Artelac^® Splash Uno (Solution) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH (Germany)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Form

Artelac® Splash Uno

Ophthalmic moisturizing solution 0.2%: dropper tubes 0.5 ml 30 pcs.

Dosage Form, Packaging, and Product Composition

Excipients: potassium chloride, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water.

0.5 ml – single-use dropper tubes (10) – strips (3) – cardboard packs.

Therapeutic Category

Medical device for eye hydration

Properties

Artelac^® Splash Uno is a sterile 0.2% solution of sodium hyaluronate, preservative-free, in single-use dropper tubes.

The hyaluronic acid (in the form of a sodium salt) contained in Artelac^® Splash Uno is a natural polymer that is part of the natural tear film of a healthy human eye.

The hyaluronic acid (in the form of a sodium salt) contained in Artelac^® Splash Uno is a natural moisturizing substance with a high ability to bind water.

It is used for preliminary and subsequent moisturizing of soft and rigid contact lenses during their wear.

Easy to apply, well tolerated and safe.

Scope of Application

Of the Artelac^® Splash Uno product

For intensive and long-lasting hydration of the anterior surface of the eye (cornea and conjunctiva)

• For dry eyes caused by lifestyle, stressful eye strain, exposure to environmental factors such as prolonged work at a computer and, as a result, infrequent blinking, staying in an air-conditioned room, cigarette smoke, as well as exposure to wind when staying outdoors;
• For severe dry eyes caused by systemic diseases, eye surgeries or taking certain medications, such as contraceptives, antihistamines, beta-blockers, antispasmodics, diuretics.

To eliminate discomfort when wearing rigid and soft contact lenses.

ICD codes

Dosage Regimen

Artelac^® Splash Uno is recommended to be instilled into the conjunctival sac of each eye, 1 drop as needed.

Method of application

1. Separate a single-use dropper tube by holding it at the mark.

2. Unscrew the upper tip of the dropper tube.

3. Tilt your head back slightly, pull the lower eyelid down with the finger of your free hand. Holding the dropper tube as vertically as possible, tip down, towards the eye, gently squeeze out one drop.

After that, close your eyes, move them from side to side and blink several times so that the drops are evenly distributed over the surface of the eye.

Avoid contact of the dropper tube tip with the eyes or touching it with your fingers to prevent possible contamination of the solution.

Recommendations for contact lens wear

When wearing soft and rigid contact lenses, Artelac^® Splash Uno can be instilled into the conjunctival sac of the eye without removing the lenses.

Contraindications

• Hypersensitivity to any of the components included in the solution (local allergic reactions that occur in rare cases). In such cases, the use of the solution should be discontinued.

Special instructions

The solution should not be used if the dropper tube is damaged.

Drug Interactions

In case of concomitant use with other ophthalmic drugs, it is recommended to observe an interval of at least 15 minutes between instillation of Artelac^® Splash Uno solution and the use of other eye drops.

Eye ointments should always be applied after instillation of Artelac^® Splash Uno solution.

Storage Conditions

The solution should be stored out of the reach of children at a temperature from 1°C (33.8°F) to 25°C (77°F).

Shelf Life

Shelf life in the closed original packaging is 2 years. Do not use after the expiration date indicated on the packaging.

Artelac^® Splash Uno does not contain a preservative and therefore each single-use packaging can be used only once.

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.