vaccine for of treatment of cancer mochevoho bubbles BCG | Imuron-vak lyophilisate for preparation of suspension for intravesical administration 8-15 mln / mg 50 mg vials 2 pcs.
Special Price
$33.12
Regular Price
$45.00
In stock
SKU
BID890407
Pharmacological action of
Imuron-vak is a microbial cell culture of the BCG-1 vaccine strain (M. bovis BCG -1, Russia), lyophilized in a 1.5% sodium glutamate monohydrate solution. Imuron-vak stimulates the immune system and has antitumor activity. With intravesical instillation, BCG acts as a non-specific immunomodulator, causing: a whole complex of immune reactions in which a number of cells of the immune system are involved, including T and B lymphocytes, macrophages, a number of cytokines. Pharmacokinetics After instillation of BCG mycobacteria into 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 instillation. The possibility of penetration of mycobacteria through the mucous membrane of the bladder has not been proven.
Imuron-vak is a microbial cell culture of the BCG-1 vaccine strain (M. bovis BCG -1, Russia), lyophilized in a 1.5% sodium glutamate monohydrate solution. Imuron-vak stimulates the immune system and has antitumor activity. With intravesical instillation, BCG acts as a non-specific immunomodulator, causing: a whole complex of immune reactions in which a number of cells of the immune system are involved, including T and B lymphocytes, macrophages, a number of cytokines. Pharmacokinetics After instillation of BCG mycobacteria into 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 instillation. The possibility of penetration of mycobacteria through the mucous membrane of the bladder has not been proven.
Pharmacological action of
Imuron-vak is a microbial cell culture of the BCG-1 vaccine strain (M. bovis BCG -1, Russia), lyophilized in a 1.5% sodium glutamate monohydrate solution. Imuron-vak stimulates the immune system and has antitumor activity. With intravesical instillation, BCG acts as a non-specific immunomodulator, causing: a whole complex of immune reactions in which a number of cells of the immune system are involved, including T and B lymphocytes, macrophages, a number of cytokines. Pharmacokinetics After instillation of BCG mycobacteria into 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 instillation. The possibility of penetration of mycobacteria through the mucous membrane of the bladder has not been proven.
Indications
Treatment of non-invasive urothelial bladder cancer:
- treatment of pre-invasive cancer of the Tis stage (carcinoma in situ).
Prevention of relapse of bladder cancer after radical treatment:
- stage Ta (carcinoma that infiltrates only the mucous membrane of the bladder): Ta G1 – G2 with multifocal and / or recurrent tumors Ta G3
- stage T1 (tumor, infiltrative tissue not affecting the muscle layer of the bladder)
- Tis stage (pre-invasive carcinoma, carcinoma in situ).
Special instructions
BCG vaccine should not be used for sc, i / c, i / m or iv administration, or for vaccination purposes.
The patient should be warned about the possibility of complications of BCG therapy. If systemic reactions to the BCG vaccine occur, consult a TB specialist.
Adverse reactions are often observed during BCG vaccine therapy for immunotherapy of bladder cancer, but these reactions are usually not severe and are usually transient. With an increase in the number of instillations, the risk of side effects increases.
When prescribing BCG therapy, it is necessary to take into account the risk of developing severe systemic BCG reactions / infections, which include: fever> 39.5 РC for at least 12 hours, fever with a temperature> 38, 5 РC for at least 48 hours miliary pneumonia caused by BCG granulomatous hepatitis deviations of indicators characterizing liver function, organ dysfunctions (not related to the genitourinary system) with granulomatous inflammation confirmed by biopsy of Reuters syndrome.
Traumatic instillation can lead to BCG-related sepsis with the possible development of septic shock and the risk of death.
Urinary tract infection should be excluded prior to each intravesical instillation of BCG vaccine (inflammation of the mucous membrane of the bladder may increase the risk of hematogenous spread of BCG infections). If urinary tract infection is detected during therapy with BCG vaccine, treatment should be interrupted until the course of antibiotic therapy is completed and urinalysis is normalized.
Cases of infection of implants and grafts in patients, such as aneurysms, have been reported.
Isolated cases have been reported where BCG bacteria persisted in the urinary tract for more than 16 months.
In case of fever or macrohematuria, vaccine should be delayed until these symptoms are relieved.
Patients with reduced bladder capacity have an increased risk of shrinking of the bladder.
In the HLA-B27 group (human leukocyte antigen B27) of positive patients, the risk of developing reactive arthritis or Reiter's syndrome is increased.
The drug should not be used in the same rooms, as well as by those employees who are associated with the preparation of cytotoxic drugs for parenteral administration. Persons with established immunodeficiency should not work with the drug. Avoid contact with skin and mucous membranes.
Intravesical therapy with the drug may cause the development of sensitivity to tuberculin and subsequently complicate the interpretation of tuberculin skin samples in the diagnosis of mycobacterial infection. Therefore, a tuberculin test should be performed before prescribing the vaccine.
Sexual transmission. Cases of transmission of BCG infection through sexual contact have not yet been recorded, however, a condom should be used during the week after use during sexual intercourse.
Patients undergoing treatment are advised to wash their hands and genitals thoroughly after urination.
A spilled solution of the drug must be rendered harmless using the methods and regimes specified in the current sanitary standards and rules for the disinfection of mycobacteria.
