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

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: metacresol; sodium hydroxide; zinc chloride; glycerol; hydrochloric acid; water for injections - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

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

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; metacresol; zinc chloride; glycerol - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

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

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: zinc chloride; polysorbate 20; metacresol; glycerol; hydrochloric acid; water for injections; sodium hydroxide - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

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

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

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

dispensing solutions, inc. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. important limitations of use: - lantus is not recommended for the treatment of diabetic ketoacidosis. intravenous short-acting insulin is the preferred treatment for this condition. lantus is contraindicated in patients with hypersensitivity to lantus or one of its excipients. pregnancy category c: subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and himalayan rabbits. insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 ,

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

eli lilly and company - 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 p

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

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [usp'u] in 1 ml - novolin 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. limitations of use: in novolin 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. novolin 70/30 is contraindicated: 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

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

a-s medication solutions - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to humalog or to any of its excipients. risk summary the limited available data with humalog in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of 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) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approxi

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

tya pharmaceuticals - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. important limitations of use: - lantus is not recommended for the treatment of diabetic ketoacidosis. intravenous short-acting insulin is the preferred treatment for this condition. lantus is contraindicated - in patients with hypersensitivity to lantus or one of its excipients [see ]. warnings and precautions (5.4) pregnancy category c: subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and himalayan rabbits. insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m . in rabbits, doses of 0.072 mg/kg/day, which is approx

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

physicians total care, inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - humulin r u-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus. humulin r u-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see dosage and administration and storage). humulin r u-100 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to humulin r u-100 or any of its excipients. never share needles and syringes. correct syringe type doses of insulin are measured in units . u-100 insulin contains 100 units/ml (1 ml=1 cc). with humulin r, it is important to use a syringe that is marked for u-100 insulin preparations. failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high. syringe use to help avoid contamination and possible infection, follow these instructions exactly. disposable syringes and needles should be used only