OSENI 12.5/30 12.5 mg alogliptin (as benzoate) / 30 mg pioglitazone (as hydrochloride) film-coated tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

alogliptin benzoate, Quantity: 17 mg (Equivalent: alogliptin, Qty 12.5 mg); pioglitazone hydrochloride, Quantity: 33.06 mg (Equivalent: pioglitazone, Qty 30 mg)

Disponible depuis:

Takeda Pharmaceuticals Australia Pty Ltd

DCI (Dénomination commune internationale):

Alogliptin benzoate,Pioglitazone hydrochloride

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; hypromellose; microcrystalline cellulose; mannitol; magnesium stearate; iron oxide red; lactose monohydrate; titanium dioxide; iron oxide yellow; macrogol 8000; hyprolose; purified talc; butan-1-ol; Shellac; Carnauba Wax; ethanol absolute; glyceryl monooleate

Mode d'administration:

Oral

Unités en paquet:

14 (sample pack), 98, 100, 10 (sample pack), 30, 28, 60, 56, 7 (sample pack), 90

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

OSENI 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 pioglitazone is appropriate,- when treatment with metformin or pioglitazone alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,OSENI can also be used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

Descriptif du produit:

Visual Identification: Pale peach, round, biconvex, film-coated tablets with A/P and 12.5/30 printed on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2015-02-10