Kollalysin (Lyophilisate) Instructions for Use

ATC Code

D03BA02 (Collagenase)

Active Substance

Collagenase (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Drug with proteolytic activity

Pharmacotherapeutic Group

Topical proteolytic agent

Pharmacological Action

An agent with proteolytic activity for topical and parenteral use in ophthalmology. Collagenase selectively acts on collagen (the main component of connective tissue), causing its destruction.

Administration of collagenase in small doses into the tissues of the burned conjunctival fornix, starting from day 15 after the burn, leads either to a slowdown in the formation of scar tissue between the burned surfaces (eyelid and eyeball), or to the prevention of the development of narrow symblepharon.

When aqueous solutions of collagenase act on keloid tissue, a lytic effect occurs, the degree of which depends on the exposure time.

Indications

For the prevention and treatment of symblepharon, cicatricial changes in the skin of the eyelids (keloid scars), conjunctiva of the eyeball after a burn, in strictures of the lacrimal drainage pathways (lacrimal canaliculi and nasolacrimal duct), corneal opacities, plastic iridocyclitis (in the stage of subsiding inflammatory phenomena), secondary cataract, vitreous opacities, retinal scars, in traumatic hemorrhage into the vitreous body occupying more than 1/2 of its volume and from 3 days after the formation of hemophthalmos.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate immediately before use with the provided solvent to achieve the required concentration.

For subconjunctival administration, inject directly into the lesion site such as an adhesion, scar, or the vitreous body.

Apply topically to the skin for the management of keloid scars.

Utilize electrophoresis or phonophoresis techniques for targeted delivery to specific ocular structures.

The dose, method of administration, and treatment schedule must be determined individually based on the indication and clinical severity.

The duration of therapy and the total course are dependent on the therapeutic response and the nature of the condition being treated.

Adverse Reactions

Possible corneal ulcers, allergic reactions.

Contraindications

Incomplete process of corneal epithelialization after a burn, combination of symblepharon with a corneal ulcer, presence of defects in the sclera, hemorrhage into the vitreous body less than 1/2 of its volume, presence of signs of blood clotting in the vitreous body, a sharply pronounced reaction after administration of 1 CU of the agent; pregnancy, lactation period (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and during the lactation period (breastfeeding).

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Special Precautions

Before using collagenase, the patient’s sensitivity to this agent is checked by administering 1 CU under the conjunctiva of the affected eye and observing for 48 hours. If there is no allergic reaction, treatment is carried out.

When the agent is applied topically to the skin, its tolerance by the skin is checked by performing skin tests with the application of a collagenase solution in therapeutic doses for 24 and 48 hours.

To prevent undesirable phenomena, it is recommended to start treatment only after the completion of corneal epithelialization and obtaining a negative test for sensitivity to collagenase.

If a corneal ulcer appears, collagenase is immediately discontinued and antibacterial drugs and agents that stimulate epithelialization are prescribed.

In case of allergic reactions, the use of collagenase is stopped and appropriate treatment is carried out.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.