Longidase 3000ME supp VAG and rect N10

Manufacturer: Петровакс Фарм НПО ООО
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Brief information

Производитель

Петровакс Фарм НПО ООО

Действующее вещество

Гиалуронидаза+Азоксимера бромид

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Suppositories for vaginal or rectal use1 sup.
active substance: 
bolgelerinde socimer (Longidasa)3000 IU
excipients: cocoa butter-to obtain a suppository weighing 1.3 g 
CHARACTERS

Longidase is a hyaluronidase conjugate with an activated n-oxide derivative of poly-1,4-ethylene piperazine.

Description of the dosage form

Suppositories are torpedo-shaped, light yellow in color, with a weak specific smell of cocoa butter, marbling is allowed.

Pharmacokinetics

Experimental study of pharmacokinetics allowed us to establish that when rectal administration of the drug Longidase is characterized by a high rate of distribution in the body, it is well absorbed into the systemic bloodstream and reaches C max in the blood after 1 hour.

The half-life is about 0.5 h, T 1/2 - from 42 to 84 h. it is Excreted mainly by the kidneys.

The drug penetrates into all organs and tissues, including passes through GEB and gematoentsefalichesky barrier. The absence of tissue accumulation was found.

The bioavailability of the drug Longidase with rectal administration is high — about 90%.

Pharmacodynamics

Longidase has hyaluronidase (enzymatic proteolytic) activity of prolonged action, chelating, antioxidant, immunomodulating and moderately pronounced anti-inflammatory properties.

The prolongation of the action of the enzyme is achieved by covalently binding it with physiologically active polymer carrier (socimer). Longidase exhibits anti-fibrotic properties, weakens the course of the acute phase of inflammation, regulates (increases or decreases, depending on the initial level) the synthesis of inflammatory mediators (IL-1 and TNF-alpha), increases the humoral immune response and the body's resistance to infection.

Pronounced anti-fibrotic properties of the drug Longidase are provided by conjugation of hyaluronidase with the carrier, which significantly increases the resistance of the enzyme to denaturing effects and the action of inhibitors: the enzymatic activity of the drug Longidase persists when heated to 37 °C for 20 days, while the native hyaluronidase under the same conditions loses its activity during the day. In the preparation of Longidase, the simultaneous local presence of the hyaluronidase enzyme and a carrier capable of binding enzyme inhibitors and collagen synthesis stimulators released during hydrolysis of matrix components (including iron, copper, and heparin ions) is provided. Due to these properties, Longidase has not only the ability to depolymerize the connective tissue matrix in fibrous granulomatous formations, but also to suppress the reverse regulatory reaction aimed at the synthesis of connective tissue components.

The specific substrate of testicular hyaluronidase is glycosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate), which form the basis of the connective tissue matrix. As a result of depolymerization (break the link between C1 acetylglucosamine and4 indianboy or glucuronic acid) glycosaminoglycans alter their main properties: reduced viscosity, reduced ability to bind water, metal ions, temporarily increases the permeability of tissue barriers, facilitates the movement of fluid in the intercellular space, increases the elasticity of connective tissue, which is manifested in the reduction of swelling tissue, flattening scars, increase range of motion of joints, reduce contractures and the prevention of their formation, reduction of adhesions.

Biochemical, immunological, histological and electron microscopic studies have shown that Longidase does not damage normal connective tissue, but causes destruction of the connective tissue changed in composition and structure in the area of fibrosis.

Longidase does not have mutagenic, embryotoxic, teratogenic or carcinogenic effects.

The drug is well tolerated by patients, there are no local or General allergic reactions.

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

Indications of the drug

Adults and adolescents over 12 years of age in the form of monotherapy and as part of the complex therapy of diseases accompanied by connective tissue hyperplasia, including on the background of the inflammatory process:

in urology: chronic prostatitis, interstitial cystitis, urethral and ureter strictures, Peyronie's disease, the initial stage of benign prostatic hyperplasia, prevention of scarring and strictures after surgery on the urethra, bladder, and ureters;

in gynecology: adhesive process (prevention and treatment) in the pelvis for chronic inflammatory diseases of the internal genitals after gynecological manipulations, including artificial abortions, previous surgical interventions on the pelvic organs; intrauterine synechiae, tubal-peritoneal infertility, chronic endomyometritis;

in dermatovenerology: limited scleroderma, prevention of fibrotic complications of sexually transmitted infections;

in surgery: prevention and treatment of adhesions after surgery on abdominal organs, long-term non-healing wounds;

in pulmonology and Phthisiology: pneumofibrosis, siderosis, tuberculosis (cavernous-fibrous, infiltrative, tuberculoma), interstitial pneumonia, fibrotic alveolitis, pleurisy;

to increase the bioavailability of antibacterial therapy in urology, gynecology, dermatovenerology, surgery, and pulmonology.

