Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dimethindene maleate, phenylephrine
Novartis Consumer Health S.A.
dimethindene maleate, phenylephrine
0,25mg/ml+2,5mg/ml
spray nasal
OTC
Novartis Consumer Health SA CH-1260 Nyon, Switzerland Regulatory Affairs Vibrocil ® Nasal Drops, Nasal Spray, Dimetindene maleate 0.025% + Phenylephrine base 0.25% SUMMARY OF PRODUCT CHARACTERISTICS Release date: 13 March 2013 Number of pages: 8 Property of Novartis Consumer Health SA Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis Consumer Health SA Novartis Consumer Health SA CONFIDENTIAL Page 2 Summary of Product Characteristics Vibrocil ® 1. NAME OF THE MEDICINAL PRODUCT Vibrocil ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Phenylephrine base and Dimetindene (INN). Chemical designation: Phenylephrine: (S)-1-(3-Hydroxyphenyl)-2-methylaminoethanol Dimetindene: 2-(2-dimethylaminoethyl)-3-[2-(2-pyridyl)ethyl]-(1H)-indene maleate. Vibrocil ® Nasal Drops, Spray: Phenylephrine 0.25% w/v, dimetindene 0.025% w/v For excipients, see 6.1 3. PHARMACEUTICAL FORM Vibrocil ® Nasal Drops, Spray 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic treatment of common cold, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in case of acute otitis media. Pre- and post-operative care (nasal surgery). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Nasal drops: _INFANTS UP TO 1 YEAR OF AGE (WITH MEDICAL ADVICE): _ 1 DROP INTO EACH NOSTRIL 3 TO 4 TIMES A DAY_ _ _Children 1 to 6 years of age_: 1 to 2 drops into each nostril 3 to 4 times a day _Adults and children over 6 years of age_: 3 to 4 drops into each nostril 3 to 4 times a day Nasal Spray _Adults and children over 6 years of age_: 1 to 2 sprays in each nostril 3 to 4 times a day. 4.3. CONTRA-INDICATIONS Known hypersensitivity to any of the ingredients. Novartis Consumer Health SA CONFIDENTIAL Page 3 Summary of Product Characteristics Vibrocil ® Like other vasoconstrictors, phenylephrine is contra-indicated in case of atrophic rhinitis and in patients who are receiving Pročitajte cijeli dokument