United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

n/a -

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosuppressants - please refer to section 4.1 of the summary of product characteristics in the product information document. ,

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - evolocumab, quantity: 420 mg - injection, solution - excipient ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections - repatha is indicated as an adjunct to diet and exercise in:,prevention of cardiovascular events,repatha is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see clinical trials).,primary hypercholesterolaemia,repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.,homozygous familial hypercholesterolaemia,repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - adalimumab, quantity: 20 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

United States - English - NLM (National Library of Medicine)

amgen usa inc. - evolocumab (unii: lkc0u3a8nj) (evolocumab - unii:lkc0u3a8nj) - repatha is indicated: - in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 10 years and older with hefh, to reduce ldl-c - as an adjunct to other ldl-c-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh), to reduce ldl-c repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in repatha. serious hypersensitivity reactions including angioedema have occurred in patients treated with repatha [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on repatha use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. in a similar study with another drug in the pcsk9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. the exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. no assessment for immune suppression was conducted with evolocumab in infant monkeys. measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other igg antibodies, crosses the placental barrier. monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, evolocumab has the potential to be transmitted from the mother to the developing fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. 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. there is a pregnancy safety study for repatha. if repatha is administered during pregnancy, healthcare providers should report repatha exposure by contacting amgen at 1-800-77-amgen (1-800-772-6436) or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting. data animal data in cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma auc. no test of humoral immunity in infant monkeys was conducted with evolocumab. risk summary there is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. human igg is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for repatha and any potential adverse effects on the breastfed infant from repatha or from the underlying maternal condition. the safety and effectiveness of repatha in combination with diet and other ldl-c-lowering therapies for the treatment of hofh have been established in pediatric patients aged 10 years and older. use of repatha for this indication is supported by evidence from an adequate and well-controlled trial in adults and pediatric patients aged 13 years and older with hofh (including 7 pediatric patients treated with repatha) and from open-label studies which included an additional 19 pediatric patients aged 11 years and older with hofh not previously treated with repatha [ see adverse reactions (6.1) and clinical studies (14)]. the safety and effectiveness of repatha as an adjunct to diet and other ldl-c-lowering therapies for the treatment of hefh have been established in pediatric patients aged 10 years and older. use of repatha for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with hefh. in the trial, 104 patients received repatha 420 mg subcutaneously once monthly and 53 patients received placebo; 39 patients (25%) were 10 to 11 years of age [see adverse reactions (6.1) and clinical studies (14)] . the safety and effectiveness of repatha have not been established in pediatric patients with hefh or hofh who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia. in controlled trials, 7656 (41%) patients treated with repatha were ≥ 65 years old and 1500 (8%) were ≥ 75 years old. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed in patients with renal impairment [see clinical pharmacology (12.3)]. no dose adjustment is needed in patients with mild to moderate hepatic impairment (child-pugh a or b). no data are available in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . - it is important that you do not try to give yourself the injection unless you have received training from your healthcare provider. - children who are 10 to 17 years of age should use the on-body infusor and prefilled cartridge under adult supervision, as instructed by the healthcare provider. - keep the on-body infusor and prefilled cartridge in the original carton to protect from light or physical damage. - the on-body infusor and prefilled cartridge must be kept in the refrigerator 36°f to 46°f (2°c to 8°c). - for your injection, take your on-body infusor and prefilled cartridge out of the refrigerator and let them sit at room temperature for at least 45 minutes before you inject. - after you remove the on-body infusor and prefilled cartridge from the refrigerator, they should be kept at room temperature at 68°f to 77°f (20°c to 25°c) in the original carton and must be used within 30 days. - do not store the on-body infusor and prefilled cartridge in temperatures