Thealoz (Solution) Instructions for Use

Marketing Authorization Holder

Laboratoires Théa (France)

Manufactured By

Excelvision (France)

Contact Information

TEA FARMA LLC (Russia)

Dosage Form

Thealoz

Moisturizing and lubricating solution for eye protection 0.3 g/10 ml: fl.

Dosage Form, Packaging, and Product Composition

Excipients: sodium chloride, trometamol, hydrochloric acid, purified water.

10 ml (300 drops) – ABAK multidose bottles (1) – cardboard packs.

Therapeutic Category

Medical device for moisturizing and protecting the ocular mucosa

Properties

Thealoz is a sterile, isotonic, preservative-free ophthalmic solution with a neutral pH. The main component, Trehalose, is a substance of natural origin present in the organisms of many animals and plants capable of surviving in extremely dry conditions.

Trehalose has physicochemical characteristics that provide protective, antioxidant, and moisturizing properties. For these reasons, it is an important element in the antithrombotic mechanism observed in certain microorganisms (a state of slowed metabolism that allows them to survive under dehydration conditions).

Trehalose also has properties that contribute to the protection and stabilization of the cell membrane by preventing protein modification and lipid damage, in addition, it exhibits antioxidant functions.

Thealoz is supplied in an ABAK multidose bottle. This patented system administers the eye drops by first passing them through a membrane filter with a pore size of 0.2 µm, thus preventing any bacterial contamination of the solution.

The bottle contains 300 drops of solution, has a neutral pH and is preservative-free, which is why it is generally well tolerated by patients.

Scope of Application

Of Thealoz product

• For the sensation of dry eyes (discomfort, burning, irritation) and fatigue resulting from exposure to external factors such as wind, smoke, air pollution, dust, dry heater air, air conditioning, air travel, prolonged computer work.

ICD codes

Dosage Regimen

Instill 1 drop of Thealoz into each eye during the day as needed.

Method of administration

• Wash hands thoroughly before use;
• Avoid contact of the lens surfaces and the tip of the bottle, especially if an eye infection is suspected;
• To instill Thealoz into the conjunctival sac, gently pull down the lower eyelid and look upward.

Close the bottle after use.

Side Effects

In rare cases mild eye irritation.

Contraindications

• History of allergic reactions to any component of the product.

Special Precautions

Thealoz can be used while wearing contact lenses.

Thealoz should not be used for injections or oral administration.

Do not use the product if the protective ring is damaged.

Drug Interactions

In case of concomitant use with other ophthalmic products, it is recommended to maintain an interval of at least 10 minutes between the instillation of Thealoz and the application of other eye drops.

Storage Conditions

Thealoz should be stored out of the reach of children at a temperature up to 25°C (77°F).

After opening the container, the solution should be used for no more than 8 weeks.

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.