Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - isoleucine; leucine ; lysine monohydrate; methionine; phenylalanine; threonine; tryptophan; valine; arginine ; histidine; alanine; aspartic acid; glutamic acid ; glycine; proline; serine; glucose monohydrate; triglycerides medium-chain ; soya bean oil, refined ph. eur.; omega-3-acid triglycerides - emulsion for infusion - 0 millilitre(s) - solutions for parenteral nutrition; combinations

Կանադա - անգլերեն - Health Canada

hospira healthcare ulc - safflower oil; soybean oil; egg phospholipids - emulsion - 10%; 10%; 1.2% - safflower oil 10%; soybean oil 10%; egg phospholipids 1.2% - caloric agents

Կանադա - անգլերեն - Health Canada

hospira healthcare ulc - soybean oil; egg phospholipids; safflower oil - emulsion - 5%; 0.9%; 5% - soybean oil 5%; egg phospholipids 0.9%; safflower oil 5% - caloric agents

Կանադա - անգլերեն - Health Canada

hospira healthcare ulc - safflower oil; soybean oil; egg phospholipids - emulsion - 5.0g; 5.0g; 700mg - safflower oil 5.0g; soybean oil 5.0g; egg phospholipids 700mg - caloric agents

Կանադա - անգլերեն - Health Canada

hospira healthcare ulc - soybean oil; egg phospholipids - emulsion - 100mg; 12mg - soybean oil 100mg; egg phospholipids 12mg - caloric agents

Կանադա - անգլերեն - Health Canada

hospira healthcare ulc - soybean oil; egg phospholipids - emulsion - 200mg; 12mg - soybean oil 200mg; egg phospholipids 12mg - caloric agents

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

proficient rx lp - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 750 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tabletsshould be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see micr

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 50 mg in 10 ml - oxaliplatin for injection, usp, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin for injection, usp should not be administered to patients with a history of known allergy to oxaliplatin for injection, usp or other platinum compounds [see warnings and precautions (5.1)] . pregnancy category d based on direct interaction with dna, oxaliplatin for injection may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of oxaliplatin for injection in pregnant women. reproductive toxicity studies in rats demonstrated adverse effects on fertility and embryo-fetal development at maternal doses that were below the recommended human dose based on body surface area. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the pati

