Dysport® has a generally well-characterised safety profile in children across indications.1
Dysport® (Clostridium botulinum type A toxin-haemagglutinin complex)
Tolerability information
Adverse events reported in paediatric patients with cerebral palsy (2 years of age or older) treated with Dysport® for upper limb focal spasticity1
| System organ class | Frequency* | Adverse drug reaction |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Common | Myalgia, muscular weakness |
| General disorders and administration-site conditions | Common Uncommon |
Influenza-like illness, fatigue, injection-site reaction (e.g. eczema, pain, swelling, bruising, rash, etc.) Asthenia |
| Skin and subcutaneous tissue disorders | Common | Rash |
Adverse events reported in paediatric patients with cerebral palsy (2 years of age or older) treated with Dysport® for dynamic equinus foot deformity1
| System organ class | Frequency* | Adverse drug reaction |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Common | Myalgia, muscular weakness |
| Renal and urinary disorders | Common | Urinary incontinence |
| Skin and subcutaneous tissue disorders | Common | Rash |
| General disorders and administration-site conditions | Common Uncommon |
Influenza-like illness, injection-site reaction (e.g. pain, erythema, bruising, etc.), gait disturbance, fatigue Asthenia |
| Injury, poisoning and procedural complications | Common | Fall |
No placebo-controlled clinical trial data are available for concomitant treatment of dynamic equinus foot deformity and upper limbs in ambulant paediatric patients with cerebral palsy.1 According to the existing data, the number of treatment-related side effects is not higher in doses of up to 30 U/kg or 1000 U, whichever is lower in comparison to treating either upper limb or lower limb muscles alone.1
*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 <1/1000.1
Reference:
- Dysport® Summary of Product Characteristics.
Abbreviations:
AE, adverse event; U, units.
For further information, please refer to the Prescribing Information or the Summary of Product Characteristics.