Instructions for Use
NAME OF PRODUCT:
Lubricant eye drops
For lubrication of the eyes in case of sensations of dryness, burning and ocular fatigue, and other minor complaints of no pathological significance, induced, for example, by dust, smoke, dry heat, air-conditioning, extended computer screen use or contact lens wear.
Active ingredient: Sodium hyaluronate 0.1%
Excipients: Sodium chloride, disodium-hydrogenphosphate, sodiumdihydrogenphosphate, purified water, disodium edetate and polyhexanide as preservatives. The solution is isotonic (300 mOsm/l) and adjusted to pH 7.3.
Multidose container of 15 ml containing 0.1% sodium hyaluronate for topical ophthalmic use.
DOSAGE AND ADMINISTRATION:
Twist the screw cap on the multidose container firmly clockwise before using VISMED® light for the first time: a spike in the screw cap will pierce the tip of the container.Twist off the screw cap and position the tip of the container above the eye to be treated: upon slight pressure,VISMED® light will easily flow out of the container. If not otherwise recommended, place one or two drops of VISMED® light into the conjunctival sac of the eye as often as needed. After blinking, the solution will disperse and form a transparent and long-lasting coating on the surface of the eye. VISMED® light may also be used while wearing contact lenses (rigid or soft). Solution from the open container may be used for up to 3 months.
CHARACTERISTICS AND MODE OF ACTION:
VISMED® light contains a highly purified specific fraction of sodium hyaluronate produced by bacterial fermentation and is therefore free from animal proteins. Sodium hyaluronate is a natural polymer, which is present throughout the human body and also in the structures of human eyes. Its main physical characteristic is viscoelasticity.This means that VISMED® light has a high viscosity between blinks and a low viscosity during blinking, ensuring efficient coating of the surface of the eye.
Sodium hyaluronate also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucusglycoprotein.
VISMED® light has been carefully formulated to have the required concentration of sodium hyaluronate (0.1%), shown to be efficacious in relieving sensations of ocular dryness. The preservative in VISMED® light has been carefully balanced to be non-cytotoxic, while keeping the solution sterile.
VISMED® light offers an unmatched combination of longlasting protection, symptomatic relief and comfort by increasing the tear film break-up time, due to its increased residence time, and coating ability, as well as providing all of the elements required to restore the normal properties ofthe tear film.
Results of acute, sub-acute and chronic toxicity studies together with the results of the foetal toxicity, fertility, periand post-natal toxicity studies show that sodium hyaluronate is very well tolerated. In addition, animal studies show that repeated topical ocular administration of sodium hyaluronate is also well tolerated.
Do not use VISMED® light at the same time as any other drug or product applied to the eye since it may modify their effects.
Store at room temperature, below 25°C, in original packagingand away from heat sources and light.
2 years if stored in original packaging.
VISMED® light is presented in a preserved, multidose bottle of 15 ml.