Active substanceBoviolanuronidase azoximeBoviolanuronidase azoxime
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  • Longidase®
    lyophilizate for injections 
  • Longidase®
    suppositories rect. the vagina. 
  • Dosage form: & nbsplyophilizate for solution for injection
    Composition:

    Composition per 1 ampoule or vial:

    Active substance: Bovihaluronidase azoxime (Longidase®) 1500 ME or 3000 ME.

    Excipient: mannitol up to 15 mg (for dosage 1500 ME) or up to 20 mg (for a dosage of 3000 ME).

    Description:The porous mass of white or white with a yellowish or brownish tint is hygroscopic.
    Pharmacotherapeutic group:Enzyme agent
    ATX: & nbsp

    V.03.A.X   Other medications

    Pharmacodynamics:

    Bovigeraluridase azoxime is a proteolytic enzyme conjugate hyaluronidase with a high-molecular-weight carrier from the group of derivatives Npoly-1,4-ethylene-piperazine oxide. Boviolanuronidase azoxime has the entire spectrum of pharmacological properties inherent in drugs with hyaluronidase activity. The specific substrate of hyaluronidase is glycosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate) - a "cementing" substance of connective tissue.As a result of hydrolysis (depolymerization), the viscosity of glycosaminoglycans decreases, the ability to bind water and metal ions. As a result, the permeability of tissues increases, their trophics improve, edemas decrease, hematomas dissolve, the elasticity of the scar-altered areas increases, contractures and adhesions are eliminated, the contractions joint mobility. The effect is most pronounced in the initial stages of the pathological process.

    Clinical effect Boviolanuronidase azoxime much higher than the effect of native hyaluronidase. Conjugation increases the stability of the enzyme to the action of temperature and inhibitors, increases its activity and leads to prolongation of the action. Enzymatic activity Boviolanuronidase azoxime is maintained with heating 37 ° C for 20 days, while native hyaluronidase in the same conditions, loses its activity during the day. AT Boviolanuronidase azoxime the pharmacological properties of the carrier possessing chelating, antioxidant, anti-inflammatory and immunomodulating activity are also preserved. Boviolanuronidase azoxime it is able to bind iron ions liberated during the hydrolysis of glycosaminoglycans - activators of free radical reactions, hyaluronidase inhibitors and stimulators of collagen synthesis, and thereby suppress the reverse reaction directed to the synthesis of connective tissue components. Polytropic properties Boviolanuronidase azoxime are realized in the expressed antifibrotic action, experimentally proved by biochemical, histological and electron microscopic studies on the model of pneumofibrosis.

    Boviolaronidase azoxime regulates the synthesis of mediators of inflammation (interleukin-1 and tumor necrosis factor-alpha) depending on the initial level, it can weaken the course of the acute phase of inflammation, increase the humoral immune response and the resistance of the organism to infection. These properties allow you to apply Boviolanuronidase azoxime during or after surgical treatment to prevent coarse scarring and adhesions. Application Boviolanuronidase azoxime in therapeutic doses during or after surgical treatment does not cause a deterioration in the course of the postoperative period or progressioninfectious process; does not slow the recovery of bone tissue. Boviolanuronidase azoxime at joint subcutaneous or intramuscular administration increases the absorption of drugs, accelerates analgesia when administered local anesthetics.

    Bovgialuronidaza azoksimer relates to a substantially non-toxic compounds that disrupt the normal functioning of the immune system, has no effect on reproductive performance of male and female rats in pre- and postnatal development of the offspring, has no mutagenic and carcinogenic properties. It has been experimentally proved that in Boviolanuronidase azoxime reduced irritating and allergic enzyme properties hyaluronidase. In therapeutic doses Boviolanuronidase azoxime well tolerated by patients.

    Pharmacokinetics:

    With parenteral administration Boviolanuronidase azoxime rapidly absorbed into the systemic circulation and reaches a maximum concentration in the blood after 20-25 minutes, it is characterized by a high rate of distribution in the body. poluraspredeleniya Period - about 0.5 hr, half-life (T1 / 2) when administered intramuscularly 36 hours after subcutaneous about 45 hours.The apparent volume of distribution is 0.43 l / kg. Conjugation does not reduce the high bioavailability of the enzyme - bioavailability of at least 90%.

    The active substance penetrates into all organs and tissues, including through blood-brain and ophthalmic barriers.

    In organism hyaluronidase is hydrolyzed, and the carrier decomposes to low molecular weight compounds (oligomers), which are mainly excreted through the kidneys in two phases. Within the first 24 hours through the kidneys, 45-50% are excreted, through the intestine no more than 3 %. Further, the elimination rate slows down, and by 4-5 days the drug is completely eliminated.

