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

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Download Opinber matsskýrsla (PAR)
26-11-2017

Virkt innihaldsefni:

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

Fáanlegur frá:

Takeda Pharmaceuticals Australia Pty Ltd

INN (Alþjóðlegt nafn):

Alogliptin benzoate,Pioglitazone hydrochloride

Lyfjaform:

Tablet, film coated

Samsetning:

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

Stjórnsýsluleið:

Oral

Einingar í pakka:

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

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Registered

Leyfisdagur:

2015-02-10