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - omalizumab (unii: 2p471x1z11) (omalizumab - unii:2p471x1z11) - omalizumab 202.5 mg in 1.4 ml - xolair is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. limitations of use: xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. xolair is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (crswnp) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. xolair is indicated for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with ige-mediated food allergy. xolair is to be used in conjunction with food allergen avoidance. limitations of use: xolair is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. xolair is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment. limitations of use: xolair is not indicated for treatment of other forms of urticaria. xolair is contraindicated in patients with severe hypersensitivity reaction to xolair or any ingredient of xolair [see warnings and precautions (5.1)] . risk summary a registry study of xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [see data] . there are risks associated with poorly or moderately controlled asthma in pregnancy [see clinical considerations ] . human igg antibodies are known to cross the placental barrier; therefore, xolair may be transmitted from the mother to the developing fetus. in animal reproduction studies, no evidence of fetal harm was observed in cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (mrhd) [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us 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/or embryo/fetal risk in women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. the level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. data human data a prospective cohort pregnancy exposure registry study conducted in the us from 2006 to 2018, included 250 pregnant women with asthma treated with xolair. of these, 246 patients were exposed to xolair in the first trimester of pregnancy, and the median exposure duration was 8.7 months. the registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to xolair) identified from healthcare databases of residents in the canadian province of quebec, and referred to as the quebec external comparator cohort ("comparator cohort"). among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%). among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. there was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. the registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort. animal data reproductive studies have been performed in cynomolgus monkeys. there was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the mrhd (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing. risk summary there is no information regarding the presence of omalizumab in human milk, or the effects on milk production. however, omalizumab is a human monoclonal antibody (igg1 kappa), and immunoglobulin (igg) is present in human milk in small amounts. the majority of infants (80.9%, 186/230) in the pregnancy exposure registry were breastfed. events categorized as "infections and infestations" were not significantly increased in infants who were exposed to xolair through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure to xolair. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition. asthma safety and effectiveness of xolair for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. use of xolair for this indication is supported by evidence from adequate and well-controlled studies. xolair was evaluated in 2 trials in 926 (xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. one trial was a pivotal trial of similar design and conduct to that of adult and adolescent asthma trials 1 and 2. the other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. in the pivotal trial, xolair-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ics dose) [see clinical studies (14.1)] . safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. chronic rhinosinusitis with nasal polyps safety and effectiveness in pediatric patients with chronic rhinosinusitis with nasal polyps (crswnp) below 18 years of age have not been established. ige-mediated food allergy the safety and effectiveness of xolair for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with ige-mediated food allergy. use of xolair for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. a significantly greater percentage of xolair-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose- limiting symptoms [see clinical studies (14.3)]. safety and effectiveness in pediatric patients with ige-mediated food allergy below 1 year of age have not been established. chronic spontaneous urticaria the safety and effectiveness of xolair for chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment have been established in pediatric patients aged 12 years and older. use of xolair in this population is supported by evidence from adequate and well-controlled studies. adolescent patients with csu were evaluated in 39 patients 12 to 17 years of age (xolair 29, placebo 10) included in three randomized, placebo-controlled csu trials. a numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. safety and effectiveness in pediatric patients with csu below 12 years of age have not been established. in clinical studies, 134 asthma patients, 20 crswnp patients, 37 csu patients and no ige-mediated food allergy patients 65 years of age or older were treated with xolair. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. - xolair prefilled syringes (you may need more than 1 prefilled syringe for your prescribed dose). see "choose the correct prefilled syringe or combination of prefilled syringes" for more information. each xolair carton contains 1 prefilled syringe. - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14 "after the injection" ) choose the correct prefilled syringe or combination of prefilled syringes xolair prefilled syringes are available in 2 dose strengths. these instructions are to be used for both dose strengths. your prescribed dose may require more than 1 injection. the table below shows the combination of prefilled syringes needed to give your full dose. check the label on the xolair carton to make sure you have received the correct prefilled syringe or combination of prefilled syringes for your prescribed dose. if your dose requires more than 1 injection, inject the medicine from all of your prescribed prefilled syringes, immediately one after another. contact your healthcare provider if you have any questions. - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not exceed 2 days. if the prefilled syringe is exposed to temperatures above 77 °f (25 °c), do not use it and throw away in a sharps disposal container. - keep your xolair prefilled syringes out of direct sunlight. - do not freeze. do not use if the prefilled syringe has been frozen. - the needle cap contains a type of natural rubber latex. tell your healthcare provider if you have a latex allergy. - do not open the sealed carton until you are ready to inject xolair. - do not take the needle cap off until you are ready to inject xolair. - do not try to take the prefilled syringe apart at any time. - do not reuse the same prefilled syringe. - do not leave the prefilled syringe unattended. - if your dose requires you to give more than 1 injection, take all cartons out of the refrigerator at the same time. the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. this may damage the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe. when holding the prefilled syringe, make sure you always hold the prefilled syringe as shown. do not touch the needle-shield wings (see "prefilled syringe parts" ). - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine in the prefilled syringe should be clear and colorless to pale brownish-yellow. do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - do not use if the packaging or prefilled syringe appears damaged, tampered with, or has been dropped. - if you are giving yourself the injection, you can inject into the front and middle of the thighs and the stomach area (abdomen). the outer area of the upper arms may also be used if the injection is being given by a caregiver. do not try to inject into the upper arm area by yourself. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be exposed, clean skin. - if your prescribed dose requires more than 1 injection, choose a different injection site for each new injection, at least 1 inch from other injection sites. - do not touch the injection site again before giving the injection. - do not fan or blow on the cleaned skin. - do not twist the needle cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - throw away the needle cap in regular household trash. do not recap the needle. - there may be 1 or more small air bubbles in the prefilled syringe. this is normal, and you should not try to remove the air bubbles. - you may also see a drop of liquid at the end of the needle. this is also normal and will not affect the dose. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - do not insert the needle through clothing. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - you must press the plunger all the way down to make sure that the full dose of medicine gets injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - if needed, cover the injection site with a small bandage. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - choose a different injection site for each new injection at least 1 inch from other injection sites. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. 14 throw away (dispose of) your used xolair prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away prefilled syringes in your household trash. - do not recap the needle. - 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 prefilled 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. prefilled syringe parts - xolair prefilled syringe . - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14) - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the prefilled syringe is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - keep your prefilled syringes out of direct light. - do not freeze. do not use if the prefilled syringe has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the prefilled syringe is damaged or appears to be tampered with. - do not take the needle cap off until you are ready to inject. - do not use if the prefilled syringe has been dropped on a hard surface or dropped after removing the needle cap. - do not try to take apart the prefilled syringe at any time. - if you need more than 1 prefilled syringe to deliver your full dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 prefilled syringe). the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe, as shown. - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine inside should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. do not try to remove the air bubbles. - do not use the prefilled syringe if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - do not use if the prefilled syringe appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh, or the stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the prefilled syringe firmly with 1 hand and pull the needle cap straight off with your other hand as shown. do not twist the cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - do not put the cap back on the prefilled syringe. throw away the needle cap in regular household trash. - you may see a drop of liquid at the end of the needle. this is normal. - use your other hand and gently pinch the area of skin that was cleaned. hold the pinched skin tightly until the injection is complete. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - while holding the prefilled syringe by the center, insert the needle all the way into the pinched skin at an angle of about 45 degrees as shown. - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - gently push the plunger all the way down until the plunger head is between the safety guard wings as shown. - you must press the plunger all the way down to make sure that the full dose of medicine is injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - release the plunger and allow the needle to be covered by the needle-shield. