Longidaza lyophilisate for preparation of the solution for injection 3000 IU ampoules 5 pcs
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Description
Porous mass of white or white with a yellowish or brownish tinge, hygroscopic.
Active ingredients
Release form
Composition
Active substance: Bovgialuronidazozoksimer (Longidaza®) 1500 IU or 3000 IU
Auxiliary substance: mannitol up to 15 mg (for dosage 1500 IU) or up to 20 mg (for dosage 3000 IU)
Pharmacological effect
Bovgialuronidaza azoxymere is a conjugate of a proteolytic enzyme hyaluronidase with a high molecular weight carrier from the group of poly-1,4-ethylene piperazine N-oxide derivatives. Bovgialuronidazozoksimer possesses the entire spectrum of pharmacological properties inherent in medicines 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. Hydrolysis (depolymerization) decreases the viscosity of glycosaminoglycans, the ability to bind water and metal ions. As a result, the permeability of tissues increases, their trophicity improves, swelling decreases, hematomas dissolve, elasticity of cicatricially altered areas increases, contractures and adhesions are eliminated, and mobility of joints increases. The effect is most pronounced in the initial stages of the pathological process.
The clinical effect of bovgialuronidase azoxymere is significantly higher than the effect of native hyaluronidase. Conjugation increases the resistance of the enzyme to the action of temperature and inhibitors, increases its activity and leads to prolonged action. Enzymatic activity Bovgialuronidazozokimer persists when heated at 37 ° C for 20 days, while native hyaluronidase in the same conditions loses its activity during the day. In Bovgialuronidazozoxymere, the pharmacological properties of the carrier with chelating, antioxidant, anti-inflammatory, and immunomodulatory activity are also preserved. Bovgialuronidazozoksimer able to bind released during hydrolysis of glycosaminoglycans iron ions - activators of free-radical reactions, hyaluronidase inhibitors and stimulants of collagen synthesis, and thereby suppress the backlash, aimed at the synthesis of components of connective tissue.The polytropic properties of Bovgialuronidaza azoxymere are realized in a pronounced anti-fibrotic effect, experimentally proven by biochemical, histological and electron microscopic studies on a pneumofibrosis model.
Bovgialuronidaza azoxymere regulates (increases or decreases depending on the initial level) synthesis of inflammatory mediators (interleukin-1 and tumor necrosis factor-alpha), can weaken the acute phase of inflammation, increase the humoral immune response and resistance of the organism to infection. These properties allow the use of Bovgialuronidase azoxymere during or after surgical treatment to prevent rough scarring and adhesions. The use of Bovgialuronidazozoksimer in therapeutic doses during or after surgical treatment does not cause deterioration of the postoperative period or the progression of the infectious process; does not slow down bone repair.
Bovgialuronidazozoksimer with joint subcutaneous or intramuscular administration increases the absorption of drugs, accelerates pain relief with the introduction of local anesthetics.
Bovgialuronidazozoksimer belongs to practically non-toxic compounds, does not violate the normal functioning of the immune system, does not affect the reproductive function of males and females of rats, pre-and postnatal development of offspring, does not have a mutagenic and carcinogenic effect. It has been experimentally proved that in Bovgialuronidaz azoxymere the irritating and allergenic properties of the enzyme hyaluronidase are reduced. At therapeutic doses of Bovgialuronidase, azoxymere is well tolerated by patients.
Pharmacokinetics
With parenteral administration of Bovgialuronidase, azoximer is rapidly absorbed into the systemic circulation and reaches a maximum concentration in the blood in 20-25 minutes, characterized by a high rate of distribution in the body. The half-distribution period is about 0.5 hours, the half-life (T?) With intramuscular injection is 36 hours, with subcutaneous administration it is about 45 hours. Apparent volume of distribution
0.43 L / kg. Conjugation does not reduce the high bioavailability of the enzyme - bioavailability of at least 90%.
The active ingredient penetrates into all organs and tissues, including through the blood-brain and ophthalmic barriers.
