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Dysport® (Clostridium botulinum type A toxin-haemagglutinin complex)
Dysport<sup>®</sup> (<em>Clostridium botulinum</em> type A toxin-haemagglutinin complex)

Dysport® (Clostridium botulinum type A toxin-haemagglutinin complex) therapeutic indications

Dysport® is indicated in paediatric patients for:

  • Upper limbs in paediatric cerebral palsy patients ≥ 2 years of age.
  • Treatment of: Dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients ≥ 2 years of age.
  • Please visit the PI link at the top of this page for the full list of indications.
Dosing and administration

Dosing and administration

Dysport® should be injected at the recommended dose, in the approved muscles, by appropriately trained physicians. For every Dysport® injection, dosing should be tailored to the individual based on the size, number and location of muscles, severity of spasticity, the presence of local muscle weakness, and the patient’s response to previous treatment and/or adverse event history with botulinum toxins.1

The dosing recommendations in the Dysport® SmPC should always be followed:1

UPPER LIMB: A maximum total dose of Dysport® per treatment session of 16 U/kg or 640 U (whichever is lower) when injecting unilaterally, or 21 U/kg or 840 U (whichever is lower) when injecting bilaterally.

Dysport® treatment may be repeated when the effect of the previous treatment had diminished, but not before 16 weeks after the previous injection.

DYNAMIC EQUINUS FOOT DEFORMITY:
A maximum total dose of Dysport® administered per treatment session of 15 U/Kg when injecting unilaterally, or 30 U/kg when injecting bilaterally. The total Dysport® dose per treatment session must not exceed 1000 U or 30 U/kg, whichever is lower.

Dysport® treatment may be reported when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.

No more than 0.5 mL should be administered at any single injection site.

The recommended doses per treatment session for each upper limb and lower limb muscle group can be viewed in the administration guide below.

Reference:

  1. Dysport® Summary of Product Characteristics.

 

Abbreviations:

SmPC, Summary of Product Characteristics; U, units.

For further information, please refer to the Prescribing Information or the Summary of Product Characteristics.

To access relevant information about Paediatric Spasticity, please choose one of the following options:

Adverse events should be reported.
Reporting forms and information can be found at www.hpra.ie or e-mail medsafety@hpra.ie.
The HPRA can also be contacted on +353 16764971. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256.

Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly to the HPRA. Reporting forms and information can be found at www.hpra.ie or email medsafety@hpra.ie. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256. By reporting side effects, you can help provide more information on the safety of this medicine.