Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE HYDROXYETHYLCELLULOSE
Chauvin Pharmaceuticals Limited
SODIUM CHLORIDE HYDROXYETHYLCELLULOSE
0.35 + 0.4 %w/w
Eye Drops Solution
Product not subject to medical prescription
Authorised
0000-00-00
Graphics&Packing Technology Section ICN POLFA RZESZÓW S.A. ULOTKA PIL Nazwa produktu Product Name MINIMS ARTIFICIAL TEARS 0.35% W/W & 0.44% W/W DRP SOL Kolor nadruku Colours Black Kraj Country (ISO) UNITED KINGDOM (UK), IRLEAND (IE) Nr wykrojnika Spec No 5336 Opracowane przez Designed by ŁUKASZ KOZIOŁ LUKASZ.KOZIOL@VALEANT.COM PHONE: +48 17 865 5537 Kod Wytwórcy Manufacturer code 76815 Nr korekty Proof No 4 Data Date 16.07.2014 Kod farmaceutyczny Pharmacode 76815 DATA MATRIX Kod wersji Valeant version code P1UKIE01 Inny kod Other code - Rozmiar czcionki Font size MINIMUM 6 PT Wymiar ulotki PIL size 80 X 140 MM Krój czcionki Font used BAUSH&LOMB BOLD Baush&Lomb Regular Gramatura papieru Paper weight - G/M 2 Komentarze Comments (Reason for the change) LEAFLET CARTON AND OVERWRAP LABEL SHOULD STATE 0.5G INSTEAD OF 0.5ML PMR_ICN-14-0143-A PACKING SITE: B&L AUBENAS FRANCE - NATHALIE CLOT, NATHALIE.CLOT@BAUSCH.COM Akceptacja Techniczna Technical Approval Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval 0.35% W/W SODIUM CHLORIDE + 0.44%W/W HYETELLOSE EYE DROPS, SOLUTION Read all this leaflet carefully before you start using your medicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Remember this medicine is for you. Do not give it to someone else. IN THIS LEAFLET: 1. What Minims ® Artificial Tears eye drops is and what it is used for 2. Before you use your eye drops 3. How to use your eye drops 4. Possible side effects 5. How to store your eye drops 6. Further information 1. WHAT MINIMS® ARTIFICIAL TEARS EYE DROPS IS AND WHAT IT IS USED FOR Minims ® Artificial Tears contains a lubricant. It is used as a substitute for natural tears. This medicine is indicated for children, adults and the elderly. 2. BEFORE YOU USE YOUR EYE DROPS There are no special precautions which should be taken bef Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Artificial Tears 0.35% w/w + 0.44% w/w Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hyetellose Ph. Eur. 0.44 % w/w and sodium chloride Ph. Eur. 0.35 % w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Sterile, single use eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of dry eye syndromes associated with deficient tear secretion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One or two drops instilled into the affected eye three or four times daily, or as often as is required. 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation persists or worsens or continued redness occurs, discontinue use and consult a physician or ophthalmologist. Keep out of reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION There is no evidence of safety of this product in human pregnancy. If therapy with artificial tears is needed in pregnancy this preparation can be used if recommended by a physician and it is considered that the benefits outweigh the possible risks. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/08/2012_ _CRN 2119869_ _page number: 1_ clear. 4.8 UNDESIRABLE EFFECTS May cause transient mild stinging or temporarily blurred vision. 4.9 OVERDOSE Overdose would not be expected to produce symptoms. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES The Прочитајте комплетан документ