Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
LEVOBUNOLOL HYDROCHLORIDE
LTT Pharma Limited
LEVOBUNOLOL HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betagan 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol. Excipient (s): Contains benzalkonium chloride 0.04 mg/ml. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye Drops, Solution _Product imported from the UK:_ A clear, colourless to light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly):_ The recommended dosage is one drop of Betagan in the affected eye(s) once or twice daily. _Paediatric Population_ Betagan is not recommended for use in children due to lack of safety and efficacy data (see Section 5.1). Intraocular pressure should be measured approximately four weeks after starting treatment with Betagan as a return to normal ocular pressure can take a few weeks. Method of administration: topical into the conjunctival sac. 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, sino-atrial block, second and third-degree atrioventricular block not controlled with a pace maker, overt cardiac failure or cardiogenic shock. IRISH MEDICINES BOARD ______________________________ Läs hela dokumentet