Allergodil spray nasal

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

azelastine (azelastine hydrochloride)

Dostupné s:

Madaus GmbH

ATC kód:

R01AC03

INN (Mezinárodní Name):

azelastine (azelastine hydrochloride)

Dávkování:

1mg/1ml

Léková forma:

spray nasal

Jednotky v balení:

10ml glass vial with pump dispenser

Druh předpisu:

OTC

Stav Autorizace:

Registered

Datum autorizace:

2022-11-03

Charakteristika produktu

1
EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS / SPC)
1.
NAME OF THE MEDICINAL PRODUCT
Allergodil

Nasal Spray
1 mg / 1 ml, nasal spray, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray puff (0.14 ml) contains:
0.14 mg of azelastine hydrochloride
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
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 in adults,
adolescents and children aged
6 years and older.
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 of azelastine
hydrochloride / day).
Spray the solution into each nostril with the 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; there is
no time limit for its use.
4.3
CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Contraindicated in children under 6 years of age.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
So far, no interactions have been reported.
4.6
FERTILITY, PREGNANCY AND LACTATION
Fertility
In
animal
studies,
effects
on
fertility
have
been
seen
after
oral
administration
(see
section 5.3).
Pregnancy
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, current medical
concepts discourage use of Allergodil Nasal Spray in the first
trimester of pregnancy.
Lactation
Alle