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - there may be a little bleeding or drop of liquid at the injection site. you can press a cotton ball or gauze over the injection site until the bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away the prefilled syringes in your household trash. - do not recap the needle. - 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 prefilled 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. - xolair autoinjector - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 15 ) - keep your unused autoinjectors in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the autoinjector is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - do not remove the autoinjector from its original carton during storage. - keep your autoinjectors out of direct light. - do not freeze. do not use if the autoinjector has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the autoinjector has been damaged or appears to be tampered with. - do not take the cap off the autoinjector until you are ready to inject. - do not use if the autoinjector has been dropped on a hard surface or dropped after removing the needle cap. - do not take apart the autoinjector at any time. - do not clean or touch the needle guard. - if you need more than 1 autoinjector to deliver your prescribed dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 autoinjector). the following steps must be followed for each autoinjector. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the autoinjector can warm up on its own to room temperature. leave the autoinjector in the carton to protect it from light. - if the autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the autoinjector out of the carton as shown. - do not turn the carton upside down to take out the autoinjector, as this may damage the autoinjector. - do not hold the autoinjector by the cap. make sure you hold the autoinjector by the middle as shown. - do not remove the cap until you are ready to inject. - look through the viewing window of the autoinjector. the medicine in the autoinjector viewing window should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. - do not use the autoinjector if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the autoinjector. do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if it appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh or stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the autoinjector firmly with 1 hand and pull the cap straight off with your other hand as shown. do not twist the cap. - do not put the cap back on the autoinjector. throw away the cap in regular household trash. - do not clean or touch the needle guard of the device. - hold the autoinjector comfortably with the needle guard directly against the skin. - the autoinjector should be at a 90-degree angle against the skin, as shown. - press straight down and hold the autoinjector firmly against the skin. the 1st click indicates that the injection has started. - hold the autoinjector tightly in place. do not change the angle of injection or remove the autoinjector until the injection is completed. - keep holding the autoinjector against the skin. the green indicator will move within the viewing window. - listen for the 2nd click . this indicates that the injection is almost complete. - hold the autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete. - after the green indicator has stopped moving and has completely filled the viewing window, lift the autoinjector straight up from the skin. the needle guard will automatically extend and lock over the needle. - if the green indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist. - do not rub the injection site. - there may be a little bleeding or a drop of liquid at the injection site. you can press a cotton ball or gauze pad over the injection site until any bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used autoinjector as described in step 15 . - repeat step 2 through step 14 for the next injection using a new autoinjector. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used autoinjectors in an fda-cleared sharps disposal container right away after use. - the xolair autoinjector is a single-dose autoinjector and should not be used again. - do not throw away (dispose of) the autoinjectors in your household trash. - do not recap the autoinjector. - 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 autoinjectors. 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.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - abatacept (unii: 7d0yb67s97) (abatacept - unii:7d0yb67s97) - abatacept 250 mg in 15 ml - orencia® is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra). orencia is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pjia). orencia is indicated for the treatment of patients 2 years of age and older with active psoriatic arthritis (psa). orencia is indicated for the prophylaxis of acute graft versus host disease (agvhd), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (hsct) from a matched or 1 allele-mismatched unrelated-donor. the concomitant use of orencia with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bdmards), janus kinase (jak) inhibitors] is not recommended. none. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to orencia during pregnancy. healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972. the data with orencia use in pregnant women are insufficient to inform on drug-associated risk. however, there are clinical considerations for administering live vaccines to infants who were exposed to orencia while in utero (see clinical considerations) . in reproductive toxicology studies in rats and rabbits, no fetal malformations were observed with intravenous administration of orencia during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (mrhd) of 10 mg/kg/month on an auc basis. however, in a pre- and postnatal development study in rats, orencia altered immune function in female rats at 11 times the mrhd on an auc basis. infants and administration of live vaccines it is unknown if abatacept can cross the placenta into the fetus when a woman is treated with orencia during pregnancy. abatacept is an immunomodulatory agent. it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. risks and benefits should be considered prior to vaccinating such infants [see warnings and precautions (5.4)] . there are no adequate and well-controlled studies of orencia use in pregnant women. the data with orencia use in pregnant women are