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

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
26-11-2017

有効成分:

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

から入手可能:

Takeda Pharmaceuticals Australia Pty Ltd

INN(国際名):

Alogliptin benzoate,Pioglitazone hydrochloride

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

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

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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.

製品概要:

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

認証ステータス:

Licence status A

承認日:

2015-02-10