Allergodil spray nasal

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

azelastine (azelastine hydrochloride)

Dostupné z:

MEDA Pharma GmbH & Co. KG

ATC kód:

R01AC03

INN (Medzinárodný Name):

azelastine (azelastine hydrochloride)

Dávkovanie:

1mg/1ml

Forma lieku:

spray nasal

Počet v balení:

10ml glass vial with pump dispenser

Typ predpisu:

OTC

Stav Autorizácia:

Registered

Dátum Autorizácia:

2016-12-09

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS / SPC
ALLERGODIL® NASAL SPRAY
LAST REVISED: SEPTEMBER 2010
_Translation from the German Language _
1. TRADE NAME OF THE MEDICINAL PRODUCT
Allergodil
®
Nasal Spray
1 mg / 1 ml
Active substance: Azelastine hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 spray puff (0.14 ml) contains:
0.14 mg of Azelastine hydrochloride
3. PHARMACEUTICAL FORM
Nasal spray, Solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allergodil Nasal Spray is an anti-allergic agent / antihistaminic
agent.
For symptomatic treatment of seasonal allergic rhinitis (hay fever)
and for
symptomatic treatment of non-seasonal (perennial) allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be sprayed into the nose; for nasal application.
Unless otherwise prescribed, spray Allergodil Nasal Spray once into
each nostril
twice daily (mornings and evenings; equivalent to a daily dose of 0.56
mg
Azelastine hydrochloride / day).
Spray the solution into each nostril with head held upright.
Duration of treatment depends on the type, severity and the
development of the
symptoms. Allergodil Nasal Spray may be used for long-term treatment;
Should
not be used continuously for more than 6 months.
4.3 CONTRA-INDICATIONS
- Hypersensitivity to azelastine and / or other components of the
formulation.
- If allergic rhinitis and rhinoconjunctivitis - Children up to age 6
years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In some cases, the use of a nasal spray detected fatigue varying
severity and
weakness, which may be caused and also the basic condition. In these
cases, it is
not recommended to drive a car and work with dangerous machinery.
Drinking
alcohol may intensify these effects.
4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
So far, no interactions have been reported.
4.6 PREGNANCY AND LACTATION
Although doses far in excess of the therapeutic dose range tested in
laboratory
animals failed to generate any evidence of an embryotoxic effect of
this medicinal
product, curren