VISIOL 20 mg pre-filled syringes, 1 pc

Product features

Visiol 20 mg pre-filled syringes are a viscoelastic solution specially developed for eye surgery.The solution contains sodium hyaluronate at a concentration of 2.0% and is sterile by moist heat.No prescription is required for this product.

Composition

1 ml of the isotonic solution (pH 6.8-7.5; osmolality: 270-330 mOsmol/kg) contains 20.0 mg sodium hyaluronate from fermentation as well as sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, mannitol and water for injections.

Areas of application

Visiol is used as a surgical aid in surgery of the anterior segment of the eye.These include, among others, cataract surgery, the implantation of an intraocular lens (IOL), corneal transplantation and glaucoma filtration.

Contraindications

Visiol must not be used if there is a known hypersensitivity to any of the ingredients.

Interactions

Visiol should not come into contact with instruments that have been sterilized with solutions of quaternary ammonium salts.

Side effects

Sodium hyaluronate is a natural component of the extracellular matrix and is well tolerated in the eye.To date, no postoperative inflammatory reactions associated with the use of Visiol have been reported.In rare cases, a temporary increase in intraocular pressure may occur following the use of various sodium hyaluronate products that have not been completely removed from the anterior chamber.

Clinical studies with Visiol have shown no evidence of a significant increase in pressure, even when the device remained partially in situ after the procedure.However, a temporary slight increase in intraocular pressure after using Visiol cannot be completely ruled out.

Dosage instructions and method of application

The pre-filled syringe is removed from the sterile packaging, the cap is removed from the Luer lock connection and a suitable cannula is attached.Before the injection, any air bubbles that may be present are removed from the syringe.

Visiol can be used at any stage of cataract surgery to achieve a deep anterior chamber, protect delicate tissues and facilitate IOL-implantation.The required amount of Visiol is slowly and carefully instilled into the anterior chamber using a cannula.Visiol can also be used to coat the surgical instruments and the IOL.

After the callus is removed, the anterior chamber is filled with Visiol.The transplant is applied to the Visiol and sewn into place.

During the trabeculectomy, the required amount of Visiol is slowly and carefully instilled into the anterior chamber through paracentesis.

Precautions

To avoid an intra- and/or postoperative increase in intraocular pressure, the usual precautionary measures for eye procedures should be observed.Overfilling the eye with Visiol should be avoided.Visiol should be administered with care, particularly in glaucoma patients and during filtering glaucoma procedures.

If there is a significant postoperative increase in intraocular pressure, appropriate measures should be taken to treat it.Visiol should be removed by suction or irrigation at the end of the procedure.Do not use if the pre-filled syringe or sterile packaging is damaged.Any solution not used immediately after opening must be discarded to ensure sterility and avoid risk of infection.

Visiol should be stored at temperatures between 2°C and 25°C.The expiry date should be noted.The used pre-filled syringe and the packaging should be disposed of in accordance with ecological considerations or local waste disposal regulations.

Properties and mode of action

Sodium hyaluronate is a biopolymer found in the extracellular matrix, particularly in the vitreous humor of the eye, synovial fluid and umbilical cord.The highly pure sodium hyaluronate from fermentation in Visiol has an average molecular weight of 1.7-1.8 million daltons.Visiol behaves pseudo-plastically, i.e.h.its viscosity decreases as shear force increases.The extrapolated zero shear viscosity of Visiol is 60,000 mPas.

In surgery of the anterior segment of the eye, Visiol creates and maintains a deep anterior chamber and allows a clear view of the operating field.It minimizes tissue contact during surgical manipulation and protects intraocular tissues, such as the delicate endothelium of the cornea, from damage by surgical instruments. Visiol can also be used to coat the instruments and the intraocular lens.It also protects the corneal endothelium from free radical damage and ensures tissue integrity and clear vision during eye surgery.The mannitol component in Visiol helps maintain the rheological properties of hyaluronic acid during phacoemulsification in cataract surgery.

Pack sizes

A pre-filled syringe of Visiol of 20 mg / 1.0 ml in sterile packaging.To be used only by a doctor.