البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
CARMELLOSE SODIUM
LTT Pharma Limited
0.5 %w/v
Eye Drops Solution
2010-11-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celluvisc 0.5% w/v, eye drops, solution, unit dose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 5mg carmellose sodium For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops, solution in single-dose container. _Product imported from Spain_ Clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tear substitute. Treatment of the symptoms of dry eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Instil 1-2 drops in the affected eye/s 4 times a day or as needed. Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening. To avoid contamination do not touch the tip to the eye or any other surface. If Celluvisc is concomitantly used with other ocular eye medications there must be an interval of at least 15 minutes between the two medications (as displacement of a medication may occur). The eye drops may be used with contact lenses. 4.3 CONTRAINDICATIONS Hypersensitivity to carmellose sodium or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation, pain, redness or changes in vision occur or if the patient’s condition is worsened, treatment discontinuation should be considered and a new assessment made. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. For the use of concomitant ocular products, see section 4.2. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2010_ _CRN 2087372_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION Due to the negligible systemic exposure and the lack of pharmacological activity Cellu اقرأ الوثيقة كاملة