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

herbal science sdn. bhd. - herba leonurus heterophyllus; fructus quercus infectoria; herba labisia pumila; radix pueraria lobata -

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

amgen inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. amjevita is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning and warnings and precautions (5)] . amjevita is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. amjevita is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data ]. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n = 10) and infant serum (n = 8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amjevita and any potential adverse effects on the breastfed child from amjevita or from the underlying maternal condition. the safety and effectiveness of amjevita have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for amjevita demonstrate that amjevita is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, amjevita is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of amjevita in patients 65 years of age and older. in patients treated with amjevita, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . instructions for use welcome! the amjevita™ sureclick® autoinjector is a single-dose prefilled autoinjector. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita sureclick autoinjector for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using amjevita sureclick autoinjector. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™(am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled sureclick® autoinjector guide to parts important: needle is inside important before you use an amjevita sureclick autoinjector, read this important information: storing your amjevita sureclick autoinjectors - keep the amjevita sureclick autoinjector and all medicines out of the reach of children. - keep the amjevita sureclick autoinjector in the original carton to protect from light or physical damage. - the amjevita sureclick autoinjector should be kept in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, you may store the amjevita sureclick autoinjector at room temperature up to 77°f (25°c) for up to 14 days. throw away amjevita if it has been kept at room temperature and not been used within 14 days. - do not store the amjevita sureclick autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita sureclick autoinjector - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita sureclick autoinjector after the expiration date on the label. - do not shake the amjevita sureclick autoinjector. - do not remove the yellow cap from the amjevita sureclick autoinjector until you are ready to inject. - do not use the amjevita sureclick autoinjector if it has been frozen. - do not use the amjevita sureclick autoinjector if it has been dropped on a hard surface. part of the amjevita sureclick autoinjector may be broken even if you cannot see the break. use a new amjevita sureclick autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the amjevita sureclick autoinjector is not made with natural rubber latex. for more information or help or call 1-800-77-amgen (1-800-772-6436). step 1: prepare a remove 1 amjevita sureclick autoinjector from the package. carefully lift the autoinjector straight up out of the box. put the original package with any unused autoinjectors back in the refrigerator. for a more comfortable injection, leave the autoinjector at room temperature for 15 to 30 minutes before injecting. - do not put the autoinjector back in the refrigerator once it has reached room temperature. - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector yet. b inspect the amjevita sureclick autoinjector. make sure the medicine in the window is clear and colorless to slightly yellow. - do not use the autoinjector if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the autoinjector has been dropped. the yellow cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the autoinjector has been dropped. - the yellow cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). c gather all materials needed for your injection. wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new autoinjector - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d prepare and clean your injection site. you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e pull yellow cap straight off, only when you are ready to inject. it is normal to see a drop of liquid at the end of the needle or yellow safety guard. - do not twist or bend the yellow cap. - do not put the yellow cap back onto the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. f stretch or pinch your injection site to create a firm surface. stretch method stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. pinch method pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin stretched or pinched while injecting. step 3: inject g hold the stretch or pinch. with the yellow cap off, place the autoinjector on your skin at 90 degrees. h firmly push the autoinjector down onto skin until it stops moving. push down important: you must push all the way down but do not touch blue start button until you are ready to inject. i when you are ready to inject, press the blue start button. j keep pushing down on your skin. your injection could take about 10 seconds. window turns yellow when injection is done important: when you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. step 4: finish k discard (throw away) the used autoinjector and the yellow cap. - put the used sureclick autoinjector in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the sureclick autoinjector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of 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 reuse the autoinjector. - 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. important: always keep the sharps disposal container out of the reach of children. l examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. commonly asked questions what will happen if i press the blue start button before i am ready to do the injection on my skin? can i move the autoinjector around on my skin while i am choosing an injection site? can i release the blue start button after i start my injection? will the blue start button pop up after i release my thumb? what do i do if i didn't hear a click after pushing the device down on my skin for 10 seconds? whom do i contact if i need help with the autoinjector or my injection? this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 07/2022 v2 turn over to continue……… welcome! amjevita™ is supplied as a single-dose prefilled syringe. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita prefilled syringe for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using the amjevita prefilled syringe. