LONGIDAZA

Active material: Longidaza with hyaluronidase activity
When ATH: V03AX
CCF: The drug is a proteolytic activity
ICD-10 codes (testimony): A15, J84, L91, L91.0, L94.0, M15, M67.1, N30, N97, T14.0, T14.1
When CSF: 12.05.09
Manufacturer: NGOs Petrovax Pharm Ltd. (Russia)

Pharmaceutical form, composition and packaging

Valium for drug of a solution for i / m and n / introductions a porous hygroscopic mass of white or white with a yellowish tint.

Excipients: mannitol (to 15 mg).

The ampules (5) – packings Valium planimetric (1) – packs cardboard.

Valium for drug of a solution for i / m and n / introductions a porous hygroscopic mass of white or white with a yellowish tint.

Excipients: mannitol (to 15 mg).

Bottles (5) – packings Valium planimetric (1) – packs cardboard.

Valium for drug of a solution for i / m and n / introductions a porous hygroscopic mass of white or white with a yellowish tint.

Excipients: mannitol (to 20 mg).

The ampules (5) – packings Valium planimetric (1) – packs cardboard.

Valium for drug of a solution for i / m and n / introductions a porous hygroscopic mass of white or white with a yellowish tint.

Excipients: mannitol (to 20 mg).

Bottles (5) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

The drug is a proteolytic activity. It has a proteolytic enzyme (gialuronidaznoj) The long-acting activity, immunomodulatory, chelating, antioxidant and anti-inflammatory action.

Prolongation of the preparation is carried out by covalent binding of the enzyme to the physiologically active macromolecular carrier (activated derivative of N-oxide of poly-1,4-etilenpiperazina), have their own pharmacological activity: It has immunomodulatory, detoxifying and antioxidant action.

The presence of a covalent bond significantly increases the stability of the enzyme to the denaturing effects and the influence of inhibitors. Enzymatic activity Longidaza^® It is stored by heating to 37 ° C for 20 d, whereas native hyaluronidase in the same conditions loses its activity during the day.

The covalent bond provides simultaneous local presence of a hydrolytic enzyme and carrier, capable of binding vacated enzyme inhibitors and stimulators of collagen synthesis (iron ions, Copper, Heparin). Due to these properties Longidaza^® not only has the ability to depolimerizirovat matrix of connective tissue in the fibro-granulomatous formations, but also inhibit the reverse regulatory response, on the synthesis of connective tissue components.

Specific substrate testicular hyaluronidase are glycosaminoglycans (hyaluronic acid, xondroitin, Chondroitin-4-sulphate, chondroitin-6-sulfate), form the basis of a matrix of connective tissue. As a result of depolymerization (breaking the link between C₁ atsetilglikozamina and C₄ glucuronic acid or induronovoy) under the influence of hyaluronidase glycosaminoglycans lose their basic properties (toughness, ability to bind water, metal ion). Hard as the formation of collagen proteins in the fibers, It increases the permeability of tissue barriers, facilitates movement of fluid in the intercellular space, increases the elasticity of connective tissue. Effect of the drug reduces the swelling of tissues, flattening scars, increase the volume of movement of joints, reduction of contractures and adhesions and preventing their formation.

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

Longidaza^® It has no mitogenic, polyclonal activity, not mutagenic, embriotoksicski, teratogenic and carcinogenic effects.

Pharmacokinetics

Absorption and distribution

When s / c or i / m administration of the drug is rapidly absorbed into the systemic circulation from the injection site, wherein C_max achieved through 20-25 m. It is characterized by high speed distribution, poluraspredeleniya period is about 30 m. It penetrates into all organs and tissues (incl. the BBB and the blood-ophthalmic barrier). Not accumulates.

Metabolism and excretion

In the body of hyaluronidase is hydrolyzed and is derived mainly kidneys. The carrier is metabolized to low molecular weight compounds (oligomers), that the kidneys. T_1/2 for different routes of administration ranges from 42 to 84 no.

Testimony

In the complex treatment of adults and adolescents over 12 years in diseases, accompanied by hyperplasia of the connective tissue.

