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Deflux Sterile eye drops based on palmitoylethanolamide and hydrophilic and moisturizing polymers No preservatives INSTRUCTIONS FOR USE COMPOSITION Palmitoylethanolamide (PEA), sodium salt of hyaluronic acid (NaHA), polyvinyl alcohol (PVA), methyl-β-cyclodextrin (MBCD), tribasic potassium citrate monohydrate, sodium chloride, glycerol, citric acid monohydrate, disodium phosphate dodecahydrate, monosodium phosphate dihydrate, purified water, in isotonic ophthalmic solution at physiological pH. PACKAGING DEFLUXA 15 single-dose containers of 0.4 ml sterile eye drops, presented in a box containing 3 blisters of 5 ml each, each blister inserted into an aluminum pouch. CHARACTERISTICS AND MECHANISM OF ACTION DEFLUXA is a sterile, isotonic ophthalmic solution at physiological pH, consisting of palmitoylethanolamide (a lipid molecule), hydrophilic and hydrating polymers (hyaluronic acid, polyvinyl alcohol and cyclodextrin), glycerol (a molecule with humectant and osmoprotective action) and mineral salts. DEFLUXA is able to rebalance the homeostasis of the ocular surface and rebuild the tear film in all cases of qualitative and quantitative changes resulting from chronic treatments with topical ocular medications with hypotensive action. Specifically, DEFLUXA stabilizes the tear film and maintains the lubrication of the ocular surface by restoring the three layers of the tear film: lipid, aqueous and mucinous. PEA, a natural lipid molecule, integrates the lipid layer of the tear film (the outermost layer), prevents water hyperevaporation and helps maintain a protective tear layer on the ocular surface. The hydrophilic and moisturizing polymers present in DEFLUXA (hyaluronic acid, polyvinyl alcohol, cyclodextrin) retain water and restore the aqueous layer of the tear film. Hyaluronic acid also has mucomimetic and mucoadhesive properties; therefore, it is able to interact with the mucin layer and stabilize it. Glycerol has a humectant and osmoprotective action, and the minerals (sodium, potassium, chloride, citrate, phosphate) have a nutritional function on the ocular surface, as well as regulating pH and osmolarity. INSTRUCTIONS DEFLUXA stabilizes the tear film, hydrates, lubricates and protects the ocular surface in all cases of qualitative and quantitative changes in the tear film, including those resulting from chronic treatments with topical ocular medications with hypotensive action. DOSAGE AND METHOD OF USE Hold the single-dose container vertically above your eye and gently pull down on the lower eyelid. Fig. 1 Peel a single-dose container from the foil by holding it at the bottom, opposite the label. Fig. 2 Gently touch the single-dose container for a few seconds (like a clinical thermometer) until all the preparation reaches the neck of the container. Fig. 3 Turn the top of the single-dose container. Fig. 4 Hold the single-dose container vertically above the eye to instill the preparation. Instill 1 or 2 drops into the eye up to 5 times a day, as directed by your doctor, by gently pressing the single-dose bottle. It is recommended to hold the single-dose bottle in an upright position (as shown in Fig. 4 ) during instillation. STORAGE METHODS AND VALIDITY - Do not use the product after the expiry date stated on the box. This period refers to the product stored at room temperature (≤25°C). - Keep the product away from light, storing the single-dose vials in the aluminum bag. - DEFLUXA does not contain preservatives. Therefore, the single-dose container and any unused portion should be discarded after opening and use. Once the single-dose container is opened, sterility requirements are no longer guaranteed. PRECAUTIONS/WARNINGS - Wash your hands before use. - Keep out of the reach and sight of children. - Do not use in case of specific hypersensitivity to one of the product components. - Do not swallow the solution. - Do not instill into the eyes at the same time as other ophthalmic products, as it may alter their effects. An interval of at least 15 minutes must be observed between one instillation and the next. - Not intended for use with contact lenses. - Not for use in children under 3 years of age. Code 9011
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