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled amjevita syringe guide to parts important: the needle is covered by the needle cap before use. important before you use an amjevita prefilled syringe, read this important information: storing your amjevita prefilled syringes - keep the amjevita prefilled syringe and all medicines out of the reach of children. - keep the amjevita prefilled syringe in the original carton to protect from light or physical damage. - the amjevita prefilled syringe should be kept in the refrigerator at 36° f to 46° f (2° c to 8° c). - if needed, you may store the amjevita prefilled syringe at room temperature up to 77° f (25° c) for up to 14 days. throw away amjevita if it has been kept at room temperature and has not been used within 14 days. - do not store the amjevita prefilled syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita prefilled syringe - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita prefilled syringe after the expiration date on the label. - do not shake the amjevita prefilled syringe. - do not remove the needle cap from the amjevita prefilled syringe until you are ready to inject. - do not use the amjevita prefilled syringe if it has been frozen. - do not use the amjevita prefilled syringe if it has been dropped on a hard surface. part of the amjevita prefilled syringe may be broken even if you cannot see the break. use a new amjevita prefilled syringe, and call 1-800-77-amgen (1-800-772-6436). - the amjevita prefilled syringe is not made with natural rubber latex. - for more information or help call 1-800-77-amgen (1-800-772-6436). step 1: prepare a   remove the prefilled syringe carton from the refrigerator. remove the number of amjevita prefilled syringes you need for your injection from the carton. grab the syringe barrel to remove the prefilled syringe from the tray as shown. put the original carton with any unused prefilled syringes back in the refrigerator. for safety reasons: - do not grab the plunger rod. - do not grab the needle cap. - do not remove the needle cap until you are ready to inject. - do not remove the finger flange. the finger flange is part of the syringe. for a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting. - do not put the syringe back in the refrigerator once it has reached room temperature. - do not try to warm the syringe by using a heat source such as hot water or microwave. - do not leave the syringe in direct sunlight. - do not shake the syringe. important: always hold the prefilled syringe by the syringe barrel. b   inspect the amjevita prefilled syringe. always hold the syringe by the syringe barrel. make sure the medicine in the syringe is clear and colorless to slightly yellow. - do not use the syringe if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new syringe, and call 1-800-77-amgen (1-800-772-6436). c   gather all materials needed for your injection(s). wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new syringe(s) - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d   prepare and clean your injection site(s).          you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e   hold the prefilled syringe by the syringe barrel with the needle cap pointing up. carefully pull the needle cap straight off and away from your body when you are ready to inject. it is normal to see a drop of liquid at the end of the needle. - do not twist or bend the needle cap. - do not put the needle cap back onto the syringe. - do not remove the needle cap from the syringe until you are ready to inject. important: throw the needle cap into the sharps disposal container provided. f   pinch your injection site to create a firm surface. pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin pinched while injecting. step 3: inject g   hold the pinch. with the needle cap off, insert the syringe into your skin at 45 to 90 degrees. do not place your finger on the plunger rod while inserting the needle. h   using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. do not pull back the plunger rod while the needle is inserted. i   when done, release your thumb, and gently pull the syringe off of your skin. step 4: finish j   discard (throw away) the used prefilled syringe and the needle cap. do not use any medicine that is left in the used syringe. - put the used amjevita prefilled syringe in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of 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 reuse the syringe. - 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. important: always keep the sharps disposal container out of the reach of children. k   examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. this instructions for use has been approved by the u.s. food and drug administration. manufactured by : amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 7/2022 v2 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) 10 mg/0.2 ml injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that a caregiver may be able to give your injections of amjevita at home, they should receive training on the right way to prepare and inject amjevita. do not try to inject until they have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex.   important: keep the syringe and sharps disposal container out of the sight and reach of children. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com, or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. important: keep the syringe out of the sight and reach of children. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68° f to 77° f (20° c to 25° c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68° f to 77° f (20° c to 25° c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored or has flakes. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at about a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on the injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an 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. disposing of sharps containers: 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. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the us food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 04/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 40 mg/0.4 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - 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 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 10 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an 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. disposing of sharps disposal containers: 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. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 80 mg/0.8 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - 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 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 15 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an 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. disposing of sharps disposal containers: 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. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita dosing: - amjevita comes in 3 different doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml. check your prescription to make sure you have the correct dose. - the color and look of the prefilled syringe will be different for each dose. the amount of medicine in the syringe will also be different for each dose. - for example, it is okay for the 20 mg/0.2 ml dose to have a small amount of medicine and the 80 mg/0.8 ml to have a large amount of medicine. check the illustrations below to see what your dose looks like in the syringe. 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave, or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for the injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an 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. disposing of sharps disposal containers: 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. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023

