Allergodil 0,5mg/ml drops eye

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

azelastine (azelastine hydrochloride)

Prieinama:

MEDA Pharma GmbH & Co. KG

ATC kodas:

S01GX07

INN (Tarptautinis Pavadinimas):

azelastine (azelastine hydrochloride)

Dozė:

0,5mg/ml

Vaisto forma:

drops eye

Vienetai pakuotėje:

6ml plastic vial-dropper

Recepto tipas:

OTC

Autorizacija statusas:

Registered

Leidimo data:

2016-09-24

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS /SPC
1. NAME OF THE MEDICINAL PRODUCT
Allergodil eye drops.
0.5 mg / ml, Eye Drops, solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Azelastine
hydrochloride
0.05%
(0.5
mg/ml).
Each
drop
contains
0.015
mg
azelastine hydrochloride.
Excipient: 1 ml contains 0.125 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution. Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of the symptoms of seasonal allergic
conjunctivitis in
adults andchildren 4 years and older.Treatment of the symptoms of
non-seasonal
(perennial) allergic conjunctivitis in adults and children 12 years
and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Seasonal allergic conjunctivitis: The usual dosage in adults and
children 4 years
and older is one drop in each eye twice daily that can be increased,
if necessary to
four times daily. If allergen exposure is anticipated Allergodil eye
drops should be
administered prophylactically, prior to the exposure.
Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in
adults and
children 12 years and older is one drop in each eye twice daily that
can be
increased, if necessary to four times daily. As safety and efficacy
have been
demonstrated in clinical trials for a period of up to 6 weeks, the
duration of any
course should be limited to a maximum of 6 weeks.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Allergodil
Eye
Drops
is
not
intended
for
treatment
of
eye
infections.
Benzalkonium chloride may cause eye irritation. Contact with soft
contact lenses
should be avoided. Contact lenses should be removed prior to
application and the
patient should wait at least 15 minutes before reinsertion. Known to
discolour soft
contact lenses.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No specific interaction studies with Allergodil