Lidaza-biolic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIDASA-BIOLIK (LIDASA-BIOLIK)

Composition:

Active substance: hyaluronidase;

1 ampoule contains 64 IU of hyaluronidase.

Pharmaceutical form. Lyophilisate for solution.

Main physicochemical characteristics: porous mass, compressed into a cream-colored tablet; dissolves easily in water.

Pharmacotherapeutic group. Hematological agents. Enzymes. ATC code B06A A03.

Pharmacological Properties

Pharmacodynamics

An enzyme preparation derived from bovine testes, with hyaluronidase as its active ingredient. Hyaluronidase causes the breakdown of its specific substrate—hyaluronic acid—which acts as the "cementing" interstitial substance of connective tissue, thereby increasing tissue permeability and improving the movement of interstitial fluids. The effect of hyaluronidase is reversible—reduction in hyaluronidase concentration restores the viscosity of hyaluronic acid.

The duration of enzyme activity lasts up to 48 hours.

The effect of the drug manifests as improved joint mobility, softening of scars, elimination and reduction of contractures, and resorption of hematomas. The action is most pronounced in the early stages of pathological processes.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

• Joint contractures;
• ankylosing spondylarthritis;
• Dupuytren's contracture (initial stage);
• scar skin changes of various origins;
• hematomas;
• slowly healing trophic ulcers (including radiation-induced);
• scleroderma;
• in ophthalmological practice (keratitis, retinopathies);
• productive inflammation in pulmonary tuberculosis;
• traumatic lesions of nerve plexuses and peripheral nerves;
• rheumatoid arthritis.

In addition, the drug LIDAZA-BIOLIK can be used to accelerate the absorption of various medicinal agents (local anesthetics, isotonic solutions, myorelaxants) when administered subcutaneously or intramuscularly.

Contraindications.

• Hypersensitivity to the active substance;
• malignant neoplasms;
• acute infectious-inflammatory processes;
• pulmonary hemorrhage and hemoptysis;
• use of estrogens;
• tuberculosis with pronounced pulmonary insufficiency.

Interaction with other medicinal products and other types of interactions.

The drug may be used concomitantly with antibiotics and sulfonamides. LIDAZA-BIOLIK accelerates the absorption of other medicinal agents (local anesthetics, isotonic solutions, myorelaxants) when administered subcutaneously or intramuscularly.

Instructions for use.

Prior to initiating treatment, a skin test with intradermal administration of 20 µl of hyaluronidase should be performed.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to affect reaction rate when driving or operating machinery.

Has not been studied. When the drug is administered subconjunctivally or applied locally to the cornea, temporary blurred vision or other visual disturbances may occur. If these effects occur, patients should wait until vision clears before driving or operating machinery.

Administration and Dosage

The drug is administered subcutaneously, under scar-affected tissues, intramuscularly, via electrophoresis, or by application to mucous membranes. In ophthalmological practice, the drug may also be administered subconjunctivally or retrobulbarly.

For injections, the contents of a 64 IU ampoule should be dissolved in 1 ml of 0.9% sodium chloride injection solution or in 1 ml of 0.5% novocaine solution.

For contractures, skin scar changes, hematomas, ankylosing spondylarthritis: administer subcutaneously near the affected area or under scar-affected tissue at a dose of 64 IU daily or every other day. Treatment course: 6–10–15 (or more) injections.

For traumatic lesions of nerve plexuses and peripheral nerves: administer subcutaneously every other day at a dose of 64 IU in novocaine solution. Treatment course: 12–15 injections; if necessary, repeat the course.

For rheumatoid arthritis: apply the drug via electrophoresis: dissolve 64 IU of LIDAZA-BIOLIK in 30 ml of distilled water, add 4–5 drops of 0.1M hydrochloric acid solution, and administer via a split electrode (anode) to two joints. Procedure duration: 20–30 minutes; treatment course: 10–15 procedures.

For productive inflammatory processes in patients with pulmonary tuberculosis: administer the drug via injections and inhalations as part of combination therapy (to enhance the concentration of antibiotics and other antibacterial agents at the site of lesion). For inhalations, dissolve the contents of one ampoule in 5 ml of 0.9% sodium chloride injection solution. Administer inhalations daily—once daily (5 ml of solution containing 64 IU). A treatment course requires 20–25 inhalations. Repeat courses, if necessary, with intervals of 1.5–2 months. Subcutaneously administer 1 ml of solution (64 IU), or the same amount intramuscularly, daily or every other day. A treatment course requires 10–20 injections.

For finer scarring of corneal lesions in keratitis: instill the drug solution (dissolve the contents of 1 ampoule in 20 ml of 0.9% sodium chloride injection solution or in 20 ml of 0.5% novocaine solution), simultaneously with the use of antibiotics and sulfonamides.

For retinopathies: administer 0.5 ml of solution subcutaneously in the temporal region (dissolve the contents of 1 ampoule in 20 ml of 0.9% sodium chloride injection solution or in 20 ml of 0.5% novocaine solution). Treatment course: 10–15 injections.

Children: Not recommended for use in children.

Overdose.

Symptoms: chills, nausea, vomiting, dizziness, tachycardia and arterial hypotension, local edema, urticaria, erythema.

Treatment: administer adrenaline, glucocorticoids, and apply antihistamine drugs.

Adverse reactions.

General disorders and administration site reactions: fever, chills, weakness; hyperemia, erythema, rash, pain, pruritus, induration, local increase in temperature, soft tissue swelling at injection site; in ophthalmological practice, following subconjunctival or retrobulbar administration – swelling, hyperemia of eyelids, periorbital area, facial skin, scleral hyperemia.

Immune system disorders: allergic reactions.

Skin and subcutaneous tissue disorders: skin rash, urticaria, pruritus, hyperemia, angioneurotic edema, sweating.

Cardiac disorders: tachycardia.

Vascular disorders: arterial hypotension.

Nervous system disorders: headache, dizziness.

Respiratory, thoracic and mediastinal disorders: dyspnea, shortness of breath.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging to protect from light at a temperature between 2 °C and 8 °C. Keep out of reach of children.

Incompatibilities. Not studied.

Packaging. Ampoules of 64 IU (international units); 10 ampoules per pack.

Prescription category. Prescription only.

Manufacturer.

LLC "BIOLIK PHARMA".

Manufacturer's location and address of business activity.

Legal entity location:

70 Pomirky St., Kharkiv, Kharkiv region, 61070, Ukraine.

Address of business activity:

Pomirky-70, building without number, Kharkiv, Kharkiv region, 61070, Ukraine.