In the body, hyaluronidase undergoes hydrolysis, and the carrier disintegrates to low molecular weight compounds (oligomers), which are eliminated mainly through the kidneys in two phases. During the first day 45-50% is excreted through the kidneys, no more than 3% through the intestines. Further, the rate of elimination slows down, by 4-5 days the drug is removed completely.
Indications
Adults in the complex therapy for the treatment and prevention of diseases involving hyperplasia of the connective tissue.
in gynecology: treatment and prevention of adhesions in the pelvis with inflammatory diseases of the internal genital organs, including tuboperitoneal infertility, intrauterine synechia, chronic endometritis;
in urology: treatment of chronic prostatitis, interstitial cystitis;
in surgery: treatment and prevention of adhesions after surgery on the abdominal organs; hypertrophic scars after injuries, burns, surgeries, pyoderma; long-term non-healing wounds;
in dermatology and cosmetology: treatment of limited scleroderma, keloid, hypertrophic, forming scars after pyoderma, injuries, burns, operations;
in pulmonology and phthisiology: treatment of pneumosclerosis, fibrosing alveolitis, tuberculosis (cavernous fibrous, infiltrative, tuberculoma);
in orthopedics: treatment of joint contracture, arthrosis, ankylosing spondylitis, hematomas;
to increase bioavailability: with the joint introduction of antibacterial drugs in urology, gynecology, surgery, dermatology, pulmonology, to enhance 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 up to 18 years (the results of clinical studies are absent).
Precautionary measures
Chronic renal failure (not used more than 1 time per week).
Influence on ability to steer vehicles, mechanisms:
The use of the drug Longidase® does not affect the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (including driving,work with moving mechanisms)
Use during pregnancy and lactation
Use of the drug Longidaza® is contraindicated in pregnant women and women during breastfeeding.
Dosage and administration
Longidase® is applied subcutaneously (near the site of injury or under scar-modified tissue) or intramuscularly at a dose of 3000 IU in a course of 5 to 25 injections (depending on the disease) with an interval between injections from 3 to 10 days.
Methods of use are chosen by the doctor depending on the diagnosis, the severity of the disease, the clinical course, the age of the patient. If necessary, a second course is recommended in 2-3 months.
In the case of treatment of diseases involving severe chronic productive process in the connective tissue, after the standard course, long-term maintenance therapy with Longidaz® 3000 IU is recommended, with intervals between injections of 10 -14 days.
To increase the bioavailability of medicinal and diagnostic agents, a dose of 1500 IU is recommended with a preliminary for 10-15 minutes intramuscular or subcutaneous administration in the same place as the main drug.
Breeding:
1. The contents of the ampoule or vial of the drug Longidas® 3000 IU are dissolved in 1.0-2.0 ml of procaine solution (0.25% or 0.5%). In the case of procaine intolerance, Longidaz® is dissolved in the same volume of 0.9% sodium chloride solution for injection or water for injection.
2. When used to increase the bioavailability, the contents of the ampoule or vial of Longidaz® 3000 IU are dissolved in 2.0 ml, and with a dosage of 1500 IU in 1.0 ml of 0.9% sodium chloride solution for injection. The solvent in the vial or ampoule must be introduced slowly, stand for 2-3 minutes, gently mix, 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 regimens and doses:
For prophylaxis adhesive disease and severe scarring after surgery on the abdominal organs and small pelvis intramuscularly in a dosage of 3000 IU 1 time in 3 days with a course of 5 injections. If necessary, the use of the drug Longidase® can be continued by a general course of up to 10 injections with the introduction of 1 time 5 days.
For treatment.
