Active Ingredient: Botulinum toxin type B
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intramuscular, 5,000 international units botulinum toxin type B, once every 12 to 16 weeks.
Regimen B: Intramuscular, 10,000 international units botulinum toxin type B, once every 12 to 16 weeks.
The initial dose is 10,000 U and should be divided between the two to four most affected muscles. Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5,000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Injections should be repeated as required to maintain good function and minimise pain. In long term clinical studies, the average dosing frequency was approximately every 12 weeks, however this may vary between subjects, and a proportion of patients maintained a significant improvement relative to baseline for 16 weeks or longer. The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
The potency of this medicinal product is expressed in botulinum toxin type B 5000 U/ml. These units are not interchangeable with the units used to express the potency of other botulinum toxin preparations.
Botulinum toxin type B solution for injection must only be administered by intramuscular injection. Particular caution should be paid to ensure that it is not injected into a blood vessel.
The initial dose of 10,000 U should be divided between the two to four most affected muscles.
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