Thealoz Duo Ophthalmic Solution 10 ml Bottle Lab.thea

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 protects ocular tissues and 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 filtration 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 in case of discomfort, stinging sensation, foreign body sensation, or eye irritation due to moderate to severe dry eyes. These symptoms can be caused by external factors such as wind, smoke, pollution, dust, exposure to sun or cold, dry heat, air conditioning, air travel, many hours spent in front of a computer screen, and eye surgery such as refractive and cataract surgery.
THEALOZ DUO provides immediate, all-day relief from dry eye symptoms, 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 extremely dry conditions. It provides protective and moisturizing properties.
Sodium hyaluronate, present in the human eye, retains water to hydrate and lubricate the eye surface. It keeps the solution on the eye 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 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 filtration 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.
You should contact a healthcare professional if symptoms worsen or do not improve.
Keep out of the 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, eye redness, and eye pain.
In such cases, contact lens wearers should remove contact lenses.
When using eye drops, annoying symptoms such as burning sensation, stinging sensation, and foreign body sensation in the eyes may occur 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 your 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 expiry date, which is indicated on the bottle and outer packaging. The expiry 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.