Active Ingredient: Botulinum toxin type A
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intramuscular, 200 international units botulinum toxin type A, one dose, over the duration of 3 months.
Recommended needle: The injection needle should be filled (primed) with approximately 1 ml of the reconstituted botulinum toxin type A solution prior to the start of the injections (depending on the needle length) to remove any air.
Administration guidance: The reconstituted solution of botulinum toxin type A (200 Units) is injected via a flexible or rigid cystoscope, avoiding the trigone and base. The bladder should be instilled with enough saline to achieve adequate visualisation for the injections and avoid backflow of the product, but over-distension should be avoided.
The needle should be inserted approximately 2 mm into the detrusor, and 30 injections of 1 ml each (total volume 30 ml) should be spaced approximately 1 cm apart (see figure above). For the final injection, approximately 1 ml of sterile unpreserved normal saline (0.9% sodium chloride for injection) should be injected so the full dose is delivered. After the injections are given, the saline used for bladder wall visualisation should be drained.
Recommended dose: The recommended dose is 200 Units of botulinum toxin type A, as 1 ml (~6.7 Units) injections across 30 sites in the detrusor muscle.
Patients should be considered for reinjection when the clinical effect of the previous injection has diminished, but no sooner than 3 months from the prior bladder injection.
No urodynamic data beyond 2 treatments and no histopathological data after repeated treatment are currently available.
Patients should not receive multiple treatments in the event of limited symptomatic improvement.
The maximum cumulative dose should not exceed 400 Units in a 12-week interval.
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