Universal reference book for medicines
Name of the preparation: IMURON-VAK (IMURON-VAC)

Active substance: nonappropriate

Type: Immunostimulating drug of bacterial origin

Manufacturer: MEDGAMAL (branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU) (Russia)
A typical clinical and pharmacological article
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Live mycobacteria strain BCG-1, multiplying intracellularly, lead to nonspecific stimulation of the cellular immune response.

INDICATIONS
- Immunotherapy of superficial (Ta, T1, Tis) bladder cancer;

- prevention of recurrence of bladder cancer after transurethral removal of the tumor.

DOSING MODE
Intravesical.


For 3-11 days before the immunotherapy the patient is given an / in Mantoux test with 2 TE purified tuberculin in standard dilution.
The sample is taken and the response is taken into account in accordance with the instructions for use of tuberculin. The Mantoux test is performed in an anti-TB dispensary or by persons having a special certificate-admission. Use of the vaccine is allowed if the diameter of the papule is less than 17 mm.

On the day of BCG immunotherapy, it is prohibited to administer parenterally other medicinal products, except for vital signs.
In the presence of pyuria, bacteriuria, dysuria before the start of treatment, it is necessary to conduct antibiotic therapy before the complete elimination of clinical symptoms of cystitis.

Prevention of recurrence of superficial bladder cancer is recommended to begin no earlier than 3 weeks after removal of the tumor.
Catheterization of the bladder is produced by an elastic catheter, without traumatizing the urethral mucosa and bladder. After emptying the bladder, it should be washed with sterile 0.9% sodium chloride solution and make sure that there is no blood in the wash fluid. After that, the dose of the vaccine is diluted in 50 ml of 0.9% sodium chloride solution and injected through the catheter into the bladder. The solution is retained in the bladder for 2 hours. It is advisable that during this time the patient change the position of the body to evenly contact the vaccine with the walls of the bladder. After 2 hours, the bladder is emptied into a container containing at least 500 ml of disinfectant solution (5% chloramine), exposure time 6 hours.

The recommended single dose of the vaccine is 100-120 mg once a week.
Immunoprophylaxis course - 6 weekly installations. In the future it is possible to carry out maintenance immunotherapy for 100-120 mg intravesical once every 3 months to 2 years.

Treatment of carcinoma in situ and papillary superficial bladder cancer : the installation should begin no earlier than 3 weeks after tumor biopsy.
The method of administration of the drug in the bladder is similar to that described above. Single dose - 100-120 mg once a week. Induction course - 6 weekly installations. After 3-4 weeks after the end of treatment, a control examination is performed.
With incomplete regression of the tumor or a positive result of urinal cytology, it is advisable to conduct a second course.
Carrying out more than two induction courses of BCG therapy is inexpedient.
With complete regression of the tumor, it is possible to carry out maintenance immunotherapy at 100-120 mg once every 3 months to 2 years.

SIDE EFFECT
Dysuria (80%), macrohematuria (40%) appear after 2-3 BCG injections, begin 2-3 h after the administration and last for 1-2 days.
With an increase in the number of instillations, the severity of adverse reactions may increase. Pass as a rule, alone or can be symptomatic treatment.

The increase in body temperature on the day of instillation (40%), not exceeding 38.5 degrees C, lasting no more than 48 hours. Special treatment does not require;can be prescribed antipyretics.


Acute cystitis (20%), not passing by the time of the next instillation.
In such cases, treatment with the vaccine should be interrupted. After excluding bacterial cystitis of non-mycobacterial etiology, antituberculosis drugs are prescribed before the symptoms disappear and within 2 weeks after the normalization of the condition. BCG therapy can be continued at a dose of 10-30% of the original.

Symptomatic granulomatous cystitis, prostatitis, epididymitis (3-5%), which requires withdrawal of the drug.
Isoniazid therapy (300 mg / day) and rifampicin (600 mg / day) for 3 months was performed. In a number of patients, the development of granulomatous infiltrates in the ureteral region may lead to a violation of the passage of urine from the upper sections of the urinary tract and require temporary drainage.

Rarely, granulomatous lesions of the kidney parenchyma.
Further BCG therapy is contraindicated. Isoniazid is administered (300 mg / day), rifampicin (600 mg / day) and ethambutol (1200 mg / day) up to 6 months.

Allergic reactions (less than 1%): skin rash, arthritis, arthralgia.
Immunotherapy should be discontinued. Prescribe NSAIDs and antihistamines.

In isolated cases - BCG-sepsis: an acute onset with an increase in body temperature above 38.5 ° C, chills, a sharp deterioration in the general condition, and sometimes a decrease in blood pressure.
Hepatic and renal failure rapidly develops. With chest X-ray, focal changes and infiltrates in the lung can be detected.Immunotherapy with a vaccine should be discontinued. After taking samples for bacteriological studies, treatment is started: isoniazid (300 mg / day), rifampicin (600 mg / day) and ethambutol (1200 mg / day), a broad-spectrum antibacterial drug for the treatment of possible urosepsis of non-tuberculous etiology. Antibiotic therapy is combined with the use of GCS (to prevent life-threatening hyperergic reaction). The lethal outcomes of BCG-sepsis are described.
CONTRAINDICATIONS
- a history of tuberculosis;

- diameter of the papule after intravenous injection of tuberculin in a dose of 2 TE (Mantoux test) 17 mm or more;

- immunodeficiency states;

- acute cystitis or macrohematuria (before the disappearance of clinical manifestations);

- severe concomitant diseases in the stage of decompensation;

- Traumatic catheterization or the appearance of blood after a catheterization of the bladder (for instillation on a given day).

SPECIAL INSTRUCTIONS
The patient should be warned about possible complications of BCG therapy.

Adverse reactions and complications are more common in patients with a small capacity of the bladder (less than 150 ml), after previous radiation therapy.

In the development of systemic side effects, the leading role belongs to the hematogenous distribution of BCG.
As a rule, they develop after gross traumatic catheterization of the bladder followed by the introduction of BCG. The infection is facilitated by the weakening of immunity, caused by HIV infection, by the use of immunosuppressants.

The diluted vaccine should be protected from exposure to daylight and administered immediately after dilution.

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