in gynecology:
- adhesions in the pelvis with inflammatory diseases of the internal genital organs intramuscularly in doses of 3,000 IU 1 every 3-5 days with a course of 10-15 injections;
- tubal-peritoneal infertility by intramuscular injection of 3000 IU in a common 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 intramuscularly in doses of 3000 IU 1 time in 5 days, in a course of 10-15 injections;
- interstitial cystitis intramuscularly in doses of 3000 IU once every 5 days, with a course of up to 10 injections;
in surgery:
- adhesive disease after surgery on the abdominal organs intramuscularly in a dosage of 3000 IU 1 time in 3-5 days with a course of 10 to 15 injections;
- nonhealing wounds intramuscularly in a dosage of 3000 IU 1 time in 5 days with a course of 5-10 injections;
in dermatovenerology, cosmetology:
- limited scleroderma intramuscularly at 3000-4500 IU 1 time in 3-5 days with a course of up to 20 injections. The dosage and course are selected individually depending on the clinical course, stage, localization of the disease and the individual characteristics of the patient;
- keloid, hypertrophic and forming scars after pyoderma, burns, surgeries, injuries: intracipital or subcutaneous near the site of lesion, the injection is every 3 days, with a course of up to 15 injections in the dosage of 3000-4500 IU. The dilution amount of the drug Longidase® is chosen by the doctor depending on the number of points of injection. 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 skin lesion, the duration of scar formation, alternation of subcutaneous and intramuscular administration is possible 1 time in 5 days at a dosage of 3000 IU, in a course of up to 20 injections.
in pulmonology and phthisiology:
- pneumosclerosis intramuscularly in doses of 3000 IU 1 time in 5 days with a course of 10 injections;
- fibrosing alveolitis intramuscularly in a dosage of 3000 IU 1 time in 5 days with a course of 15 injections, then supportive therapy 1 time in 10 days with a general course of up to 25 injections;
- tuberculosis intramuscularly in a dosage of 3000 IU 1 time in 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 IU 1 time in 10 days);
in orthopedics:
- joint contractures subcutaneously near the site of the lesion at a dosage of 3000 IU 1 time in 3 days with a course of 5 to 15 injections;
- arthrosis, ankylosing spondyloarthritis subcutaneously near the site of the lesion in a dosage of 3000 IU 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;
- subcutaneous hematomas near the site of lesion at a dose of 3000 IU 1 time in 3 days with a course of up to 5 injections;
to increase bioavailability:
in case of joint subcutaneous or intramuscular administration with diagnostic or medicinal preparations (antibiotics, chemotherapy drugs, anesthetics, etc.).Longidase® is administered pre-10-15 minutes in a dosage of 1500 IU in the same way and in the same place as the main drug.
Side effects
Often (> 1/100, <1/10) - pain at the injection site. Sometimes (> 1/1000, <1/100), reactions can occur at the injection site in the form of redness, itching and swelling. All local reactions pass independently in 48-72 hours. Very rarely (<1/10 000) allergic reactions.
Overdose
Overdose symptoms can manifest as chills, fever, dizziness, hypotension. Drug administration is stopped and symptomatic therapy is prescribed.
Interaction with other drugs
Bovgialuronidazo azoksimer can be combined with antibiotics, antiviral, antifungal drugs, bronchodilators. When used in combination with other drugs (antibiotics, local anesthetics, diuretics) Bovgialuronidase azoximer increases bioavailability and enhances their action. When used together with large doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogen or antihistamine drugs, the enzymatic activity of Bovgialuronidase azoxyimer can be reduced.
Do not use Bovgialuronidaza azoksimer simultaneously with drugs containing furosemide, benzodiazepines, phenytoin.
special instructions
If you need to stop taking the drug Longidase®, the cancellation can be done immediately, without gradually reducing the dose. In case of skipping the introduction of a regular dose of the drug, its subsequent use should be carried out as usual, as indicated in this instruction or recommended by a doctor. The patient should not administer a double dose in order to compensate for missed doses.
Before starting treatment, tell your doctor about all the medicines you are taking. Before using the drug, consult your doctor. Read the instructions for use of the drug and save it.
Carefully follow the instructions given in the instructions for use of the drug. If you have any questions, ask your doctor or pharmacist for clarification.
In chronic renal failure, the drug is prescribed no more than 1 time per week.
With the development of an allergic reaction should stop using the drug Longidase® and consult a doctor.
Do not use the drug in the presence of visual signs of its unsuitability (packaging defect, change in the color of the powder).
Do not inject the drug Longidase® in the zone of acute infectious inflammation because of the danger of the spread of localized infection.
Storage conditions
In a dry place protected from light at a temperature not higher than 15 ° C. Keep out of the reach of children.
Shelf life after opening
2 years. Do not apply after the expiration date.