insufficient to inform on drug-associated risk. intravenous administration of abatacept during organogenesis to mice (10, 55, or 300 mg/kg/day), rats (10, 45, or 200 mg/kg/day), and rabbits (10, 45, or 200 mg/kg every 3 days) produced exposures in rats and rabbits that were approximately 29 times the mrhd on an auc basis (at maternal doses of 200 mg/kg/day in rats and rabbits), and no embryotoxicity or fetal malformations were observed in any species. in a study of pre- and postnatal development in rats (10, 45, or 200 mg/kg every 3 days from gestation day 6 through lactation day 21), alterations in immune function in female offspring, consisting of a 9-fold increase in t-cell-dependent antibody response relative to controls on postnatal day (pnd) 56 and thyroiditis in a single female pup on pnd 112, occurred at approximately 11 times the mrhd on an auc basis (at a maternal dose of 200 mg/kg). no adverse effects were observed at approximately 3 times the mrhd (a maternal dose of 45 mg/kg). it is not known if immunologic perturbations in rats are relevant indicators of a risk for development of autoimmune diseases in humans exposed in utero to abatacept. exposure to abatacept in the juvenile rat, which may be more representative of the fetal immune system state in the human, resulted in immune system abnormalities including inflammation of the thyroid and pancreas [see nonclinical toxicology (13.2)] . there is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. however, abatacept was present in the milk of lactating rats dosed with abatacept. polyarticular juvenile idiopathic arthritis the safety and effectiveness of orencia for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pjia) have been established (orencia may be used as monotherapy or concomitantly with methotrexate). use of orencia for this indication is supported by evidence from the following studies: the safety and effectiveness of orencia use in pjia in pediatric patients less than two years of age have not been established. acute graft versus host disease prophylaxis the safety and effectiveness of orencia for the prophylaxis of acute graft versus host disease (agvhd), in combination with a calcineurin inhibitor and methotrexate, in pediatric patients aged 2 years of age and older undergoing hsct from a matched or 1 allele-mismatched unrelated donor have been established. use of orencia for this indication is supported by evidence from: furthermore, the course of disease is sufficiently similar in pediatric patients aged 2 years to less than 6 years to that of patients aged 6 years and older to allow extrapolation of data to younger pediatric patients [see clinical pharmacology (12.3) and clinical studies (14.4)] . no new safety signals were observed in pediatric patients aged 6 years and older in study gvhd-1. the safety and effectiveness of orencia for this indication have not been established in pediatric patients less than 2 years of age. psoriatic arthritis subcutaneous administration the safety and effectiveness of subcutaneous orencia have been established for treatment of psoriatic arthritis in pediatric patients 2 to 17 years old. use of orencia in this age group is supported by evidence from adequate and well-controlled studies of orencia in adults with psa, pharmacokinetic data from adult patients with ra, adult patients with psa, and pediatric patients with pjia, and safety data from clinical studies in pediatric patients 2 to 17 years old with pjia using the subcutaneous formulation. the observed pre-dose (trough) concentrations are generally comparable between adults with ra and psa and pediatric patients with jia with active polyarthritis, and the pk exposure is expected to be comparable between adult psa and pediatric patients with psa. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2, 14.3)]. the safety and effectiveness of subcutaneous orencia have not been established in pediatric patients less than 2 years old with psoriatic arthritis. intravenous administration the safety and effectiveness of intravenous orencia in pediatric patients with psoriatic arthritis have not been established. a juvenile animal study conducted in rats dosed with abatacept from 4 to 94 days of age (prior to immune system maturity) showed an increase in the incidence of infections leading to death at all doses compared with controls. altered t-cell subsets including increased t-helper cells and reduced t-regulatory cells were observed. in addition, inhibition of t-cell-dependent antibody responses (tdar) was observed. upon following these animals into adulthood, lymphocytic inflammation of the thyroid and pancreatic islets was observed. in contrast, studies in adult mice and monkeys have not demonstrated similar findings. as the immune system of the rat is undeveloped in the first few weeks after birth, the relevance of these results to humans is unknown. rheumatoid arthritis a total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received orencia in clinical studies. no overall differences in safety or effectiveness were observed between geriatric patients (patients aged 65 years of age and older) and younger adults, and other reported clinical experience has not identified differences in responses between geriatric patients and younger adults, but greater sensitivity of some geriatric patients cannot be ruled out. the frequency of serious infection and malignancy among orencia-treated patients over age 65 was higher than for those under age 65. because there is a higher incidence of infections and malignancies in the geriatric population in general, caution should be used when treating geriatric patients. acute graft versus host disease prophylaxis of the 116 patients in study gvhd-1 who received orencia at a dose of 10 mg/kg for the prophylaxis of agvhd, 12 (10%) were 65 years of age and older, and 2 (2%) patients were 75 years of age and older [see clinical studies (14.4)]. clinical studies of orencia for agvhd did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. orencia ® (oh-ren-see-ah) (abatacept) prefilled syringe with bd ultrasafe passive ™ needle guard orencia ® prefilled syringe with bd ultrasafe passive ™ needle guard (abatacept) injection read these instructions before you start using your orencia prefilled syringe