Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Sodium chloride
Bausch + Lomb Ireland Limited
S01AX; S01AX03
Sodium chloride
Eye drops, solution
Other antiinfectives; zinc compounds
Marketed
1983-04-01
Bausch & Lomb MINIMS® SALINE 0.9% W/V EYE DROPS, SOLUTION SODIUM CHLORIDE 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® Saline eye drops are and what they are 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® SALINE EYE DROPS ARE AND WHAT THEY ARE USED FOR Minims® Saline contains a salt solution. It is used to irrigate (wash out) the eyes. Minims® Saline is indicated for children, adults and the elderly. 2. BEFORE YOU USE YOUR EYE DROPS There are no special precautions which should be taken before using this product. IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING You can use Minims® Saline as it will not harm your baby, and it is safe to use during breastfeeding. DRIVING AND USING MACHINES As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines. 3. HOW TO USE YOUR EYE DROPS The drops are for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion. DOSAGE The amount of solution used should be enough to irrigate the eye properly. METHOD OF ADMINISTRATION If you are putting the eye drops in yourself, then follow these instructions carefully: 1. Wash your hands. 2. Use a mirror, this will help you to see what you are doing. 3. Twist off the cap from the Minims body of the unit. 4. Pull your lower eyelid down gently, and then gently squeeze until some liquid falls inside your lower eyelid. Make sure the dropper does not touch any parts of your eye. 5. Close the eyelids. 6. Repeat steps 4 and 5 for the other eye if necessary, then throw Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 03 June 2022 CRN00CTZ8 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Saline 0.9% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride 0.9% w/v. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops, solution Single use, clear, colourless, sterile eye drops, solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical ocular irrigating solution. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) and Children: Adequate solution should be used to irrigate the eye. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Not applicable. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Not applicable. Health Products Regulatory Authority 03 June 2022 CRN00CTZ8 Page 2 of 3 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Minims Saline is an isotonic solution of sodium chloride used for irrigation of the eye. There are no pharmacodynamic properties of relevance for this product. 5.2 PHARMACOKINETIC PROPERTIES There are no pharmacokinetic properties which are applicable for this product. 5.3 PRECLINICAL SAFETY DATA There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE 15 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25°C. Do not freeze. Store in the original container to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER A sealed conical shaped container fitted with a twist and pull off cap made from Ph. Eur. grade polypropylene for containers and closures for parenteral and opthalmic preparations. Each Minims unit contains Կարդացեք ամբողջական փաստաթուղթը