Immunobladder should not be given to the following patients.
Immunosuppressed patients due to complicated diseases, such as AIDS, leukemia, malignant lymphoma, or patients under anticancer therapy (e.g., cytotoxic drugs, radiation), or persons with congenital or acquired immune deficiencies.
[Immunosuppressed and/or immunodeficiency patients might not respond to this immuno-modulating agent properly and also are at increased risk to develop disseminated BCG infection.]
Persons who live with HIV infection and patients receiving immunosuppressive dose of steroid or other immunosuppressive agents.
[Immunosuppressed and/or immunodeficiency patients might not respond to this immuno-modulating agent properly and also are at increased risk to develop disseminated BCG Infection.]
Patients with active tuberculosis.
[Patients with active tuberculosis are at higher risk to develop severe adverse reactions with Immunobladder.]
Patients with febrile illness, urinary tract infection, or gross hematuria.
[Patients with febrile illness, urinary tract infection, or gross hematuria are at increased risk to develop severe adverse reactions with Immunobladder.]
Pregnant women or women suspected of being pregnant.
[In animal reproduction studies, Immunobladder was confirmed not to influence on the reproductive abilities of the animal and fetus when administered prior to or at the early stage of pregnancy, but the effects of Immunobladder given at the later stages of the pregnancy on fetus and in maintaining the pregnancy have not been determined.]
Patients with previous history of systemic hypersensitivity to BCG.
[Serious adverse reactions may occur.]