn baby. - are breastfeeding or plan to breastfeed. it is not known if epinephrine passes into your breast milk. tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. tell your healthcare provider about all of your known allergies. especially tell your healthcare provider if you take certain asthma medicines. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg and other medicines may affect each other, causing side effects. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may affect the way other medicines work, and other medicines may affect how epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg work. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. use your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take. how should i use epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? - each epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) contains only 1 dose of medicine (single-dose). - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors deliver a fixed dose of epinephrine. the auto-injectors cannot be reused. do not try to reuse epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose has been injected. the dose has been injected if the orange tip is extended and the window is blocked. - epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg should be injected into the middle of your outer thigh (upper leg). it can be injected through your clothing if needed. do not inject into a vein or into the buttocks, fingers, toes, hands or feet. - read the instructions for use at the end of this patient information leaflet about the right way to use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. - your healthcare provider will show you how to safely use the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector). - use your single-dose epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg exactly as your healthcare provider tells you to use it. you may need to use a second epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if symptoms continue or recur. only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. - caution: never put your thumb, fingers, or hand over the orange tip. never press or push the orange tip with your thumb, fingers, or hand. the needle comes out of the orange tip. accidental injection into finger, hands or feet may cause a loss of blood flow to these areas. if an accidental injection happens, go immediately to the nearest emergency room. tell the healthcare provider where on your body you received the accidental injection. - your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) may come packaged with an epinephrine injection trainer and separate epinephrine injection trainer instructions for use. the epinephrine injection trainer has a grey color. the grey epinephrine injection trainer contains no medicine and no needle. keep the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors away from young children. the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors and epinephrine injection trainer are not toys. for young children, use of the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors should be supervised by an adult. periodically practice with your epinephrine injection trainer before an allergic emergency happens to make sure you are able to safely use the real epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) in an emergency. always carry your real epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) with you in case of an allergic emergency. additional training resources are available at www.tevaepinephrine.com . - do not drop the auto-injector. if the auto-injector is dropped, check for damage and leakage. throw away (dispose of) the auto-injector and replace if damage or leakage is noticed or suspected. what are the possible side effects of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg may cause serious side effects. - the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg should only be injected into the middle of your outer thigh (upper leg). do not inject the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg into your: veins buttocks fingers, toes, hands, or feet if you accidentally inject epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg into any other part of your body, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - veins - buttocks - fingers, toes, hands, or feet if you accidentally inject epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg into any other part of your body, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - rarely, patients who have used epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may develop infections at the injection site within a few days of an injection. some of these infections can be serious. call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away swelling tenderness the area feels warm to the touch - redness that does not go away - swelling - tenderness - the area feels warm to the touch - cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. if you inject a young child with epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg, hold their leg firmly in place before and during the injection to prevent injuries. ask your healthcare provider to show you how to: - hold the young child firmly in place (restrain). - with 1 hand, quickly twist the yellow cap off the epinephrine injection, 0.3 mg auto-injector or the green cap off the epinephrine injection, 0.15 mg auto-injector in the direction of the “twist arrow” to remove it. - grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. - with your other hand, pull off the blue safety release. - if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. talk to your healthcare provider about all your medical conditions. common side effects of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg include: - fast, irregular or “pounding” heartbeat - sweating - headache - weakness - shakiness - paleness - feelings of over excitement, nervousness or anxiety - dizziness - nausea or vomiting - breathing problems these side effects may go away with rest. tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? - store epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg at room temperature between 68° to 77°f (20° to 25°c). - protect from light. - do not expose to extreme cold or heat. for example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer. - examine the contents in the clear window of your auto-injector periodically. the solution should be clear. if the solution is discolored (pinkish or darker than slightly yellow) or contains solid particles, replace the unit. - always protect your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) from damage and water. - the blue safety release helps to prevent accidental injection. keep the blue