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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 adults for:

  • Spasmodic torticollis
  • Blepharospasm
  • Hemifacial spasm
  • Persistent severe primary axillary hyperhidrosis (interfering with daily living and resistant to topical treatment)
  • Please visit the PI link at the top of this page for the full list of indications.
Tolerability information

Tolerability information

With over 30 years of experience in the UK (licensed in December 1990),1 Dysport® is well tolerated in adults with cervical dystonia.2,3

Adverse events reported for cervical dystonia in the Dysport® SmPC2

System organ class Frequency* Adverse drug reaction
Nervous system disorders Common Headache, dizziness, facial paresis
Eye disorders Common
Uncommon
Vision blurred, visual acuity reduced
Diplopia, ptosis
Respiratory, thoracic and mediastinal disorders Common
Rare
Dysphonia, dyspnoea
Aspiration
Gastrointestinal disorders Very common
Uncommon
Dysphagia, dry mouth
Nausea
Musculoskeletal and connective tissue disorders Very common
Common
Uncommon
Muscle weakness
Neck pain, musculoskeletal pain, myalgia, pain in extremity, musculoskeletal stiffness
Muscle atrophy, jaw disorder

*The frequency of AEs reported in placebo-controlled trials after a single administration is defined as: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1000 to <1/100; rare ≥1/10 000 to <1/1000.2
Dysphagia appeared to be dose related and occurred most frequently following injection into the sternomastoid muscle. A soft diet may be required until symptoms resolve. These side effects may be expected to resolve within 2–4 weeks.2

References:

  1. IPSEN Data on File: DYS-UK-003254.
  2. Dysport® Summary of Product Characteristics.
  3. Truong D, et al. Parkinsonism Relat Disord. 2010;16:316–323.

 

Abbreviations:

AE, adverse event; SmPC, Summary of Product Characteristics.

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

To access relevant information about Cervical Dystonia, 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.