Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ROSE BENGAL
Chauvin Pharmaceuticals Limited
ROSE BENGAL
1.0 %w/v
Eye Drops Solution
Withdrawn
2008-01-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Rose Bengal 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1% w/v solution of rose bengal For excipients, see 6.1. 3 PHARMACEUTICAL FORM Single-use, sterile eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a diagnostic stain. Rose bengal solution stains degenerated conjunctival and corneal epithelial cells. It is particularly useful in demonstrating these changes in Sjögren’s syndrome, where lack of tears has caused damage. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Adults (including the elderly) and Children:_ One or two drops, as required. 4.3 CONTRAINDICATIONS Rose bengal can produce severe stinging in dry eyes, where it should be used with care. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Rose bengal should not be instilled into the eye when the patient is wearing contact lenses. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION The use of rose bengal over the last 15 years has not shown any adverse effects. In the absence of any teratology studies, however, rose bengal is not recommended in pregnancy unless the therapeutic benefit exceeds the potential risk. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 12/10/2005_ _CRN 2015555_ _page number: 1_ 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 Rose bengal may discolour the eye lids and/or conjunctiva. 4.9 OVERDOSE As Minims are single-dose units, overdose is unlikely to occur. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Not Aqra d-dokument sħiħ