safety release on until you need to use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. - your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg has an expiration date. replace it before the expiration date. throw away (dispose of) expired, unwanted, or unused epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg in an fda-cleared sharps disposal container. do not throw away the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal visit the fda’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines. - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal visit the fda’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines. keep epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg and all medicines out of the reach of children. general information about the safe and effective use of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for a condition for which it was not prescribed. do not give your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to other people. this patient information leaflet summarizes the most important information about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg that is written for health professionals. for more information and video instructions on the use of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg go to www.tevaepinephrine.com or call 1-888-838-2872. what are the ingredients in epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? active ingredients : epinephrine inactive ingredients: sodium chloride, sodium metabisulfite, sodium tartrate (dihydrate), hydrochloric acid, and water important information - the epinephrine injection, 0.3 mg (auto-injector) has a yellow colored label. - the epinephrine injection, 0.15 mg (auto-injector) has a green colored label. - the epinephrine injection trainer has a grey color and contains no medicine and no needle. - your auto-injector is designed to work through clothing. - the blue safety release on the epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) helps to prevent accidental injection of the device. do not remove the blue safety release until you are ready to use it. - choking hazard: the blue safety release is a small part that may become a choking hazard for children. throw away the blue safety release immediately after using epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injector. - only inject into the middle of the outer thigh (upper leg). never inject into any other part of the body. - never put your thumb, fingers, or your hand over the orange tip. the needle comes out of the orange tip. - if an accidental injection happens, get emergency medical help right away. instructions for use epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml for allergic emergencies (anaphylaxis) read this instructions for use carefully before you use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. before you need to use your single-dose epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg auto-injector, make sure your healthcare provider shows you the right way to use it. parents, caregivers, and others who may be in a position to administer epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) should also understand how to use it as well. if you have any questions, ask your healthcare provider. your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) a dose of epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg requires 3 steps: prepare, administer and get emergency medical help step 1. prepare epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for injection quickly twist the yellow cap off the epinephrine injection, 0.3 mg auto-injector or the green cap off the epinephrine injection, 0.15 mg auto-injector in the direction of the “twist arrow” to remove it. [ppi ifu image 2] grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. with your other hand, pull off the blue safety release. important: the blue safety release is a small part that may become a choking hazard for children. throw away the blue safety release immediately after using epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. note: the needle comes out of the orange tip. to avoid an accidental injection, never put your thumb, fingers or hand over the orange tip. if an accidental injection happens, get emergency medical help right away. step 2. administer epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if you are administering epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to a young child, hold the leg firmly in place while administering an injection. [1] place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. swing and push the auto-injector firmly until it ‘clicks’. the click signals that the injection has started. [1] hold firmly in place for 3 seconds (count slowly 1,2,3). the injection is now complete. [1] remove the auto-injector from the thigh. the orange tip will extend to cover the needle. if the needle is still visible, do not attempt to reuse it. [1] massage the injection area for 10 seconds. step 3. get emergency medical help now. you may need further medical attention. you may need to use a second epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) if symptoms continue or recur. take your used auto-injector with you when you go to see a healthcare provider. tell the healthcare provider that you have received an injection of epinephrine. show the healthcare provider where you received the injection. give your used epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) to the healthcare provider for inspection and proper disposal. ask for a refill, if needed. note: keep the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors away from young children. the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors and epinephrine injection trainer are not toys. for young children, use of the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors should be supervised by an adult. a carrying tube is not provided as seen with other products. