Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
POLYVINYL ALCOHOL
Allergan Pharmaceuticals Ireland
POLYVINYL ALCOHOL
1.4 %w/v
Eye Drops Solution
Product not subject to medical prescription
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Liquifilm Tears Ocular Lubricant, 1.4% w/v, eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Polyvinyl alcohol 1.4% w/v Excipient: Benzalkonium Chloride 0.005% w/v For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. A clear, colourless solution with a pH of 6.0-7.5 and osmolality of 200-260 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a lubricant and artificial tear in dry eye and other ocular irritation syndromes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage schedule: One to two drops as required or directed. Route of administration: Topical instillation into conjunctival sac. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Use with soft contact lenses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation, pain, redness and changes in vision occur or worsen or persist for more than 72 hours, treatment should be discontinued and a new assessment considered. To avoid contamination, the dropper tip should not be allowed to touch the eye or any other surface. Contact lenses should be removed before each application and may be reinserted after 15 minutes. Liquifilm Tears contain benzalkonium chloride which is irritant to the eye and could cause discolouration of soft lenses. Avoid contact with soft contact lenses. Remove contact lenses before Liquifilm Tears is used and wait for at least 15 minutes before reinsertion. Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. IRISH MEDICINES BOARD _________________________________ Lugege kogu dokumenti