Full Data Page (Products) List
Notes
Remogen Omega (Eye Drops Vials).
Details
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How Supplied Sterilised clear, colourless, hypotonic, physiological pH, micro-emulsion eye drops in single-use (0.25ml x 5) plastic vials in pouch, box of 4 pouches. |
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Dosing ECP/HCP to advise. Generally 1 or 2 drops on eye as required. |
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Formulation Sterile solution containing:, Eicosapentaenoic Acid (EPA) Ethyl Ester 1.2mg, Docosahexaenoic Acid (DHA) Ethyl Ester 0.02mg, Alpha-Tocopheryl Acetate (Vitamin E), Glycerol, Polyacrylic Acid, Acrylates/Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Di-Sodium Phosphate and Water for Injections. |
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Contact Lens Use Yes, if required. |
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Indications "Licensed Indication: REMOGEN® OMEGA soothes, refreshes, lubricates, nourishes, hydrates and protects the ocular surface in all cases of qualitative and quantitative alterations and instability of the tear film that cause sensations of dryness, burning and discomfort of the eyes. In particular it can be used in case of symptoms and signs of dry eye and/or ocular surface damage, due to diseases such as superficial keratitis, Sjögren’s syndrome or primary dry eye syndrome. For lubrication of the eyes in case of sensation of dryness, burning and ocular fatigue and other minor complaints of no pathological significance induced, for example, by dust, smoke, dry heat, air conditioning, wind, cold, extended computer screen use, diseases of the immune system of the ingestion of drugs that reduce the tear secretion. Due to its protective action on the corneal and conjunctiva epithelia REMOGEN® OMEGA can be used in all cases of ocular irritation." See Notes 3. |
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Contra-Indications/Cautions Hypersensitivity to product/class/component. "Do not touch the tip of the opened container and do not touch the surface of the eye with tip of the opened container. Any solution not used immediately after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not use REMOGEN® OMEGA if the aluminium pouch or the containers are damages. Store between 2˚C and 8˚C! Do not use REMOGEN® OMEGA after the expiry date indicated on the container and the folding box. This period refers to the product kept in the refrigerator (2˚C – 8˚C). Outside the refrigerator, the product has a shelf-life of 3 months if stored at a temperature below 25˚C and in its original packaging. Keep the product away from light, storing the singe-dose containers in the aluminium pouch. If discomfort persists while using REMOGEN® OMEGA consult a clinician. Keep out of reach of children." Pregnancy/lactation - EDDB. Advise pt to read and understand all accompanying product information before first use - EDDB. Pt to wait at least 15 minutes between two different eye drops. |
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Adverse Reactions "On rare occasions transient disorders such as irritation of the conjunctiva, foreign body sensation, watery eyes or sticky eyelids, itching, redness, stinging or burning sensation of the eye as well as short-term blurred vision may occur". If irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP. If vision changes or irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP. |
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Legal Category N/A |
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Notes 1. Confirm storage instructions by reference to product information. 2. Because products are regularly improved and change, product data and advice may occasionally change. As a result, EDDB recommends that you and your patient always read the product label and Patient Information Leaflet carefully before using any products. Please do not solely rely on the information provided on this website. Because of this, EDDB is unable to accept liability for any inaccuracies or incorrect information contained on this site. 3. "REMOGEN® OMEGA has been formulated for ocular surface damage caused by blepharitis, dry eye and eye surgery. Its unique formula has been developed to:Nourish the ocular surface with vital nutrients. Omega-3 fatty acids4 reconstitute the lipid layer of the tear filmVitamin E limits lipid oxidation and prevents free radical damage after eye surgery. Rebalance the homeostasis of the tear film. Reduce hyperosmolarity Hydrate the eye. Protect the corneal and conjunctival ephithelia." 4. 5. 6.
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Product information
Not every product may be listed, or have full data. Every effort is being made to fill in the gaps as soon as possible. It will continue to grow in breadth and depth as data arrives and products are released, almost on a daily basis. Endeavours will be made to include information on 'retailers' drops such as Sainsbury's, Superdrug etc, so you can have data available when your patient tells you they are using Tesco Allergy Drops (Sodium Cromoglicate) and asks "can I use it with my contact lenses?". If you would like to propose products for the database, have any ideas, suggestions, would like to provide missing data or see any factual inaccuracies please email adpconsultancy@gmail.com