above 77°f (25°c) such as in your vehicle's glove box or trunk. do not freeze. - do not shake the on-body infusor or prefilled cartridge. - do not remove the on-body infusor and prefilled cartridge from the box or clear tray until you are ready to inject. - do not touch the start button until you place the loaded on-body infusor and prefilled cartridge onto your skin and are ready to inject. - after you insert the cartridge into the on-body infusor, make sure you give your injection within 5 minutes. waiting longer than 5 minutes can dry out the medicine. - you can only press the start button 1 time. if an error occurs, the on-body infusor cannot be used. - do not use the on-body infusor and prefilled cartridge if either has been dropped onto a hard surface. part of the on-body infusor and prefilled cartridge may be broken even if you cannot see the break. use a new on-body infusor and prefilled cartridge. - do not reuse the on-body infusor and prefilled cartridge. the on-body infusor and prefilled cartridge are for single-dose only. - do not let the on-body infusor get wet from water or any other liquids. it contains electronics that should not get wet. - the single-dose on-body infusor for subcutaneous injection is made to only be used with the prefilled cartridge. - moderate physical activities can be done during the injection process, such as walking, reaching and bending. - do not use the on-body infusor and prefilled cartridge after the expiration date on the carton. - the on-body infusor and prefilled cartridge are not made with natural rubber latex. - do not try to warm the prefilled cartridge by using a heat source such as hot water or a microwave. - do not touch the start button until the on-body infusor is on the skin and you are ready to inject. - do not use if the white paper cover is missing or damaged. - clear tray containing the on-body infusor and prefilled cartridge - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container - your thigh - stomach area (abdomen), except for a two -inch area right around your navel - outer area of upper arm (only if someone else is giving the injection) - do not touch this area again before injecting. - do not inject into areas where the skin is tender, bruised, red or hard. avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair. - do not use if the medicine is cloudy or discolored or contains flakes or particles. - do not use if any part of the cartridge looks cracked or broken. - do not use if pieces of the cartridge are missing or not securely attached. - do not remove or rotate the cartridge top or bottom. - do not touch the bottom of the cartridge after cleaning with alcohol wipe. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not close the door if the cartridge is missing or not fully inserted. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not pull the skin adhesive backing off the on-body infusor. - do not touch the skin adhesive. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not touch the needle cover area. - do not place the loaded on-body infusor on your body if the red status light flashes continuously. - do not fold the skin adhesive over onto itself. - do not move the loaded on-body infusor after it has been placed onto your skin. - you may hear a pumping sound. - you may feel a pinch. - make sure you see a green, flashing status light. - you may hear beeps that mean your injection has started. - the status light changes to solid green . - you hear several beeps. - the plunger fills medicine window all the way. - the used on-body infusor will beep when removed from your skin. - it is normal to see a few drops of fluid on your skin after you remove the used on-body infusor. - the on-body infusor contains batteries, electronics, and a needle. - put the used on-body infusor in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the on-body infusor in your 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. - do not recycle the on-body infusor or sharps disposal container or throw them into household trash. manufactured by : amgen inc. one amgen center drive thousand oaks, ca 91320-1799 © 2015-2021 amgen inc. all rights reserved. revised: 9/2021 v8 u.s. license number 1080 this instructions for use contains information on how to inject repatha. - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - the orange cap on the repatha sureclick autoinjector contains a needle cover (located inside the cap) that contains dry natural rubber, which is made from latex. tell your healthcare provider if you are allergic to latex. - keep the autoinjector and all medicines out of the reach of children. - keep the autoinjector in the original carton to protect from light. - keep the autoinjector in the refrigerator at 36°f to 46°f (2°c to 8°c). - after removing from the refrigerator, the autoinjector may be kept at room temperature between 68°f to 77°f (20°c to 25°c) and must be used within 30 days. - throw away repatha that has been stored at room temperature for more than 30 days. - do not store the autoinjector in extreme heat or cold. for example, avoid storing the autoinjector in your vehicle's glove box or trunk. - do not freeze or use the autoinjector if it has been frozen. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the orange cap from the autoinjector until you are ready to inject. leaving the cap off for more than 5 minutes can dry out the medicine. