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

astrazeneca pty ltd - exenatide, quantity: 250 microgram/ml - injection, solution - excipient ingredients: sodium acetate; water for injections; metacresol; glacial acetic acid; mannitol - exenatide is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, or a combination of metformin and a basal insulin, but are not achieving adequate glycaemic control.

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

astrazeneca pty ltd - exenatide, quantity: 250 microgram/ml - injection, solution - excipient ingredients: sodium acetate; metacresol; glacial acetic acid; mannitol; water for injections - exenatide is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, or a combination of metformin and a basal insulin, but are not achieving adequate glycaemic control.

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - byetta® - solution for injection (sc) - 250 mcg/ml (5mcg/dose)

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

astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 250 ug in 1 ml - byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)] . limitations of use byetta is contraindicated in patients with: risk summary limited data with byetta in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). based on animal reproduction studies, there may be risks to the fetus from exposure to byetta during pregnancy. byetta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide during pregnancy and lactation in association with maternal effects. in mice, exenatide administered during gestation and lactation caused increased neonatal deaths at systemic exposure 3-times

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

physicians total care, inc. - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 250 ug in 1 ml - byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. byetta is not a substitute for insulin. byetta should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. the concurrent use of byetta with prandial insulin has not been studied and cannot be recommended. based on postmarketing data byetta has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. byetta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using byetta. other antidiabetic therapies should be considered in patients with a history of pancreatitis. byetta is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components. pregnancy category c there are no adequate and well-c

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - exenatide - injection, solution - 250mcg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - exenatide - solution for injection - 250microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - exenatide - solution for injection - 250microgram/1ml

Canada - English - Health Canada

astrazeneca canada inc - exenatide - solution - 5mcg - exenatide 5mcg - incretin mimetics

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - exenatide 250 µg/ml;   - solution for injection - 10µg/40µl - active: exenatide 250 µg/ml   excipient: glacial acetic acid mannitol metacresol sodium acetate trihydrate water for injection - adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic control. to improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin with or without metformin and/or a thiozolidinedione.