Hilo-kea®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ХІЛО-КЕА® (HYLO-CARE®)

Composition:

Active substances: hyaluronic acid, dexpanthenol;

1 ml of solution contains 1 mg of sodium hyaluronate and 20 mg of dexpanthenol;

Excipients: citric acid anhydrous, sodium citrate, water for injections.

Dosage form: Eye drops.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group: Medicinal products used in ophthalmology. Artificial tear substitutes and other neutral preparations.

ATC code: S01XA20.

Pharmacological properties.

Pharmacodynamics.

The primary goal of dry eye treatment is to increase the stability and volume of the precorneal tear film. It has been shown that hyaluronic acid, present in the drug as sodium hyaluronate, has a chemical structure, molecular weight, and rheological properties similar to mucin – a component of human tears. When applied topically, hyaluronic acid enhances the stability of the precorneal tear film, positively affects the epithelial layer, promotes an increase in tear volume and corneal hydration, and reduces tear evaporation from the ocular surface.

Dexpanthenol is a biological precursor and alcohol analogue of pantothenic acid – a vitamin of group B. With ophthalmic use, dexpanthenol accelerates epithelialization, for example, after second- and third-degree burns, and promotes tissue granulation. It improves symptoms of various forms of conjunctivitis and supports healing of mechanical corneal injuries and reduction of irritations caused by wearing contact lenses.

Pharmacokinetics.

Sodium hyaluronate is not absorbed after topical application. There is no evidence indicating that hyaluronic acid can penetrate through the cornea. Even after direct injection into the anterior chamber of the eye, only immeasurably low concentrations of hyaluronic acid were detected in the systemic circulation, which were rapidly metabolized by the liver. Therefore, systemic toxic effects are not expected with the use of this drug.

When applied topically, dexpanthenol penetrates through the skin, allowing high local concentrations to be achieved. In vivo, dexpanthenol is rapidly converted into pantothenic acid, which is widely distributed in the body, primarily in the form of coenzyme A.

Clinical characteristics.

Indications.

• For corneal moisturizing and symptomatic treatment of dry eye (dry eye syndrome);
• for stimulation of re-epithelialization in superficial corneal lesions.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Xilo-KEA® eye drops with other ophthalmic medicinal products should be avoided. If such necessity does exist, these products should be administered no later than 30 minutes before application of Xilo-KEA® eye drops. However, ophthalmic ointments should always be applied last.

Since, upon local ophthalmic administration, the drug immediately reaches the target organ and exerts primarily a physical effect (moisturizing of the ocular surface) without systemic action, no medicinal interactions of the drug are expected, except for physical interactions with locally applied ophthalmic drops.

Special precautions for use.

The medicine XHLO-KEA® is intended for individual use by a single person only. The product can be used while wearing contact lenses, making their use more comfortable. However, to prevent possible incompatibility reactions with contact lens care products, it is recommended to wait approximately 30 minutes after inserting contact lenses before instilling XHLO-KEA® eye drops. In cases of severe or persistent dry eye syndrome, medical advice should be sought.

When instilling eye drops, avoid any contact between the container tip and the eye or skin.

Use during pregnancy or breastfeeding.

There have been no controlled studies on the use of the medicine during pregnancy or breastfeeding.

Nevertheless, XHLO-KEA® may be used during pregnancy or breastfeeding, as it does not possess systemic pharmacological activity.

Effect on the ability to drive or operate machinery.

In isolated cases, immediately after instillation, XHLO-KEA® eye drops may cause transient blurred vision, even when properly administered at usual doses. Since this may prolong reaction time, it is recommended to wait some time after instillation before driving or operating complex machinery, ensuring that visual acuity has fully returned.

Method of Administration and Dosage.

Typically, instill 1 drop of the medication into each eye 3 times daily. If necessary, the frequency of instillation may be increased. A significant increase in the frequency of instillation of ХІЛО-КЕА® (e.g., more than 10 times daily) may be performed at the discretion of an ophthalmologist and under his/her supervision.

The duration of treatment is determined individually by the physician.

Note. The COMOD container system allows the release of 10 ml of solution, which corresponds to approximately 300 drops. Due to technical reasons, a small amount of drops remains in the container at the end of use.

Children.

Data on the use of the medicinal product in children are lacking.

Overdose.

No cases of overdose have been reported.

Side effects.

Since the XHILO-KEA® preparation does not contain preservatives, it is well tolerated even during prolonged use. In extremely rare cases, local hypersensitivity reactions have been reported, including irritation, burning sensation, redness, lacrimation, pain, and itching in the eye, as well as eyelid swelling, which disappeared immediately after discontinuation of the product.

Shelf life. 3 years.

The product should not be used after the expiry date stated on the packaging.

The product can be used for 6 months after first opening the container.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml of ophthalmic solution in a multidose plastic container equipped with an air-tight pump and closed with a cap. One container per cardboard box.

Availability. Over-the-counter.

Manufacturer. URSAPHARM Arzneimittel GmbH.

Manufacturer's address and place of business.

Industriestrasse 35, 66129 Saarbrucken, Germany.