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

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

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

Disponível em:

Takeda Pharmaceuticals Australia Pty Ltd

DCI (Denominação Comum Internacional):

Alogliptin benzoate,Pioglitazone hydrochloride

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

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

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Licence status A

Data de autorização:

2015-02-10