ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 100 mg/ml;  ;  ;   - solution for injection - 80 mg/0.8ml - active: adalimumab 100 mg/ml       excipient: mannitol polysorbate 80 water for injection - rheumatoid arthritis humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 100 mg/ml;  ;  ;   - solution for injection - 80 mg/0.8ml - active: adalimumab 100 mg/ml       excipient: mannitol polysorbate 80 water for injection - rheumatoid arthritis humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab -

ארצות הברית - אנגלית - NLM (National Library of Medicine)

cordavis limited - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - 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 )] . - 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. - 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. - 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 - 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. - 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

קנדה - אנגלית - Health Canada

abbvie corporation - adalimumab - solution - 40mg - adalimumab 40mg - disease-modifying antirheumatic agents

קנדה - אנגלית - Health Canada

abbvie corporation - adalimumab - solution - 40mg - adalimumab 40mg - disease-modifying antirheumatic agents

קנדה - אנגלית - Health Canada

abbvie corporation - adalimumab - solution - 40mg - adalimumab 40mg - disease-modifying antirheumatic agents

קנדה - אנגלית - Health Canada

abbvie corporation - adalimumab - solution - 80mg - adalimumab 80mg - disease-modifying antirheumatic agents

קנדה - אנגלית - Health Canada

abbvie corporation - adalimumab - solution - 80mg - adalimumab 80mg - disease-modifying antirheumatic agents