Longidaza lyophilizate for preparation of solution for injection 3000IU vials, 5pcs

Composition

1 fl. contains longidase with hyaluronidase activity 3000 IU

auxiliary substance:

mannitol-up to 20 mg

Pharmacological action

A drug with proteolytic activity. It has enzymatic proteolytic (hyaluronidase) activity of prolonged action, immunomodulatory, chelating, antioxidant and anti-inflammatory effects.

Prolongation of the drug’s action is carried out due to covalent binding of the enzyme with a physiologically active high-molecular carrier (an activated derivative of poly-1,4-ethylene piperazine N-oxide), which has its own pharmacological activity: it has an immunomodulatory, detoxifying and antioxidant effect.

The presence of a covalent bond significantly increases the resistance of the enzyme to denaturing effects and the influence of inhibitors. The enzymatic activity of Longidase is preserved when heated to 37°C for 20 days, while native hyaluronidase under the same conditions loses its activity during the day.

The covalent bond provides simultaneous local presence of a hydrolytic enzyme and a carrier capable of binding released enzyme inhibitors and stimulators of collagen synthesis (iron, copper ions, heparin). Due to these properties, Longidase has not only the ability to depolymerize the connective tissue matrix in fibrogranulomatous formations, but also to suppress the reverse regulatory reaction aimed at the synthesis of connective tissue components.

The specific substrate of testicular hyaluronidase is glucosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate), which form the basis of the connective tissue matrix. As a result of depolymerization (breaking the bond between C1 of acetylglucosamine and C4 of glucuronic or induronic acids) under the influence of hyaluronidase, glucosaminoglycans lose their basic properties (viscosity, ability to bind water, metal ions). It also hinders the formation of collagen proteins into fibers, increases the permeability of tissue barriers, facilitates the movement of fluid in the intercellular space, and increases the elasticity of connective tissue. The effect of the drug leads to a decrease in swelling of the tissue, flattening of scars, increasing the volume of joint movement, reducing contractures and adhesions and preventing their formation.

The drug reduces the manifestations of the acute phase of the inflammatory process, regulates (increases or decreases depending on the initial level) the synthesis of inflammatory mediators (interleukin-1 and tumor necrosis factor), increases the body’s resistance to infection and humoral immune response.

Longidase does not have antigenic properties, mitogenic, polyclonal activity, and does not have allergenic, mutagenic, embryotoxic, teratogenic, or carcinogenic effects.

Indications

The drug is prescribed to adults as part of a complex therapy for the treatment and prevention of diseases accompanied by connective tissue hyperplasia.

In gynecology:

• treatment and prevention of pelvic adhesions in inflammatory diseases of the internal genital organs, including tubo-peritoneal infertility, intrauterine synechiae, and chronic endometritis.

In Urology:

• treatment of chronic prostatitis;
• treatment of interstitial cystitis.

In surgery:

• treatment and prevention of adhesions after surgical interventions on the abdominal organs;
• hypertrophic scars after injuries, burns, operations, pyoderma;
• long-term non-healing wounds.

In dermatovenerology and cosmetology:

• treatment of limited scleroderma;
• treatment of keloid, hypertrophic, emerging scars after pyoderma, injuries, burns, operations.

In pulmonology and phthisiology:

In orthopedics:

• treatment of joint contracture, arthrosis, ankylosing spondylitis, hematomas.

To increase bioavailability:

• with the combined use of antibacterial drugs in urology, gynecology, surgery, dermatovenerology, pulmonology, to enhance the effect of local anesthetics.

Use during pregnancy and lactation

• the drug Longidaza is contraindicated during pregnancy
• in children under 12 years of age (efficacy and safety have not been studied).

Contraindications

• increased individual sensitivity to enzymes with hyaluronidase activity
• malignant neoplasms

With caution, the drug is prescribed for acute renal failure, pulmonary bleeding.

Side effects

Local reactions:  pain at the injection site; in some cases – hyperemia of the skin and swelling of the tissues at the injection site.

Other services:  rarely-allergic reactions.

All adverse reactions pass in 48-72 hours.

Interaction

Longidase is compatible with antibiotics, antivirals, antifungal and antihistamines, bronchodilators, cytostatics, and corticosteroids.

When used together, it increases the bioavailability of drugs, accelerates the onset of analgesia when local anesthetics are administered.

How to take, course of use and dosage

Longidase is used subcutaneously (near the lesion site or under scar-changed tissues) or intravenously at a dose of 3000 IU in a course of 5 to 25 injections (depending on the disease) with an interval between injections of 3 to 10 days.

Methods of application are chosen by the doctor depending on the diagnosis, severity of the disease, clinical course, and age of the patient. If necessary, it is recommended to repeat the course in 2-3 months.

