Nydase-Imbio (Lyophilisate) Instructions for Use

ATC Code

B06AA03 (Hyaluronidase)

Active Substance

Hyaluronidase (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with proteolytic activity

Pharmacotherapeutic Group

Enzyme agent

Pharmacological Action

An enzyme agent isolated from bovine testes. It breaks down the main component of the connective tissue intercellular substance – hyaluronic acid (a mucopolysaccharide consisting of acetylglucosamine and glucuronic acid, which is the cementing substance of connective tissue). Hyaluronidase causes the breakdown of hyaluronic acid into glucosamine and glucuronic acid, thereby reducing its viscosity.

It increases tissue and vascular permeability, facilitates the diffusion of fluids in the interstitial space. It reduces tissue swelling, softens and flattens scars, increases the range of motion in joints, reduces contractures and prevents their formation.

The action of hyaluronidase is reversible: when its concentration decreases, the viscosity of hyaluronic acid is restored.

The duration of action after subcutaneous 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 with a productive nature of inflammation (as part of complex therapy to increase the concentration of antibacterial agents in the lesions).

Traumatic lesions of nerve plexuses and peripheral nerves (plexitis, neuritis).

In ophthalmology: for finer scarring of affected areas of the cornea, retinopathy of various etiologies, hemorrhage into the vitreous body.

To improve the absorption of drugs administered subcutaneously and intramuscularly.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate immediately before use with water for injection or 0.9% sodium chloride solution.

For subcutaneous or intramuscular administration, administer a single dose of 64 Units.

Inject directly into the affected area, such as the scar periphery, joint, or hematoma. Avoid injection into sites of active infection or neoplasm.

For inhalation therapy, use a dose of 64-128 Units dissolved in 3-5 ml of solvent. Perform the procedure once or twice daily.

In ophthalmology, for subconjunctival or retrobulbar administration, the dose is determined individually based on the specific condition.

To enhance drug absorption, mix 64-128 Units with the primary drug solution prior to subcutaneous or intramuscular injection.

The typical treatment course consists of 5 to 10 injections administered every other day or 2-3 times per week.

Repeat courses may be considered after a 1-2 month interval, based on clinical assessment of efficacy and tolerability.

Prior to initiating a full course, perform a test for hypersensitivity via subcutaneous administration of a small dose.

Adverse Reactions

Possible allergic reactions; at the injection site – pain and infiltrates.

In some cases ventricular fibrillation.

Contraindications

Malignant neoplasms, acute infectious and inflammatory diseases, pulmonary hemorrhage, hemoptysis, pulmonary tuberculosis with respiratory failure, recent hemorrhage into the vitreous body, simultaneous use of estrogens, hypersensitivity to hyaluronidase.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Special Precautions

The solution should not be administered through a catheter that has previously been used to administer solutions containing cations.

Before starting treatment, it is advisable to perform a test with the subcutaneous administration of hyaluronidase.

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

Drug Interactions

Hyaluronidase improves the absorption of drugs administered subcutaneously or intramuscularly, accelerates the onset of anesthesia when local anesthetics are administered.

It should be used with caution in combination with other drugs, as an unpredictable increase in absorption and enhancement of systemic action is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.