Snup spray nasal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

xylometazoline (xylometazoline hydrochloride)

Available from:

STADA Arzneimittel AG

ATC code:

R01AA07

INN (International Name):

xylometazoline (xylometazoline hydrochloride)

Dosage:

0,5mg/ml

Pharmaceutical form:

spray nasal

Units in package:

15ml (150 dose) plastic bottle

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-06-13

Summary of Product characteristics

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Snup
®
nasal spray 0.05%, solution
Snup
®
nasal spray 0.1%, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Snup_
_®_
_ nasal spray 0.05% _
1 ml of nasal spray, solution contains 0.5 mg xylometazoline
hydrochloride.
Each puff (of approx. 0.09 ml of solution) contains 0.045 mg
xylometazoline hydrochlo-
ride.
_Snup_
_®_
_ nasal spray 0.1% _
1 ml of nasal spray, solution contains 1 mg xylometazoline
hydrochloride.
Each puff (of approx. 0.09 ml of solution) contains 0.09 mg
xylometazoline hydrochlo-
ride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray, solution
Clear, colorless solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
For detumescing the nasal mucosa in the event of colds and attacks of
runny colds
(vasomotor rhinitis), allergic rhinitis.
•
For facilitating the flow of secretion in inflammation of the
paranasal sinuses as well
as in catarrh of the tubal middle ear associated with colds.
Snup
®
nasal spray 0.05% is intended for children between ages 2 and 6 years.
Snup
®
nasal spray 0.1% is intended for adults and school-age children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Snup
®
is intended for nasal use.
_ _
_SNUP_
_®_
_ NASAL SPRAY 0.05% _
Unless otherwise prescribed, children between 2-6 years when necessary
are given 1
puff of nasal spray into each nostril up to three times daily.
SNUP
® NASAL SPRAY 0.1%
Unless otherwise prescribed, adults and school-age children from 6
years of age when
necessary should put 1 puff of nasal spray_ _into each nostril up to
three times daily.
1
The recommended single dose of Snup
®
should not be given more than three times a
day. Do not use more than the recommended dosage.
The dosage will depend on the individual sensitivity and clinical
response.
Snup
®
_ _should not be used for longer than 7 days except on the advice of a
doctor. Wait
several days before re-using these medicinal products.
A doctor should always be consulted about