Irbesartan/Hydrochlorothiazide LAPL 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
28-11-2017

유효 성분:

irbesartan, Quantity: 150 mg; hydrochlorothiazide, Quantity: 12.5 mg

제공처:

Lupin Australia Pty Limited

INN (국제 이름):

Hydrochlorothiazide,Irbesartan

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: colloidal anhydrous silica; mannitol; magnesium stearate; crospovidone; povidone; poloxamer; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 3350; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid

관리 경로:

Oral

패키지 단위:

28 tablets (2 x 14 tablets), 30 tablets (2 x 15 tablets), 56 tablets (4 x 14 tablets), 98 tablets (7 x 14 tablets), 14 tablets (1 x 14 tablets)

수업:

Medicine Registered

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Irbesartan/HCTZ tablets are indicated for the following:Treatment of hypertension.Treatment should not be initiated with this fixed-dose combination.

제품 요약:

Visual Identification: Light peach, biconvex, oval shaped, film coated tablets, imprinted 'IT1' in black ink on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2013-06-28