4.1 Therapeutic indications
Dysport is indicated for symptomatic treatment of focal spasticity of:
– Upper limbs in adults
– Lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (TBI)
– Dynamic equinus foot deformity in ambulant paediatric cerebral palsy patients, two years of age or older
– Upper limbs in paediatric cerebral palsy patients, two years of age or older.
Dysport is indicated in adults for symptomatic treatment of:
– Spasmodic torticollis
– Hemifacial spasm
– Severe primary hyperhidrosis of the axillae, which does not respond to topical treatment with antiperspirants or antihidrotics.
4.2 Posology and method of administration
The units of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
Dysport should only be administered by appropriately trained physicians.
For the treatment of focal spasticity, Dysport can also be administered by healthcare professionals having received appropriate training and qualification in accordance with national guidelines (e.g., Royal College of Physicians).
For instructions on reconstitution of the powder for solution for injection, handling and disposal of vials please refer to section 6.6.
Focal spasticity in adults
Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, and/or adverse event history with Dysport. In clinical trials, doses of 500 units and 1000 units were divided among selected muscles at a given treatment session as shown below.
No more than 1 ml should generally be administered at any single injection site. The total dose should not exceed 1000 units at a given treatment session.