OSENI 25/45 25 mg alogliptin (as benzoate) / 45 mg pioglitazone (as hydrochloride) film-coated tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

pioglitazone hydrochloride, Quantity: 49.59 mg (Equivalent: pioglitazone, Qty 45 mg); alogliptin benzoate, Quantity: 34 mg (Equivalent: alogliptin, Qty 25 mg)

Tilgængelig fra:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Alogliptin benzoate,Pioglitazone hydrochloride

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

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

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

Visual Identification: Red, round, biconvex, film-coated tablets with A/P and 25/45 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

Autorisation status:

Licence status A

Autorisation dato:

2015-02-10