מדינה: טייוואן
שפה: סינית
מקור: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ISOTRETINOIN
荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)
D10AD04
乳膏劑
ISOTRETINOIN (8428000691) 0.5MG
鋁軟管
製 劑
醫師藥師藥劑生指示藥品
STIEFEL LABORATORIES (PTE) LTD, SINGAPORE 103 GUL CIRCLE, SINGAPORE 629589 SG
isotretinoin
粉刺、尋常性痤瘡。
註銷日期: 2016/05/30; 註銷理由: 許可證已逾有效期; 有效日期: 2014/08/11; 英文品名: ISOTREX CREAM 0.05%
已註銷
1999-08-11
ISOTREX _ _ TM Cream DESCRIPTION ISOTREX Cream 0.05 % and 0.1 % contain isotretinoin 0.05% w/w and 0.1% w/w respectively in an aqueous cream base. EXCIPIENTS Benzyl alcohol Butylated hydroxytoluene Cetostearyl alcohol Chlorocresol Di-n-butyl adipate Light Liquid Paraffin Polyoxyethylene stearyl ether PEG-5 glyceryl mono stearate Carbomer Propylene glycol Purified Water Sodium hydroxide CLINICAL INFORMATION INDICATIONS ISOTREX Cream is indicated for the topical treatment of mild to moderate acne vulgaris and is effective in treating both inflammatory and non-inflammatory lesions. The cream is particularly suitable for patients with sensitive or dry skin. DOSAGE AND ADMINISTRATION Apply ISOTREX Cream sparingly over the entire affected area once or twice daily. The skin should be thoroughly cleansed and dried before application. Patients should be advised that 6-8 weeks of treatment may be required before the full therapeutic effect is observed. CONTRAINDICATIONS • ISOTREX Cream is contraindicated in patients with known hypersensitivity to any of the ingredients. • ISOTREX Cream is contraindicated during pregnancy or in women of childbearing. WARNINGS AND PRECAUTIONS Isotretinoin should be used with caution in patients with a history of local tolerability reactions or photoallergy. Use with caution in patients with a personal or family history of skin cancer. Contact with the mouth, eyes, mucous membranes, abraded or eczematous skin should be avoided. Care should be taken not to let the medicine accumulate in skin fold areas and in the nasolabial folds. Due to the irritant nature of isotretinoin, caution should be used when applying to sensitive areas of skin, such as the neck, or in patients with concomitant rosacea or perioral dermatitis. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If irritancy or dermatitis occur, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be disco קרא את המסמך השלם