Relins Therapy (Ophthalmic product) Instructions for Use

Marketing Authorization Holder

Doctor Klaus, LLC (Republic of Belarus)

Contact Information

DOCTOR KLAUS LLC (Russia)

Dosage Form

Relins Therapy

Ophthalmic moisturizing product: fl. 10 ml

Dosage Form, Packaging, and Product Composition

Ophthalmic moisturizing product in the form of a sterile, isotonic borate buffer solution, odorless, transparent, colorless or yellowish, without visible mechanical inclusions.

Composition dexpanthenol (2%), sodium hyaluronate (0.15%), boric acid, sodium chloride, sodium borate, disodium edetate, polyquaternium-7, PHMG, purified water.

There are about 25 drops in 1 ml of the product.
The product is sterilized by membrane filtration.

10 ml – polymer bottles (1) – cardboard packs.

Therapeutic Category

Medical device for moisturizing the mucous membrane of the eye

Properties

The RELINS THERAPY ophthalmic moisturizing product is intended for moisturizing, lubricating, and protecting the anterior surface of the eyes.

Description and principle of action

The moisturizing, lubricating, and protective properties of RELINS THERAPY are due to the hyaluronic acid (in the form of its sodium salt) and dexpanthenol included in its composition.

RELINS THERAPY uses sodium hyaluronate, which has a smaller molecular size compared to hyaluronic acid, allowing the substance to penetrate tissues more easily and spread evenly over the corneal surface.

Sodium hyaluronate is a polysaccharide with a pronounced ability to retain water, which provides a high degree of moisturizing and lubrication of the corneal surface. Hyaluronic acid is a component of tears and is also a structural component of the vitreous body, conjunctiva, and lacrimal gland, where it retains moisture, maintaining the stability of the tear film and protecting the eyes from drying out.

Dexpanthenol is a precursor of pantothenic acid (vitamin B₅), which is found in all living organisms and plants. Dexpanthenol effectively supports the moisturizing properties of sodium hyaluronate, which has a high ability to bind water, and has caring and soothing properties.

When using RELINS THERAPY, a uniform thin film is formed on the anterior surface of the cornea, protecting the eye from drying out, relieving the sensation of discomfort, dryness, fatigue, pain, and eye irritation for a long time, which is not washed away by blinking and does not cause a decrease in visual acuity. The product effectively and quickly relieves the “dry eye” effect of varying severity, namely: eliminates the sensation of a foreign body, burning, pain in the eyes, helps relieve fatigue during intense visual load, eliminates discomfort when wearing all types of contact lenses.

Constant and sufficient moisturizing of the anterior surface of the eye with RELINS THERAPY promotes the normal physiological course of the corneal restoration process during rehabilitation after injuries and traumas of various etiologies and during rehabilitation after surgical interventions.

Main causes of “dry eye” syndrome

• Reduced tear production or increased evaporation of moisture from the eye surface;
• Wearing all types of contact lenses;
• Hormonal changes in women (during pregnancy, breastfeeding, as well as during menstruation, menopause and postmenopause);
• Aging (“dry eye” syndrome is most often observed in women after 40 years, after 60 years – in approximately 75% of people);
• Exposure to climatic factors (wind, cold, intense solar radiation, polluted air, etc.);
• Exposure to external factors when using air conditioners and heaters, as well as when working in rooms with dry air, in dusty or smoky (including cigarette smoke) areas, when working with chemicals, etc.;
• Long-term driving;
• Prolonged work at a computer or watching TV;
• Work of beauty industry masters, jewelers, or other meticulous activities associated with high visual load and the need for concentration;
• Mechanical damage to the eyes or consequences of surgical intervention;
• Taking certain medications, such as contraceptives, antihistamines, beta-blockers, antispasmodics, etc.;
• Past infectious-inflammatory and other eye diseases;
• Various chronic diseases, such as rheumatoid arthritis, diabetes, thyroid diseases, asthma, etc.