In case of skin contact, the contaminated area must be treated with a suitable disinfectant.
Composition
Active ingredient: BCG microbial cells (not less than 400 million and not more than 750 million viable BCG cells) - 50 mg.
Excipient: stabilizer - sodium glutamate monohydrate.
Drug Interactions
During the course of intravesical instillations of Imuron-vak, the simultaneous administration of drugs to which BCG mycobacteria are sensitive should be avoided: anti-TB drugs, fluoroquinolones, doxycycline or gentamicin.
Overdose
There is no evidence that an overdose may cause symptoms other than the described adverse reactions.
Storage conditions
In the dark place at a temperature of 0–8 РC. In accordance with SP 3.3.2.1248-03
Active ingredient
BCG bladder cancer vaccine
Dosage form
lyophilisate for solution preparation
Imuron-vak is a microbial cell culture of the BCG-1 vaccine strain (M. bovis BCG -1, Russia), lyophilized in a 1.5% sodium glutamate monohydrate solution. Imuron-vak stimulates the immune system and has antitumor activity. With intravesical instillation, BCG acts as a non-specific immunomodulator, causing: a whole complex of immune reactions in which a number of cells of the immune system are involved, including T and B lymphocytes, macrophages, a number of cytokines. Pharmacokinetics After instillation of BCG mycobacteria into 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 instillation. The possibility of penetration of mycobacteria through the mucous membrane of the bladder has not been proven.
Indications
Treatment of non-invasive urothelial bladder cancer:
- treatment of pre-invasive cancer of the Tis stage (carcinoma in situ).
Prevention of relapse of bladder cancer after radical treatment:
- stage Ta (carcinoma that infiltrates only the mucous membrane of the bladder): Ta G1 – G2 with multifocal and / or recurrent tumors Ta G3
- stage T1 (tumor, infiltrative tissue not affecting the muscle layer of the bladder)
- Tis stage (pre-invasive carcinoma, carcinoma in situ).
Special instructions
BCG vaccine should not be used for sc, i / c, i / m or iv administration, or for vaccination purposes.
The patient should be warned about the possibility of complications of BCG therapy. If systemic reactions to the BCG vaccine occur, consult a TB specialist.
Adverse reactions are often observed during BCG vaccine therapy for immunotherapy of bladder cancer, but these reactions are usually not severe and are usually transient. With an increase in the number of instillations, the risk of side effects increases.
When prescribing BCG therapy, it is necessary to take into account the risk of developing severe systemic BCG reactions / infections, which include: fever> 39.5 РC for at least 12 hours, fever with a temperature> 38, 5 РC for at least 48 hours miliary pneumonia caused by BCG granulomatous hepatitis deviations of indicators characterizing liver function, organ dysfunctions (not related to the genitourinary system) with granulomatous inflammation confirmed by biopsy of Reuters syndrome.
Traumatic instillation can lead to BCG-related sepsis with the possible development of septic shock and the risk of death.
Urinary tract infection should be excluded prior to each intravesical instillation of BCG vaccine (inflammation of the mucous membrane of the bladder may increase the risk of hematogenous spread of BCG infections). If urinary tract infection is detected during therapy with BCG vaccine, treatment should be interrupted until the course of antibiotic therapy is completed and urinalysis is normalized.
Cases of infection of implants and grafts in patients, such as aneurysms, have been reported.
Isolated cases have been reported where BCG bacteria persisted in the urinary tract for more than 16 months.
In case of fever or macrohematuria, vaccine should be delayed until these symptoms are relieved.
Patients with reduced bladder capacity have an increased risk of shrinking of the bladder.
In the HLA-B27 group (human leukocyte antigen B27) of positive patients, the risk of developing reactive arthritis or Reiter's syndrome is increased.
The drug should not be used in the same rooms, as well as by those employees who are associated with the preparation of cytotoxic drugs for parenteral administration. Persons with established immunodeficiency should not work with the drug. Avoid contact with skin and mucous membranes.
Intravesical therapy with the drug may cause the development of sensitivity to tuberculin and subsequently complicate the interpretation of tuberculin skin samples in the diagnosis of mycobacterial infection. Therefore, a tuberculin test should be performed before prescribing the vaccine.
Sexual transmission. Cases of transmission of BCG infection through sexual contact have not yet been recorded, however, a condom should be used during the week after use during sexual intercourse.
Patients undergoing treatment are advised to wash their hands and genitals thoroughly after urination.
A spilled solution of the drug must be rendered harmless using the methods and regimes specified in the current sanitary standards and rules for the disinfection of mycobacteria.
In case of skin contact, the contaminated area must be treated with a suitable disinfectant.
Composition
Active ingredient: BCG microbial cells (not less than 400 million and not more than 750 million viable BCG cells) - 50 mg.
Excipient: stabilizer - sodium glutamate monohydrate.
Drug Interactions
During the course of intravesical instillations of Imuron-vak, the simultaneous administration of drugs to which BCG mycobacteria are sensitive should be avoided: anti-TB drugs, fluoroquinolones, doxycycline or gentamicin.
Overdose
There is no evidence that an overdose may cause symptoms other than the described adverse reactions.
Storage conditions
In the dark place at a temperature of 0–8 РC. In accordance with SP 3.3.2.1248-03
Active ingredient
BCG bladder cancer vaccine
Dosage form
lyophilisate for solution preparation
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