Artelac^® Night 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® Night Uno

Ophthalmic solution 0.24%: dropper-tubes 0.5 ml 10 pcs.

Dosage Form, Packaging, and Product Composition

Excipients: carbomer, glycerol, lipid component (medium-chain triglycerides), sodium hydroxide, purified water.

0.5 ml – single-use dropper-tubes (10) – strips (1) – cardboard packs.

Therapeutic Category

Medical device for eye hydration

Properties

Artelac^® Night Uno is an ophthalmic solution containing 0.24% hyaluronic acid (in the form of sodium hyaluronate).

The advanced formula is characterized by very good tolerance, as it does not contain preservatives or buffers. The medical device does not contain a medicinal product in its composition.

Artelac^® Night Uno is a complex hydration product that supports all three layers of the tear film: the lipid, aqueous, and mucous phases with the aim of improving and maintaining the hydration of the ocular surface for any symptoms of dryness and discomfort in the eyes.

The lipid component – medium-chain triglycerides – has a protective effect by reducing the evaporation of the lipid layer in the tear film.

The natural moisturizer – Hyaluronic acid (in the form of sodium hyaluronate), which is found in the structures of a healthy human eye and in the natural tear film, together with glycerol (glycerin) attracts moisture, supporting and restoring the aqueous layer in the tear film.

The carbomer component, due to its viscous structure, binds water molecules and restores the mucin layer. Carbomer also has a long-lasting moisturizing effect.

Artelac^® Night Uno is a product for maintaining the healthy state of the eye surface, it distributes over the surface and provides intensive hydration for immediate and long-lasting relief of symptoms. It is an ideal product for any user suffering from such dry eye symptoms as fatigue, irritation, burning and/or watering.

Can be used both at home and in healthcare facilities.

Scope of Application

Of the product Artelac^® Night Uno

For moisturizing the anterior surface of the eye (cornea and conjunctiva)

• For dry eye syndrome, which requires additional moisturizing of the conjunctiva and cornea, of moderate and severe degree, Sjögren’s syndrome;
• To eliminate dryness, sensation of grit in the eyes, burning, tearing, itching, redness, eye fatigue that have arisen as a result of past diseases, including conjunctivitis, keratoconjunctivitis;
• To eliminate increased eye dryness in case of systematic use of such medicinal products as anti-inflammatory, hormonal agents, antibiotics, antihistamines, antiglaucoma, antidepressants, beta-blockers, antispasmodics, diuretics;
• For eye hydration after ophthalmic surgical interventions, including laser refractive surgeries (LASIK and others), as well as for microtraumas of the cornea;
• To eliminate discomfort in patients who use contact lenses, including for the prevention of dry eyes;
• For the prevention of conjunctival-corneal xerosis in case of environmental pollution (smoke, smog, dust and other negative factors);
• With increased visual loads during frequent work at a computer or any display medium;
• For dry eyes due to being in a room with dry air from air conditioning or heating;
• For dryness or tearing due to windy weather.

ICD codes

Dosage Regimen

Instill 1 drop of Artelac^® Night Uno into the conjunctival sac of the eye as needed. It can be used every day and as often as necessary, during the day and at night.

There are no restrictions on the duration of use.

After use, the dropper-tube should be discarded.

Method of application

Carefully separate one dropper-tube from the strip.

Unscrew (do not pull) the top cap of the dropper-tube.

Tilt your head back slightly and gently pull down the lower eyelid with the finger of your free hand. Hold the dropper-tube as vertically as possible to your eye, with the opening pointing downward. Make sure that the dropper-tube does not touch the eye to avoid possible injury or damage. Then gently squeeze the body of the dropper-tube to release one drop. Then close your eye and roll it slowly to optimally distribute the drop over the surface of the eye.

Side effects

Local hypersensitivity reactions have been reported very rarely. Use in such cases should be discontinued and a doctor should be consulted.

From the organ of vision: temporary blurred vision after instillation, due to the presence of the carbomer component in the composition.

Contraindications

• Hypersensitivity to any of the product components.

Special instructions

Avoid contact of the bottle tip with fingers or any other surfaces to avoid possible contamination of the solution.

After use, shake off any remaining drops.

Remove contact lenses before use.

Wait approximately 15 minutes before using another ophthalmic product or before inserting contact lenses.

Do not use if the packaging or dropper-tube is damaged.

Disposal

Artelac^® Night Uno, subject to disposal after use, as well as upon expiration of the shelf life or in case of packaging integrity violation, belongs to hazard class A. When used at home, disposal in household waste containers is permitted.

Medical devices after use as intended in healthcare facilities are classified as hazard class B. After hardware methods of deactivation using physical methods and changing the appearance of the waste, which excludes the possibility of their reuse, class B waste can be accumulated, temporarily stored, transported, destroyed, and disposed of together with class A. The packaging of deactivated class B medical waste must be marked indicating the deactivation of medical waste. Disposal must be carried out by accredited organizations.

Effect on the ability to drive vehicles and operate machinery

This product may cause temporary blurred vision after instillation due to the presence of the carbomer component in the composition, which may negatively affect the ability to drive vehicles or operate machinery.

Storage Conditions

Artelac^® Night Uno 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 – 2 years. Do not use after the expiration date.

After opening the bottle, Artelac^® Night Uno should be used within 6 months.

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.