国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
escin, diethylamine salicylate
Madaus GmbH
առկա չէ (M02AC)
escin, diethylamine salicylate
0.01g/g+ 0.05g/g
gel for external use
40g aluminium tube
OTC
Registered
2020-12-30
I:\RUZ\ALLOPA TH\Reparii Akut\OOSS IER\TEI L-1 B\Texte Verlanqerunq 2008\spc-en-aea-november -2008-14te-novelle. rtf Seite 1 von 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT REPARIL® - GEL N Active substances: Escin 1 % and 2-Hydroxybenzoic acid, diethylazan salt (Diethylamine salicylate) 5 % 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 g gel contains: Active substances: Escin 1 g 2-Hydroxybenzoic acid, diethylazan (Diethylamine salicylate) 5g Other ingredients: For the complete listing of other ingredients see section 6.1. 3. PHARMACEUTICAL FORM Gel 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For topical, supportive symptomatic treatment of minor complaints following acute blunt injuries (e.g., contusions, sprains) If complaints persist for more than 2 days or deteriorate, a doctor should be consulted. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Apply Reparil®-gel N 3 times daily. Depending on the size of the painful area to be treated, an amount of the size of a cherry or walnut, equivalent to 2.5 g to 6.0 g of gel (0.13 mg to 0.3 mg diethylamine salicylate) is required. The maximum total daily dose is 20 g of gel, equivalent to 1 g of diethylamine salicylate. METHOD OF ADMINISTRATION For topical use only! Do not ingest! Spread a thin layer of Reparil®-gel N onto the affected areas of the skin and rub the medicine in gently. Before applying a dressing Reparil®-gel N should dry for several minutes on the skin. The use of an occlusive bandage is not recommended. 1:\RUZ\ALLOPATH\ReparilAkut\DOSSIER\TEIL-1 8\Texte Verlangerung 2008\spc-en-aea-november-2008-14te-novelle.rtf Seite 2 von 5 DURATION OF USE: The treating doctor will determine the length of treatment. As a rule, treatment over 1-2 days is sufficient. There is no evidence for the therapeutic benefit of treatment with Reparil®-gel N beyond this period. SPECIFIC PATIENT GROUPS: ELDERLY PATIENTS: No special dose adjustment is required. Because of the potential side effect profile, elderly patients should be mon 完全なドキュメントを読む