Lidase lyophilisate for the preparation of injection solution 1280ME, No. 10

Burn, traumatic, postoperative scars; long-term non-healing ulcers (including radiation); Dupuytren's contracture; joint stiffness, joint contractures (after inflammatory processes, injuries), osteoporosis, ankylosing spondylitis, severe diseases of the lumbar discs; chronic tendovaginitis, scleroderma (skin manifestations), hematoma of soft tissues of superficial localization; preparation for skin-plastic surgery for cicatricial contractions. Pulmonary tuberculosis (complicated by nonspecific bronchial lesions), inflammatory processes in the upper respiratory tract and bronchi with obstruction symptoms. Traumatic lesions of the nerve plexuses and peripheral nerves (plexitis, neuritis). Hyphema, hemophthalmos, retinopathy of various etiologies.

In case of cicatricial lesions subcutaneously (under the scar-altered tissue) or intramuscularly (near the site of the lesion), 64 AU (1 ml) is injected daily or every other day (only 10-20 injections).
In case of traumatic lesions of the nerve plexuses and peripheral nerves, it is injected subcutaneously into the area of ??the affected nerve (64 AU in a solution of procaine) every other day; per course - 12-15 injections. Repeat the course of treatment if necessary.
When used in ophthalmic practice, the drug is administered subconjunctivally - 0.3 ml, parabulbar - 0.5 ml, as well as by electrophoresis.
Patients with pulmonary tuberculosis with a productive nature of inflammation are prescribed in complex therapy to increase the concentration of antibacterial drugs in the lesions in the form of injections and / or inhalations! Inhalations are carried out daily 1 time using 5 ml of solution (320 EU). The course of treatment consists of 20-25 inhalations.
If necessary, repeat courses are carried out at intervals of 1.5-2 months.
Outwardly, in the form of dressings soaked in a solution of the drug. To prepare the solution, every 64 UE is dissolved in 10 ml of sterile 0.9% sodium chloride solution or boiled water at room temperature. With this solution, a sterile bandage folded in 4-5 layers is moistened, applied to the affected area, covered with wax paper and fixed with a soft bandage. The dose depends on the area of ??the lesion (20-60 IU / sq. Cm), on average - 300 IU per dressing. The bandage is applied daily for 15-18 hours for 15-60 days. With prolonged use, every 2 weeks take a break for 3-4 days.
When applied by electrophoresis, 300 IU is dissolved in 60 ml of distilled water, 2-3 drops of a 0.1% solution of hydrochloric acid are added and injected 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 should be used within 24 hours.

1 bottle contains:
Active substance : Lidase - 64 UE

Hypersensitivity, acute infectious and inflammatory diseases, recent hemorrhages, acute intercurrent diseases, children under 18 years of age. For inhalation administration - pulmonary tuberculosis with severe respiratory failure; pulmonary, bleeding, hemoptysis; malignant neoplasms, fresh vitreous hemorrhage. Concomitant administration of estrogens. There are no data on the use of the drug in children.

WITH CARE
Pregnancy, lactation period.

Trade name of the drug : Lidaza

International Non-Proprietary Name (INN) : Hyaluronidase

Dosage form : Lyophilisate for preparation of solution for injection and local use.

Composition : 1 bottle contains:
Active substance : Lidase - 64 UE
Description : Lyophilized powder or porous mass compacted into a tablet, white or white with a yellowish, pinkish, beige, cream or brownish tint.

Pharmacotherapeutic group : Enzymatic agent
PHARMACOLOGICAL PROPERTIES
An enzyme preparation isolated from the testes of cattle. It breaks down the main component of the interstitial substance of connective tissue - hyaluronic acid (mucopolysaccharide, which contains acetylglucosamine and glucuronic acid, is a 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 the joints, reduces contractures and prevents their formation. Hyaluronidase causes the breakdown of hyaluronic acid to glucosamine and glucuronic acid and thereby reduces its viscosity. The duration of action for intradermal administration is up to 48 hours.

INDICATIONS FOR USE
Burn, traumatic, postoperative scars; long-term non-healing ulcers (including radiation); Dupuytren's contracture; joint stiffness, joint contractures (after inflammatory processes, injuries), osteoporosis, ankylosing spondylitis, severe diseases of the lumbar discs; chronic tendovaginitis, scleroderma (skin manifestations), hematoma of soft tissues of superficial localization; preparation for skin-plastic surgery for cicatricial contractions. Pulmonary tuberculosis (complicated by nonspecific bronchial lesions), inflammatory processes in the upper respiratory tract and bronchi with obstruction symptoms. Traumatic lesions of the nerve plexuses and peripheral nerves (plexitis, neuritis). Hyphema, hemophthalmos, retinopathy of various etiologies.

