VIPDOMET 12.5/850; 12.5 mg alogliptin (as benzoate) / 850 mg metformin hydrochloride film-coated tablets blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Werkstoffen:

metformin hydrochloride, Quantity: 850 mg; alogliptin benzoate, Quantity: 17 mg (Equivalent: alogliptin, Qty 12.5 mg)

Beschikbaar vanaf:

Takeda Pharmaceuticals Australia Pty Ltd

INN (Algemene Internationale Benaming):

Alogliptin benzoate,Metformin hydrochloride

farmaceutische vorm:

Tablet, film coated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

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

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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.

Product samenvatting:

Visual Identification: Light yellow, oblong, biconvex, film-coated tablet with 12.5/850 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

Autorisatie-status:

Licence status A

Autorisatie datum:

2013-10-22