Imuron-Vac (Imuron-vac)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBCG vaccine for immunotherapy of bladder cancerBCG vaccine for immunotherapy of bladder cancer
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  • Imuron-Vac
    lyophilizate v / vesular 
    MEDGAMAL (a branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU)     Russia
  • Uro-BCG medak
    lyophilizatesuspension v / vesular 
    medac GmbH     Germany
    • Dosage form: & nbsp
    lyophilizate for suspension preparation for intravesical administration
    Composition:

    Active substance:

    In one ampoule, Imuron-vacc contains:

    - 25 mg of BCG microbial cells (at least 2x108 and no more than 3,75x108 viable BCG cells)

    - 30 mg of BCG microbial cells (not less than 2.4x108 and not more than 4.5x108 viable BCG cells)

    In one vial, Imuron-vacc contains:

    - 25 mg of BCG microbial cells (at least 2x108 and no more than 3,75x108 viable BCG cells),

    - 50 mg of BCG microbial cells (not less than 4x108 and not more than 7.5x108 viable BCG cells)

    Excipients: stabilizer - sodium glutamate monohydrate.

    Description:
    Porous mass, powdery or in the form of a tablet of light yellow color. It is hygroscopic.
    Pharmacotherapeutic group:Immunomodulating agent
    ATX: & nbsp

    J.07   Vaccines

    Pharmacodynamics:

    Imuron-vacc is a culture of microbial cells of the vaccine strain BCG-1 (M.bovis VSG-1, Russia) lyophilized in a 1.5% solution of sodium glutamate monohydrate.

    Imuron-vacc stimulates the immune system and has antitumor activity.

    With an intravesical installation, BCG acts as a nonspecific immunomodulator, triggering a whole range of immune responses involving a number of immune system cells, including T and B lymphocytes, macrophages, a number of cytokines.

    Pharmacokinetics:
    After the installation of mycobacteria BCG in the bladder, they bind to fibronectin and attach to the wall of the bladder. The remainder is excreted in the urine in the first hours after the installation. The possibility of penetration of mycobacteria through the mucosa of the bladder has not been proven.
    Indications:

    The drug is intended for surface immunotherapy (Ta, Tl, Tis) of bladder cancer or prevention of its recurrence after transurethral removal of tumors.

    Contraindications:

    1. Previously endured tuberculosis.

    2. The size of the local reaction to intradermal injection of tuberculin in a dose of 2 TE (Mantoux test) is 17 mm or more.

    3. Immunodeficiency conditions.

    4. Acute cystitis or macrohematuria (before the disappearance of clinical manifestations).

    5. Severe concomitant diseases in the stage of decompensation. Traumatic catheterization or the appearance of blood after a catheterization of the bladder are contraindications for instillation of BCG on a given day.

    Imuron-vacc is not recommended for use in children due to lack of data on efficacy and safety.

    Carefully:

    - Low bladder capacity (less than 150 ml);

    - Radiation therapy of a bladder in the anamnesis.

    Pregnancy and lactation:Not recommended (no clinical studies were performed).
    Dosing and Administration:

    For 3 - 11 days. before immunotherapy, the patient is given an intradermal 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 an employee who has a special certificate-admission for tuberculin samples. The use of Imuron-vacc is allowed at a papule size of less than 17 mm in diameter.

    A single therapeutic dose (50-100 mg of BCG microbial cells) is contained in two to four ampoules / bottles of 25 mg or one or two vials of 50 mg of the drug.

    Imuron-vacc is used intravesically.

    The intravesical instillation should be started no earlier than 3 weeks after the biopsy in the treatment of superficial bladder cancer or after transurethral removal of the tumor.

    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.

    The patient should not drink 4 hours before the procedure and within 2 hours after instillation. 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 0.9% sodium chloride solution for injections and make sure that there is no blood impurity in the wash fluid. After that, a single therapeutic dose of the drug is diluted in 50 ml of 0.9% sodium chloride solution for injections and injected through a catheter into the bladder. The patient is asked to hold the solution in the bladder for 2 hours. It is advisable that during this time the patient move, change the position of the body every 15 minutes to evenly contact the drug with the walls of the bladder. After 2 hours, the bladder is emptied into a container containing at least 500 ml of a certified disinfectant solution (following the disinfection regimens specified in the instructions for use). After each instillation, hyperhydration is recommended for 48 hours (in the absence of contraindications).

    The recommended single dose of Imuron-vacc 50-100 mg once a week.

    The induction course of immunotherapy consists of 6 weekly instillations of the drug. When complete tumor regression is achieved, it is advisable to carry out maintenance immunotherapy in the same or reduced dose with intervals of 3-6 months for 1-3 years. The scheme of maintenance therapy is determined by the attending physician.

    Breeding vaccine. Ampoules / vials of vaccine are carefully examined before opening.

    The drug is not applicable for:

    - absence of marking on ampoule / vial or incorrect filling thereof;

    - expired shelf life;

    - in the presence of cracks and incisions on the ampoule / vial;

    - when changing the physical properties of the drug (shriveled tablet, discoloration, etc.).

    Dry preparation is diluted immediately before use with 0.9% sodium chloride solution for injections.

    1) Ampoules. The neck and head of the ampoule are wiped off with alcohol, the place of sealing the ampoule (head) is cut and carefully, using tweezers break off. Then they saw out and break off the neck of the ampoule, wrapping the sawn end in a sterile gauze napkin. In ampoules with the drug is transferred with a sterile syringe with a long needle for 3-4 ml of 0.9% sodium chloride solution for injections.

