Land: Cypern
Språk: grekiska
Källa: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
TIMOLOL MALEATE; DORZOLAMIDE HYDROCHLORIDE
SAPIENS PHARMACEUTICALS LTD (0000008387) IEROU LOCHOU 39, KAPSALOS, LEMESOS, 3082
S01ED51
TIMOLOL, COMBINATIONS
EYE DROPS, SOLUTION
TIMOLOL MALEATE (0025839752) 34,15MG; DORZOLAMIDE HYDROCHLORIDE (8000002380) 111,3MG
OCULAR USE
Εθνική Διαδικασία
TIMOLOL, COMBINATIONS
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 5ML (290023101) 5 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
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, Läs hela dokumentet