Ektal M

Composition

Ectoin 2%, Hyaluronic acid 0,1%, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, purified water.

Packaging

The box is composed of 2 foil pouches, each one containing one strip of 5 single-dose vials. Every single-dose vial is filled at 0,5 ml and it is reclosable.

Description

EktalM is a medical device for ophthalmic use, consisting of a hypotonic sterile solution with physiological pH, and preservative-free, based on ectoine and sodium hyaluronate.

Ectoine is a natural molecule that protects ocular tissues from external damage, particularly from ultraviolet radiation or artificial blue light emitted by video screens. Due to its antioxidant action against free radicals, it inhibits photo-oxidative damage against 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, responsible for controlling its evaporation.

Sodium hyaluronate, a highly biocompatible polymer, replenishes the aqueous layer of the tear film thanks to its moisturizing effect. In combination, sodium hyaluronate and ectoine stabilize the ocular surface, maintaining a high concentration of water and preventing dry eye syndrome.

EktalM is indicated to protect, stabilize and hydrate the ocular surface in all cases of:

- photo-exposure of the eyes to sunlight, at seaside, at the mountains or even daily outdoors;

- prolonged use of artificial light sources (PC, tablet, smartphone, TV);

- ophthalmic stress caused by extreme environmental conditions, such as high salinity, temperature changes, dry environment;

EktalM can be instilled before the application and during the use of contact lenses to improve application and comfort.

Read the instructions of use with care.

Instructions for use

1. Open the protective foil pouch.
2. Carefully clean hands before the use.
3. Separate the single-dose vial from the strip and open it by twisting the cap.
4. Gently press the single-dose vial and instill 1-2 drops per eye.
5. After the instillation, close the vial and reuse the residue solution within 12 hours;
6. Store the unused vials in their original package.
7. The product is single patient to avoid possible contamination.
8. The product can be used with contact lenses.

Warnings

The product is for ophthalmic use only, do not ingest or use otherwise than the indication of use.
Once open, the single-dose vial can be reclosed with its cap and the residue solution can be reused within 12 hours to avoid possible contamination of the product.
Keep out of reach and sight of children.
During the instillation do not touch the eye or other surfaces with the nozzle of the single-dose vial.
Do not use the product in case of known incompatibility to even one single component of the formulation.
If necessary, check with your optician for the compatibility with the contact lenses use.
In case of adverse reaction during the use, suspend the treatment and consult your doctor or pharmacist.
Consult your doctor for use during pregnancy, lactation and for children.
The treatment with ophthalmic drugs or other ophthalmic medical devices must be carried out under the supervision of a doctor who can evaluate possible interactions.
In case of compromised ocular surface or damage cornea consult your doctor.
Do not use the product after the expiration date indicated on the package.
In the event of any serious claims or incidents concerning the device, it should be reported the incident to the manufacturer and the competent authority of the Member State in which the user is established, to provide more information on the safety of this medical device.

Validity

36 months with the package intact.