Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
acetylcysteine
Salutas Pharma GmbH
R05CB01
acetylcysteine
200mg
powder for oral solution
(20) sachets 3g
OTC
Registered
2018-06-21
a Novartis Company SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ACC® 200 mg Hot drink POWDER FOR ORAL SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: acetylcysteine 1 sachet (3 g of powder) contains 200 mg acetylcysteine. For a full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM Powder for oral solution. _Description: _White, homogenous powder with lemon and honey aroma._ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secretolytic therapy in case all bronchopulmonary diseases accompanied by impaired formation and transport of secretion such as acute and chronic bronchitis, obstructive bronchitis, bronchiolitis, bronchiectasia, pneumonia, laryngitis, tracheitis, bronchial asthma, mucoviscidosis, sinusitises, otitis media. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION If not otherwise prescribed, the following dosage is recommended for ACC 200 mg: _ _ - Adults and adolescents over the age of 14: 1 sachet twice or three times daily (400-600 mg of acetylcysteine per day) - Children from 6 to 14 years of age: 1 sachet two times daily (400 mg of acetylcysteine per day) - Children from 2 to 6 years of age: ½ sachet two or three times daily (200-300 mg of acetylcysteine per day). Mucoviscidosis - Children over the age of 6 years: 1 sachet 3 times daily (600 mg of acetylcysteine per day) Children from 2 to 6 years of age: ½ sachet 4 times daily (400 mg of acetylcysteine per day) Method of administration 2 KNGL: 721-7769 To be taken orally as a hot drink. Contents of a sachet are dissolved in a glass of hot water while stirring. Drink as hot as possible after meals. The mucolytic effect of ACC is supported by fluid supply. The duration of treatment The duration of treatment depends on the type and severity of the disease. In case of acute short-term cold-related diseases the therapy lasts 5-7 days. In case of chronic bronchitis and mucoviscidosis, longer-term treatment should be performed. Maximum duration of treatment is 3-6 months. 4.3 CON Прочитать полный документ