Timodor drops eye

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

timolol (timolol maleate), dorzolamide (dorzolamide hydrochloride)

متاح من:

Diamond Pharma

ATC رمز:

S01ED51

INN (الاسم الدولي):

timolol (timolol maleate), dorzolamide (dorzolamide hydrochloride)

جرعة:

20mg/ml+ 5mg/ml

الشكل الصيدلاني:

drops eye

الوحدات في الحزمة:

10ml bottle-dropper with 5ml drops

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2020-12-30

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Timodor eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 20 mg dorzolamide (as dorzolamide
hydrochloride) and 5 mg timolol
(as timolol maleate).
Preservative: Benzalkonium chloride 0.075 mg/mL
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, slightly viscous, colourless aqueous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timodor eye drops, solution is indicated in the treatment of elevated
intraocular pressure (IOP) in
patients with open-angle glaucoma or pseudo-exfoliative glaucoma when
topical beta-blocker
monotherapy is not sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of Timodor eye drops, solution in the
(conjunctival sac of the) affected eye(s)
two times daily
.
If another topical ophthalmic medicinal product is being used, the
other agent should be
administered at least ten minutes apart
.
Patients should be instructed to wash their hands before use and avoid
allowing the tip of the
container to come into contact with the eye or surrounding structures
.
Patients should also be instructed that ocular solutions, if handled
improperly, can become
contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and
subsequent loss of vision may result from using contaminated solutions
.
Patients should be informed of the correct handling of the ophthalmic
Timodor bottles.
Paediatric population
Efficacy in paediatric patients has not been established. Safety in
paediatric patients below the age
of two years has not been established.
Method of administration
1.
The tamperproof seal on the bottle neck must be unbroken before the
product is being used for
the first time. A gap between the bottle and the cap is normal for an
unopened bottle
.
2.
The cap of the bottle should be taken off
.
3.
The patient's head must be tilted back and the lower eyelid must be
pulled gently down to form a
small pocket between the eyelid and the