Expiration date: 04/2025

The composition and form of issue:

Lyophilisate for preparation of solution for intramuscular and subcutaneous injection. 1 ampoule or flask contains:

longidasa with hyaluronidase activity of 1500 IU

3000 IU

auxiliary substances: mannitol — up to 15 or 20 mg 

in ampoules or vials made of neutral glass, in a contour acheikova package 5 vials or 5 vials in a cardboard pack 1 pack.

Description pharmaceutical form:

Porous mass of white or white with a yellowish or brownish color, hygroscopic.

Pharmacokinetics:

For parenteral administration the active substance is rapidly absorbed into the systemic circulation and reaches the Cmax in the blood after 20-25 min, the highest speed of distribution in the body. T1/2 about 0, 5 h, T1/2 in the/m introduction — 36 h, with p/C — about 45 h. the Apparent Vd is 0, 43 l/kg. Conjugation does not reduce the high bioavailability of the enzyme (bioavailability 90%).

Active substance penetrates into all organs and tissues, including across the BBB and gematoentsefalichesky barrier.

In the body of the hyaluronidase undergoes hydrolysis, and the media breaks down to low molecular weight compounds (oligomers), which are excreted primarily through the kidneys in two phases. During the first day through the kidneys is excreted 45-50% , through the intestines — not more than 3%. Further, the clearance rate slows down to 4-5-th day the drug is excreted completely.

Description pharmacological action:

Largedataset a conjugate proteolytic enzyme with hyaluronidase macromolecular carrier from the group of derivatives of N-oxide poly-1, 4-etilenpiperazina. Longidasa has all spectrum of pharmacological properties of drugs with hyaluronidase activity. A specific substrate of hyaluronidase are glycosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate) — cementing substance of connective tissue.

As a result of the hydrolysis (depolymerization) decreases the viscosity of glycosaminoglycans, the ability to bind water and ions of metals. As a result, increases the permeability of tissues, improves trophism, reduce swelling, dissolve hematomas, improves elasticity rubtsovoizmenennah sites, eliminate contractures and adhesions, increase joint mobility. The effect is most pronounced in the initial stages of the pathological process.

The clinical effect of the drug Longidasa significantly higher than the effect of native hyaluronidase. Conjugation increases the stability of enzyme the effect of temperature and inhibitors, increases its activity and leads to prolongation of the action. The enzymatic activity of the drug Longidasa is saved when heated to 37 °C for 20 days, while the native hyaluronidase in the same conditions loses its activity during the day. In preparation Longidase saved and pharmacological properties of the medium with gelatinosa, antioxidant, anti-inflammatory and immunomodulatory activity. Longidasa able to bind the liberated during the hydrolysis of glycosaminoglycans iron ions — the promoters of free radical reactions, inhibitors of hyaluronidase and stimulators of collagen synthesis and thereby suppress the reverse reaction aimed at the synthesis of components of connective tissue.

Polytropic properties of the drug Longidasa implemented in the expressed protivopoloznom action, it has been experimentally proven biochemical, histological and electron microscopic studies on the model of pulmonary fibrosis.

Drug Longidasa adjusts (increases or reduces depending on the source level) the synthesis of inflammatory mediators (IL-1 and tumor necrosis factor alpha) may be reduced during the acute phase of inflammation, increase humoral immune response and resistance of organism to infection. These properties allow the use of the drug Longidasa during or after surgical treatment for prevention of rough scarring and adhesions.

The use of the drug Longidasa in therapeutic doses during or after surgery does not cause deterioration in the postoperative period or progression of the infectious process does not slow bone recovery.

Longidasa with joint p/to or/m introduction increases the absorption of drugs, accelerates the anesthesia with the injection of local anesthetics. Longidasa applies to practically non-toxic compounds, does not disturb normal functioning of the immune system, has no effect on the reproductive function of males and females of rats on pre - and postnatal development of the offspring, is not mutagenic and carcinogenic. Experimentally proved that the drug reduced Longidasa irritating and allergenic properties of the enzyme hyaluronidase. At therapeutic doses, Longidasa well tolerated by patients.

