Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Side effects related to spread of toxin distant from the site of administration have been reported (see section 4.8) which, in some cases, was associated with dysphagia, pneumonia and/or significant debility resulting, very rarely, in death. Patients treated with therapeutic doses may present with excessive muscle weakness. The risk of occurrence of such undesirable effects may be reduced by using the lowest effective possible dose and by not exceeding the maximum recommended dose.

Dysport should only be used with caution and under close medical supervision in patients with subclinical or clinical evidence of marked defective neuromuscular transmission (e.g. myasthenia gravis). Such patients may have an increased sensitivity to agents such as Dysport, which may result in excessive muscle weakness with therapeutic doses. Patients with underlying neurological disorders are at increased risk of this side effect.

Caution should be exercised when treating adult patients especially the elderly, with focal spasticity affecting the lower limbs, who may be at increased risk of fall. In placebo-controlled clinical studies, where patients were treated for lower limb spasticity, 6.3% and 3.7% of patients experienced a fall in the Dysport and placebo groups, respectively.

Dry eye has been reported with the use of Dysport in the treatment of blepharospasm and hemifacial spasm (see section 4.8). Reduced tear production, reduced blinking, and corneal disorders, may occur with the use of botulinum toxins, including Dysport.

Very rare cases of death, occasionally in the context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B. Patients with disorders resulting in defective neuromuscular transmission, difficulty in swallowing or breathing are more at risk of experiencing these effects. In these patients, treatment must be administered under the control of a specialist and only if the benefit of treatment outweighs the risk.

Dysport should be administered with caution to patients with pre-existing swallowing or breathing problems, as these can worsen following the distribution of the effect of toxin into the relevant muscles. Aspiration has occurred in rare cases and is a risk when treating patients who have a chronic respiratory disorder.

The recommended posology and frequency of administration for Dysport must not be exceeded (see section 4.2).

Patients and their care-givers must be warned of the necessity to seek immediate medical treatment in case of swallowing, speech or respiratory problems.

Dysport should not be used to treat spasticity in patients who have developed a fixed contracture.

As with any intramuscular injection, Dysport should only be used where strictly necessary in patients with prolonged bleeding times, infection or inflammation at the proposed site(s) of injection.

Caution should be taken when Dysport is used where the targeted muscle shows excessive weakness or atrophy.

Dysport should only be used to treat a single patient, during a single session. Specific precautions must be taken during the preparation and administration of the product (see section 4.2) and for the inactivation and disposal of any unused reconstituted solution (see section 6.6).

Antibody formation to botulinum toxin has been noted rarely in patients receiving Dysport.
Clinically, neutralising antibodies might be suspected by a substantial deterioration in response to therapy and/or the need for consistent use of increased doses.


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When treating glabellar lines, it is essential to study the patient’s facial anatomy prior to administration. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to this anatomy, as a result of previous surgical interventions should be taken into consideration.
Caution should be taken when the targeted muscle shows excessive weakness or atrophy.

Careful consideration should be given before the injection of patients who have experienced a previous allergic reaction to a product containing botulinum toxin type A. The risk of a further allergic reaction must be considered in relation to the benefit of treatment.

Paediatric use
For the treatment of spasticity associated with cerebral palsy in children, Dysport should only be used in children of 2 years of age or over. Post-marketing reports of possible distant spread of toxin have been very rarely reported in paediatric patients with comorbidities, predominantly with cerebral palsy. In general, the dose used in these cases was in excess of that recommended (see section 4.8).
There have been rare spontaneous reports of death sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including following off- label use (e.g. neck area). Extreme caution should be exercised when treating paediatric patients who have significant neurologic debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Treatment in patients with poor underlying health status should be administered only if the potential benefit to the individual patient is considered to outweigh the risks.

Effects on Driving

4.7   Effects on ability to drive and use machines
There is a potential risk of muscle weakness or visual disturbances which, if experienced, may temporarily impair the ability to drive or operate machinery.