VIPDOMET 12.5/500; 12.5 mg alogliptin (as benzoate) / 500 mg metformin hydrochloride film-coated tablets blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

metformin hydrochloride, Quantity: 500 mg; alogliptin benzoate, Quantity: 17 mg (Equivalent: alogliptin, Qty 12.5 mg)

MAH:

Takeda Pharmaceuticals Australia Pty Ltd

INN:

Alogliptin benzoate,Metformin hydrochloride

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: microcrystalline cellulose; mannitol; magnesium stearate; titanium dioxide; hypromellose; crospovidone; povidone; purified talc; iron oxide yellow

administration_route:

Oral

units_in_package:

196, 20, 120, 14, 28, 112, 60, 56, 200, 98, 180, 10

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

VIPDOMET is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,VIPDOMET can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

leaflet_short:

Visual Identification: Pale yellow, oblong, biconvex, film-coated tablet with 12.5/500 debossed on one side and 322M debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Registered

authorization_date:

2013-10-22