Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fluorescein sodium
Bausch Health Ireland Limited
S01JA; S01JA01
Fluorescein sodium
2 percent weight/volume
Eye drops, solution
Colouring agents; fluorescein
Marketed
1983-04-01
Bausch & Lomb MINIMS® FLUORESCEIN SODIUM 1% W/V MINIMS® FLUORESCEIN SODIUM 2% W/V EYE DROPS, SOLUTION FLUORESCEIN SODIUM 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 ® Fluorescein sodium 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® FLUORESCEIN SODIUM EYE DROPS ARE AND WHAT THEY ARE USED FOR Minims ® Fluorescein sodium contains a diagnostic agent. The active substance, fluorescein sodium, is a temporary dye used to: . help your doctor or eye specialist to examine your eye, . help your doctor or eye specialist to measure the pressure inside your eye by a test called tonometry, . help in the fitting of hard contact lenses. Scratches on the conjunctiva (the lining of the inside of the eyelids and part of the eye) are stained yellow or orange by fluorescein. Damages to the cornea (the transparent membrane covering the surface of the eye) are stained green. Any foreign bodies which are stuck in your eye are surrounded by a green ring. This medicine is indicated for children, adults and the elderly. 2. BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS IF . you are allergic to the active substance (fluorescein). . you wear soft contact lenses. IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative. CONTACT LENSES Your doctor will ask you to remove your soft contact lenses prior to the administration of the drops. There is no information on the effect of this product on soft contact lenses. Therefore, do not wear your soft contact lenses until the effects of the drops have comp Read the complete document
Health Products Regulatory Authority 02 May 2019 CRN008VKY Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Fluorescein Sodium 2%, w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2% w/v solution of Fluorescein Sodium _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Eye Drops, solution (Eye Drops) Clear, orange-red, aqueous single-use eye drop solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a diagnostic stain. Fluorescein does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions or ulcers are stained a bright green and foreign bodies are surrounded by a green ring. Fluorescein can be used in diagnostic examinations including Goldmann tonometry and in the fitting of hard contact lenses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, Children and the Elderly Instil dropwise into the eye. Sufficient solution should be applied to stain the damaged areas. Excess may be washed away with sterile saline solution. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to Fluorescein. Not to be used with soft contact lenses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Special care should be taken to avoid microbial contamination. Each Minims unit should be discarded after a single use. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Safety for use in pregnancy and lactation has not been established, therefore use only when considered essential by the physician. Health Products Regulatory Authority 02 May 2019 CRN008VKY Page 2 of 3 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear. 4.8 UNDESIRABLE EFFECTS ADRs are very rare (<1/10,000), including isolated reports. Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophtha Read the complete document