LATANOPROST/TIMOLOL NORMON 50 /5.0 Eye Drops Solution
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
31-05-2024
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Δραστική ουσία:
LATANOPROST TIMOLOL MALEATE
Διαθέσιμο από:
Laboratorios Normon S.A.
INN (Διεθνής Όνομα):
LATANOPROST TIMOLOL MALEATE
Δοσολογία:
50 /5.0
Φαρμακοτεχνική μορφή:
Eye Drops Solution
Τρόπος διάθεσης:
Product subject to prescription which may not be renewed (A)
Καθεστώς αδειοδότησης:
Withdrawn
Ημερομηνία της άδειας:
2012-03-05
Αρχείο Π.Χ.Π.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost/Timolol Normon 50 microgram/5.0 mg per ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 microgram Latanoprost and 6.8 mg Timolol maleate equivalent to 5 mg Timolol.
Excipient: Benzalkonium chloride 0.2 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.
Osmolality: 280~320 mOsmol/kg
pH: 5.0 – 7.0
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 the elderly):_
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:_
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.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
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.
4.3 CONTRAINDICATIONS
Latanoprost / Timolol Eye drops, solution is contraindicated in patients with:
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Reactive airway disease including bronchial asthma or a history of bronchial asthma,
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