Immunobladder Dosage/Direction for Use

Formulation: Each vial (80 mg) of Immunobladder is usually reconstituted with 2 mL of accompanying diluent (isotonic sodium chloride solution, JP) to make a 40 mg/mL suspension. The reconstituted suspension is further diluted by adding 39 mL of isotonic sodium chloride solution, JP, to make a diluted homogeneous BCG suspension for instillation.
Method of administration: A urethral catheter is inserted into bladder under aseptic conditions, the bladder is drained, and then a suspension containing 80 mg of BCG is instilled very slowly. The patient is asked to retain the suspension for a total of up to two hours if possible. This procedure is repeated usually once a week for eight weeks.
The dosage and number of the administration can be appropriately increased or decreased according to the status of the disease and patient's conditions. The interval of administration can also be extended if needed.
Precaution: For patients treated with antibiotics for other infectious disease, intravesical instillations of Immunobladder should be postponed until completion of the treatment.
Route of administration: Immunobladder should be used only for intravesical instillation. Do not inject percutaneously or by other routes (e.g. intracutaneously, subcutaneously, intramuscularly or intravenously).
Administration: Care should be taken not to traumatize the urinary tract when inserting a urethral catheter for the instillation of Immunobladder. If damage of urinary tract has occurred, the instillation of Immunobladder should be postponed for 7 to 14 days.
Velocity of instillation: Immunobladder should be instilled as slowly as possible.
Void: As for the first void after instillation of Immunobladder, patients should be advised to void while seated to void completely. In order to avoid an accident due to dizziness, it is advisable to stand up slowly after void.
Disposal of urine: Take the first urine after instillation of Immunobladder in an appropriate container (e.g. urinal) and disinfected in order to prevent BCG infection before flushing.
One of the methods for disinfections is adding a half volume of 10% sodium hypochlorite solution and standing for 15 minutes.