Philippines - English - FDA (Food And Drug Administration)

pnf pharmaceutical, inc.; distributor: aristo pharma philippines, inc. - insulin human (rdna) - suspension for injection (im/sc) - 100 iu/ml (30% soluble insulin human / 70% isophane insulin human)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: pnf pharmaceutical, inc. :; distributor: multicare pharmaceuticals phils., inc. - insulin human (rdna) - suspension for injection (im/sc) - 100 iu/ml suspension for injection (im/sc) (30% soluble insulin human / 70% isophane insulin human)

Philippines - English - FDA (Food And Drug Administration)

pnf pharmaceutical, inc.; distributor: duopharma trade phils., inc. - insulin human (dna) - suspension for injection (im/sc) - 100 iu/ml (30% soluble insulin human / 70% isophane insulin human)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: pnf pharmaceutical, inc.; distributor: jackpharma inc. - insulin human (rdna) - suspension for injection (im/sc) (30% soluble insulin human/ 70% isophane insulin human) - 100 iu/ml

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - diabetes mellitus - drugs used in diabetes - insulin aspart sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

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

nucare pharmaceuticals,inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - novolin r is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin r is contraindicated: - during episodes of hypoglycemia - in patients with hypersensitivity to novolin r or any of its excipients 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 m

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

physicians total care, 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. enter section text here 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

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)

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)

novo nordisk - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day,