Imuron-vak

General characteristics. Structure:

Active agent: mycobacteria of tuberculosis of a strain of BTsZh-1 of 30 mg; 25 mg.

Pharmacological properties:

Live mycobacteria of a strain of BTsZh-1, breeding intracellularly, lead to nonspecific stimulation of a cellular immune response.

Indications to use:

— immunotherapy superficial (That, T1, Tis) bladder paka;
— prevention of a recurrence of cancer of bladder after a transurethral oncotomy.

Route of administration and doses:

Vnutripuzyrno.

For 3-11 days to carrying out an immunotherapy to the patient carry out boiled and smoked Mantoux reaction about 2 THOSE the purified tuberculine in standard cultivation. Statement of test and the accounting of response are carried out according to the application instruction of tuberculine. Mantoux reaction is carried out in an antitubercular clinic or the persons having the special reference admission. Use of a vaccine is allowed if diameter of a papule less than 17 mm.

In day of carrying out the BTsZh-immunotherapy it is forbidden to enter parenterally other medicinal sedstvo, except necessary according to vital indications. In the presence of a pyuria, a bacteriuria, dysurias prior to treatment it is necessary to carry out antibacterial therapy before complete elimination of clinical symptoms of cystitis.

Prevention of a recurrence of superficial cancer of bladder is recommended to begin not earlier than in 3 weeks after an oncotomy. Catheterization of a bladder is made a plastic catheter, without injuring mucous an urethra and a bladder. After bladder emptying it it is necessary to wash out sterile 0.9% solution of sodium of chloride and to be convinced that in washing liquid there is no blood impurity. After that a dose of a vaccine dissolve 0.9% of solution of sodium of chloride in 50 ml and enter on a catheter into a bladder. Solution keeps in a bladder during 2 h. It is desirable that during this time the patient changed position of a body for uniform contact of a vaccine with bladder walls. In 2 h the bladder is emptied in the capacity containing not less than 500 ml of disinfecting solution (5% chloroamine), time of exposure of 6 h.

The recommended single dose of a vaccine - 100-120 mg once a week. An immunoprevention course - 6 weekly installations. Further carrying out the supporting immunotherapy on 100-120 mg vnutripuzyrno 1 time in 3 months up to 2 years is possible.

Treatment of a carcinoma of in situ and papillary superficial cancer of a bladder: installations should be begun not earlier than in 3 weeks after a tumor biopsy. The technique of administration of drug in a bladder is similar described above. A single dose - 100-120 mg once a week. An induction course - 6 weekly installations. In 3-4 weeks after the end of treatment control examination is conducted.

At incomplete regression of a tumor or a positive take of a cytologic research of urine carrying out the second year is reasonable. Carrying out more than two induction courses of BTsZh-therapy is inexpedient.

At full regression of a tumor carrying out the supporting immunotherapy on 100-120 mg of 1 times in 3 months up to 2 years is possible.

Features of use:

The patient has to be warned about possible complications of BTsZh-therapy.

Side reactions and complications meet at patients with the small capacity of a bladder (less than 150 ml), after the previous radiation therapy more often.

In development of system side effects the leading value belongs to hematogenous distribution of BTsZh. As a rule, they develop after rough traumatic catheterizations of a bladder with the subsequent introduction of BTsZh. Generalization of an infection is promoted by the immunity easing caused by HIV infection, reception of immunodepressants.

The divorced vaccine needs to be protected from impact of a day sunlight and to enter right after cultivation.

Side effects:

The dysuria (80%), gross hematuria (40%) appear after 2-3 introductions of BTsZh, begin in 2-3 h after introduction and proceed during 1-2 C increase in number of instillations expressiveness of side reactions can increase. Pass, as a rule, independently or the symptomatic treatment can be carried out.

The fervescence in day of instillation (40%) which is not exceeding 38.5 hail. With, lasting no more than 48 h. Does not demand special treatment; antipyretics can be appointed.

The acute cystitis (20%) which is not passing by the time of the following instillation. In such cases treatment by a vaccine has to be interrupted. After an exception of bacterial cystitis of a nemikobakterialny etiology therapy by antitubercular drugs before disappearance of symptoms and during 2 weeks after normalization of a state is appointed. BTsZh-therapy can be continued in the dose making 10-30% of initial.

Symptomatic granulematozny cystitis, prostatitis, epididymite (3-5%) that demands drug withdrawal. Carry out therapy by an isoniazid (300 mg/days) and rifampicin (600 mg/days) within 3 months. At a number of patients development of granulematozny infiltrates in the field of mouths of ureters can lead to disturbance of a passage of urine from upper parts of urinary tract and demand their temporary drainage.

Seldom - granulematozny defeat of a parenchyma of a kidney. Further BTsZh-therapy is contraindicated. Carry out therapy by an isoniazid (300 mg/days), rifampicin (600 mg/days) and Ethambutolum (1200 mg/days) up to 6 months.

Allergic reactions (less than 1%): skin rash, arthritis, arthralgia. The immunotherapy has to be stopped. Appoint NPVP and antihistaminic drugs.

In isolated cases - BTsZh-sepsis: the acute beginning with fervescence is above 38.5 °C, a fever, sharp deterioration in the general state, sometimes - decrease in the ABP. Quickly the liver and renal failure develops. At a X-ray analysis of a thorax focal changes and infiltrates in lungs can come to light. The immunotherapy has to be stopped by a vaccine. After sampling for bacteriological researches begin treatment: an isoniazid (300 mg/days), rifampicin (600 mg/days) and Ethambutolum (1200 mg/days), antibacterial drug of a broad spectrum of activity for treatment of a possible urosepsis of not tubercular etiology. Antibacterial therapy is combined using GKS (for the purpose of prevention of life-threatening giperergichesky reaction). Lethal outcomes of BTsZh-sepsis are described.

Interaction with other medicines:

There are no data.

Contraindications:

— tuberculosis in the anamnesis;
— diameter of a papule after boiled and smoked administration of tuberculine in a dose 2 THOSE (Mantoux reaction) of 17 mm and more;
— immunodeficiency;
— acute cystitis or a gross hematuria (before disappearance of clinical manifestations);
— serious associated diseases in a decompensation stage;
— traumatic catheterization or emergence of blood after bladder catheterization (for instillation in this day).

Overdose:

There are no data.

Storage conditions:

At a temperature of 0-8 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for пригот. сусп. for an intravesical vved. 30 mg: amp. 1 pieces.

Lyophilisate for пригот. сусп. for an intravesical vved. 25 mg: amp. 10 pieces.