In the case of treatment of diseases accompanied by a severe chronic productive process in connective tissue, after the standard course, long-term maintenance therapy with Longidase is recommended with breaks between injections-10-14 days.

To increase the bioavailability of drugs and diagnostic tools, a dose of 1500 IU is recommended with a preliminary 10-15-minute intravenous or subcutaneous injection in the same place as the main drug.

Breeding

• The contents of the ampoule or vial of Longidase are dissolved in 1-2 ml of procaine solution (0.25% or 0.5%). In case of procaine intolerance, the drug is dissolved in the same volume of 0.9% sodium chloride solution for injection or water for injection.
• When used to increase bioavailability, the contents of the ampoule or vial of Longidase are dissolved in 2 ml, and with a dose of 1500 IU-in 1 ml of 0.9% sodium chloride solution for injection.

The solvent in the vial or ampoule should be introduced slowly, stand for 2-3 minutes, mix carefully, without shaking, so as not to foam the protein. The prepared solution for parenteral use is not subject to storage. Do not enter I / O!

Recommended prevention and treatment regimens

For the prevention of adhesive disease and rough scarring after surgical interventions on the abdominal and pelvic organs in / m at a dose of 3000 IU 1 time in 3 days with a course of 5 injections. If necessary, the use of the drug can be continued with a general course of up to 10 injections when administered 1 time in 5 days.

For treatment

in gynecology:

• pelvic adhesions in inflammatory diseases of the internal genitalia – i / m 1 time in 3-5 days with a course of 10-15 injections;
• tubal-peritoneal infertility-i / m with a general course of up to 15 injections: the first 5 injections 1 time in 3 days, then-1 time in 5 days.

in urology:

• chronic prostatitis – i / m 1 time in 5 days, a course of 10-15 injections;
• interstitial cystitis-i/m 1 time in 5 days, a course of up to 10 injections.

in surgery:

• adhesive diseases after surgical interventions on the abdominal organs – i / m 1 time in 3-5 days with a course of 10 to 15 injections;
• long-term non-healing wounds-i / m 1 time in 5 days with a course of 5-10 injections.

in dermatovenerology, cosmetology:

• limited scleroderma – in / m 1 time in 3-5 days with a course of up to 20 injections. The dose and course are selected individually depending on the clinical course, stage, localization of the disease and individual characteristics of the patient;
• keloid, hypertrophic and emerging scars after pyoderma, burns, operations, injuries – intra-articular or subcutaneous use near the site of the lesion use 1 time in 3 days, a course of up to 15 injections in a dosage of 3000-4500 ME. The volume of dilution of the drug Longidase is chosen by the doctor depending on the number of injection points. If necessary, the course can be continued according to the scheme 1 time in 5 days up to 25 injections. Depending on the area of the skin lesion, the age of scar formation, it is possible to alternate subcutaneous and intramuscular use 1 time in 5 days at a dose of 3000 IU, with a course of up to 20 injections.

in pulmonology and phthisiology:

• pulmonary fibrosis – /m 1 every 5 days for a course of 10 injections;
• fibroporous alveolitis – /m 1 every 5 days course 15 injections, further supportive therapy 1 time every 10 days total rate of up to 25 injections;
• TB/m 1 every 5 days course to 25 injections; depending on the clinical picture and the severity of the disease may be prolonged therapy (from 6 months to 1 year at a dose of 3000 ME 1 time every 10 days).

in orthopedics:

• joint contractures-subcutaneous injection near the lesion site at a dose of 3000 IU 1 time in 3 days with a course of 5 to 15 injections;
• osteoarthritis, ankylosing spondylitis-subcutaneous injection near the site of the lesion at a dose of 3000IU 1 time in 3 days with a course of up to 15 injections, if necessary, treatment can be continued with injections 1 time in 5 days. The duration of maintenance therapy is chosen by the doctor depending on the severity of the disease;
• hematoma-subcutaneous injection near the lesion site at a dose of 3000 IU 1 time in 3 days with a course of up to 5 injections.

To increase bioavailability: when combined subcutaneous or intramuscular use with diagnostic or medicinal preparations (antibiotics, chemotherapy drugs, anesthetics, etc. ), Longidase is pre-administered 10-15 minutes in a dose of 1500 IU in the same way and in the same place as the main drug.

Overdose

Currently, no cases of overdose of the drug Longidase have been reported.

Special instructions

The drug should not be administered in the area of an infectious lesion, acute inflammation or tumor.

Form of production

Lyophilizate for solution preparation for intravenous and subcutaneous use

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 15 °C

Shelf life

2 years

Active ingredient

Bovhyaluronidase azoximer

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as directed by your doctor

Indications

Prostatitis, Arthritis, Burns, Osteoarthritis, Adhesions, Tuberculosis, Wounds, Scars, Pyoderma