国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
carbocisteine
Bosnalijek d.d.
R05CB03
carbocisteine
125mg/5ml
syrup
250ml glass bottle (200ml syrup) and measuring spoon
OTC
Registered
2016-08-30
1. NAME OF THE MEDICINAL PRODUCT BRONCHOBOS ® 125 mg/5 ml syrup carbocisteine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of syrup contains: Carbocisteine 125 mg For a full list of excipients, see section 6.1_._ 3. PHARMACEUTICAL FORM Syrup. 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 or viscous mucus. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Children 2 - 5 years: 2.5 - 5 ml four times daily. Children 5 - 12 years: 10 ml three times daily. Children over 12 years of age are recommended to use BRONCHOBOS 250 mg/5 ml syrup. _NOTE: _ For dosage of BRONCHOBOS 125 mg/5 ml syrup a 5 ml dosing spoon graduated in 2.5 ml and supplied in the box is used. Each dosing spoon of BRONCHOBOS 125 mg/5 ml syrup contains 125 mg carbocisteine. METHOD OF ADMINISTRATION BRONCHOBOS 125 mg/5 ml syrup is for oral administration. 1.3.1 Summary of Product Characteristics SmPCD004206/1 BRONCHOBOS 125 mg/5 ml syrup Page: 1 / 6 1.3.1 Summary of Product Characteristics SmPCD004206/1 BRONCHOBOS 125 mg/5 ml syrup Page: 1 / 6 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). Use in patients with active peptic ulceration. BRONCHOBOS 125 mg/5 ml syrup is contraindicated for use in children less than 2 years of age. 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 125 mg/5 ml syrup contains ethanol 96% (alcohol). In keeping with the dosage instructions when applying 2.5 ml of syrup in the body is brought to 62.5 mg of alcohol, when applying 5 ml of syrup in the organism enters the 125 mg of alcohol, 完全なドキュメントを読む