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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 for symptomatic treatment of focal spasticity including:

  • Adult upper limbs
  • Adult ankle joint due to stroke or traumatic brain injury (TBI).
  • Please visit the PI link at the top of this page for the full list of indications.
Dosing and administration

Dosing and administration

To enable long-lasting symptom control of adult spasticity, Dysport® should be injected at the recommended dose in the approved muscles. For every Dysport® injection, dosing should be tailored to the individual based on the size, number and location of muscles, severity of spasticity, any local muscle weakness, and the patient’s response to previous treatment and adverse event history.1

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

Upper limbs: doses greater than 1000 U and up to 1500 U can be administered when the shoulder muscles are also injected. The total dose recommended in the selected shoulder muscles is up to 500 U.
Lower limbs: maximum dose across lower limbs is 1500 U at a given treatment session.
No more than 500 U/1 ml should generally be administered at any single injection site.
Maximum combined dose across both upper and lower limbs is 1500 U at a given treatment session.

Adult spasticity dilution tables2

Adult upper limb spasticity dilution table

Adult lower limb spasticity dilution table

Volume Injected (ml) Volume of injectable NaCl solution (0.9%) used to reconstitute a vial of Dysport® 500 U
1ml 2.5ml 5ml
Dysport® units delivered
0.1 50 20 10
0.2 100 40 20
0.3 150 60 30
0.4 200 80 40
0.5 250 100 50
0.6 300 120 60
0.7 350 140 70
0.8 400 160 80
0.9 450 180 90
1.0 500 200 100
1.1   220 110
1.2   240 120
1.3   260 130
1.4   280 140
1.5   300 150
1.6   320 160
1.7   340 170
1.8   360 180
1.9   380 190
2.0   400 200
2.1   420 210
2.2   440 220
2.3   460 230
2.4   480 240
2.5   500 250
2.6     260
2.7     270
2.8     280
2.9     290
3.0     300
3.1     310
3.2     320
3.3     330
3.4     340
3.5     350
3.6     360
3.7     370
3.8     380
3.9     390
4.0     400
4.1     410
4.2     420
4.3     430
4.4     440
4.5     450
4.6     460
4.7     470
4.8     480
4.9     490
5.0     500
Volume Injected (ml) Volume of injectable NaCl solution (0.9%) used to reconstitute a vial of Dysport® 500 U
1ml 2.5ml 5ml
Dysport® units delivered
0.1 50 20 10
0.2 100 40 20
0.3 150 60 30
0.4 200 80 40
0.5 250 100 50
0.6 300 120 60
0.7 350 140 70
0.8 400 160 80
0.9 450 180 90
1.0 500 200 100
1.1   220 110
1.2   240 120
1.3   260 130
1.4   280 140
1.5   300 150
1.6   320 160
1.7   340 170
1.8   360 180
1.9   380 190
2.0   400 200
2.1   420 210
2.2   440 220
2.3   460 230
2.4   480 240
2.5   500 250
2.6     260
2.7     270
2.8     280
2.9     290
3.0     300
3.1     310
3.2     320
3.3     330
3.4     340
3.5     350
3.6     360
3.7     370
3.8     380
3.9     390
4.0     400
4.1     410
4.2     420
4.3     430
4.4     440
4.5     450
4.6     460
4.7     470
4.8     480
4.9     490
5.0     500

Retreating: treatment may be repeated every 12–16 weeks based on clinical symptom return (or longer, as necessary, but not before 12 weeks).*1

Locating injection sites: although actual location of injection sites can be determined by palpation, use of injection guiding techniques, e.g. electromyography, electrical stimulation or ultrasound, is recommended to target injections.1

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

*The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport® and muscles to be injected.1

References:

  1. Dysport® Summary of Product Characteristics.
  2. Dysport® dosing and administration guide.

 

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 Adult 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.