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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

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

Dostopno od:

Takeda Pharmaceuticals Australia Pty Ltd

INN (mednarodno ime):

Alogliptin benzoate,Pioglitazone hydrochloride

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

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

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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 dovoljenje:

Licence status A

Datum dovoljenje:

2015-02-10