Bacillus calmette-Guerin strain (BCG vaccine)

Bacillus calmette-Guerin strain (BCG vaccine) is a medicine used for treatment of early-stage bladder cancer. It is recommended for people with early bladder cancer that has not yet reached the bladder muscle. It kills the cancer cells and reduces the risk of cancer coming back again (recur). Bacillus calmette-Guerin strain (BCG vaccine) is administered by a healthcare professional. It is instilled directly into the bladder through the urethra. For it to be effective, you should complete the course of the vaccine. You should not discontinue even if you get better until the course is completed. Some common side effects of this medicines include difficulty in urination, urinary tract infection, and fever. These are usually mild and go away with time. However, if they persist or get worse, you should let your doctor know. Before receiving the vaccine, you should let your doctor if you have ever had an allergic reaction to any vaccine. Also tell your doctor if you have any problems with your heart, kidneys, or liver. Some other medicines may react with this vaccine, so let your doctor know of all the medication you are taking. Pregnant or breastfeeding should consult their doctors first before receiving this vaccine. Bacillus calmette-Guerin strain (BCG vaccine) is a type of bacteria. It works by activating the cells in the immune system which helps destroy cancer cells lining the bladder.

• Early-stage bladder cancer

Live BCG vaccine is an attenuated strain of bacillus Calmette-Guérin; used for active immunisation against tuberculosis. It is also used as an active immunotherapy for the treatment of bladder carcinoma in situ by causing a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder. This local inflammatory response results in destruction of superficial tumor cells of the urothelium.

Adult Dose: Intradermal Active immunisation against tuberculosis Adult: 0.2-0.3 ml (full strength dilution); conduct postvaccinal tuberculin test (5 TU of PPD) 2-3 mth later; if test is negative, repeat vaccination. Dose to be given via intradermal inj. Intravesical Immunotherapy of bladder cancer Dosage: The content of 1 vial is required for 1 bladder instillation. Duration: A standard treatment schedule consists of 1 intravesical instillation of BCG-Medac per week for 6 consecutive weeks as induction therapy. BCG treatment must not start until 2-3 weeks after transurethral resection (TUR). After a treatment-free interval of 4 weeks, intravesical administration should continue using maintenance therapy for at least 1 year. Induction Therapy (Prophylactic Treatment of Recurrence): BCG therapy should begin about 2-3 weeks after TUR or bladder biopsy, and without traumatic catheterisation, and be repeated at weekly intervals for 6 weeks. In intermediate and high-risk tumours, this should be followed by maintenance therapy. Maintenance Therapy: One schedule consists of a 12-month therapy with treatments at monthly intervals. Another maintenance scheme consists of 3 instillations at weekly intervals at month 3, 6, 12, 18, 24, 30 and 36. In this scheme, a total of 27 instillations are administered during a period of 3 years. Child Dose: Intradermal Active immunisation against tuberculosis Child: 1 mth: 0.2-0.3 ml (full strength dilution); conduct postvaccinal tuberculin test (5 TU of PPD) 2-3 mth later; if test is negative, repeat vaccination. Dose to be given via intradermal inj.

Your doctor or nurse will give you this medicine. Kindly do not self administer.

Common: • Difficulty in urination • Urinary tract infection • Fever

[SAFE] Bacillus calmette-Guerin strain (BCG vaccine) does not usually affect your ability to drive. Bacillus calmette-Guerin strain (BCG vaccine) helps treat bladder cancer and also prevents cancer from coming back after bladder surgery. It is put into your bladder through a tube by a doctor or nurse. Do not drink any liquid 4 hours before or 2 hours after you get this medicine. You will be asked to urinate immediately before and 2 hours after Bacillus calmette-Guerin strain (BCG vaccine) is given to you. Inform your doctor if you are also taking medicines for tuberculosis, other medications such as antibiotics or those that affect the immune system.

Hypersensitivity to any of the ingredients of BCG-Medac. BCG-Medac should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (eg, positive HIV serology, leukaemia, lymphoma), cancer therapy (eg, cytostatic drugs, radiation) or immunosuppressive therapy (eg, corticosteroids). BCG-Medac should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals by anamnesis. Past history of radiotherapy of the bladder. BCG-Medac must not be instilled before 2-3 weeks after a TUR, a bladder biopsy or a traumatic catheterisation. Perforation of the bladder. Acute urinary tract infection (UTI). Use in lactation: There are no adequate data from the excretion of these bacteria in breastmilk. This treatment is contraindicated in nursing women.

Concurrent use with antimicrobials may interfere with efficacy of intravesicular BCG and suppress the immune response to BCG vaccination. Immune globulins may reduce the therapeutic effect of live organism vaccines. Increased risk of infections associated with vaccines (live organism) when used with immunosuppressants. Immune response of BCG vaccination may be compromised when used within 30 days of another live organism vaccine.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Bacillus calmette-Guerin strain (BCG vaccine). Please consult your doctor.

[CONSULT YOUR DOCTOR] Bacillus calmette-Guerin strain (BCG vaccine) may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[UNSAFE] Bacillus calmette-Guerin strain (BCG vaccine) is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

[CONSULT YOUR DOCTOR] There is limited information available on the use of Bacillus calmette-Guerin strain (BCG vaccine) in patients with kidney disease. Please consult your doctor. [CONSULT YOUR DOCTOR] There is limited information available on the use of Bacillus calmette-Guerin strain (BCG vaccine) in patients with liver disease. Please consult your doctor.