Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
LATANOPROST
Clonmel Healthcare Ltd
LATANOPROST
50 Microgram/ML
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-06-04
ZANOPRO 50MICROGRAMS/ML EYE DROPS, SOLUTION Latanoprost PACKAGE LEAFLET: INFORMATION FOR THE USER IN THIS LEAFLET: 1. What Zanopro is and what it is used for 2. Before you use Zanopro 3. How to use Zanopro 4. Possible side effects 5. How to store Zanopro 6. Further information 1. WHAT ZANOPRO IS AND WHAT IT IS USED FOR Zanopro are eye drops used in patients with a condition known as open angle glaucoma which causes an increase in pressure in the eye. The active ingredient in Zanopro is one of a group of medicines known as prostaglandins. Zanopro is a medicine that lowers the pressure within your eye by increasing the natural outflow of fluid from inside the eye into the blood stream. Zanopro is also used to treat increased eye pressure and glaucoma in all ages of children and babies. 2. BEFORE YOU USE ZANOPRO Zanopro can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Zanopro has not been investigated in prema- turely born infants (less than 36 weeks gestation). DO NOT USE ZANOPRO – if you are allergic (hypersensitive) to Latanoprost or any of the other ingre dients of Zanopro. TAKE SPECIAL CARE WITH ZANOPRO Talk to your doctor, or the doctor treating your child or your pharmacist before you use Zanopro or before you give this to your child if you think any of the following apply to you or your child: • If you or your child are about to have or have had eye surgery (including cataract surgery) • If you or your child suffer from eye problems (such as ey সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanopro 50 micrograms/ml, eye drops solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of eye drops contains 50 micrograms of latanoprost. 2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipient: 0.2 mg benzalkonium chloride/ml eye drops solution. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution (eye drops). The solution is a clear colourless liquid. pH 6.4-7.0 Osmolality 240-290 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ocular use _Recommended dosage for adults (including the elderly):_ Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Zanopro is administered in the evening. The dosage of Zanopro should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. 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. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. IRISH MEDICINES BOARD _________________________________________________ সম্পূর্ণ নথি পড়ুন