Isofra spray nasal

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

framycetin (framycetin sulfate)

Disponibil de la:

Sophartex

Codul ATC:

R01AX08

INN (nume internaţional):

framycetin (framycetin sulfate)

Dozare:

8000U/ml

Forma farmaceutică:

spray nasal

Unități în pachet:

15ml plastic vial with pump dispenser

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2016-12-19

Caracteristicilor produsului

APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF MEDICINAL PRODUCT
ISOFRA, NASAL SPRAY, SOLUTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Framycetin sulphate
...............................................................................
800 000 IU
Methylparahydroxybenzoate (E218)
...................................................... 0.100 g
Sodium chloride
.....................................................................................
0.756 g
Sodium citrate
........................................................................................
0.106 g + s.q. pH 5.5
Citric acid monohydrate
.........................................................................
0.040 g + s.q. pH 5.5
Purified water
.........................................................................................
s.q.f. 100 ml
3. PHARMACEUTICAL FORM
Nasal spray, solution.
4. CLINICAL DATA
4.1 THERAPEUTIC INDICATIONS
Adjuvant topical treatment of infections of the rhinopharyngeal mucous
membrane.
The physicians should take into account the official recommendations
on appropriate use of
antibacterial drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
NASAL ROUTE
Hold the bottle upright, with the tip upwards, and press.
•
_Adults_
: 1 spray into each nostril 4 to 6 times daily.
•
_Children from 2 years_
: 1 spray into each nostril 3 times daily.
The treatment should not exceed a few days.
4.3 CONTRA-INDICATIONS
This medicine is contraindicated in case of hypersensitivity to one of
the constituents, in particular to
parabens, framycetin and to other aminoglycosides.
4.4 WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_ _
Once the bottle is opened, especially after the first use of nasal
preparation, a microbial contamination
may occur.
This medicine contains methyl parahydroxybenzoate (E218) and may cause
allergic reactions
(possibly delayed) and exceptionally bronchospasm.
4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
4.6 PREGNANCY AND BREAST-FEEDING
PREGNANCY:
The studies carried out