Instructions for use Lidaza-Biopharma powder for solution for injection 64 U vial No. 10
Composition
active ingredient: 1 vial contains 64 IU of hyaluronidase (obtained from bovine testicles);
excipients: sodium chloride, disodium phosphate dodecahydrate, dextran 70.
Dosage form
Powder for solution for injection.
Main physicochemical properties: powder compacted into a tablet or lyophilized porous mass from white to cream color of varying intensity. A dry crust is allowed on the surface.
Pharmacotherapeutic group
Hematological agents. Enzymes. ATX code B06A A03.
Pharmacological properties
Pharmacodynamics
Hyaluronidase is an enzyme whose specific substrate is hyaluronic acid. The latter is a mucopolysaccharide consisting of acetylglucosamine and glucuronic acid. Hyaluronic acid has high viscosity; biological significance is as a "cementing" intermediate substance of connective tissue. The effect of the drug is to improve joint mobility, soften scars, eliminate and reduce contractures, and resolve hematomas. The effect is most pronounced at the initial stage of pathological processes. Hyaluronidase ("spreading factor") causes the breakdown of hyaluronic acid to glucosamine and glucuronic acid, and thereby leads to an increase in tissue permeability and improved movement of interstitial fluids. The effect of hyaluronidase is reversible - a decrease in concentration restores the viscosity of hyaluronic acid.
Pharmacokinetics
Didn't study.
Indication
Joint contractures; ankylosing spondylitis; Dupuytren's contracture (initial stage); cicatricial skin changes of various origins; hematomas (at the stage of organization); scleroderma; in ophthalmological practice (keratitis, retinopathy); productive nature of pneumonia in patients with pulmonary tuberculosis; traumatic lesions of the nerve plexuses and peripheral nerves; rheumatoid arthritis.
Contraindication
Hypersensitivity to the active substance; malignant neoplasms; acute infectious-inflammatory processes; pulmonary bleeding and hemoptysis; use of estrogens; acute stage of hematomas; tuberculosis with severe pulmonary insufficiency.
Interaction with other medicinal products and other types of interactions
The drug accelerates the absorption of other drugs (local anesthetics, isotonic solutions, muscle relaxants) when administered subcutaneously and intramuscularly.
Application features
The drug can be used together with physiotherapeutic treatment methods, including phonophoresis.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not studied.
It should be used with caution in patients whose activities require concentration of attention and high speed of psychomotor reactions. When using the drug subconjunctivally and locally on the cornea, temporary blurring and other visual disturbances are possible. If these phenomena occur, the patient should wait until vision is restored before driving a car or working with other mechanisms.
Use during pregnancy or breastfeeding
There are no data on the efficacy and safety of the drug during pregnancy or breastfeeding. The drug is contraindicated in pregnant women. Breastfeeding should be discontinued during treatment.
Method of administration and doses
The drug Lidaza-Biopharma is administered subcutaneously, under scar tissue, intramuscularly, in the form of inhalations, by electrophoresis methods or applications to mucous membranes. In ophthalmological practice, the drug can also be administered subconjunctivally, retrobulbarly.
For injections, dissolve the contents of the vial in 1 ml of 0.9% sodium chloride solution or in 1 ml of 0.5% novocaine solution.
For contractures, scars of various origins, hematomas, ankylosing spondylitis, administer under the skin near the site of the lesion or under scar tissue in adults at a dose of 64 U. Injections are daily or every other day. The course of treatment is 6-10-15 injections.
In case of traumatic lesions of the nerve plexuses of peripheral nerves, it is administered subcutaneously every other day to adults at a dose of 64 U in a solution of novocaine. The course of treatment (12-15 injections) can be repeated if necessary.
In rheumatoid arthritis, the drug is applied by electrophoresis: for adults, dissolve 64 IU of lidase in 30 ml of distilled water, add 4-5 drops of 0.1 N hydrochloric acid solution and inject from a bifurcated electrode (anode) into two joints. The duration of the procedure is 20-30 minutes, the course of treatment is 10-15 sessions.
For finer scarring of the affected areas of the cornea in keratitis, instill a solution of the drug (dissolve 1 bottle of the drug in 20 ml of isotonic sodium chloride solution or in 20 ml of 0.5% novocaine solution) while simultaneously using antibiotics and sulfonamides.
In case of retinopathies, 0.5 ml of solution should also be injected under the skin of the temple (dissolve 1 vial of the drug in 20 ml of isotonic sodium chloride solution or in 20 ml of 0.5% novocaine solution). The course of treatment is 10-15 injections.
Children
There is no data on the efficacy and safety of the drug in children, so the drug should not be used in pediatric practice.
Overdose
Symptoms: chills, nausea, vomiting, dizziness, tachycardia and hypotension, local edema, urticaria, erythema.
Treatment: administration of adrenaline, glucocorticoids, use of antihistamines.
In case of overdose of the drug and allergic reactions, the use of the drug should be discontinued.
Adverse reactions
General reactions of the body: weakness, increased body temperature, chills, sweating.
From the nervous system: dizziness, headache.
From the cardiovascular system: arterial hypotension, tachycardia.
Respiratory system: difficulty breathing, shortness of breath.
Allergic reactions, including flushing, skin rash, itching, urticaria, angioedema.
Local reactions: with intramuscular, subcutaneous administration, rashes, hyperemia, erythema, itching, redness, swelling, pain, and a feeling of heat at the injection site may occur; in ophthalmological practice with subconjunctival, retrobulbar administration - edema, hyperemia of the eyelids, paraorbital area, facial skin, hyperemia of the sclera.
Expiration date
2 years.
Storage conditions
Store in the original packaging to protect from light at a temperature of 2 ° C to 8 ° C. Keep out of the reach of children.
Incompatibility. Use only the recommended diluent. Do not mix the prepared solution with other medicinal products. Use immediately after preparation of the solution.
Packaging
5 vials in a blister. 2 blisters with vials in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC "FZ "BIOPHARMA", Ukraine.
Location of the manufacturer and its business address
Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37
