ISOTRETINOIN ASCENT isotretinoin 10mg capsule

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:

isotretinoin, Quantity: 10 mg

제공처:

Douglas Pharmaceuticals Australia Pty Ltd

INN (국제 이름):

Isotretinoin

약제 형태:

Capsule, soft

구성:

Excipient Ingredients: butylated hydroxyanisole; sorbitol solution (70 per cent) (non-crystallising); titanium dioxide; Gelatin; brilliant scarlet 4R; partially hydrogenated soya oil; glycerol; Soya Oil; hydrogenated vegetable oil; yellow beeswax; disodium edetate; iron oxide black; dl-alpha-tocopherol; purified water

관리 경로:

Oral

패키지 단위:

15 capsules, 60 capsules, 90 capsules, 30 capsules

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ISOTRETINOIN ASCENT is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

제품 요약:

Visual Identification: Light violet coloured oblong soft gelatin capsules, containing a yellow-orange opaque viscous liquid; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2012-06-08