Scope of Application

Of Relins Therapy product

RELINS THERAPY is indicated for use to moisturize the eyes and eliminate discomfort caused by mechanical irritation of the eye surface when wearing contact lenses and reduced secretion of the lacrimal glands, as well as

• For “dry eye” syndrome, accompanied by discomfort, dryness, foreign body sensation, burning, irritation, redness of the eyes;
• As a moisturizing care product that promotes accelerated restoration of the cornea after ophthalmic surgeries, as well as after injuries and traumas of various etiologies;
• To relieve fatigue during intense visual load;
• When wearing all types of contact lenses to relieve discomfort;
• For comfortable insertion of rigid contact lenses.

RELINS THERAPY may be prescribed or recommended by an ophthalmologist or contact lens specialist for moisturizing, lubricating, and protecting the anterior surface of the eyes, including when wearing all types of contact lenses. The product is intended for personal individual use both at home and in medical institutions, subject to the instructions for use and precautions.

ICD codes

Dosage Regimen

RELINS THERAPY is compatible with all types of rigid and soft contact lenses and promotes their comfortable wearing, while it is not necessary to remove the lenses before instillation.

There are about 25 drops in 1 ml of the product.

1. It is recommended to use RELINS THERAPY, 1-2 drops in each eye 3 times a day or as needed.
2. Before using RELINS THERAPY, you should thoroughly wash your hands with soap.
3. Remove the protective cap from the bottle, do not touch the open tip of the bottle dropper insert.
4. Tilt your head back, pull the lower eyelid down, look up, and instill 1-2 drops of RELINS THERAPY into the space formed between the eyelid and the eyeball (into the middle of the conjunctival cavity).
5. Blink several times and slowly close your eyes so that RELINS THERAPY is distributed evenly over the entire surface of the eye.
6. It is recommended not to use other ophthalmic products for 15 minutes.

The frequency of instillation is set individually depending on sensations and/or according to the recommendations of an ophthalmologist or contact lens specialist. There are no restrictions regarding the duration of use of RELINS THERAPY.

In case of using RELINS THERAPY for comfortable insertion of rigid contact lenses, instill 1 drop into each lens and put on the lens according to the instructions from the manufacturer of the rigid contact lenses.

Side effects

No side effects have been detected.

Possible: allergic reactions, irritation, itching in case of individual intolerance or non-compliance with the instructions for use.

Contraindications

• Hypersensitivity to the components of the product;
• Allergic reaction to any component of the product;
• Simultaneous use of therapeutic ophthalmic drugs for inflammatory processes and acute phases of eye diseases, as well as immediately after ophthalmic surgeries.

Use during pregnancy and lactation

Data on the experience of using RELINS THERAPY by women during pregnancy and lactation are absent; prescription is possible only after consultation with a doctor.

Special instructions

Children under 14 years of age should consult a doctor before using RELINS THERAPY.

Do not use RELINS THERAPY if unpleasant sensations in the eyes are observed within 15 minutes after instillation; if unpleasant sensations persist after discontinuation of use, you should consult an ophthalmologist.

If simultaneous use with therapeutic eye drops or care products is necessary, you should consult a doctor.

In case of concomitant use with ophthalmic drugs, it is recommended to maintain a pause of at least 15 minutes between the instillation of RELINS THERAPY and other products.

It is not necessary to remove the lenses before instillation.

RELINS THERAPY is supplied sterile and does not require additional disinfection or processing.

It is not allowed to use RELINS THERAPY from one bottle by several persons.

RELINS THERAPY should be stored out of the reach of children.

Effect on the ability to drive vehicles and mechanisms

RELINS THERAPY does not have a negative effect on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving cars and other vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Immediately after instillation of RELINS THERAPY, “blurred” vision is possible, which passes within 5-15 seconds. In this case, you should wait for the distribution of RELINS THERAPY over the surface of the eye and stabilization of vision.

Dispensing Status

Available without a prescription.

Storage Conditions

RELINS THERAPY should be stored in a tightly closed bottle in a place protected from direct sunlight at a temperature from +1°C (33.8°F) to +25°C (77°F), at a relative air humidity of not more than 80% (at 25°C (77°F)).

Shelf Life

The shelf life is 2 years from the date of manufacture. Use RELINS THERAPY before the expiration date indicated on the box and bottle.

The shelf life after opening the bottle is 90 days.

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.