Indications:

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

• in gynecology: treatment and prevention of adhesive process in the pelvis in inflammatory diseases of internal genital organs, including tubal-peritoneal infertility, intrauterine adhesions, and chronic endometritis
  
• urology: chronic prostatitis, interstitial cystitis
  
• in surgery: treatment and prevention of adhesions after surgical interventions on the organs of abdominal hypertrophic scarring after injuries, burns, operations, pyoderma nonhealing wounds
  
• in dermatology and cosmetology: treatment of localized scleroderma, keloid, hypertrophic, forming scars after pyoderma, trauma, burns, operations
  
• in pulmonology and Phthisiology: the treatment of pulmonary fibrosis, fibroporous alveolitis, tuberculosis (cavernous-fibrotic, infiltrative, it's a tuberculoma)
  
• in Orthopaedics: the treatment of contractures of joints, arthrosis, ankylosing spondylitis, hematomas
  
• to increase bioavailability: the joint introduction of antibacterial drugs in urology, gynecology, surgery, dermatology, pulmonology, to enhance the action of local anesthetics.
  

Contraindications:

• hypersensitivity to drugs on the basis of hyaluronidase
  
• acute infectious diseases
  
• pulmonary hemorrhage and hemoptysis
  
• fresh hemorrhage in the vitreous body
  
• malignant neoplasms
  
• renal failure
  
• the age of 18 years (clinical studies available).
  

Caution: should not be administered in the area of acute infectious inflammation (because of the danger of spreading a localized infection) chronic renal failure (used not more than 1 time per week) the development of an allergic reaction (discontinue use of the drug).

Before starting treatment you must inform your doctor about all drugs taken by the patient.

Application of pregnancy and breast-feeding:

You should not use the drug Longidasa pregnant women and women during breastfeeding.

Side effects:

Often (>1/100, <1 10="">1/1000, <1 100="" 48="" 72="" 1="" 10000="" p="">

Drug interactions:

Drug Longidasa can be combined with antibiotics, antiviral, anti-fungal drugs, bronchodilators.

When used in combination with other drugs (antibiotics, local anesthetics, diuretics) Longidasa increases the bioavailability and enhances their effect. If applied with large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may be reduced the enzymatic activity of the drug Logidata.

You should not use the drug Longidasa simultaneously with drugs containing furosemide, benzodiazepines, phenytoin.

Method of application and dose:

N/a (near the site of the damage or under rubtsovoizmenennah tissue) or/m in a dose of 3000 ME rate from 5 to 25 injections (depending on the severity of the disease) with an interval between doses of 3 to 10 days.

Applications are selected by the doctor depending on diagnosis, disease severity, clinical course, age of the patient.

If necessary, it is recommended to repeat the course in 2-3 months.

In the case of the treatment of diseases involving serious chronic productive process in the connective tissue after a standard course it is recommended that long-term maintenance therapy with Longidase 3000 IU with intervals between injections 10-14 days.

To increase biodostupnostthew of drugs recommended dose of 1500 IU with prior (10-15 min)/m or p/to the introduction in the same location as the main drug.

Breeding

1. The contents of the ampoule or vial of the drug Longidase 3000 IU dissolved in 1-2 ml of procaine (0, 25 or 0, 5%). In case of intolerance procaine drug Longidasa dissolved in the same volume of sodium chloride 0, 9% for injection or water for injection.

2. When applied with the aim of increasing the bioavailability of the contents of the ampoule or vial of the drug Longidase 3000 IU dissolved in 2 ml and at a dose of 1500 IU in 1 ml solution of sodium chloride 0, 9% for injection.

The solvent into the vial or ampoule should be administered slowly to endure for 2-3 minutes, stir gently, not shaking, so as not to foam the protein.

The prepared solution for parenteral administration shall not be stored. Not administered intravenously!

