Your Ophthalmologist has prescribed you. Poly (carboxymethylglucose sulfate) Medical device. Patient Information
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1 Your Ophthalmologist has prescribed you Poly (carboxymethylglucose sulfate) Medical device Patient Information
2 Why is it so important to treat diseases of the cornea? The cornea plays a major role in sight. A healthy cornea is essential for good vision. The cornea is also the eye s first line of defence against external aggression. The cornea PROTECTS the eye against bacteria, dust and other foreign bodies. The cornea is a transparent STRUCTURE with a highly organized architecture designed to maintain its integrity. 2
3 What happens when the cornea is injured? Superficial corneal damage can be repaired by the eye s in-built healing mechanisms before infection develops. When the damage is deeper, the healing process takes much longer. It is important TO SEE AN OPHTHALMOLOGIST quickly. COMPLIANCE with the treatment prescribed is ESSENTIAL for a successful outcome. Epithelium Bowman s layer Lens Macula Stroma Cornea Optical nerve Descemet s membrane Endothelium Retina 3
4 What happens when the cornea is injured? Persistent epithelial defects, healing defects, keratitis or neurotrophic ulcers... What are they? These are serious conditions which require diagnosis and treatment by an ophthalmologist specialising in, for example: Persistent epithelial defects: Very slow healing of corneal wounds or failure to heal with standard treatments, sometimes with recurrence of the impairment. Neurotrophic or recurrent keratitis or ulcers: Major healing difficulties caused by loss of corneal sensitivity potentially resulting in corneal perforation. When local treatments fail, these conditions often require major surgery, a graft or long-term treatment. D0 D5 D8 Photos copyright V. Ratnalingam 4
5 The mechanism of action of belongs to the REGENERATING AGENT family (or RGTA ). These agents are used for MATRIX THERAPY (or corneal matrix repair therapy). triggers REGENERATION of damaged tissues for ENHANCED HEALING and makes it possible to DELAY OR AVOID a more invasive surgical procedure. The pharmaceutical company Théa has carried out scientific studies to develop. This medical device is a regulated healthcare product which, in compliance with the relevant legislation, bears CE marking. 5
6 An effective and simple treatment. Each box contains 5 detachable and ready-to-use single-dose units. Preservative-free. Store at room temperature (between 4 C and 25 C). an effective treatment Dosage regimen: 1 TO 2 DROPS ONCE A WEEK. YOUR OPHTHALMOLOGIST MAY ADJUST THIS DOSE. 6 Ask your ophthalmologist if you have any questions
7 How to use? The recommended dosage is 1 TO 2 DROPS ONCE A WEEK. Your ophthalmologist may adjust this dosage. The length of your course of treatment may vary depending on how quickly you heal. Do not use the drops more often: this could slow down the healing process. Ask your ophthalmologist if you have any questions 7
8 Method of administration Your treatment is supplied in single-dose units. Throw the container away after each use, even if it is not completely empty. 01 Wash your hands and make sure you are sitting comfortably. 02 Open the single-dose unit and gently pull down the lower lid of the eye you are going to treat. 03 Hold the tip of the container as close as you can to the eye without touching it. 04Squeeze the container gently to release a single drop into the eye, then let go of the lower lid. 05 Throw the container away. 8 Ask your ophthalmologist if you have any questions
9 How to get? (Information for patients) Your ophthalmologist has prescribed for you. It is important that you START YOUR TREATMENT QUICKLY. Any pharmacy can order for you. is not reimbursed by the national healthcare insurance system. The recommended retail price is 60 (VAT included). Three boxes are generally required for a course of treatment at the recommended dose. Ask your ophthalmologist if you have any questions 9
10 Are there any precautions for use? If you are going to use several different types of drops USE OTHERS. FIRST AND THEN WAIT AT LEAST 15 MIN BEFORE USING ANY Don t forget to tell your ophthalmologist about any other treatments you are taking (including over-the-counter medications). These drops must not be used with certain local antibiotics (for example, aminoglycoside antibiotics containing neomycin or gentamicin). Do not use solutions containing silver, copper or iodine salts. Do not use the drops if you are allergic to any of the ingredients. 10 Read the patient information leaflet carefully Ask your ophthalmologist if you have any questions
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12 Poly (carboxymethylglucose sulfate) Medical device WCAC BPAT BA Laboratoires Théa - 12, rue Louis Blériot Clermont-Ferrand Cedex 2 - France Tél. : Fax :
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