EktalM is a medical device for ophthalmic use consisting of a hypotonic sterile solution with physiological pH, without preservatives, based on ectoine and sodium hyaluronate. Ectoine is a natural molecule capable of protecting eye tissues from external damage, in particular from ultraviolet radiation or artificial blue light emitted by video screens. Due to its antioxidant action against free radicals, ectoine inhibits photo-oxidative damage to proteins and lipids, reduces the release of stress mediators, and promotes the production of protective substances. It also stabilizes the lipid layer of the tear film, which is responsible for controlling its evaporation.
Sodium hyaluronate, a polymer with high biological compatibility, restores the aqueous layer of the tear film due to its moisturizing action. In combination, sodium hyaluronate and ectoine stabilize the ocular surface, maintaining a high concentration of water and preventing dry eye syndrome.
EktalM is intended for the protection, stabilization, and moisturizing of the ocular surface in the following cases:
- photoexposure of the eyes to sunlight at the seaside, in the mountains, or even daily outdoors;
- prolonged use of artificial light sources (PC, tablet, smartphone, television);
- ophthalmic stress caused by extreme environmental conditions such as high salinity, temperature fluctuations, and dry environment.
EktalM can be instilled before and during the use of contact lenses for better application and
comfort.
INSTRUCTIONS FOR USE:
1. Open the protective foil pouch.
2. Wash your hands thoroughly before use.
3. Detach the single-dose container from the strip and open it by turning the cap.
4. Gently press the single-dose container and instill 1–2 drops into each eye.
5. After instillation, close the container and reuse the remaining solution within 12 hours.
6. Store unused containers in the original packaging.
7. The product is intended for use by one patient only to avoid possible infection.
8. The product can be used with contact lenses.
FREQUENCY OF USE:
Instill 1–2 drops into the eye 1–2 times a day or as prescribed by a physician. COMPOSITION: ectoine 2%, sodium hyaluronate 0.1%, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, purified water.
PACKAGING:
The box consists of 2 foil pouches, each containing one strip of 5 single-dose containers. Each single-dose container is filled with 0.5 ml and can be reclosed.
WARNINGS
• The product is intended for ophthalmic use only; do not swallow and do not use otherwise than indicated in the instructions.
• After opening the single-dose container, it must be closed with the appropriate cap and the remaining solution must be used within 12 hours from the moment of opening in order to avoid possible contamination of the product.
• Keep out of the reach of children.
• During instillation, do not touch the eye or other surfaces with the tip of the single-dose container.
• Do not use the product in case of known incompatibility with at least one component of the product.
• If necessary, consult your optometrist regarding compatibility with the use of contact lenses.
• In case of any adverse reaction during use, discontinue treatment and consult a physician or pharmacist.
• Consult a physician regarding use during pregnancy, lactation, and for children.
• Treatment with ophthalmic drugs or other ophthalmic medical devices should be carried out under the supervision of a physician who can assess possible interactions.
• In case of damage to the ocular surface or damage to the cornea, consult a physician.
• Do not use the product after the expiry date indicated on the packaging.
• In case of any serious complaints or incidents related to the device, the incident should be reported to the manufacturer and the competent authority of the Member State in which the user resides in order to provide more information on the safety of this medical device.
SHELF LIFE: 36 months with intact packaging.
Manufacturer:
Enable Innovations S. r. l., Via Claudio Tolomeo n°26, 41012, Carpi (MO), Italy
Authorized Representative in Ukraine:
VISUS PHARM LLC, 5-B Budindustrii Street, Kyiv, 01013, Ukraine. Tel.: +380 44 281-24-06.
Email: info@visuspharm.com