Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; protamine sulfate; metacresol; zinc oxide; glycerol; dibasic sodium phosphate heptahydrate; phenol - for the treatment of insulin dependent diabetic patients.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: zinc oxide; water for injections; phenol; sodium hydroxide; glycerol; metacresol; protamine sulfate; hydrochloric acid; dibasic sodium phosphate heptahydrate - for the treatment of insulin dependent diabetic patients.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin - human -

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - solution for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - solution for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - suspension for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - suspension for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - suspension for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd, israel - insulin (human) - suspension for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

ABD - İngilizce - NLM (National Library of Medicine)

a-s medication solutions - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - humulin r is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. humulin r is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to humulin r or any of its excipients [see warnings and precautions (5.5)] risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7% and has been reported to be as high as 20-25% in women with a hba1c >10%. the estimated background risk of miscarriage for the indicated population 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data human data while available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. all available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size. risk summary available data from published literature suggests that exogenous human insulin products, including humulin r, are transferred into human milk. there are no adverse reactions reported in breastfed infants in the literature. there are no data on the effects of exogenous human insulin products, including humulin r on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for humulin r and any potential adverse effects on the breastfed child from humulin r or from the underlying maternal condition. humulin r is indicated to improve glycemic control in pediatric patients with diabetes mellitus. the dosage of humulin r must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see dosage and administration (2.3), warnings and precautions (5.3)] . the effect of age on the pharmacokinetics and pharmacodynamics of humulin r has not been studied. elderly patients using humulin r may be at increased risk of hypoglycemia due to co-morbid disease [see warnings and precautions (5.3)] . the effect of renal impairment on the pharmacokinetics and pharmacodynamics of humulin r has not been studied. patients with renal impairment are at increased risk of hypoglycemia and may require more frequent humulin r dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of humulin r has not been studied. patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent humulin r dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)] . instructions for use humulin ® (hu-mu-lin) r (insulin human) injection, for subcutaneous or intravenous use 3 ml or 10 ml multiple-dose vial (100 units/ml) read the instructions for use before you start taking humulin r and each time you get a new vial. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your syringes with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. supplies needed to give your injection - a 3 ml or 10 ml multiple-dose humulin®  r vial - a u-100 insulin syringe and needle - 2 alcohol swabs - 1 sharps container for throwing away used needles and syringes. see “disposing of used needles and syringes” at the end of these instructions. preparing the dose - wash your hands with soap and water. - check the humulin r label to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use humulin r past the expiration date printed on the label or 31 days after you first use it. - always use a new syringe or needle for each injection to help make sure the syringe needle is sterile and to prevent blocked needles. do not reuse or share your syringes or needles with other people. you may give other people a serious infection or get a serious infection from them. if you use humulin r with humulin n: - humulin n is the only type of insulin that can be mixed with humulin r. do not mix humulin r with any other type of insulin. - humulin r should be drawn up into the syringe first, before you draw up humulin n. talk to your healthcare provider if you are not sure about the right way to mix humulin r and humulin n. - give your injection right away. giving your injection - inject your insulin exactly as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - you may see a drop of insulin at the needle tip. this is normal and does not affect the dose you received. - if you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. do not rub the area. - do not recap the needle. recapping the needle can lead to a needle stick injury. disposing of used needles and syringes: - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes 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. - 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. how should i store humulin r? all unopened vials: - store all unopened vials in the refrigerator at 36° to 46°f (2° to 8°c). - do not freeze. do not use if it has been frozen. - keep away from heat and out of direct light. - unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator. - unopened vials should be thrown away after 31 days if they are stored at room temperature after vials have been opened: - store opened vials in the refrigerator or at room temperature up to 86°f (30°c) for up to 31 days. - keep away from heat and out of direct light. - throw away all opened vials after 31 days, even if there is still insulin left in the vial. general information about the safe and effective use - keep humulin r vials, syringes, needles, and all medicines out of the reach of children. - always use a new syringe or needle for each injection. - do not reuse or share your syringes or needles with other people. you may give other people a serious infection or get a serious infection from them. if you have any questions or problems with your humulin, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin and insulin, go to www.humulin.com. scan this code to launch the humulin.com website this instructions for use has been approved by the u.s. food and drug administration. humulin® is a trademark of eli lilly and company. instructions for use revised: june 2022 manufactured by: eli lilly and company, indianapolis, in 46285, usa us license number 1891 copyright © 1997, 2022, eli lilly and company. all rights reserved. linr100vl-0004-ifu-20220627