Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: myHealthbox
Latanoprost, Timolol
Tubilux Pharma
S01ED51
Latanoprost, Timolol
50 micrograms/ml + 5 mg/ml
Eye drops
Eye solution use
1 × 2.5 ml, 3 × 2.5 ml, 6 × 2.5 ml bottle
POM - Prescription Only Medicine
Tubilux Pharma
Ophthalmological-betablocking agents - timolol, combinations
Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Authorised
2014-01-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml Eye Drops, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol. Excipient: Benzalkonium chloride 0.20 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended dosage for adults (including older people): Recommended therapy is one eye drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. _ _ Method of administration: Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. 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 drug is being used, the drugs should be administered at least five minutes apart. _ _ _Paediatric population: _ Safety and effectiveness in children and adolescents has not been established. No data are available. 4.3 CONTRAINDICATIONS Latanoprost+Timolol is contraindicated in patients with: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Reactive airway disease including Prečítajte si celý dokument