    2) Bottles.Remove the protective plastic cap cover Flip-off, Rubber stopper wiped with alcohol. The vial with the drug is injected with a sterile syringe with a long needle 5-6 ml of 0.9% sodium chloride solution for injections.

    After exposure for 3-5 minutes, followed by 2-4-fold mixing with a syringe, a thick coarsely dispersed suspension of white with a gray or yellow hue of color should form. Visible particulates do not affect the effectiveness and safety of the drug.

    The contents of ampules / vials with the same syringe are transferred into a vial of 0.9% sodium chloride solution for injections (total volume - 50 ml) and mixed thoroughly.

    The diluted drug must be protected from sunlight and used immediately after breeding. Ampoules, vials from the drug, the catheter after the procedure is immersed in a disinfectant solution, (following disinfection regimes indicated in the instructions for use). Allowed disinfection of the instrument by boiling for 40 min

    Side effects:

    Adverse reactions.

    a) Local.

    - Dysuria is noted in 80%, macrogemaria - in 40% of patients. Appear after 2-3 BCG injections, begin 2-3 hours after instillation and continue for 1-2 days. With an increase in the number of installations, the severity of adverse reactions may increase.Pass as a rule, alone or can be symptomatic treatment.

    b) Systemic.

    - The increase in body temperature, not exceeding 38.5 ° C, is observed in 40% of patients on the instillation day. Typically, the duration of fever is not more than 48 hours. Special treatment does not require or can be used antipyretic drugs.

    Complications

    a) Local

    - Acute cystitis, not passing by the time of the next instillation, is noted in 20% of patients. In such cases, treatment with Imuron-vacc should be interrupted. After the exclusion of bacterial cystitis of non-mycobacterial etiology, antituberculosis drugs are prescribed prior to the disappearance of symptoms and within 2 weeks after the normalization of the condition. BCG therapy can be continued at a dose ranging from 10 to 30% of the original.

    Symptomatic granulomatous cystitis, prostatitis, epididymitis in 3-5% of patients. With the development of such complications, BCG therapy is interrupted. Isoniazid is administered (300 mg per day) and rifampicin (600 mg per day) for 3 months. 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 urinary tract and require a temporary drainage.

    - Granulomatous lesions of the kidney parenchyma are rare. Further BCG therapy for these patients is contraindicated. Carried out therapy with isoniazid (300 mg daily), rifampicin (600 mg per day) and ethambutol (1200 mg daily) up to 6 months.

    b) Systemic.

    In the development of systemic complications, the hematogenic spread of BCG is of paramount importance. As a rule, they develop with the introduction of BCG after gross traumatic catheterization of the bladder. Generalized infection immunity contributes to weakening caused by HIV infection, taking immunosuppressants and other causes.

    - Allergic reactions. They are noted in the form of skin rashes, arthritis, arthralgias in less than 1% of patients. Immunotherapy Imuron-vacc with these patients should be discontinued. Assign non-steroidal anti-inflammatory drugs, antihistamines.

    BCG-sepsis is extremely rare (isolated cases). It is characterized by a sharp onset: an increase in body temperature above 38.5 ° C, a chill, a sharp deterioration in the general condition. Sometimes there is a drop in blood pressure.Hepatic and renal failure rapidly develops. With chest X-ray, focal changes and infiltrates in the lung can be detected. After taking samples for bacteriological studies for the presence of an agent, treatment is started. Immunotherapy Imuron-vacc should be discontinued.

    Prescribe therapy with three antituberculous drugs: isoniazid (300 mg per day), rifampicin (600 mg per day) and ethambutol (1200 mg per day). A broad-spectrum antibiotic is mandatory for the treatment of possible urosepsis of non-tuberculous etiology. Antibiotic therapy is combined with the use of corticosteroids: hormonal therapy prevents a life-threatening hyperergic reaction. The lethal outcomes of BCG-sepsis are described.

    The patient should be warned about possible complications.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:There is no evidence that an overdose can cause other symptoms than the described adverse reactions.
    Interaction:During the course of intraurveal imuron-vaccine installations, simultaneous administration of agents to which BCG mycobacteria are susceptible should be avoided: antituberculous drugs, fluoroquinolones, doxycycline or gentamicin.
    Special instructions:

    Imuron-vacc is stored in a dedicated room in the refrigerator under lock and key. In the same room, catheters are treated and the vaccine is diluted. The utensils and instruments used for BCG immunotherapy are categorically forbidden to use for other purposes. They are stored in a separate closet under lock and key.

    It is recommended to work in gloves.

    Spilled diluted vaccine is removed with a tissue moistened with a disinfectant.

    Local and systemic manifestations of toxicity can affect the performance of potentially hazardous activities (driving, working with moving mechanisms, etc.).

    Form release / dosage:Lyophilizate for suspension preparation for intravesical administration 8-15 million / mg.
    Packaging:

    In ampoules containing 25 or 30 mg of BCG microbial cells.

    In vials containing 25 or 50 mg of BCG microbial cells.

    10 ampoules in a pack of cardboard with instructions for use and a scarifier ampoule.

    1, 2, 4 bottles in a pack of cardboard with instructions for use. The bottle can be further packed in a blister pack of PVC film.

    Storage conditions:The preparation is stored according to SP 3.3.2.1248-03 at a temperature of 0 to 8 ° C in the original packaging in order to protect it from light.

    Keep out of the reach of children.

    Reconstitute the drug immediately.

    Transported according to SP 3.3.2.1248-03 at a temperature of 0 to 8 ° C.

    Shelf life:2 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:P N001970 / 01
    Date of registration:06.05.2008 / 29.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:MEDGAMAL (a branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU) MEDGAMAL (a branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU) Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.11.2017
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