País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levamisole (levamisole hydrochloride)
Gedeon Richter PLC
levamisole (levamisole hydrochloride)
50mg
tablets
Prescription
1. NAME OF THE MEDICINAL PRODUCT DECARIS 50 MG TABLETS DECARIS 150 MG TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Decaris 50 mg tablets: Each tablet contains 50 mg levamisole (in the form of 59.0 mg levamisole hydrochloride). Decaris 150 mg tablet: The tablet contains 150 mg levamisole (in the form of 177.0 mg levamisole hydrochloride). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. _Decaris 50 mg tablets: _ Pale orange coloured, round, flat, bevel-edged, quadrisect tablets with a characteristic slight apricot odour. _Decaris 150 mg tablet: _ Almost white, round, flat, bevel-edged tablet with impressed "DECARIS 150" inscript on one side. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decaris is indicated for the treatment of infections caused by the following gastro-intestinal worm species: _Ascaris lumbricoides, Necator americanus and Ancylostoma duodenale. _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The Decaris 150 mg tablet should not be used for the treatment of children! _Adults:_ A single dose of 150 mg tablet (1 tablet). _Children:_ A single dose of 2.5 mg/kg of body mass from the 50 mg tablet. from 3 to 6 years of age (10-20 kg of body mass) 25-50 mg (1/2-1 tab.) in a single dose from 6 to 10 years of age (20-30 kg of body mass) 50-75 mg (1-1.5 tab.) in a single dose from 10 to 14 years of age (30-40 kg of body mass) 75-100 mg (1.5-2 tab.) in a single dose The tablet should be taken with some water, after a meal, preferably in the evening. Laxatives or special diet are not needed. If it is necessary, treatment can be repeated after a 7-14 day interval. 2/5 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients; drug induced agranulocytosis (in anamnesis), children aged below 3 years, period of lactation. The 150 mg tablet in contraindicated for the treatment of children! 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE During administration and for at least 24 hours following intake a Llegiu el document complet