In pulmonology, Urology, gynecological inflammation in the development of interstitial type:

- Pnevmofybroz, tuberculosis, alveolitis;

- Chronic interstitial cystitis;

- Adhesions in the pelvis;

- Tubal-peritoneal infertility.

In orthopedics, Surgery, Cosmetology:

- Keloid, hypertrophic, inverted scars pyoderma, injuries, burns, operations;

- Nonhealing wounds;

- Joint contractures, arthritis, hematoma;

- Adhesive disease.

In dermatology:

- Limited scleroderma various localization.

In order to increase the bioavailability of drugs and diagnostic agents.

Dosage regimen

Dosing regimen and route of administration adjusted individually, depending on the disease, the age and weight of the patient.

Longidazu^® introduced n / a (near the site of injury or a scar-altered tissue) or / m. The course is from 5 to 15 injections with an interval between administrations of 3 to 10 days.

If necessary, recommend carrying out repeated course through 2-3 Months.

In diseases, accompanied by severe chronic productive process in connective tissue, recommended after a standard course of maintenance therapy Longidaza^® dose 3000 ME with breaks between injections 10-14 days.

Recommended treatment regimens

1.In pulmonology, Urology, Gynecology, dermatology

At respiratory diseases drug prescribed / m at a dose 3000 ME 1 once every 3-5 day general course 10 injection. Further possible long-term therapy (from 3-4 Months before 1 year) dose 3000 ME 1 once every 10-14 days.

At diseases of the pelvic organs drug prescribed / m at a dose 3000 ME 1 once every 3-5 the general course of the day 5 to 15 injection.

At Limited scleroderma different shapes and localization introducing drug / m dose 3000-4500 ME 1 once every 3 day course 5-15 injection. The dose and duration of treatment is selected individually depending on the clinical course, stage, localization of the disease.

2. In orthopedics, Surgery, Cosmetology

At keloid, hypertrophic, inverted scars pyoderma, burns, operations the drug is administered at a dose of intraruminal 3000 In ME 1-2 ml 1-2 times a week course 5-10 Injection and / or / m 1 once every 3-5 days before the general course 10 injection.

At nonhealing wounds drug prescribed / m at a dose 1500-3000 ME 1 once every 5 days course 5-7 injection.

At joint contractures, artritax, gematomax Longidazu^® appoint / m dose 3000 ME 1-2 times a week course from 7 to 15 injection.

At adhesive disease the drug is introduced into / m 1 once every 3-5 day dose 3000 IU general course of 7 to 15 injection.

3. In order to increase the bioavailability of drugs and diagnostic agents (antibiotics, himiopreparatov, anesthetics) Longidazu^® introduced 1 once every 3 of the day in a dose of 1500 ME. The course should not exceed 10 injection.

Patients with renal insufficiency the drug should not be prescribed more often 1 times a week.

Preparation of the solution

For i / m, n / a or / in the introduction of the contents of the vial (ampoule) dissolved in 1.5-2 ml 0.25% or 0.5% procaine solution. When intolerance drug procaine dissolved 0.9% sodium chloride or water for injection.

A solution for parenteral administration must not be stored.

Side effect

Local reactions: soreness at the injection site; in some cases, local reactions manifested as skin redness and swelling at the injection site.

All adverse reactions pass through 48-72 no.

Other: rarely – allergic reactions.

Contraindications

- Malignant neoplasms;

- Pregnancy;

- Children up to age 12 years (efficacy and safety have not been studied);

- Individual hypersensitivity to the drug.

FROM caution prescribers with acute renal failure, pulmonary hemorrhage.

Pregnancy and lactation

The drug is contraindicated during pregnancy.

Cautions

The drug should not be administered in the area of ​​infectious lesions, acute inflammation or swelling.

Overdose

Currently, cases of drug overdose Longidaza^® not reported.

Drug Interactions

Longidaza^® compatible with antibiotics, antiviral, antifungal and antihistamines, bronholitikami, cytostatics, GCS.

In a joint application increases the bioavailability of drugs, faster onset of analgesia when administered local anesthetics.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, reach of children, at a temperature no higher than 15 ° C. Shelf life – 2 year.