Allergodil drops eye

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

azelastine (azelastine hydrochloride)

Inapatikana kutoka:

MEDA Pharma GmbH & Co. KG

ATC kanuni:

S01GX07

INN (Jina la Kimataifa):

azelastine (azelastine hydrochloride)

Kipimo:

0,5mg/ml

Dawa fomu:

drops eye

Vitengo katika mfuko:

plastic vial-dropper 6ml

Dawa ya aina:

OTC

Idhini hali ya:

Registered

Idhini ya tarehe:

2021-08-12

Tabia za bidhaa

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Translation from the German Language
EXPERT INFORMATION
(= German Summary of Product Characteristics / SmPC)
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 of azelastine
hydrochloride.
Excipient with known effect: Each ml contains 0.125 mg of benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colorless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of the symptoms of seasonal allergic
conjunctivitis in adults and
children 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:
Unless otherwise prescribed, the usual dosage in adults and children 4
years and older is one
drop in each eye twice daily. This dosage can be increased, if
necessary to up 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:
Unless otherwise prescribed, the usual dosage in adults and children
12 years and older is one
drop in each eye twice daily. This dosage can be increased, if
necessary to up to four times
daily.
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As safety and efficacy have been demonstrated in clinical trials for a
period of up to 6 weeks,
the duration of any treatment course should be limited to a maximum of
6 weeks.
Advice for use without prescription: Patients should be advised to
contact their doctor if
symptoms worsen or do not improve after 48 hours. It should be pointed
out to the patient,
that use for more than 6 weeks must take place under medical
supervision even in case of
seasonal allergic conjunctivitis.
4.3 CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the e