    Indications:

    Adults in the complex therapy for the treatment and prevention of diseases accompanied by hyperplasia of connective tissue.

    in gynecology: treatment and prevention of adhesions in the small pelvis with inflammatory diseases of internal genital organs, including tubal peritoneal infertility, intrauterine synechia, chronic endometrium;

    in urology: treatment of chronic prostatitis, interstitial cystitis;

    in surgery: treatment and prevention of adhesions after surgical interventions on the organs of the abdominal cavity; hypertrophic scars after injuries, burns, surgeries, pyoderma; long-term non-healing wounds;

    in dermatovenereology and cosmetology: treatment of limited scleroderma, keloid, hypertrophic, emerging scars after pyoderma, trauma, burns, surgeries;

    in pulmonology and phthisiology: treatment of pneumosclerosis, fibrosing alveolitis, tuberculosis (cavernous-fibrous, infiltrative, tuberculoma);

    in orthopedics: treatment of joint contractures, arthrosis, ankylosing spondylitis, hematoma;

    to increase bioavailability: with the joint introduction of antibacterial drugs in urology, gynecology, surgery, dermatovenereology, pulmonology, to strengthen the action of local anesthetics.

    Contraindications:

    Hypersensitivity to drugs based on hyaluronidase, acute infectious diseases, pulmonary hemorrhage and hemoptysis, fresh vitreous hemorrhage, malignant neoplasms, acute renal failure, age under 18 years (results of clinical studies are absent).

    Carefully:

    Chronic renal failure (not used more than once a week).

    Pregnancy and lactation:

    Contraindicated use of the drug Longidasa ® pregnant women and women during breastfeeding.

    Dosing and Administration:

    Longitudinalase ® is applied subcutaneously (near the lesion site or under the scar tissue) or intramuscularly at a dose of 3000 ME a course of 5 to 25 injections (depending on the disease) with an interval between administrations from 3 to 10 days.

    Methods of application are chosen by the doctor depending on the diagnosis, severity of the disease, clinical course, age of the patient. If necessary, a second course is recommended after 2-3 months.

    In the case of treatment of diseases accompanied by a severe chronic productive process in connective tissue, after a standard course, prolonged maintenance therapy with Longidase 3000 ME with interruptions between injections - 10-14 days.

    To increase the bioavailability of drugs and diagnostic agents, a dose of 1500 ME at preliminary for 10-15 minutes intramuscular or hypodermic introduction in the same place, as the basic preparation.

    Breeding:

    - Contents of the ampoule or bottle of Longidasa® 3000 ME are dissolved in 1.0-2.0 ml of the procaine solution (0.25% or 0.5%).In case of procaine intolerance, Longidasa® is dissolved in the same volume of a 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® 3000 ME is dissolved in 2.0 ml, and with a dosage of 1500 ME in 1.0 ml of sodium chloride solution 0.9% for injection.

    The solvent in the vial or ampoule should be injected slowly, soak for 2-3 minutes, gently stir, not shaking, so as not to foam the protein. The prepared solution for parenteral administration is not subject to storage.

    Do not administer intravenously!

    Recommended schemes of prevention and treatment

    For prevention adhesions and gross scarring after surgery on the organs of the abdominal cavity and small pelvis intramuscularly at a dosage of 3000 ME 1 every 3 days with 5 injections. If necessary, the use of the Longidasa® preparation can be continued by a general course of up to 10 injections when administered once every 5 days,

    For treatment:

    in gynecology:

    - adhesive process in the small pelvis with inflammatory diseases of internal genitalia intramuscularly by 3000 ME 1 every 3-5 days with a course of 10-15 injections;

    - tubal peritoneal infertility intramuscularly to 3000 ME a common course for up to 15 injections: the first 5 injections 1 every 3 days, then 1 every 5 days;

    in urology:

    - chronic prostatitis intramuscularly to 3000 ME 1 every 5 days, course of 10-15 injections;

    - interstitial cystitis intramuscularly to 3000 ME 1 every 5 days, up to 10 injections;

    in surgery:

    - an adhesion disease after surgical interventions on the organs of the abdominal cavity intramuscularly at a dosage of 3000 ME 1 every 3-5 days with a course of 10 to 15 injections;

    - long-term non-healing wounds intramuscularly at a dosage of 3000 ME 1 every 5 days with a course of 5-10 injections;

    in dermatovenereology, cosmetology:

    - intramuscularly scleroderma by 3000-4500 ME 1 time in 3-5 days with a course of up to 20 injections. Dosage 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, surgeries, trauma: intradermal or subcutaneous injection near the site of the lesion once every 3 days, with a course of up to 15 injections at a dosage of 3000-4500 ME. The amount of dilution of the Longidas preparation * is chosen by the doctor depending on the number of injection points. If necessary, the course can be continued on a schedule once every 5 days to 25 injections.Depending on the area of ​​skin lesion, the prescription of scar formation, it is possible to alternate subcutaneous and intramuscular administration once every 5 days in a dosage of 3000 ME, course up to 20 injections.

    in pulmonology and phthisiology:

    - pneumosclerosis intramuscularly to 3000 ME 1 every 5 days with a course of 10 injections;

    - fibrosing alveolitis intramuscularly at a dosage of 3000 ME 1 every 5 days with a course of 15 injections, then maintenance therapy once every 10 days with a general course up to 25 injections;

    - intramuscular injection at dosage of 3000 ME 1 every 5 days with a course of up to 25 injections; depending on the clinical picture and the severity of the course of the disease, long-term therapy is possible (from 6 months to 1 year at a dosage of 3000 ME 1 time in 10 days);

    in orthopedics:

    - contracture of the joints subcutaneously near the lesion in a dosage of 3000 ME 1 every 3 days with a course of 5 to 15 injections;

    - arthrosis, ankylosing spondylitis, subcutaneously near the lesion in a dosage of 3000 ME 1 every 3 days with a course of up to 15 injections, if necessary, treatment can be continued with injections once every 5 days. The duration of maintenance therapy is chosen by the doctor depending on the severity of the disease;

    - hematomas subcutaneously near the lesion in a dosage of 3000 ME 1 every 3 days for up to 5 injections;

    to increase bioavailability: when combined subcutaneously or intramuscularly with diagnostic or medicinal products (antibiotics, chemotherapy, anesthetics, etc.). Longitudinalase® is administered preliminary for 10-15 minutes at a dosage of 1500 ME in the same way and in the same place as the main drug.

    Side effects:

    Often (> 1/100, <1/10) - tenderness at the injection site. Sometimes (> 1/1000, <1/100), reactions at the injection site in the form of redness of the skin, itching and swelling are possible. All local reactions take place independently after 48-72 hours. Very rarely (<1/10 000) allergic reactions.

    Overdose:

    Symptoms of overdose can be manifested by chills, fever, dizziness, hypotension. The drug is discontinued and symptomatic therapy is prescribed.

    Interaction:

    Boviolaronidase azoxime can be combined with antibiotics, antiviral, antifungal agents, bronchodilators. When used in combination with other medicines (antibiotics, local anesthetics, diuretics) Boviolanuronidase azoxime increases bioavailability and enhances their effect. When combined with high doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogen or antihistamines, enzyme activity may be decreased Boviolanuronidase azoxime.

    Do not use Boviolanuronidase azoxime simultaneously with preparations containing furosemide, benzodiazepines, phenytoin.

    Special instructions:

    If it is necessary to stop taking Longidasa ®, cancellation can be done immediately, without a gradual dose reduction.

    If you miss the introduction of a regular dose of the drug, its subsequent use should be carried out as usual, as indicated in this manual or recommended by a doctor. The patient should not enter a doubled dose to compensate for missed doses.

    Before starting treatment, tell your doctor about all medications you take. Before using the drug, check with your doctor. Read the instructions for use and save it.

    Follow the instructions in the instructions for use. If you have any questions, ask your doctor or pharmacist for an explanation.

    In chronic renal failure, the drug is prescribed no more than 1 time per week.When developing an allergic reaction, stop using Longidasa® and consult a doctor.

    Do not use the drug in the presence of visual signs of its unfitness (defect packaging, change the color of the powder).

    Do not administer the Longidasa® preparation into the acute infectious inflammation zone because of the risk of spreading a localized infection.

    Effect on the ability to drive transp. cf. and fur:

    The use of Longidasa® does not affect the ability to perform potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms).

    Form release / dosage:

    Lyophilizate for solution for injection 1500 ME, 3000 ME.

    Packaging:

    For 15 mg (for a dosage of 1500 ME) or 20 mg (for a dosage of 3000 ME) in ampoules or bottles with a capacity of 3 ml dark glass 1 hydrolytic class. For 5 ampoules or vials with the drug in a contour cell packaging from a polyvinyl chloride film. One contour mesh package together with instructions for use in a pack of cardboard.Or 5 ampoules or vials, together with instructions for use in a pack of cardboard with an insert of cardboard.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000764
    Date of registration:07.05.2010 / 19.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:NPO PETROVAKS PHARM, LLC NPO PETROVAKS PHARM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.08.2016
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