Akistan drops eye (solution)

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

latanoprost

Доступна с:

Pharmaselect International Beteiligungs GmbH

код АТС:

S01EE01

ИНН (Международная Имя):

latanoprost

дозировка:

50mcg/ml

Фармацевтическая форма:

drops eye (solution)

Штук в упаковке:

2,5ml plastic vial

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2023-03-10

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Akistan 50 microgram/ml eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 50 micrograms of latanoprost
(equivalent to 0.005% w/v).
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect: 1ml contains 0.2 mg Benzalkonium chloride
(equivalent to 0.02%
w/v)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless liquid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular
hypertension.
Reduction
of
elevated
intraocular
pressure
in
paediatric
patients
with
elevated
intraocular
pressure and paediatric glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dosage for _adults (including the elderly)_:
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is
obtained if Akistan is administered in the evening.
The dosage of Akistan should not exceed once daily since it has been
shown that more frequent
administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the
lachrymal sac be compressed at the medial canthus (punctal occlusion)
for one minute. This
should be performed immediately following the instillation of each
drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after
15 minutes.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least
five minutes apart.
_ _
_Paediatric population_
Akistan may be used in paediatric patients at the same posology as in
adults. No data are
available for preterm infants (less than 36 weeks gestational age).
Data in the age group ˂ 1 year
(4 patients) are very limited (see Section 5.1).
Meth