Suppositories vaginal and rectal torpedo-shaped, light yellow color, with a weak specific odor of cocoa butter, marble staining is allowed. 1 supp. bovyhaluronidase azoxime (longidase ® ) 3000 IU PHARMACHOLOGIC EFFECT Longidase ® has hyaluronidase (enzymatic) activity of prolonged action, chelating, antioxidant, immunomodulating and moderately expressed anti-inflammatory action. The prolonged action is achieved by covalent binding of the enzyme with a physiologically active polymeric carrier (azoxime).Longuidase ® exhibits antifibrotic properties, weakens the course of the acute phase of inflammation, regulates (increases or decreases, depending on the initial level) the synthesis of inflammatory mediators (interleukin-1 and TNF?), Increases the humoral immune response and resistance of the organism to infection. The pronounced antifibrotic properties of the Longidase ® preparation are provided by the conjugation of hyaluronidase with the carrier, which significantly increases the stability of the enzyme to the denaturing effects and action of the inhibitors: the enzymatic activity of the Longidase ® preparation persists with heating to 37 ° C for 20 days, while native hyaluronidase in the same conditions begins to lose its activity during the day. The Longidasa ® preparation provides simultaneous local presence of the proteolytic enzyme hyaluronidase and a carrier capable of binding the enzyme inhibitors released during hydrolysis of matrix components and collagen synthesis stimulants (iron ions, copper ions, heparin and others).Due to these properties, Longidase ®has not only the ability to depolymerize the matrix of connective tissue in fibro-granulomatous formations, but also to inhibit the reverse regulatory reaction directed to 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 (the breakdown of the bond between C 1 acetyl glycosamine and C 4 glucuronic or induric acids), glycosaminoglycans change their basic properties: viscosity decreases, the ability to bind water, metal ions decreases, the permeability of tissue barriers temporarily improves, fluid movement in the intercellular space improves, connective tissue, which is manifested in a decrease in swelling of the tissue, flattening of the scars, increasing the volume of movement of the joints, reducing contractures and preventive measuresREPRESENTATIONS 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 that has changed in composition and structure in the field of fibrosis. Longidase ® does not have mutagenic, embryotoxic, teratogenic and carcinogenic effects. The drug is well tolerated by patients, there are no local and common allergic reactions. The use of Longidasa ® in therapeutic doses during or after surgery does not cause a worsening of the course of the postoperative period or the progression of the infectious process;does not slow down the restoration of bone tissue. PHARMACOKINETICS Suction and distribution Experimental study of pharmacokinetics made it possible to establish that, when administered rectally, Longidasa ® is characterized by a high rate of distribution in the body, is absorbed well into the systemic bloodstream and reaches C max in the blood after 1 hour. The bioavailability of Longidasa ® during rectal administration is high - about 90%. The half-distribution period is about 0.5 h. The drug penetrates into all organs and tissues (including through the BBB and hemato-ophthalmic barrier).Do not cumulate in tissues. Excretion T 1/2 from 42 hours to 84 hours. It is excreted mainly by the kidneys. INDICATIONS Adults and adolescents over 12 years of age in the form of monotherapy and as part of complex therapy of diseases accompanied by hyperplasia of connective tissue (including and against the background of the inflammatory process). In urology: - chronic prostatitis; - Interstitial cystitis; - strictures of the urethra and ureters; - Peyronie's disease; - the initial stage of benign prostatic hyperplasia; - Prevention of scar formation and strictures after surgical interventions on the urethra, bladder, ureters. In gynecology: - prevention and treatment of adhesive process in the small pelvis in chronic inflammatory diseases of internal genital organs; - prevention and treatment of the adhesive process in the small pelvis after gynecological manipulations (including artificial abortions, previously performed surgical interventions on the pelvic organs); - intrauterine synechia; - tubal peritoneal infertility; chronic endometriometritis. In dermatovenerology: - limited scleroderma; - prevention of fibrotic complications of sexually transmitted infections. In surgery: - prevention and treatment of adhesions after surgical interventions on the abdominal organs; - long-term non-healing wounds. In pulmonology and phthisiology: - pneumofibrosis; - siderosis; - tuberculosis (cavernous-fibrous, infiltrative, tuberculoma); - interstitial pneumonia; - fibrosing alveolitis; pleurisy. To increase the bioavailability of antibiotic therapy in urology, gynecology, dermatovenereology, surgery and pulmonology. DOSING MODE Longuidase ® Suppositories 3000 IU is recommended for rectal or intravaginal application 1 time / day for the night, for the course - 10-20 injections. Adults are intravaginal: 1 suppository 1 time / day at night;The suppository is inserted into the vagina in the supine position. To adolescents aged 12 to 18 years, suppositories are administered only rectally. Adults and adolescents over 12 years of age rectally: 1 suppository 1 time / day after cleansing of the intestine. The treatment regimen is adjusted depending on the severity, stage and duration of the disease.It is possible to administer the drug every other day or with interruptions of 2-3 days. Recommended treatment regimens In urology On 1 suppository every other day - 10 introductions, then in 2-3 days - 10 introductions.General course of 20 introductions. In gynecology Rectally or intravaginally with 1 suppository in 2 days - 10 administrations, then, if necessary, maintenance therapy is prescribed. In dermatovenerology For 1 suppository in 1-2 days - 10-15 introductions. In surgery On 1 suppository in 2-3 days - 10 introductions. In pulmonology and phthisiology On 1 suppository in 2-4 days - 10-20 vestings. If necessary, a repeated course of Longidas ® is recommended not earlier than 3 months or prolonged maintenance therapy - 1 suppository 1 time / 5-7 days for 3-4 months. SIDE EFFECT The frequency of unwanted reactions is classified as follows: very often (? 10%);often (? 1% and <10%);infrequently (? 0.1% and <1%);rarely (? 0.01% and <0.1%);very rarely (<0.001%). Very rarely: local reactions in the form of redness, swelling, itching of the perianal zone, vaginal itching due to individual sensitivity to the components of the drug. CONTRAINDICATIONS - pulmonary hemorrhage and hemoptysis; - fresh vitreous hemorrhage; - malignant neoplasms; acute renal failure; - Pregnancy; - lactation period; - Children under 12 years of age (no clinical trial results); - Hypersensitivity to drugs based on hyaluronidase. With caution and not more than 1 time per week used in patients with chronic renal failure, pulmonary haemorrhage in history. PREGNANCY AND LACTATION Contraindicated use of the drug during pregnancy and during breastfeeding (clinical experience is not available). APPLICATION FOR FUNCTIONS OF THE LIVER Contraindicated use of the drug in acute kidney failure. With caution and not more than 1 time per week used in patients with renal insufficiency. APPLICATION FOR CHILDREN Contraindicated in the use of the drug in children under 12 years (the results of clinical studies are not available). SPECIAL INSTRUCTIONS When developing an allergic reaction, discontinue the use of Longidase ® . When applied against the background of acute foci of infection to prevent the spread of infection, it is necessary to prescribe the Longidasa ® preparation under the cover of antimicrobial agents. Do not use the drug in the presence of visual signs of its unfitness (packaging defect, color change of the suppository). If you miss the introduction of the next dose, then the drug should be used in the usual mode (do not inject twice the dose). If it is necessary to stop taking Longidase ®, the cancellation can be done immediately, without a gradual dose reduction. Impact on the ability to drive vehicles and manage mechanisms The use of Longidas ® does not affect the ability to drive vehicles, service mechanisms and other types of work that require increased concentration and speed of psychomotor reactions. OVERDOSE Symptoms of overdose can be manifested by chills, fever, dizziness, hypotension. Treatment: the drug is discontinued and symptomatic therapy is prescribed. DRUG INTERACTION The preparation of Longidase ® can be combined with antibiotics, antiviral, antifungal drugs, bronchodilators. When prescribed in combination with other medicines (antibiotics, local anesthetics, diuretics), the possibility of increasing bioavailability and enhancing their action should be taken into account. When combined with high doses of salicylates, cortisone, ACTH, estrogens or antihistamines, the enzymatic activity of Longidase ® can be reduced. Do not use Longidase ® at the same time as preparations containing furosemide, benzodiazepines, phenytoin. TERMS OF RELEASE FROM PHARMACY The drug is approved for use as a means of OTC. TERMS AND CONDITIONS OF STORAGE The drug should be stored in a dry, protected from light, out of reach of children at a temperature of 2 ° to 15 ° C.Shelf life - 2 years.