Contraindications

hypersensitivity to drugs based on hyaluronidase;

pulmonary bleeding and hemoptysis;

fresh hemorrhage in the vitreous body;

malignant neoplasm;

acute renal failure;

pregnancy (no clinical experience);

breastfeeding period;

children under 12 years of age (no clinical results available).

With caution (use no more than 1 time a week): chronic renal failure, pulmonary bleeding in the history.

Use during pregnancy and lactation

It is contraindicated during pregnancy and breast-feeding (there is no clinical experience).

Dosage and administration

Rectally (adults and adolescents older than 12 years), 1 supp. 1 time per day after bowel cleansing.

Vaginally (adults) 1 supp. Once a day (at night), the suppository is inserted into the vagina in the supine position.

Teenagers from 12 to 18 years of age are given suppositories only rectally.

The administration scheme is adjusted depending on the severity, stage and duration of the disease: Longidase is prescribed every other day or with breaks of 2-3 days.

Recommended regimens and doses:

- in urology: 1 supp. in a day-10 introductions, then in 2-3 days-10 introductions, with a total course of 20 supp.;

- in gynecology: rectally or vaginally 1 supp. after 2 days-10 injections, then if necessary, maintenance therapy is prescribed;

- in dermatovenerology: 1 supp. after 1-2 days-10-15 introductions;

- in surgery: 1 supp. after 2-3 days-10 introductions;

- in pulmonology and Phthisiology: 1 supp. after 2-4 days-10-20 introductions.

If necessary, it is recommended to repeat the course of the drug Longidase no earlier than 3 months or long-term maintenance therapy-1 supp. 1 time in 5-7 days for 3-4 months.

Side effect

The frequency of adverse reactions is presented according to the following classification: very often — ≥10%; often - ≥1% and <10%; infrequently - ≥0.1 % and <1%; rarely - ≥0.01% and <Of 0.1%; very rare — <0.001%.

Very rarely — local reactions in the form of redness, edema, itching of the perianal zone, vaginal itching due to individual sensitivity to the components of the drug.

Interaction

The drug Longidaza can be combined with antibiotics, antiviral, antifungal drugs, bronchodilators. When prescribing in combination with other drugs (antibiotics, local anesthetics, diuretics), you should consider the possibility of increasing the bioavailability and enhancing their action.

When combined with high doses of salicylates, cortisone, ACTH, estrogens or antihistamines, the enzymatic activity of the drug Longidase may be reduced . Do not use the drug Longidaza simultaneously with drugs containing furosemide, benzodiazepines, phenytoin..

Overdose

Symptoms: chills, fever, dizziness, hypotension.

Treatment: discontinuation of drug administration, administration of symptomatic therapy.

Special instruction

To suspend the use of Longidaza in the development of allergic reactions.

When used against the background of exacerbation of foci of infection to prevent the spread of infection, prescribe under the cover of antimicrobial agents.

When taking the drug, strictly follow the instructions given in the description.

If the patient has any questions, contact your doctor or pharmacist for clarification.

If adverse reactions occur, or if there is a side reaction that is not mentioned in the description, you should contact your doctor.

Do not use the product if there are visual signs of its unsuitability (packaging defect, changing the color of the suppository).

If you skip the next dose of the drug, then use it as usual (do not enter a double dose).

If you need to stop taking Longidase, you can cancel it immediately, without gradually reducing the dose.

Influence on the ability to drive vehicles, mechanisms. The use of the drug Longidaza does not affect the ability to control vehicles, maintenance of mechanisms and other types of work that require increased concentration and speed of psychomotor reactions.

Form release

Vaginal and rectal suppositories, 3000 IU. 5 supp. in contour cell packaging made of PVC film. 1, 2 or 4 contour cell packages are placed in a pack of cardboard.

Conditions of supply of pharmacies

Without a prescription.

Manufacturer

LLC NPO Petrovax Pharm.

Owner of the registration certificate: LLC NPO Petrovax Pharm.

Legal address/address for filing consumer claims / Packed: 1 Sosnovaya street, Podolsk, Moscow region, 142143, Russia.

Tel. / Fax: (495) 926-21-07.

e-mail: info@petrovax.ru

For claims: tel.: (495) 730-75-45, e-mail: adr@petrovax.ru

Production/packaging (primary packaging): 115598, Russia, Moscow, Zagoryevskaya str., 10, korp. 4.

Tel. / Fax: (495) 329-17-18.

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

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