Lydase-M (Lyophilisate) Instructions for Use

ATC Code

B06AA03 (Hyaluronidase)

Active Substance

Hyaluronidase (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Other hematological agents; enzymes

Pharmacological Action

An enzyme preparation isolated from bovine testes. It cleaves the main component of the interstitial substance of connective tissue – hyaluronic acid (a mucopolysaccharide consisting of acetylglucosamine and glucuronic acid, which is the cementing substance of connective tissue), reduces its viscosity, increases tissue and vascular permeability, facilitates the movement of fluids in interstitial spaces; reduces tissue swelling, softens and flattens scars, increases the range of motion in joints, reduces contractures and prevents their formation.

Hyaluronidase causes the breakdown of hyaluronic acid into glucosamine and glucuronic acid, thereby reducing its viscosity.

The duration of action after intradermal administration is up to 48 hours.

Indications

• Burn, traumatic, and postoperative scars;
• Long-term non-healing ulcers (including radiation-induced);
• Dupuytren’s contracture;
• Joint stiffness, joint contractures (after inflammatory processes, injuries), osteoarthritis, ankylosing spondylitis, severe lumbar disc diseases;
• Chronic tenosynovitis, scleroderma (skin manifestations), superficially located soft tissue hematoma;
• Preparation for skin-plastic surgery for scar contractures;
• Pulmonary tuberculosis (complicated by nonspecific bronchial lesions), inflammatory processes in the upper respiratory tract and bronchi with signs of obstruction;
• Traumatic lesions of nerve plexuses and peripheral nerves (plexitis, neuritis);
• Hyphema, hemophthalmos, retinopathies of various etiologies.

ICD codes

Dosage Regimen

Lyophilisate

For scar lesions, administer subcutaneously (under scar-altered tissues) or intramuscularly (near the lesion site) 64 UE (1 ml) daily or every other day (a total of 10-20 injections).

For traumatic lesions of nerve plexuses and peripheral nerves, administer subcutaneously in the area of the affected nerve (64 UE in a procaine solution) every other day; the course consists of 12-15 injections. The course of treatment is repeated if necessary.

When used in ophthalmological practice, dissolve the contents of the vial in 20 ml of water for injections (0.1% solution). The drug is administered subconjunctivally – 0.3 ml, parabulbarly – 0.5 ml, and also by electrophoresis.

For patients with pulmonary tuberculosis with a productive nature of inflammation, it is prescribed in complex therapy to increase the concentration of antibacterial drugs in the lesions in the form of injections and/or inhalations. Inhalations are performed daily, once a day. To perform one inhalation, dissolve the contents of one vial (64 UE) in 5 ml of 0.9% sodium chloride solution. The course of treatment consists of 20-25 inhalations. If necessary, repeat courses are conducted with intervals of 1.5-2 months.

Topically, in the form of dressings soaked in the drug solution. To prepare the solution, dissolve every 64 UE in 10 ml of sterile 0.9% sodium chloride solution or boiled water at room temperature. Soak a sterile dressing, folded in 4-5 layers, with this solution, apply it to the affected area, cover with waxed paper and secure with a soft bandage. Apply the dressing daily for 15-18 hours over 15-60 days. With prolonged use, take a break for 3-4 days every 2 weeks.

When using the electrophoresis method, dissolve 1 vial of the drug (64 UE) in 60 ml of distilled water, add 2-3 drops of 0.1% hydrochloric acid solution and administer from the anode to the affected area for 20-30 minutes. The course of treatment is 15-20 sessions.

The application dosing regimen can be alternated with electrophoresis.

The prepared solution must be used within 24 hours.

Adverse Reactions

Possible allergic reactions; with prolonged use – local irritant effect.

Contraindications

• Hypersensitivity;
• Acute infectious and inflammatory diseases;
• Recent hemorrhages;
• Acute intercurrent diseases;
• Malignant neoplasms;
• Fresh hemorrhage into the vitreous body;
• Age under 18 years;
• Concomitant use of estrogens.

For inhalation administration

• Pulmonary tuberculosis with severe respiratory failure;
• Pulmonary hemorrhage, hemoptysis.

Use in Pregnancy and Lactation

The drug should be used with caution during pregnancy and lactation.

Pediatric Use

Contraindicated for use under the age of 18 years.

Special Precautions

The solution should not be administered through a catheter that previously contained solutions containing cations.

Solutions for injections are prepared with 0.9% sodium chloride solution or 0.5% procaine solution, for inhalations – with 0.9% sodium chloride solution, for electrophoresis – with distilled water.

Before starting treatment, it is advisable to perform a test with intradermal administration of 20 µl of hyaluronidase.

The drug should not be injected into areas of infectious inflammation and tumors.

Hyaluronidase should not be used in cases of acute hemorrhage.

Effect on the ability to drive vehicles and operate machinery

The use of the drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms chills, nausea, vomiting, dizziness, tachycardia, decreased blood pressure, local edema, urticaria, erythema.

Treatment administration of epinephrine, glucocorticosteroids; antihistamines.

Drug Interactions

Improves the absorption of drugs administered subcutaneously or intramuscularly, enhances the effect of local anesthetics.

Storage Conditions

The drug should be stored in a light-protected place, out of the reach of children, at a temperature not exceeding 15°C (59°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.