Vibrocil

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

dimethindene maleate, phenylephrine

Disponibil de la:

Novartis Consumer Health S.A.

INN (nume internaţional):

dimethindene maleate, phenylephrine

Dozare:

0,25mg/ml+2,5mg/ml

Forma farmaceutică:

spray nasal

Tip de prescriptie medicala:

OTC

Caracteristicilor produsului

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