Each 1 ml of solution contains: sodium hyaluronate 1.8 mg, sodium chloride 2.8 mg, potassium chloride 1.0 mg, disodium-hydrogenphosphate 3.2 mg, sodium citrate 0.3 mg, magnesium chloride 0.09 mg, calcium chloride 0.09 mg and water for injections to 1 ml.
The formulation is hypotonic (140-160 mOsm/l) and free of preservative.
Pharmacology: Pharmacodynamics: VISLUBE contains sodium hyaluronate, a natural polymer, which is also present in the structures of the human eye. The particular physical characteristics of sodium hyaluronate confer to VISLUBE its viscoelastic, mucomimetic and water retaining properties. In clinical studies, VISLUBE was shown to stabilize the tear film and increase the tear film break-up time (tear film BUT). This resulted in a reduction in the subjective ocular symptoms of burning, photophobia, pain and foreign body sensations and objective signs including tear film BUT, tear volume and staining with Rose Bengal and fluorescein together with an improvement in patient comfort and well being. The hypotonic formulation of VISLUBE also enhanced the treatment effect of VISLUBE in dry eye patients by compensation of the hypertonicity of tears in these patients. Tear hyperosmolarity, a core mechanism of dry eye disease, stimulates inflammatory cascade and cell apoptosis leading to ocular surface damage. Thus hypotonic eye drops would be a reasonable alternative for dry eye treatment. Evidence from many studies showed that treatment with hypotonic eye drops (150 mOsm/l) providing better results in improving signs and symptoms of dry eye disease compared to isotonic eye drops (300 mOsm/l).
VISLUBE also showed a marked reduction in the expression of the CD44 protective marker, the hyaluronic acid receptor which is over-expressed in inflammatory diseases, and increased the expression of protective markers such as mucus and goblet cells, CD63 and UIC2. It also reduced the expression of other inflammatory markers such as human leucocyte antigen-DR (HLA-DR) and cluster differentiation CD40 and caused a decrease in the expression of apoptosis markers such as Fas and Apo2.7. Sodium hyaluronate can also reduce toxic effect from Benzalkonium Chloride (BAK) on the ocular surface by neutralizing the cationic charge of BAK, entrapping BAK molecule into its sponge-like structure, and forming a cytoprotective coat on cell membrane. Moreover, sodium hyaluronate can stimulate corneal epithelial cell migration and proliferation leading to rapid corneal wound healing. The results from many studies showed the ability of sodium hyaluronate to increase healing rate, reduce wound area and improve ocular surface damage. Thus, this would explain the protective, anti-inflammatory, the BAK toxicity reducing, and wound healing effects of VISLUBE.
Pharmacokinetics: Due to its high molecular weight, sodium hyaluronate is not expected to pass through the conjunctiva and the corneal epithelium. Following intraocular administration of sodium hyaluronate, the t½ for elimination of the product from the aqueous humour was around 10.5 h and no product was detected 24 h after administration. After parenteral administration of sodium hyaluronate, this molecule is efficiently metabolized in the liver (t½=2.5 to 5.5 min).
Treatment of dry eye and ocular surface damage due to some conditions and/or diseases for example, post operative eye surgeries; eg. Cataract surgery, LASIK, prolonged use of preservative-containing eye drops such as antiglaucoma drugs. In addition, it can be used for the treatment of superficial keratitis, Sjogren syndrome or primary dry eye syndrome (Keratoconjunctivitis sicca). Temporary relief of dryness, burning and ocular fatigue induced, for example, by dust smoke, dry heat, air conditioning, extended computer screen use or contact lens wear.
Twist off tab. If not otherwise recommended, place one or two drops of VISLUBE into the conjunctival sac of the eye as often as needed. Do not touch the tip of container to the eyes and/or any surface. After blinking, the solution will disperse and form a transparent and long lasting coating on the surface of the eye. VISLUBE may also be used while wearing contact lenses (rigid or soft).
Given the nature of the product and the route of administration, no problems of overdosage are expected as the excess fluid will flow from the eye. A toxicology study following topical ocular administration of VISLUBE, conducted in the rabbit, showed that overdosing with VISLUBE did not result in any clinical or histological adverse events.
Individual hypersensitivity to any constituent of the product.
Pregnancy and lactation: There is no experience regarding the safety of VISLUBE in human pregnancy or lactation. Administration during pregnancy or lactation is therefore depending on physician judgment.
Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of the container. As VISLUBE does not contain preservatives it should be used and discarded after opening. However, based on data from in-use stability study, if used as recommended and carefully recapped, the solution can be used within 12 hours after opening. Do not use VISLUBE if the container is damaged. If discomfort persists while using VISLUBE or reappears after discontinuation of treatment, consult a physician. Patients who experience blurred vision after application of the eye drops should not drive or use machinery until their vision has cleared.
There is no experience regarding the safety of VISLUBE in human pregnancy or lactation. Administration during pregnancy or lactation is therefore depending on physician judgment.
No undesirable effects are expected if used as recommended.
Do not use VISLUBE at the same time as any other drug or product applied to the eye since it may modify their effects. If more than one type of eye drops are applied to the eye, administer them at least five minutes apart. Avoid using VISLUBE with quaternary ammonium compound.
Twist off cap. Instill solution into eye.
Store between 2°C and 25°C.
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Eye drops (monodose) 0.18% x 0.3 mL x 4 x 5's.
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