Nasivin drops nasal

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

oxymetazoline (oxymetazoline hydrochloride)

Tilgjengelig fra:

Merck KGaA

ATC-kode:

R01AA05

INN (International Name):

oxymetazoline (oxymetazoline hydrochloride)

Dosering :

0,5mg/ml

Legemiddelform:

drops nasal

Enheter i pakken:

glass bottle 10ml

Resept typen:

OTC

Autorisasjon status:

Registered

Autorisasjon dato:

2016-04-05

Preparatomtale

OGYI/17501/2013
OGYI/17503/2013
OGYI/17505/2013 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NASIVIN 0.1 MG/ML NASAL DROPS, SOLUTION
NASIVIN 0.25 MG/ML NASAL DROPS, SOLUTION
NASIVIN 0.5 MG/ML NASAL DROPS, SOLUTION
2.
QUALITATIVE AND QUANTITTATIVE COMPOSITION
_Nasivin 0.1 mg/ml nasal drops, solution _
_ _
Each millilitre contains 0.10 mg oxymethazoline hydrochloride.
One drop (40 microlitre) contains 4 micrograms of oxymethazoline
hydrochloride.
_Nasivin 0.25 mg/ml nasal drops, solution _
_ _
Each millilitre contains 0.25 mg oxymethazoline hydrochloride.
One drop (40 microlitre) contains 10 micrograms of oxymethazoline
hydrochloride.
_Nasivin 0.5 mg/ml nasal drops, solution _
_ _
Each millilitre contains 0.5 mg oxymethazoline hydrochloride.
One drop (40 microlitre) contains 20 micrograms of oxymethazoline
hydrochloride.
For a full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Nasal drops, solution.
Almost clear, colorless to pale yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute colds (rhinitis), as well as attacks of vasomotor and allergic
rhinitis.
For enhancing the discharge of secretion in paranasal sinusitis as
well as in syringitis related to
rhinitis.
For diagnostic decongestion of mucous membranes in paranasal
sinusitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nasivin nasal drops are
intended for intranasal administration.
_FOR NEWBORNS AND INFANTS UNTIL THE AGE OF 1 YEAR: _
Up to the age of 4 weeks, instil 1 drop of Nasivin 0.1 mg/ml nasal
drops, solution
_ _
into each nostril 2-
3 times daily.
From the 5
th
week of life until the age of 1 year, instil 1-2 drops Nasivin 0.1
mg/ml nasal drops,
solution into each nostril 2-3 times daily.
The single dose given for the product must not be administered more
than 3 times daily.
_FOR CHILDREN BETWEEN 1 AND 6 YEARS OF AGE: _
From 1 to 6 years of age instil 1-2 drops of the Nasivin 0.25 mg/ml
nasal drops, solution
_ _
into each
2
nostril 2-3 times daily. The single dose given for the produ