Země: Arménie
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
benfotiamine
Dragenopharm Apotheker Puschl GmbH
A11DA03
benfotiamine
300mg
tablets film-coated
(30/3x10/) in blister
OTC
Registered
2021-02-25
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MILGAMMA PROTEKT Active substance: Benfotiamine 300 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated scored tablet contains 300 mg of benfotiamine (lipid-soluble vitamin B 1 derivative). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White oblong film-coated tablet with score line on both sides The tablets can be divided into two equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The only established therapeutic indication of the mono-preparations is the treatment or prophylaxis of clinical vitamin B 1 deficiency conditions, if these cannot be resolved by dietary means. Clinically diagnosed vitamin B 1 deficiency can occur in: Deficient diet and malnutrition (e.g. beriberi), long-term parenteral nutrition, null diet, haemodialysis, malabsorption, chronic alcoholism (alcohol toxic cardiomyopathy, Wernicke encephalopathy, Korsakov syndrome), increased requirement (e.g. pregnancy and lactation). Treatment of neuropathies and cardiovascular disorders that are caused by vitamin B 1 deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Unless otherwise prescribed, the usual dosage in the treatment of clinical vitamin B 1 deficiency is 300 mg Milgamma protekt once a day. The usual dosage in the prophylaxis of clinical vitamin B 1 deficiency conditions (e.g. neuropathies and cardiovascular disorders), if these cannot be reached by dietary means, is 150 mg Milgamma protekt once a day. The duration of administration is determined by the therapeutic response. _ _ Milgamma protekt is initially taken over a period of at least 3 weeks in cases of vitamin B 1 deficiency. Thereafter maintenance treatment is governed by therapeutic response with 150 or 300 mg Milgamma 2 protekt. In case of missing or insufficient therapeutic response after 3 weeks in cases of vitamin B 1 deficiency therapy should be reconsidered. _Paediatric Population _ Safety and efficacy in children Přečtěte si celý dokument