XALATAN Eye drops, solution (2022)
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Περιεχόμενα
Name of the medicinal product
Xalatan 50 micrograms/mL Eye drops, solution.
Qualitative and quantitative composition
1 mL Eye drops solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipients with known effect: Benzalkonium chloride 0.2 mg/mL is included as a ...
Pharmaceutical form
Eye drops, solution. The solution is a clear, colourless liquid.
Therapeutic indications
Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension in adults (including the elderly). Reduction of elevated IOP in paediatric patients with elevated ...
Posology and method of administration
Posology Adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Xalatan is administered in the evening. The dosage of Xalatan ...
Contraindications
Hypersensitivity to latanoprost or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Xalatan may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye ...
Interaction with other medicinal products and other forms of interaction
Definitive drug interaction data are not available. There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn ...
Effects on ability to drive and use machines
Xalatan has minor influence on the ability to drive and use machines. In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients ...
Undesirable effects
Summary of the safety profile The majority of adverse reactions relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.4). Other ...
Overdose
Symptoms Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if Xalatan is overdosed. Treatment If Xalatan is accidentally ingested the following information ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma preparations and miotics, prostaglandin analogues ATC code: S01EE01 The active substance latanoprost, a prostaglandin F<sub>2α</sub> analogue, ...
Pharmacokinetic properties
Absorption Latanoprost (mw 432.58) is an isopropyl ester prodrug which per se is inactive, but after hydrolysis to the acid of latanoprost becomes biologically active. The prodrug is well absorbed through ...
Preclinical safety data
The ocular as well as systemic toxicity of latanoprost has been investigated in several animal species. Generally, latanoprost is well tolerated with a safety margin between clinical ocular dose and systemic ...
List of excipients
Sodium chloride Benzalkonium chloride Sodium dihydrogen phosphate monohydrate (E339i) Disodium phosphate anhydrous (E339ii) Water for injections
Incompatibilities
<em>In vitro</em> studies have shown that precipitation occurs when eye drops containing thiomersal are mixed with Xalatan. If such medicinal products are used, the eye drops should be administered with ...
Shelf life
<u>Before first opening:</u> 2 years. <u>After first opening of container:</u> 4 weeks.
Special precautions for storage
Do not store above 25°C. After first opening: Use within 4 weeks (see section 6.3). Keep the bottle in the outer carton in order to protect from light.
Nature and contents of container
Dropper container (5 mL) of polyethylene with a screw cap and tamper evident overcap of polyethylene. Each dropper container contains 2.5 mL Eye drops, solution corresponding to approximately 80 drops ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 50622/0065
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 December 1996 Date of latest renewal: 22 November 2015
Date of revision of the text
06/2022
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