Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
carbocisteine
Bosnalijek d.d.
R05CB03
carbocisteine
250mg/5ml
syrup
250ml glass bottle (200ml syrup) and measuring spoon
OTC
Registered
2016-08-30
1. NAME OF THE MEDICINAL PRODUCT BRONCHOBOS ® 250 mg/5 ml syrup carbocisteine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of syrup contains: Carbocisteine 250 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup (clear, slightly viscous solution with raspberry color and odor). 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS INCLUDING THE ELDERLY:_ Dosage is based upon an initial daily dosage of 2250 mg carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. 15 ml tds reducing to 10 ml tds. _CHILDREN:_ BRONCHOBOS 250 mg/5 ml syrup is intended for children over 12 years of age, in doses recommended for adults. BRONCHOBOS 125 mg/5 ml syrup is intended for children under 12 years of age. METHOD OF ADMINISTRATION BRONCHOBOS 250 mg/5 ml syrup is for oral use. 1.3.1 Summary of Product Characteristics SmPCD004207/1 BRONCHOBOS 250 mg/5 ml syrup Page: 1 / 6 1.3.1 Summary of Product Characteristics SmPCD004207/1 BRONCHOBOS 250 mg/5 ml syrup Page: 1 / 6 _NOTE: _ For dosage of BRONCHOBOS 250 mg/5 ml syrup a 5 ml dosing spoon graduated at 2.5 ml and supplied in the box is used. Each dosing spoon of BRONCHOBOS 250 mg/5 ml syrup contains 250 mg carbocisteine. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Use in patients with active peptic ulceration. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication. BRONCHOBOS 250 mg/5 ml syrup contains ethanol 96% (alcohol). In keeping with the dosage in Đọc toàn bộ tài liệu