Oxyal^® (Solution) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Tubilix Pharma, S.p.A. (Italy)

Dosage Form

Oxyal®

Ophthalmic moisturizing solution 0.15%: fl. 10 ml

Dosage Form, Packaging, and Product Composition

Excipients: boric acid, Protector, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, Oxyd 0.06%, purified water.

10 ml – bottles (1) – cardboard packages.

Properties

Oxyal^® is a moisturizing ophthalmic solution containing 0.15% hyaluronic acid.

The hyaluronic acid contained in the preparation is obtained by fermentation, not by extraction from animal raw materials.

The activity of hyaluronic acid is optimized and prolonged due to the synergistic action of Protector – a film-forming polymer.

The presence of electrolytes (chlorides, sodium, potassium, calcium, and magnesium), which are necessary for cellular biochemical processes, and the slightly reduced isotonicity of the solution help maintain physiological conditions on the eye surface.

Oxyal^® contains Oxyd, a created and patented preservative system developed in the research laboratory of Tubilix Pharma, which transforms into oxygen, water, and sodium chloride upon contact with the cornea.

These substances, which are naturally found in tear fluid, do not irritate the eye mucosa and support the healthy condition of epithelial cells.

Oxyal^® moisturizes and lubricates the eye surface, quickly and for a long time relieves discomfort when wearing soft and rigid contact lenses, and also reduces the sensation of dryness, irritation, and eye fatigue caused by external factors such as prolonged exposure to video screens and monitors, air conditioning, dust, pollution, smoke, and other environmental and stress influences.

Scope of Application

Of the Oxyal^® product

• For moisturizing and lubricating the eye surface;
• For long-term relief of discomfort associated with contact lens wear, adverse environmental influences, and stress.

ICD codes

Dosage Regimen

Before using the Oxyal^® solution, it is necessary to ensure that the packaging seal is intact.

Hands should be washed thoroughly.

To open the bottle, it is necessary to completely unscrew the cap until the ring separates, indicating that the bottle has not been opened previously.

Turn the bottle upside down and instill 1 or 2 drops into each eye, or as recommended by a specialist.

After use, the bottle must be tightly closed.

If there is no improvement, a specialist should be consulted.

Side Effects

Rare cases of moderate eye irritation have been reported with the use of the preparation.

Contraindications

• Hypersensitivity to any of the components of the preparation.

Special Instructions

Do not instill Oxyal^® into the eye(s) together with other preparations, as their action may be altered.

To avoid possible contamination, do not touch the tip of the dropper to any surfaces.

If pain, eye redness, or decreased vision occurs after instillation, the use of the preparation should be discontinued.

If the listed symptoms do not subside or intensify, the patient should consult a doctor.

Any remaining preparation should be discarded.

Do not swallow the solution.

Storage Conditions

Oxyal^® should be stored out of reach of children, in a place protected from sunlight at a temperature below 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years. Do not use the solution after the expiration date.

After opening the bottle, the solution must be used within 60 days.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.