LATANOPROST / TIMOLOL YES 50 /5.0 Eye Drops Solution
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
28-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
LATANOPROST TIMOLOL MALEATE
थमां उपलब्ध:
Yes Pharmaceutical Development Services GmbH
INN (इंटरनेशनल नाम):
LATANOPROST TIMOLOL MALEATE
डोज़:
50 /5.0
फार्मास्यूटिकल फॉर्म:
Eye Drops Solution
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
0000-00-00
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost / Timolol YES 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:_
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:
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive
pulmonary disease.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.
Hypersensitivity to the active substances or to any
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