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Description Oviso Ultra Intense A medical device in the form of a sterile solution with a physiological pH for ophthalmic use. The drops are based on a patented technology of cross-linking hyaluronic acid (HA) with urea, which enhances and strengthens the unique mechanical properties of hyaluronic acid, providing it with significantly longer resistance to degradation by hyaluronidase than linear HA, thus providing a stronger and longer-lasting moisturizing and lubricating effect than linear HA. No preservatives. Composition Aqueous solution of cross-linked sodium hyaluronate (including cross-linked sodium hyaluronate 0.4%), trometamol, hydrochloric acid 2N, sodium chloride, water for injection. Package contents OSD dispenser bottle (ocular squeeze applicator) containing 10 ml of eye solution. Action The hydrated structure of cross-linked HA has the ability to gradually release water over a longer period, improving the lubricating properties of linear HA while simultaneously enhancing its moisturizing effect. Therefore, this solution is indicated as an adjunct in the treatment of dry eye syndrome. Cross-linked HA imparts lubricating, moisturizing, and regenerative properties to the product, providing relief from dry eye conditions caused by dry eye syndrome, irritation, or eye fatigue due to inflammation, or environmental factors. Indications Oviso Ultra Intense is recommended for: to restore and improve tear film stability in dry eye syndrome; after refractive eye surgery; to relieve the symptoms of redness, fatigue and discomfort of the eyes or ocular mucosa caused by: – environmental factors (air conditioning, excessive exposure to sunlight, wind, smoke, pollution, sea or pool water, sea air); – dry eyes resulting from excessive fatigue caused by long-term work at the computer or studying; – secondary disorders of the lacrimal gland function following inflammation, chronic blepharitis; – secondary disorders of the lacrimal gland function after various types of eye surgery or eyelid plastic surgery; – wearing soft or semi-rigid contact lenses. How to use a medical device Wash and dry your hands thoroughly before use; Before first use, remove the protection. Remove the protective cap and open the bottle; Turn the bottle upside down and gently squeeze to release 2 drops into each eye, unless otherwise directed. After each drop, wait a few seconds without squeezing the bottle to allow air to flow through the sterile filter. Otherwise, it will be more difficult to extract the drops. Contraindications and precautions Before use, please read the instructions for use or the label. Do not use if you are allergic to any of the products ingredients. If you experience any disturbing symptoms or adverse reactions, discontinue use and consult your doctor. Store out of reach of children. Protect from light and moisture. As the bottle gradually empties, it may be necessary to apply more pressure to dispense the drops. This is due to the closure system, which maintains the sterility and chemical and physical properties of the preservative-free solution. A small amount of solution will always remain in the bottle. After use, shake off the remaining drop from the applicator tip. The bottle should be closed immediately with the protective cap. Do not replace the protective cap if the bottle is still squeezed. Do not touch anything with the applicator tip, including your eye or fingers. The contents should be used within 3 months of first opening. Notes and precautions The product is intended for ophthalmic use only. The product is intended for use by one person. Do not use the product if the bottle is damaged or not fully closed upon first opening. Do not use the product if particles are visible in the solution or if its color has changed. During application, do not touch your eyes or any other surface with the edge of the bottle dispenser. Do not use the product after the expiry date indicated on the packaging and label. If side effects occur while using the product, discontinue use and contact your doctor. Do not use the product in case of hypersensitivity to any of the solution ingredients. Storage conditions: Store at a temperature between 2°C and 30°C, in a dry place, away from heat sources and direct sunlight. Dispose of the product in accordance with local waste management regulations. Keep out of the reach and sight of children. For external use, do not swallow. Do not tamper with the dispenser or remove it from the bottle. Any serious incident involving the product must be reported to the manufacturer and the competent authority of the Member State in which the user is resident. Possible side effects of a medical device Immediately after application, the product may cause slight, temporary blurring of vision due to the viscosity of the solution. Therefore, it is recommended to wait a few seconds before undertaking any activity requiring clear vision. Using the product with other medications Oviso Ultra Intense are compatible with contact lenses. There is no information about interactions with medications or other eye drops, however, other eye drops should only be used after a minimum of 15 minutes. Pregnancy and breastfeeding Pregnant or breastfeeding women should consult their doctor before using the product.
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