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Adverse event reporting information is available at the bottom of this webpage.

This website has been commissioned by Ipsen Pharmaceuticals Ltd. and is intended for an Irish audience

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.
Efficacy information

Efficacy information

Dysport® significantly improved muscle tone in a Phase 3, double-blind, randomised study of paediatric patients with cerebral palsy and upper limb spasticity.1

 

The majority of children with upper limb spasticity receiving Dysport® achieved a ≥1 grade improvement in PGA at Week 6 of the first treatment cycle.2

Dysport® significantly reduced muscle tone in the GSC at the ankle joint compared with baseline.3

Dysport® significantly improved PGA compared with placebo in children with lower limb spasticity.3

 

*Investigators chose either elbow or wrist flexors for the primary target muscle group.1,2
†Statistically significant vs 2 U/kg control group.1,2

References:

  1. Ipsen Data on File: DYS-UK-003863.
  2. Delgado MR, et al. Poster presentedat ISPRM. 2020.
  3. Delgado MR, et al. Paediatrics. 2016;137(2):e20152830.

 

Abbreviations:

GSC, gastrocsoleus muscle complex; ITT, intention-to-treat; MAS, Modified Ashworth Scale; PGA, Physician’s Global Assessment; U, units.

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

Resources

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.

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

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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.

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This section provides information to support patients that have been prescribed Dysport® (Clostridium botulinum type A toxin-haemagglutinin complex).

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This section is for members of the general public.

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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.