Description
Medical device.
Indicated for the protection, hydration, and lubrication of the eye in the treatment of moderate to severe dry eye syndrome.
For ophthalmic use only.
- Adults.
- Children: the product must be administered by a parent or guardian.
- Pregnant or breastfeeding women based on current knowledge.
- Contact lens wearers.
Ophthalmic solution composed of trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid, and water for injections.
THEALOZ DUO is a sterile, phosphate-free, hypotonic, and pH-neutral solution.
The solution is supplied in an ABAK multi-dose bottle. This innovative and patented device dispenses the eye drops through a 0.2 mcm filter, preventing any bacterial contamination of the solution without the use of preservatives.
Therefore, THEALOZ DUO is gentle on the eyes as it is preservative-free. The absence of preservatives allows for the protection of ocular tissues and also does not cause reactions in users sensitive to preservatives.

Instructions for use
Dosage: 1 drop in each eye, 4 to 6 times a day.
No special training is required to use THEALOZ DUO.
Wash hands thoroughly before use. Do not use any tools to open the bottle.
When using THEALOZ DUO for the first time, the first drop takes longer to come out due to the bottle's filtering system.
Apply one drop into the eyelid cavity, gently pulling down the lower eyelid and looking up. Gently close the eye after application.
Replace the cap on the bottle after use.
Recommended for discomfort, stinging, foreign body sensation, or eye irritation due to moderate to severe dry eye. Such symptoms can be caused by external factors such as wind, smoke, pollution, dust, sun or cold exposure, dry heat, air conditioning, airplane travel, long hours spent in front of a computer screen, and eye surgery such as refractive and cataract surgery.
THEALOZ DUO provides immediate relief from dry eye symptoms, lasting all day, as described below.
THEALOZ DUO is well-tolerated on the ocular surface and can be used by contact lens wearers, regardless of the type of lenses.
The main ingredients of THEALOZ DUO are trehalose and sodium hyaluronate.
Trehalose is a natural substance found in many plants and animals, which can survive in conditions of extreme dryness. It provides protective and moisturizing properties.
Sodium hyaluronate, present in the human eye, retains water to hydrate and lubricate the eye's surface. It keeps the solution on the eye's surface, providing long-lasting relief and shortening the healing time of the corneal epithelium.
Thanks to the combination of trehalose and sodium hyaluronate, THEALOZ DUO offers long-term protection, hydration, and lubrication of the eye's surface.

Instructions for use
Dosage: 1 drop in each eye, 4 to 6 times a day.
No special training is required to use THEALOZ DUO.
Wash hands thoroughly before use.
Do not use any tools to open the bottle.
When using THEALOZ DUO for the first time, the first drop takes longer to come out due to the bottle's filtering system (see Device Description).
Apply one drop into the eyelid cavity, gently pulling down the lower eyelid and looking up. Gently close the eye after application.
Replace the cap on the bottle after use.

Components
Trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid, and water for injections.

Warnings
Do not inject or ingest.
Do not use THEALOZ DUO if you are allergic to any of its ingredients (see Device Description).
Multi-dose product for a single patient.
Do not use the same bottle for multiple people to prevent cross-contamination.
Check that the packaging is intact before using this product.
Check that the tamper-evident seal on the bottle is intact before using it for the first time.
To avoid contamination, do not touch the tip of the bottle with any surface.
A healthcare professional should be contacted if symptoms worsen or do not improve.
Keep out of sight and reach of children.
After use, do not drive or operate machinery. If vision is blurred, wait a few minutes for vision to clear.
Wait at least 10 minutes between using two different ophthalmic products.
Do not dilute THEALOZ DUO or mix with other solutions.
After first use, if exposed to low atmospheric pressure, the bottle may leak.
The following side effects have been reported: rare possibility of blurred vision, allergic reactions, rare possibility of eye irritation, ocular redness, and eye pain.
In such cases, contact lens wearers should remove contact lenses.
When using eye drops, uncomfortable symptoms may occur, such as burning, stinging, and foreign body sensation in the eyes for a short period.
If you notice any side effects or unusual sensations after using this product, contact a healthcare professional and report the information to the local distributor, manufacturer, or local health authority (see contacts at the end of the instructions for use).

Storage
Store at a temperature between 8 °C and 30 °C. Do not expose the product to direct light and humidity.
Do not use after the expiration date, which is stated on the bottle and outer packaging. The expiration date refers to the last day of that month, provided the packaging is intact and has been stored correctly.
Shelf life after opening: 6 months.

Format
10 ml bottle.