DORZOTIM EYE DROPS, SOLUTION

Страна: Кипър

Език: гръцки

Източник: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Активна съставка:

TIMOLOL MALEATE; DORZOLAMIDE HYDROCHLORIDE

Предлага се от:

SAPIENS PHARMACEUTICALS LTD (0000008387) IEROU LOCHOU 39, KAPSALOS, LEMESOS, 3082

АТС код:

S01ED51

INN (Международно Name):

TIMOLOL, COMBINATIONS

Лекарствена форма:

EYE DROPS, SOLUTION

Композиция:

TIMOLOL MALEATE (0025839752) 34,15MG; DORZOLAMIDE HYDROCHLORIDE (8000002380) 111,3MG

Начин на приложение:

OCULAR USE

Вид предписание :

Εθνική Διαδικασία

Терапевтична област:

TIMOLOL, COMBINATIONS

Каталог на резюме:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 5ML (290023101) 5 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
S/DORZON comp/SPC/CYPRUS/16 06 2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dorzon comp (20+5) mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding
to 20 mg
dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg
timolol.
Excipient: 0.075 mg benzalkonium chloride/ml eye drops, solution
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
S/DORZON comp/SPC/CYPRUS/16 06 2009
Eye drops, solution.
Clear, slightly viscous, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dorzon comp (20+5) mg/ml eye drops solution is indicated in the
treatment of elevated intra-
ocular 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
The dose is one drop of Dorzon comp (20+5) mg/ml eye drops solution in
the (conjunctival
sac of the) affected eye(s) two times daily.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption
is reduced. This may result in a decrease in systemic side effects and
an increase in local activity.
If more than one topical ophthalmic medicinal product is being used,
the products should be
administered at least ten minutes apart.
Please see section 6.6 'Instructions for use and handling'.
_Paediatric use:_
Efficacy in paediatric patients has not been established.
Safety in paediatric patients below the age of two years has not been
established. (For
information regarding safety in paediatric patients
2 and < 6 years of age, see section 5.1).
4.3
CONTRAINDICATIONS
Dorzon comp (20+5) mg/ml eye drops solution is contra-indicated in
patients with:
• reactive airway disease, including bronchial asthma or a history
of bronchial asthma, or
severe chronic obstructive pulmonary disease
• sinus bradycardia, sick sinus syndrome sino-atrial block,