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

sanofi-aventis australia pty ltd - insulin glulisine, quantity: 3.49 mg/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; metacresol; polysorbate 20; trometamol; hydrochloric acid; sodium hydroxide - apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - insulin glulisine 3.49 mg/ml - solution for injection - 100 iu/ml - active: insulin glulisine 3.49 mg/ml excipient: hydrochloric acid metacresol polysorbate 20 sodium chloride sodium hydroxide trometamol water for injection - apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

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

sanofi-aventis australia pty ltd - insulin glulisine, quantity: 3.49 mg/ml - injection, solution - excipient ingredients: trometamol; sodium chloride; polysorbate 20; hydrochloric acid; sodium hydroxide; water for injections; metacresol - apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

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

sanofi-aventis australia pty ltd - insulin glulisine, quantity: 3.49 mg/ml - injection, solution - excipient ingredients: sodium chloride; trometamol; water for injections; hydrochloric acid; metacresol; polysorbate 20; sodium hydroxide - apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - insulin glulisine 3.49 mg/ml - solution for injection - 100 iu/ml - active: insulin glulisine 3.49 mg/ml excipient: cresol hydrochloric acid polysorbate 20 sodium chloride sodium hydroxide trometamol water for injection - apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

Kenya - English - Pharmacy and Poisons Board

sanofi-aventis kenya ltd p.o. box 20337-00200 - insulin glulisine - solution for injection in pre-filled pen - insulin glulisine 100iu/ml - insulins and analogues for injection fast-acting

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - insulin glulisine - injection, solution - 3.49 mg (100 units) - insulin glulisine 3.49 mg (100 units)

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

sanofi-aventis u.s. llc - insulin glulisine (unii: 7xiy785azd) (insulin glulisine - unii:7xiy785azd) - insulin glulisine 100 [iu] in 1 ml - apidra is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. apidra is contraindicated: - during episodes of hypoglycemia - in patients with known hypersensitivity to insulin glulisine or to any of the excipients in apidra; systemic allergic reactions have occurred with apidra [see adverse reactions (6.1)] . risk summary available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator. insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during org

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

sanofi-aventis (malaysia) sdn. bhd. - insulin glulisine -

Israel - English - Ministry of Health

sanofi israel ltd - insulin glulisine - solution for injection - insulin glulisine 100 u/ml - insulin glulisine - insulin glulisine - treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required.