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector and call 1-844-repatha (1-844-737-2842). - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not leave the autoinjector in direct sunlight. - do not shake the autoinjector. - do not remove the orange cap from the autoinjector yet. - do not use the autoinjector if the medicine is cloudy or discolored or contains flakes or particles. - do not use the autoinjector if any part appears cracked or broken. - do not use the autoinjector if the autoinjector has been dropped. - do not use the autoinjector if the orange cap is missing or not securely attached. - do not use the autoinjector if the expiration date printed on the label has passed. - new autoinjector - alcohol wipes - cotton balls or gauze pads - adhesive bandages - sharps disposal container (see step 4: finish ) - thigh - stomach (abdomen), except for a 2 inch area around your navel (belly button) - outer area of upper arm (only if someone else is giving you the injection) - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you want to use the same injection site, make sure it is not the same spot you used for the last injection. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not twist, bend, or wiggle the orange cap. - do not put the orange cap back onto the autoinjector. - do not put fingers into the yellow safety guard. - do not remove the orange cap from the autoinjector until you are ready to inject. - 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. - do not reuse the autoinjector. - do not recap the autoinjector or put fingers into the yellow safety guard. manufactured by: amgen inc. one amgen center drive thousand oaks, ca 91320-1799 u.s. license no: 1080 © 2015-2022 amgen inc. all rights reserved. revised: 8/2022 v9 this printed material is recyclable. - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - the gray needle cap on the repatha prefilled syringe contains dry natural rubber, which is made from latex. tell your healthcare provider if you are allergic to latex. - keep the repatha prefilled syringe in the original carton to protect from light during storage. - keep the repatha prefilled syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - if removed from the refrigerator, the repatha prefilled syringe should be kept at room temperature at 68°f to 77°f (20°c to 25°c) in the original carton and must be used within 30 days. - do not freeze the repatha prefilled syringe or use a repatha prefilled syringe that has been frozen. - do not use the repatha prefilled syringe if the packaging is open or damaged. - do not remove the gray needle cap from the repatha prefilled syringe until you are ready to inject. - do not use the repatha prefilled syringe if it has been dropped onto a hard surface. part of the repatha prefilled syringe may be broken even if you cannot see the break. use a new repatha prefilled syringe and call 1-844-repatha (1-844-737-2842). - do not use the repatha prefilled syringe after the expiration date. - 1 repatha prefilled syringe in carton - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container (see step 4: finish) check the expiration date on the repatha prefilled syringe carton: do not use if this date has passed. - thigh - stomach (abdomen), except for a two inch area around your belly button - peel paper off of tray. - place the tray on your hand. - turn the tray over and gently press the middle of the tray's back to release the syringe into your palm. - if prefilled syringe does not release from tray, gently press on back of tray do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap. this could damage the syringe. do not remove the gray needle cap from the prefilled syringe until you are ready to inject. always hold the prefilled syringe by the syringe barrel. - the name repatha appears on the prefilled syringe label. - the medicine in the prefilled syringe is clear and colorless to slightly yellow. - the expiration date on the prefilled syringe has not passed. if the expiration date has passed, do not use the prefilled syringe. do not use the prefilled syringe if any part of the prefilled syringe appears cracked or broken. do not use the prefilled syringe if the gray needle cap is missing or not securely attached. do not use the prefilled syringe if the medicine is cloudy or discolored or contains particles. - put the used syringe in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the syringe in your 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. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. thousand oaks, ca 91320-1799 © 2015-2016, 2021 amgen inc. all rights reserved. issued: 5/2021 v3

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

royce pharma manufacturing sdn. bhd. - dicyclomine hydrochloride; polymethylsiloxane,activated/simethicone -

United States - English - NLM (National Library of Medicine)

amgen inc - evolocumab (unii: lkc0u3a8nj) (evolocumab - unii:lkc0u3a8nj) - evolocumab 140 mg in 1 ml - repatha is indicated: - in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 10 years and older with hefh, to reduce ldl-c - as an adjunct to other ldl-c-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh), to reduce ldl-c repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in repatha. serious hypersensitivity reactions including angioedema have occurred in patients treated with repatha [see warnings and precautions (5.1)]. risk summary available data fr

Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - general hospital - the device is designed to provide automated peritoneal dialysis therapy.