Laservis SmPC
Prescribing Information
NAME OF PRODUCT:
LASERVIS®
Sodium hyaluronate 0.25%
INTENDED USE:
Viscous masking and wetting solution in excimer laser surgery and other surgical procedures. Sterile, free from preservatives.
COMPOSITION:
1 ml of isotonic solution contains 2.5 mg sodium hyaluronate obtained by fermentation, sodium chloride, potassium chloride, disodium-hydrogenphosphate, sodium citrate, magnesium chloride, calcium chloride, glucose and water for injection.
INDICATIONS:
Viscous masking and wetting solution in excimer laser surgery and other surgical procedures.
CONTRA-INDICATIONS:
Hypersensitivity to the product.
INTERACTIONS:
Avoid using LASERVIS® with instruments sterilised with quaternary ammonium salts solution.
DOSAGE AND ADMINISTRATION:
Take the LASERVIS® container out of the sterile sachet, twist off the cap from the container and attach an appropriate sterile cannula. By squeezing the container apply the product onto the surface of the cornea or the stroma before, and alternating with, laser treatment. Sufficient solution should be applied to cover the surface of the cornea or the stroma. The product may also be applied onto the surface of the eye before bandaging.
WARNINGS:
Do not use LASERVIS® if the container is damaged. As LASERVIS® does not contain preservatives, any solution not used during the procedure should be discarded. Store at a temperature not exceeding 25°C (77°F). Do not use LASERVIS® after the expiry date. Keep out of the reach of children.
CHARACTERISTICS AND MODE OF ACTION:
LASERVIS® contains sodium hyaluronate, a natural polymer which is also present in the structures of the eye. The physical characteristics of sodium hyaluronate confer important rheological properties to the product. LASERVIS® has been formulated to have a photoablation rate similar to that of corneal tissue.
LASERVIS® forms a stable and uniform coating on the delicate surfaces of the eye, filling depressions on the cornea and effectively masking tissues to be protected against ablation by the laser pulses. This contributes to a smoother surface of the cornea after the procedure and to a reduction of scar formation, regression and duration of haze. LASERVIS® also ensures that the cornea remains wet and transparent during surgical procedures.
PACKAGING:
1 strip of 5 x 2 mL mono-use containers in a sterile sachet.