and each time you get a refill. there may be new information. before you use the prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it and decides that you or a caregiver may be able to give your injections of orencia at home. important: before you begin: get to know your prefilled syringe there are 3 types of prefilled syringes: the type of prefilled syringe you receive depends on the dose prescribed by your healthcare provider. the 125 mg/ml prefilled syringe is shown below. before use after use the prefilled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection. go to step 1 step 1:  preparing for an orencia injection gather and place supplies for your injection on a clean, flat surface. only the prefilled syringe is included in the package: let your prefilled syringe warm up. remove 1 prefilled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature. wash your hands well with soap and water. go to step 2 step 2: examine the prefilled syringe hold the prefilled syringe by the body with the needle cover pointing down as shown. check the liquid. note : the 50 mg prefilled syringe is shown. note: it is normal to see an air bubble. do not attempt to remove it. go to step 3 step 3:  check the dose on the prefilled syringe hold the syringe at eye level. look closely to make sure that the amount of liquid in the prefilled syringe is at or just above the fill line for your prescribed dose: do not use if your prefilled syringe does not have the correct amount of liquid. call your pharmacist immediately. go to step 4 step 4: choose and prepare an injection site choose your injection site. choose your injection site in either the stomach (abdomen) , front of the thighs , or outer area of upper arm (only if caregiver administered). rotate injection site. gently clean injection site. remove the needle cover by holding the body of the prefilled syringe with one hand and pulling the cover straight off with your other hand. do not put the needle cover back on the needle after you remove it. throw away the needle cover in your household trash. note : it is normal to see a drop of fluid leaving the needle. go to step 5 step 5: inject your dose of orencia hold the body of the prefilled syringe in your hand using your thumb and index finger. with your other hand, pinch the area of skin you cleaned. insert the needle. gently insert the needle into the pinched skin at a 45° angle. complete all steps to deliver your full dose of the medicine. inject: push the plunger with your thumb as far as it will go. release the needle guard: slowly lift your thumb from the plunger to activate the needle guard. confirm: after a complete injection, the needle guard will cover the needle and you may hear a click. remove the prefilled syringe and let go of the pinched skin. go to step 6 step 6: after the injection care of injection site: throwing away (disposing of) used prefilled syringes:         see frequently asked questions for additional throwing away (disposal) information. if your injection is administered by a caregiver, this person must also be careful handling the syringe to prevent accidental needle stick injury and possibly spreading infection. keep the orencia prefilled syringes and the sharps disposal container out of the reach of children. how to store orencia prefilled syringe go to next page frequently asked questions q. why do i need to allow the prefilled syringe to warm up at room temperature for 30 minutes prior to injecting? a. this step is primarily for your comfort. never try to speed up the warming process in any way, like using the microwave or placing the syringe in warm water. q. is it necessary to hold the skin pinch during the entire time i inject the dose? a. you must pinch the skin during needle insertion however, for your comfort you may release the skin pinch as you deliver the injection. q. what if my prefilled syringe appears to be broken or damaged? a. do not use the prefilled syringe. contact your healthcare provider or pharmacist for further instructions. q. what if i cannot clearly see the liquid inside the syringe? a. look at the syringe closely by holding at eye level and up to the light. you may tilt the syringe slowly to get a better view of the drug fluid. if you still have trouble, contact your healthcare provider or pharmacist for further instructions. q. is it normal to feel a little bit of burning or pain during injection? a. you may feel a prick from the needle. sometimes, the medicine can cause slight irritation near the injection site. discomfort should be mild to moderate. if you have any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider. go to next page frequently asked questions q. how should i dispose of a used prefilled syringe? a. place the used prefilled syringe into an fda-cleared sharps disposal container. if you do not have one you may use a household container that is: q. how should i keep my prefilled syringes cool while traveling? a. store them in a cool carrier between 36ºf to 46ºf (2ºc to 8ºc). do not freeze them. keep them in the original carton and protected from light. your healthcare provider may know about special carrying cases. q. can i take my prefilled syringes on an airplane? a. generally, you are allowed to carry your prefilled syringes with you on an airplane. do not put them in your checked luggage. you should carry your prefilled syringes with you in your travel cooler at a temperature of 36ºf to 46ºf (2ºc to 8ºc). keep your prefilled syringes in the original carton, and with its original preprinted labels and protected from light. q. what if my prefilled syringe does not stay cool for an extended period of time? is it dangerous to use? a. contact 1-800-673-6242 for more information. go to back cover if you have questions or concerns about your prefilled syringe, please contact your healthcare provider or call our toll-free help line at 1-800-673-6242. bristol-myers squibb company princeton, nj 08543 usa, u.s. license number 1713 this instructions for use has been approved by the u.s. food and drug administration. orencia is a registered trademark of bristol-myers squibb company. bd ultrasafe passive™ is a trademark of becton, dickinson, and company. revised 10/2023       orencia ® clickject ™ (oh-ren-see-ah) (abatacept) prefilled