Septanazal for adults spray nasal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

xylometazoline (xylometazoline hydrochloride), dexpanthenol

Available from:

KRKA d.d.

ATC code:

առկա չէ (R01AB) վերարտադրված դեղի առաջին դեղաձև, դեղաչափ

INN (International Name):

xylometazoline (xylometazoline hydrochloride), dexpanthenol

Dosage:

1mg/ml+ 50mg/ml 10ml (100 doses) plastic container with pump dispenser

Pharmaceutical form:

spray nasal

Units in package:

1mg/ml+50mg/ml 10ml (100 doses) plastic container with pump dispenser

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-08-04

Summary of Product characteristics

1.3.1
Xylometazoline + Dexpanthenol
SPC, Labeling and Package Leaflet
AM
SmPCPIL144298_1
06.02.2020 – Updated: 06.02.2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Septanazal for adults 1 mg/50 mg in 1 ml nasal spray, solution
Septanazal for children 0.5 mg/50 mg in 1 ml nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Septanazal for adults_
Each ml of nasal spray, solution, contains 1 mg xylometazoline
hydrochloride and 50 mg
dexpanthenol.
One spray contains 0.1 ml of nasal spray, solution, containing 0.1 mg
xylometazoline hydrochloride
and 5.0 mg dexpanthenol.
_Septanazal for children_
Each ml of nasal spray, solution, contains 0.5 mg xylometazoline
hydrochloride and 50 mg
dexpanthenol.
One spray contains 0.1 ml of nasal spray, solution, containing 0.05 mg
xylometazoline hydrochloride
and 5.0 mg dexpanthenol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless liquid solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For reducing the swelling of the nasal mucosa in rhinitis and
promoting the healing of skin and
mucosal lesions, for bouts of vasomotor rhinitis, and for the
treatment of nasal respiratory obstruction
after nasal surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose of Septanazal for adults is one spray into each nostril
up to 3 times a day as needed.
The dosage depends on individual sensitivity and clinical efficacy.
Duration of treatment is limited to 7 days unless otherwise instructed
by the doctor. Repeated use is
possible only after a break of several days.
_Paediatric population_
The administration of the product in children under 12 years of age
should be supervised by an adult.
CONFIDENTIAL
Septanazal for adults nasal spray 1mg/50mg/ml,
Septanazal for children nasal spray 0.5 mg/50 mg/ml
VOL: 1; P: 24 / 128
1.3.1
Xylometazoline + Dexpanthenol
SPC, Labeling and Package Leaflet
AM
SmPCPIL144298_1
06.02.2020 – Updated: 06.02.2020
Page 2 of 7