מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
framycetin (framycetin sulfate)
Sophartex
R01AX08
framycetin (framycetin sulfate)
8000U/ml
spray nasal
15ml plastic vial with pump dispenser
Prescription
Registered
2016-12-19
APPENDIX I SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT ISOFRA, NASAL SPRAY, SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Framycetin sulphate ............................................................................... 800 000 IU Methylparahydroxybenzoate (E218) ...................................................... 0.100 g Sodium chloride ..................................................................................... 0.756 g Sodium citrate ........................................................................................ 0.106 g + s.q. pH 5.5 Citric acid monohydrate ......................................................................... 0.040 g + s.q. pH 5.5 Purified water ......................................................................................... s.q.f. 100 ml 3. PHARMACEUTICAL FORM Nasal spray, solution. 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS Adjuvant topical treatment of infections of the rhinopharyngeal mucous membrane. The physicians should take into account the official recommendations on appropriate use of antibacterial drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NASAL ROUTE Hold the bottle upright, with the tip upwards, and press. • _Adults_ : 1 spray into each nostril 4 to 6 times daily. • _Children from 2 years_ : 1 spray into each nostril 3 times daily. The treatment should not exceed a few days. 4.3 CONTRA-INDICATIONS This medicine is contraindicated in case of hypersensitivity to one of the constituents, in particular to parabens, framycetin and to other aminoglycosides. 4.4 WARNINGS AND SPECIAL PRECAUTIONS FOR USE _ _ Once the bottle is opened, especially after the first use of nasal preparation, a microbial contamination may occur. This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed) and exceptionally bronchospasm. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND BREAST-FEEDING PREGNANCY: The studies carried out קרא את המסמך השלם