国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TERBINAFINEHYDROCHLORIDE 10 mg/g
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
D01AE15
TERBINAFINEHYDROCHLORIDE 10 mg/g
Crème
BENZYLALCOHOL (E 1519) ; CETOSTEARYLALCOHOL ; CETYLALCOHOL ; CETYLPALMITAAT ; ISOPROPYLMYRISTAAT ; NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 60 (E 435) ; SORBITANMONOSTEARAAT (E 491) ; WATER, GEZUIVERD,
Cutaan gebruik
Terbinafine
Hulpstoffen: BENZYLALCOHOL (E 1519); CETOSTEARYLALCOHOL; CETYLALCOHOL; CETYLPALMITAAT; ISOPROPYLMYRISTAAT; NATRIUMHYDROXIDE (E 524); POLYSORBAAT 60 (E 435); SORBITANMONOSTEARAAT (E 491); WATER, GEZUIVERD;
2005-12-13
Terbinafine 10 mg/g, cream, Niddafin NL/H/0747/001, Binanidda NL/H/0748/001 Name change PT, RTQ, 06.04.21 1 PACKAGE LEAFLET: INFORMATION FOR THE USER BINANIDDA 1% CREME, CREME 10 MG/G _ _ terbinafine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 1 to 2 weeks. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you use [Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR - [Nationally completed name] belongs to the group of antifungal preparations. [Nationally completed name] is used to treat patients with fungal and yeast infections of the skin. - [Nationally completed name] is active against certain yeasts and skin fungi, of which athlete’s foot is the most well-known. See also section 3 for more information about the other fungal infections. You must talk to your doctor, if you do not feel better or if you feel worse after 1 to 2 weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME] DO NOT USE [NATIONALLY COMPLETED NAME] - if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). You can recognise hypersensitivity for example by red spots and lumps on the skin or itching. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using [Nationa 阅读完整的文件
Terbinafine 250 mg, tablets, NL/H/0747+0748/001 Excipients guideline, 04.05.20 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Binanidda 1% crème, crème 10 mg/g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 10 mg of terbinafine hydrochloride. Excipients with known effect 80 mg Cetyl alcohol and Cetostearyl alcohol/gram cream. 10 mg benzyl alcohol/gram cream. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White or almost white cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin, caused by dermatophytes, such as Trichophyton (e.g. T. Rubrum, T. Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. Candida albicans). Pityriasis (tinea) versicolor, caused by Pityrosporum orbiculare (Malassezia furfur). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and adolescents (>12 years of age) _ Duration and frequency of the treatment Tinea pedis: once daily for one week. Tinea cruris and tinea corporis: once daily for one week Cutaneous candidiasis: once daily for 1 to 2 weeks Pityriasis versicolor: once or twice daily for 2 weeks [Nationally completed name] 10 mg/g cream can be applied once or twice daily. The skin should be dry and clean. The cream should be applied to the affected _ _ skin and surrounding area in a thin layer and then rubbed in gently. If the event of intertriginous infection _ _ (submammary, interdigital, intergluteal or inguinal) the skin may be covered with a sterile gauze following application of the cream, especially at night. Relief of symptoms usually occurs within a few days. Terbinafine 250 mg, tablets, NL/H/0747+0748/001 Excipients guideline, 04.05.20 2 Irregular use or premature discontinuation increases the risk of recurrence of the symptoms. If no improvement is seen after two weeks, the diagnosis should be reconsidered. _Elderly _ There are no indications 阅读完整的文件