巴斯德BCG(Immunobladder intravesical)

【Function and Indications】

BCG intravesical instillation dry powder (Immunobladder intravesical) is suitable for intravesical use to treat primary recurrent carcinoma in situ CIS of the bladder to reduce the frequency of tumor recurrence. It is suitable for the treatment of carcinoma in situ with or without papillary tumors, but not for the treatment of papilloma alone. This drug can also be used as a salvage therapy for bladders that fail to respond to other carcinoma in situ CIS treatment courses.
Treatment and prevention of primary or recurrent carcinoma in situ of the bladder, or superficial papillary carcinoma (TA and T1) after transurethral resection.

【Model and Specifications】

Each bottle contains 80mg (dry weight) and 5% Monosodium glutamate.

【Usage and Dosage】

Intravesical instillation.

Intravesical treatment and prevention of bladder carcinoma in situ CIS should be started 7 to 14 days after biopsy or transurethral resection, with a single dose of 3 vials.

【Clinical Research】

BCG immunotherapy promotes local inflammation of the bladder with histiocytes and thrombus cells infiltrating it. The local inflammatory effect is caused by the significant removal or reduction of bladder surface cancer. Its true mechanism is unknown.

【Precautions】

1. This drug is classified as an infectious agent because it contains live attenuated mycobacterium.

2. All materials used to infuse this product, such as syringes and catheters, should be placed in a plastic bag immediately after use, marked as “infectious waste” and discarded as biohazardous waste.

3. When using this drug to treat bladder carcinoma in situ, you must be careful not to introduce contamination into the urethra and cause improper damage to the urinary tract mucosa.

4. It is recommended to use it one week after transurethral resection, because there have been reports of deaths when using this product after traumatic catheterization.

5. If the physician believes that bladder catheterization has caused trauma, this product should not be used and treatment must be postponed for at least one week.
6. If the patient has a fever or severe physical discomfort during treatment, isoniazid 300 mg per day should be used until the symptoms are relieved. If symptoms persist, the BCG immunization should be stopped, and Isoniazid preventive treatment should be started before any re-infusion of BCG.
7. If systemic BCG infection is suspected (i.e., if the patient has a fever of more than 39 degrees or a fever of more than 38 degrees for 2 days), isoniazid 300 mg per day, rifampicin 600 mg per day, and ethambutol 120 mg per day should be considered for rapid-acting anti-tuberculosis therapy.

【Adverse reactions and contraindications】

1. Most local adverse reactions occur after the third intravesical instillation. The most common ones are: dysuria, frequent urination, hematuria, cystitis, urgency, urinary tract infection, urinary incontinence and cramping pain. Symptoms usually begin 2 to 4 hours after instillation and last for 24 to 72 hours;

2. Systemic reactions generally last 1 to 3 days after each instillation. The most common ones are: malaise, fever, chills, anemia, nausea, vomiting, anorexia, muscle pain, joint pain, arthritis, diarrhea, low white blood cells, nephrotoxicity and genital pain, granulomatous prostatitis, epididymitis, orchitis and renal ulcer.

【Contraindications】

The following symptoms and dangers:

1. Patients who are taking immunosuppressive therapy or patients with impaired immune systems should not receive BCG immunotherapy agents because they may cause systemic sepsis due to the inability to resist Bacillus.

2. Combination of bone marrow suppressants and immunosuppressants, or radioactive drugs may impair the reaction of this drug, thereby increasing the risk of osteomyelitis or disseminated BCG infection.

3. Unless the cause of the fever has been determined and evaluated, this drug should not be used in patients with fever. If the cause of the fever is infection, this drug should be discontinued until the fever subsides.

4. Patients with urinary tract infection should not be treated with this drug, as there is a risk of disseminated BCG infection or increased risk of bladder irritation.

[Pregnant women use]

In controlled animal studies, this drug has adverse reactions to the embryo (to teratogenicity), but no human pregnant women studies have been conducted; this drug can only be used if the possible benefits outweigh the potential risks.

[Children use]

There is no basis for controlled children use.

[Storage]

Store at 2℃-8℃, avoid freezing and avoid sunlight.

[Manufacturer]

Japan.