OSENI 25/30 25 mg alogliptin (as benzoate) / 30 mg pioglitazone (as hydrochloride) film-coated tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

pioglitazone hydrochloride, Quantity: 33.06 mg (Equivalent: pioglitazone, Qty 30 mg); alogliptin benzoate, Quantity: 34 mg (Equivalent: alogliptin, Qty 25 mg)

Disponible desde:

Takeda Pharmaceuticals Australia Pty Ltd

Designación común internacional (DCI):

Alogliptin benzoate,Pioglitazone hydrochloride

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: iron oxide yellow; magnesium stearate; hyprolose; microcrystalline cellulose; lactose monohydrate; purified talc; titanium dioxide; hypromellose; croscarmellose sodium; iron oxide red; macrogol 8000; mannitol; Shellac; ethanol absolute; iron oxide black; 1-butanol

Vía de administración:

Oral

Unidades en paquete:

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

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: Peach, round, biconvex, film-coated tablets with A/P and 25/30 printed on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estado de Autorización:

Registered

Fecha de autorización:

2015-02-10