Recommended models for the prevention and treatment

For the prevention of adhesive disease and rough scarring after surgical interventions on the organs of abdominal cavity and small pelvis — in/m at a dosage of 3000 IU 1 once in 3 day course of 5 injections. If necessary, the use of the drug Longidasa can be continued a total course of 10 injections with the introduction of 1 time per 5 days.

For the treatment of

in gynecology:

• adhesions in the pelvis in inflammatory diseases of internal genital organs — /m 3000 IU 1 once in 3-5 days, a course of 10-15 injections
  
• tubal-peritoneal infertility — /m 3,000 IU General course to 15 injections: the first 5 injections, 1 every 3 days, followed by 1 every 5 days
  

in urology:

• chronic prostatitis — /m 3000 IU 1 once in 5 days, a course of 10-15 injections
  
• interstitial cystitis — I/m 3000 IU 1 once in 5 days, course — up to 10 injections
  

in surgery:

• adhesive disease after surgical interventions on the organs of abdominal cavity/m at a dosage of 3000 IU 1 once in 3-5 days, a course of 10 to 15 injections
  
• nonhealing wounds — in/m at a dosage of 3000 IU 1 once in 5 days, a course of 5-10 injections
  

in dermatology, cosmetology:

• limited scleroderma — /m 3000-4500 IU 1 once in 3-5 days, a course of 20 injections. The dosage and rate of selected individually, depending on the clinical course of, stage, localization of the disease and the individual patient
  
• keloid, hypertrophic and formed scars after pyoderma, burns, operations, injuries — vnutriportovaya or p/K (close to the lesion) introduction in doses of 3000-4500 IU, 1 time per 3 day rate — up to 15 injections. The amount of dilution of the drug Longidasa is chosen by the doctor depending on the number of injection points. If necessary, the course may be continued according to the scheme 1 time in 5 days to 25 injections. Depending on the area affected of the skin, limitation of scar formation, possible interleaving p/to and/m of 1 times in 5 days at a dosage of 3000 IU, course — up to 20 injections.
  

in pulmonology and Phthisiology:

• pulmonary fibrosis — /m 3000 IU 1 once in 5 days course — 10 injections
  
• fibrosing alveolitis — in/m at a dosage of 3000 IU 1 once in 5 days, a course of 15 injections, then — maintenance therapy — 1 time per 10 days total rate of up to 25 introductions
  

tuberculosis - in/m at a dosage of 3000 IU 1 once in 5 days, course — up to 25 injections depending on the clinical picture and severity of the disease may long-term treatment (from 6 months to 1 year at a dosage of 3000 IU 1 once in 10 days)

in orthopedics:

• contracture of joints — n/a near defeat in the dosage of 3000 IU 1 once in 3 day rate — from 5 to 15 injections
  
• arthritis, ankylosing spondylitis — p/K near the site of the damage in a dosage of 3000 IU 1 once in 3 day rate — up to 15 injections, if necessary, the treatment can be continued with 1 injection every 5 days. Duration of maintenance therapy is chosen by the doctor depending on the severity of the disease
  
• hematoma — n/a near defeat in the dosage of 3000 IU 1 once in 3 day rate of up to 5 injections
  

to increase bioavailability: when combines subcutaneous or intramuscular injection, diagnostic or medicinal products (including antibiotics, chemotherapy drugs, anesthetics). Longidasa introduced previously for 10-15 minutes at a dosage of 1500 IU the same manner and at the same place as the main drug.

Overdose:

Symptoms: chills, fever, dizziness, hypotension.

Treatment: introduction of a drug stop and prescribe symptomatic therapy.

Special instructions:

If necessary, the cessation of drug treatment, Longidasa cancellation can be carried out immediately, without a gradual dose reduction.

In the case of missing the introduction of another dose of drug should be administered as soon as the patient remembers about it, then the drug should be used as usual.

The patient should not enter twice the dose to compensate for missed doses.

Effects on ability to drive or to perform work requiring high speed physical and mental reactions. Has no effect.