CONTRAINDICATIONS
Hypersensitivity, acute infectious and inflammatory diseases, recent hemorrhages, acute intercurrent diseases, children under 18 years of age. For inhalation administration - pulmonary tuberculosis with severe respiratory failure; pulmonary, bleeding, hemoptysis; malignant neoplasms, fresh vitreous hemorrhage. Concomitant administration of estrogens. There are no data on the use of the drug in children.

WITH CARE
Pregnancy, lactation period.

DOSAGE AND METHOD OF APPLICATION
In case of cicatricial lesions subcutaneously (under the scar-altered tissue) or intramuscularly (near the site of the lesion), 64 AU (1 ml) is injected daily or every other day (10-20 injections in total).
In case of traumatic lesions of the nerve plexuses and peripheral nerves, it is injected subcutaneously into the area of ??the affected nerve (64 AU in a solution of procaine) every other day; per course - 12-15 injections. Repeat the course of treatment if necessary.
When used in ophthalmic practice, the drug is administered subconjunctivally - 0.3 ml, parabulbar - 0.5 ml, as well as by electrophoresis.
Patients with pulmonary tuberculosis with a productive nature of inflammation are prescribed in complex therapy to increase the concentration of antibacterial drugs in the lesions in the form of injections and / or inhalations! Inhalations are carried out daily 1 time using 5 ml of solution (320 EU). The course of treatment consists of 20-25 inhalations.
If necessary, repeat courses are carried out at intervals of 1.5-2 months.
Outwardly, in the form of dressings soaked in a solution of the drug. To prepare the solution, every 64 UE is dissolved in 10 ml of sterile 0.9% sodium chloride solution or boiled water at room temperature. With this solution, a sterile bandage folded in 4-5 layers is moistened, applied to the affected area, covered with wax paper and fixed with a soft bandage. The dose depends on the area of ??the lesion (20-60 IU / sq. Cm), on average - 300 IU per dressing. The bandage is applied daily for 15-18 hours for 15-60 days. With prolonged use, every 2 weeks take a break for 3-4 days.
When applied by electrophoresis, 300 IU is dissolved in 60 ml of distilled water, 2-3 drops of a 0.1% solution of hydrochloric acid are added and injected 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 should be used within 24 hours.

SIDE EFFECTS
Allergic reactions; with prolonged use - local irritating effect.

OVERDOSE
Symptoms : chills, nausea, vomiting, dizziness, tachycardia, decreased blood pressure, local edema, urticaria, erythema.
Treatment : the introduction of epinephrine, glucocorticosteroids; antihistamines.

INTERACTION WITH OTHER DRUGS
Improves the absorption of drugs administered subcutaneously or intramuscularly, enhances the effect of local anesthetics.

SPECIAL INSTRUCTIONS
The solution should not be injected through a catheter into which solutions containing cations were previously injected.
Solutions for injections are prepared in 0.9% sodium chloride solution or 0.5% procaine solution, for inhalation - in 0.9% sodium chloride solution, for electrophoresis - in distilled water.
Before starting treatment, it is advisable to conduct a test with intradermal injection of 20 ?l of hyaluronidase.
Should not be injected into areas of infectious inflammation and tumors.
Do not use hyaluronidase for acute hemorrhages.

RELEASE FORM
Lyophilisate for preparation of solution for injection and local use, 64UE.
64 UE (conventional units) in glass bottles with a capacity of 5 ml, sealed with rubber stoppers and rolled with aluminum caps. 10 vials in cardboard boxes with instructions for use.
Packing complete with a solvent: a vial with a preparation with a capacity of 5 ml and an ampoule with a 0.9% sodium chloride solution make up one set.
5 sets with an ampoule knife or scarifier and instructions for the use of lidase are placed in ten-place packs of cardboard box.

SHELF LIFE
2 years. Do not use after the expiration date printed on the package.

STORAGE CONDITIONS
In dry, protected from light at a temperature not exceeding 15 ? —.
Keep out of the reach of children.

TERMS OF RELEASE FROM PHARMACIES
By prescription.