autoinjector orencia ® clickject ™ (abatacept) injection prefilled autoinjector 125 mg/ml, single-dose autoinjector, for subcutaneous use only read these instructions before you use the clickject autoinjector and each time you get a refill. there may be new information. before you use the autoinjector for the first time, make sure your healthcare provider shows you the right way to use it. important: before you begin: get to know the clickject autoinjector before use after use gather supplies for your injection on a clean, flat surface (only the clickject autoinjector is included in the package): go to step 1 step 1:  prepare your autoinjector let your clickject autoinjector warm up. remove 1 autoinjector from the refrigerator and let it rest at room temperature for 30 minutes . do not remove the autoinjector needle cover while allowing it to reach room temperature. wash your hands well with soap and water. examine the clickject autoinjector: go to step 2     step 2:  prepare for injection                choose your injection site in either the stomach (abdomen) , front of the thighs , or outer area of upper arm (only if caregiver administered). rotate injection site. gently clean injection site: pull orange needle cover straight off. go to step 3     step 3:  inject your dose position the autoinjector so you can see the viewing window and it is at a 90° angle to the injection site. with your other hand, gently pinch the cleaned skin . complete all steps to deliver your full dose of medicine: push down on the skin to unlock the autoinjector. press button, hold for 15 seconds and watch the window. remove the clickject autoinjector from the injection site by lifting it straight up. after you remove it from your skin, the transparent tip will lock over the needle. release the pinched skin. go to step 4     step 4:  after the injection care of injection site: throwing away (disposing of) used clickject autoinjectors:         see frequently asked questions for additional throwing away (disposal) information. if your injection is administered by a caregiver, this person must also handle the autoinjector carefully to prevent accidental needle stick injury and possibly spreading infection. keep autoinjector and the sharps disposal container out of the reach of children. how to store orencia clickject autoinjector continued on next page     frequently asked questions q. why do i need to allow the autoinjector to warm up at room temperature for 30 minutes prior to injecting? a. this step is primarily for your comfort. if the medicine is cold, the injection may take longer than 15 seconds. never try to speed the warming process in any way, like using the microwave or placing the autoinjector in warm water. q. what if i accidentally remove the needle cover (orange cap) before i’m ready to use the autoinjector? a. if you remove the cover before you are ready to use the autoinjector, be careful. do not try to replace it. use the autoinjector as soon as possible. while you prepare for the injection, carefully place the autoinjector on its side on a clean, flat surface. be sure to keep the autoinjector away from children. q. what if the autoinjector appears to be broken or damaged? a. do not use the autoinjector. contact your healthcare provider or pharmacist for further instructions. q. what if the injection was not triggered? a. before the injection can be triggered, the device must be unlocked. to unlock, firmly push the autoinjector down on the skin without touching the button. when the stop-point is felt, the device is unlocked and can be triggered by pushing the button. q. i feel a little bit of burning or pain during injection. is this normal? a. when giving an injection, you may feel a prick from the needle. sometimes, the medicine can cause slight irritation near the injection site. if this occurs, the discomfort should be mild to moderate. if you experience any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider or pharmacist immediately. you are encouraged to report side effects of prescription drugs to the fda. visit www.fda.gov/medwatch or call 1-800-fda-1088. q. how do i know i received my full dose? a. before lifting the autoinjector from the injection site, check to make sure that the blue indicator has stopped moving. then, before throwing away (disposing of) the autoinjector, check the bottom of the transparent viewing window to make sure there is no liquid left inside. if the medicine has not been completely injected, consult your healthcare provider or pharmacist. continued on next page frequently asked questions q. how should i throw away (dispose of) a used autoinjector? a. place used autoinjector into an fda-cleared sharps disposal container right away after use. q. how should i keep my autoinjector cool while traveling? a. your healthcare provider or pharmacist may be familiar with special carrying cases for injectable medicines. store in the refrigerator at 36°f to 46°f (2°c to 8°c). do not freeze. protect from light. q. can i take my autoinjector on board an aircraft? a. generally, this is allowed. be sure to pack your autoinjector in your carry-on, and do not put it in your checked luggage. you should carry it with you in your travel cooler at a temperature of 36°f to 46°f (2°c to 8°c) until you are ready to use it. airport security procedures and airline policies change from time to time, so it’s best to check with airport authorities and the airline for any special rules. prior to flying, get a letter from your healthcare provider to explain that you are traveling with prescription medicine that uses a device with a needle; if you are carrying a sharps container in your carry-on baggage, notify the screener at the airport. q. what if my autoinjector does not stay cool for an extended period of time? is it dangerous to use? a. contact 1-800-673-6242 for details.     if you have questions or concerns about your autoinjector, please contact a healthcare provider or call our toll-free help line at 1-800-673-6242. bristol-myers squibb company princeton, nj 08543 usa, u.s. license number 1713 this instructions for use has been approved by the u.s. food and drug administration. orencia is a registered trademark and clickject is a trademark of bristol-myers squibb company. revised 1/2024