Immunobladder Special Precautions

Administration with special caution (Immunobladder should be administered with special caution to the following patients.
Patients with previous history of tuberculosis or persons who showed strong positive reaction in tuberculin skin-testing [These patients may drastically respond to Immunobladder].
Patients with history of drug allergy.
Important precautions: Immunobladder should be used after giving the patient or his/her appropriate representative enough information about his/her disease status, necessity to use Immunobladder, method of administration of Immunobladder, period of administration, expected adverse reactions, and necessity of reporting to his/her doctor on adverse reactions, if they occur.
Care should be taken not to traumatize the urinary tract or not to introduce contaminants into the urinary system when administered.
Patients should be monitored for the presence and degree of subjective and/or objective symptoms due to adverse reaction after each intravesical instillation.
Patients should be advised to be attentive to systemic adverse reactions, such as fever, chills, malaise, flu-like symptoms, or increased fatigue, and to report promptly to their physician if he/she experiences any of these symptoms, as well as severe urinary adverse reactions, such as burning, pain by voiding, urgency, frequency of urination, or other symptoms such as joint pain, cough, or skin rash.
It is advisable to perform tuberculin skin-testing prior the start of treatment with Immunobladder.
Use in the elderly: The incidence of superficial bladder cancer and carcinoma in situ (CIS) of the bladder is higher in elderly persons.
No trends toward increased adverse reactions or abnormalities in laboratory examinations have been observed in elderly patients.
Use in children: The safety in children has not been established (no clinical experience).