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Sodium hyaluronate 0.2% Lubrication and hydration of the surface of the eye LCA PHARMACEUTICAL Preservative free HOW TO USE ? You are advised to pull your bottom eyelid down, look up, and then pull the top eyelid upward and look down, in order to make sure that the solution spreads over the whole surface of the eye in order to increase the volume of the tear film, and hydrate the tissues. The single-dose container should be discarded after use. POSOLOGY FOR OCULAR IRRIGATION 2 to 4 times a day, the irrigation is carried out directly onto the surface of the eyeball, by pressing the sides of the bottle to squirt out a jet of the solution. Sodium hyaluronate 0.2% Lubrification and hydration of the surface of the eye Hyaline is a sterile, isotonic and preservative-free ophthalmic solution intended for the symptomatic treatment of disorders affecting the surface of the eye. MECHANISM OF ACTION • The sodium hyaluronate present in Hyaline is a natural polymer which has viscoelastic properties that lubricate and hydrate the surface of the eye. • Hyaline has a physiological pH of 7.4, which promotes the action of lyzozyme in the tears. • Hyaline has the same molarity as tears (335 mOsm./Kg). • The fact that it contains no preservative or antiseptic eliminates the potential risk of allergy or cytotoxicity. The presentation in a single-dose container ensures that the product is sterile, safe and effective each time it is used. Hyaline produces optimum humidification of all the mucous membranes of the surface of the eye. Hyaline relieves the symptoms of ocular irritations : • • • • • Sensation of a foreign body in the eye. Sensation of dry eyes. Poorly defined oculo-palpebral discomfort. Burning sensations. Tingling sensations. IDENTIFICATION AND NAME : HYALINE : Sterile solution containing 0.20% Sodium hyaluronate for ophthalmic use. COMPOSITION : Sodium hyaluronate………....0.200 g. Sodium chloride………… ....0.900 g. Excipients : q.s.p………..........100 ml. FORM AND CONTENTS IN TERMS OF VOLUME : This is a sterile ophthalmic solution for directly irrigating the surface of the eye. HYALINE is supplied in 2-ml single-dose containers. MECHANISM OF ACTION : HYALINE IS A STERILE, ISOTONIC AND PRESERVATIVEFREE OPHTHALMIC SOLUTION INTENDED FOR THE SYMPTOMATIC TREATMENT OF DISORDERS AFFECTING THE SURFACE OF THE EYE. The organoleptic characteristics of HYALINE are very similar to those of the aqueous phase of the tear film, which ensures very good efficacy and safety : • The sodium hyaluronate present in HYALINE is a natural polymer with viscoelastic properties that lubricate and hydrate the surface of the eye. • HYALINE has a physiological pH of 7.4, which promotes the action of lyzozyme in the tears. • HYALINE has the same osmolarity as the tears (335 mOsm./Kg). L C A P H A R M A C E U T I C A L • The fact that it contains no preservative or antiseptic eliminates the potential risk of allergy or cytotoxicity. The presentation in a single-dose container ensures that the product is sterile, safe and effective each time it is used. HYALINE ensures optimum humidification and lubrication of all the mucous membranes of the surface of the eye HYALINE relieves the symptoms of ocular irritations : • Sensation of a foreign body in the eye. • Sensation of dry eyes. • Poorly defined oculo-palpebral discomfort. • Burning sensations. • Tingling sensations. INDICATIONS : • Symptomatic treatment of disorders affecting the surface of the eye. • Treatment of ocular irritation. • Adjuvant treatment for dryness of the surface of the eye. PRECAUTIONS FOR USE : HYALINE has no contraindication. HYALINE contains no preservative, which means that it can be used by subjects with soft contact lenses. If you are in any doubt, do not hesitate to ask you doctor or your pharmacist for advice. The single-dose container must be used immediately after opening, discarded after use and must not be kept for subsequent use. To avoid contamination, you are advised to wash your hands before using it, and not to allow the tip of the single-dose container to come into contact with your fingers or eyes. If several local ocular treatments are used, the efficacy of eyedrops or of an ocular ointment may be impaired as a result of simultaneously instilling HYALINE ocular irrigation solution. You should wait 10 minutes between successive ocular instillations, and always start by the irrigation with HYALINE ophthalmic solution unless specifically instructed otherwise by your doctor. STORAGE BEFORE OPENING : Do not use after the limit date shown on the outer packaging. Store at room temperature. ATHLETES : HYALINE ophthalmic solution does not contain any active constituent that could test positive in antidoping tests. METHOD AND ROUTE OF ADMINISTRATION : • Route : ocular external. • Method of administration : irrigation of the surface of the eye. • When and how often HYALINE should be administered : 2 to 4 times a day, spread over the day. HOW TO USE HYALINE ? POSOLOGY : FOR OCULAR IRRIGATION : 2 to 4 times a day, the irrigation is carried out directly onto the surface of the eyeball, by pressing the sides of the bottle to squirt out a jet of the solution. You are advised to pull your bottom eyelid down, look up, and then pull the top eyelid upward and look down, in order to make sure that the solution spreads over the whole surface of the eye in order to increase the volume of the tear film, and hydrate the tissues. HYALINE : 2 ml pack of 16 - ACL Code : 4574488 2 ml pack of 28 - ACL Code : 4703046 9, allée Prométhée, 28000 CHARTRES, France - Phone : +33 (0)2.37.33.39.30 - Fax : +33 (0)2.37.33.39.39 - Email : [email protected] - Web : www.lca-pharma.com