国家: 以色列
语言: 英文
来源: Ministry of Health
LATANOPROST
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
S01EE01
EYE DROPS, SOLUTION
LATANOPROST 50 MCG/ML
OCULAR
Required
PFIZER MANUFACTURING BELGIUM NV/SA
LATANOPROST
LATANOPROST
Reduction of elevated intraocular pressure as a first line treatment in patients with open-angle galucoma and ocular hypertension.
2021-02-28
Xalatan Eye Drops PIL CC 061222 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only XALATAN ® EYE DROPS LATANOPROST 50 MCG/ML Inactive ingredients and allergens: See section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is intended for the treatment of adults over 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? For reducing intraocular pressure in patients with open-angle glaucoma and intraocular hypertension. THERAPEUTIC GROUP: belongs to the prostaglandin F2 analogue group. It increases the flow of the intraocular fluid into the bloodstream. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (listed in section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH XALATAN, TELL THE DOCTOR IF: • You are suffering, or have suffered in the past, from eye problems (such as eye pain, inflammation, irritation, blurred vision). • You suffer from dry eyes. • You suffer from severe asthma or the asthma is not adequately controlled. • You are about to undergo, or have recently undergone, eye surgery, including surgery for cataract removal. • You wear contact lenses. You can still use Xalatan, however, please see directions for using the drops in section 3: “How to use this medicine?” • You are suffering, or have suffered in the past, from a viral infection of the eye caused by the herpes simplex virus (HSV). DRUG INTERACTIONS I 阅读完整的文件
Xalatan Eye Drops LPD CC 280822 2022-0077005 XALATAN ® EYE DROPS 1. NAME OF THE MEDICINAL PRODUCT Xalatan ® Eye drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of eye drops, solution contains 50 micrograms of latanoprost. 2.5 mL of eye drops, solution (content of a dropper container) contains 125 micrograms of latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipients with known effect Benzalkonium chloride 0. 2mg/mL is included as a preservative. Sodium dihydrogen phosphate monohydrate 4.60 mg/mL. Disodium phosphate anhydrous 4.74 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 as a first line treatment in patients with open angle glaucoma and ocular hypertension. 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 intraocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. 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. Xalatan Eye Drops LPD CC 280822 2022-0077005 Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart. 4.3 CONTRAINDICATIONS Hypersensitivity to latanoprost or to any of the excipients listed in section 6.1 阅读完整的文件