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

alvogen inc. - amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine aspartate monohydrate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. attention deficit hyperactivity disorder (adhd) a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental eff

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

astellas pharma us, inc. - gilteritinib fumarate (unii: 5rzz0z1gjt) (gilteritinib - unii:66d92mgc8m) - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a fms-like tyrosine kinase 3 (flt3) mutation as detected by an fda-approved test. xospata is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. anaphylactic reactions have been observed in clinical trials [see adverse reactions (6) and description (11)] . risk summary based on findings from animal studies (see data) and its mechanism of action, xospata can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on xospata use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (auc24 ) approximately 0.4 times the auc

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

amgen usa inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of mod

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

corepharma, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine sulfate 1.875 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.

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

zydus pharmaceuticals (usa) inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi) - amphetamine sulfate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.

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

epic pharma, llc - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. in patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions ]. patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and drug interactions ]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have not been studied in the geriatric population. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions ]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, can result in overdose and death [see overdosage ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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

elite laboratories, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years and older. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules administration is contraindicated in patients: - known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions (6.2)] - taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and precautions (5.8) and drug interactions (7.1) ] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermediciations/. risk summary available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see data ). adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy (see clinical considerations ). no apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (mrhd) of 20 mg/day given to adolescents, on a mg/m2 basis. however, in a pre- and post-natal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine.  in addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine.  long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions amphetamines, such as dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, cause vasoconstriction and thereby may decrease placental perfusion. in addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. data animal data amphetamine (d- to l- enantiomer ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. these doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (mrhd) of 20 mg/day given to adolescents, on a mg/m2 basis. fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the mrhd given to adolescents on a mg/m2 basis) or greater to pregnant animals. administration of these doses was also associated with severe maternal toxicity. a study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. these doses are approximately 0.8, 2, and 4 times the mrhd of 20 mg/day given to adolescents, on a mg/m2 basis. all doses caused hyperactivity and decreased weight gain in the dams. a decrease in pup survival was seen at all doses. a decrease in pup body weight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. when pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. a number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically can result in long-term neurochemical and behavioral alterations. reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. risk summary based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk, at relative infant doses of 2 to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. there are no reports of adverse effects on the breastfed infant. long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. it is possible that large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established. because of the potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. the safety and effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules have been established in pediatric patients with adhd 6 years of age and older. the safety and efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in pediatric patients less than 6 years of age have not been established. long-term effects of amphetamines in pediatric patients has not been well established. long-term growth suppression growth should be monitored during treatment with stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.5)]. juvenile animal toxicity data juvenile rats treated with mixed amphetamine salts early in the postnatal period through sexual maturation demonstrated transient changes in motor activity. learning and memory was impaired at approximately 6 times the maximum recommended human dose (mrhd) given to children on a mg/m2 basis. no recovery was seen following a drug-free period. a delay in sexual maturation was observed at a dose approximately 6 times the mrhd given to children on a mg/m2 basis, although there was no effect on fertility. in a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to approximately day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. the latter doses are approximately 0.6, 2, and 6 times the mrhd of 30 mg/day, given to children on a mg/m2 basis. post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. performance in the morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. a delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules has not been studied in the geriatric population. due to reduced clearance of amphetamines in patients with severe renal impairment (gfr 15 to < 30 ml/min/1.73m2 ), the recommended dose should be reduced.  dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are not recommended in patients with esrd (gfr < 15 ml/min/1.73m2 ) [see dosage and administration (2.6), clinical pharmacology (12.3)]. d-amphetamine is not dialyzable. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance   dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).