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are single-dose injectable devices that deliver a fixed dose of epinephrine. the auto-injector cannot be reused. do not attempt to reuse epinephrine injection after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle tip is extended and the window is blocked. your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) may come packaged with an epinephrine injection trainer and separate epinephrine injection trainer instructions for use. the epinephrine injection trainer has a grey color. the grey epinephrine injection trainer contains no medicine and no needle. practice with your epinephrine injection trainer, but always carry your real epinephrine injection, 0.3 mg auto-injector or epinephrine injection, 0.15 mg auto-injector in case of an allergic emergency. if you are administering epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to a young child, ask your healthcare provider to show you how to (1) hold the young child firmly in place (restrain), (2) with 1 hand, quickly twist the yellow cap off the epinephrine injection, 0.3 mg (auto-injector) or the green cap off the epinephrine injection, 0.15 mg (auto-injector) in the direction of the “twist arrow” to remove it, (3) grasp the auto-injector in your fist with the orange tip (needle end) pointing downward and (4) with your other hand, pull off the blue safety release, and how to properly hold the leg in place while administering a dose. do not try to take the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) apart. this patient information and instructions for use have been approved by the u.s. food and drug administration. keep this and all medications out of the reach of children. epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml tevaepinephrine.com register your epinephrine injection 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) at www.tevaepinephrine.com and find out more about: free epinephrine injection auto-injector refill reminder program. it is important to keep your auto-injector up-to-date. register up to 6 epinephrine injection 0.3 mg (auto-injectors) or epinephrine injection 0.15 mg (auto-injectors) and receive automatic refill reminder alerts. receive periodic information related to allergies and allergens. instructional video for more information about epinephrine injection 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) and proper use of the products, call teva at 1-888-838-2872 or visit www.tevaepinephrine.com. epinephrine injection trainer instructions for use in an emergency: do not use the grey trainer. use your real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector. important information the trainer label has a grey color. the trainer contains no medicine and no needle. keep the grey trainer away from young children. the trainer is not a toy. young children should only practice with the trainer under adult supervision. periodically practice with the grey trainer before an allergic emergency (anaphylaxis) happens to make sure you are able to safely use the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector in case of an emergency. always carry your real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector in case of an allergic emergency. small parts like the blue safety release may become a choking hazard for children. put the blue safety release back on the trainer and reset it immediately after practicing. the epinephrine injection trainer familiarize yourself with this grey trainer. practice until you are comfortable using it. your grey trainer: [trainer-ifu image] • never put your thumb, other fingers, or hand over the orange tip (below grey safety cap). • the orange tip is where the needle comes out of your epinephrine injection 0.3 mg auto-injector or epinephrine injection 0.15 mg auto-injector. practice instructions [1] 1 prepare the trainer for simulated injection grasp the grey trainer in your fist with the orange tip pointing downward and twist off grey cap in the direction of “twist arrow”. with your other hand, pull off blue safety release. removing the blue safety release unlocks the trainer. 2 administer the trainer simulation if practicing with a young child, hold the leg firmly in place while using the epinephrine injection trainer. ask your healthcare provider to show you how to: 1. hold the young child firmly in place (restrain). 2. with 1 hand, quickly twist the grey cap off the epinephrine injection trainer in the direction of the “twist arrow” to remove it. 3. grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. 4. with your other hand, pull off the blue safety release, and how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens. [1] [1] place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. swing and push the trainer firmly until it ‘clicks’. the click signals that the injection has started. hold firmly in place for 3 seconds (count slowly 1,2,3). remove the trainer from the thigh and massage the injection area for 10 seconds. the orange tip automatically extends out after use. note: in an actual emergency, you would need to seek emergency medical help right away. the actual auto-injector is made to work through clothing. do not inject into any other part of the body. [1] 3 to reset the trainer note: with the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others. practice session information in case of an allergic emergency, use the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector and not the grey trainer. follow instructions above. repeat as often as needed until you are able to self-inject quickly and correctly. reread: the trainer instructions for use the “patient information” that comes with your epinephrine injection 0.3 mg auto-injector or epinephrine injection 0.15 mg auto-injector train others who could help you in an emergency: • your parents, caregivers, and others who may be in a position to administer epinephrine injection 0.3 mg or epinephrine injection 0.15 mg should know how to help you during an allergic emergency (anaphylaxis). before an emergency occurs, have them: practice activating the trainer read these trainer instructions and the “patient information” for more information about the epinephrine injection 0.3 mg auto-injector and epinephrine injection 0.15 mg auto-injector and the proper use of the products, go to www.tevaepinephrine.com. caution: important differences between the trainer and your real yellow epinephrine injection 0.3 mg (auto-injector) or real green epinephrine injection 0.15 mg (auto-injector) [1] [0.3 mg injector] [0.15 mg injector] trainer (grey) epinephrine injection 0.3 mg (yellow) epinephrine injection 0.15 mg (green) contains medicine? no yes yes has needle? no yes yes comes in carrier tube? no no no color of label grey yellow green has expiration date? no yes yes can be reused? yes no (use only one time) no (use only one time) okay to remove and replace cap and/or safety release? yes no (remove just one time before use) no (remove just one time before use) pressure needed to hold against thigh? moderate strong strong this trainer instructions for use has been approved by the u.s. food and drug administration. keep this and all medications out of the reach of children. repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-8762 put the blue safety release back on the trainer.

Malaizija - anglų - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Malaizija - anglų - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Izraelis - anglų - Ministry of Health

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