Apo-Sitagliptin

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Sitagliptin phosphate monohydrate 64.25mg equivalent to 50 mg sitagliptin

Предлага се от:

Apotex NZ Ltd

INN (Международно Name):

Sitagliptin phosphate monohydrate 64.25 mg (equiv to 50 mg sitagliptin)

дозиране:

50 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Sitagliptin phosphate monohydrate 64.25mg equivalent to 50 mg sitagliptin Excipient: Calcium hydrogen phosphate Croscarmellose sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Macrogol 8000 Magnesium stearate   Microcrystalline cellulose Purified talc Titanium dioxide

Вид предписание :

Prescription

Произведено от:

Apotex Pharmachem Inc

Терапевтични показания:

Monotherapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. Combination with Metformin: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin as initial therapy or when diet and exercise, plus the single agent do not provide adequate glycaemic control. Combination with a Sulfonylurea: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycaemic control. Combination with a PPAR-gamma agonist: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a PPAR-gamma agonist (i.e. thiazolidinediones) as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycaemic control. Combination with Metformin and a Sulfonylurea: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. Combination with Metformin and a PPAR-gamma agonist: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a PPAR-gamma agonist (i.e. thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. Combination with Insulin: Sitagliptin is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in combination with premixed or long/intermediate acting insulin (with or without metformin).

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/AL, AL/AL, Closed closure: PVC/PVdC film&Al foil , Al foil & Al foil - 28 dose units - 18 months from date of manufacture stored at or below 25°C

Дата Оторизация:

2015-11-13