Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Latanoprost
Pfizer Healthcare Ireland
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Prostaglandin analogues1); latanoprost
Marketed
1997-07-25
PAA103204 335959 Puurs N/A 9 pt Ireland 05 Leaflet 2981 I028/F 298 105 x 520 mm I-XALATAN PB IE PAR-2018-0002054 PROFILE BLACK 13:48 BARCODE Nº ITF 2 OF 5 SUPPLIER Nº DATE: 04 SEP 2018 TIME: PERIGORD Nº SUPPLIER SMALLEST BODY TEXT SIZE MARKET PROOF Nº COMPONENT DRAWING Nº DIMENSIONS MATERIAL NAME PAR NUMBER COLOURS PRINTING NON-PRINTING SOURCE CODE Package Leaflet: Information for the User Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or the doctor treating your child or pharmacist. • This medicine has been prescribed for you or for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or the doctor treating your child or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Xalatan is and what it is used for 2. What you need to know before you use Xalatan 3. How to use Xalatan 4. Possible side effects 5. How to store Xalatan 6. Contents of the pack and other information 1. What Xalatan is and what it is used for Xalatan belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream. Xalatan is used to treat conditions known as open angle glaucoma and ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. Xalatan is also used to treat increased eye pressure and glaucoma in all ages of children and babies. 2. What you need to know before you use Xalatan Xalatan can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Xalatan has not been investigated in prematurely born infants (less than 36 weeks g Прочитать полный документ
Health Products Regulatory Authority 24 November 2019 CRN008L99 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xalatan 50 micrograms/mL Eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL Eye drops solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipient with known effect Benzalkonium chloride 0.2 mg/mL is included as a preservative. Sodium dihydrogen phosphate monohydrate (E339i) 7.70 mg/mL. Disodium phosphate anhydrous (E339ii) 1.55 mg/mL. For the 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 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 IOP and paediatric glaucoma. 4.2 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 should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect. If one dose is missed, treatment should continue with the next dose as normal. _Paediatric population_ Xalatan Eye drops, solution may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year (4 patients) are limited (see section 5.1). Method of administration As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. Health Products Regulatory Authority 24 November 2019 CRN008 Прочитать полный документ