Dysport Special Precautions

Side effects related to spread of toxin distant from the site of administration have been reported (see Adverse Reactions) which, in some cases, were 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 dose and by not exceeding the recommended dose.
Botulinum Toxin Type A should only be used with caution and under close supervision in patients with subclinical or clinical evidence of marked defective neuro-muscular transmission (e.g. myasthenia gravis). Such patients may have an increased sensitivity to agents such as Botulinum Toxin Type A which may result in excessive muscle weakness with therapeutic doses. Patients with underlying neurological disorders are at increased risk of this side effect. Very rare cases of death, occasionally in the context of dysphagia, pneumopathy 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 Botulinum toxin type A must not be exceeded (see Dosage & Administration).
Patients and their care-givers must be warned of the necessity to seek immediate medical treatment in case of problems with swallowing, speech or respiratory problems.
For the treatment of spasticity associated with cerebral palsy in children, Botulinum Toxin Type A should only be used in children of 2 years of age or over.
Dysport should not be used to treat spasticity in patients who have developed a fixed contracture. As with any intramuscular injection, Botulinum toxin type A should only be used where strictly necessary in patients with prolonged bleeding times, infection or inflammation at the proposed site(s) of injection.
Botulinum Toxin Type A 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 Dosage & Administration) and for the inactivation and disposal of any unused reconstituted solution (see Special precautions for disposal under Cautions for Usage).
This product contains a small amount of human albumin. The risk of transmission of viral infection cannot be excluded with absolute certainty following the use of human blood or blood products.
Antibody formation to botulinum toxin has been noted rarely in patients receiving Botulinum Toxin Type A. Clinically, neutralising antibodies might be suspected by a substantial deterioration in response to therapy and/or a need for consistently increasing doses.
When treating glabellar lines, it is essential to study the patient's facial anatomy prior to administering. 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.
The effect of administering different botulinum neurotoxins during the course of treatment with Botulinum Toxin Type A is unknown and must be avoided.
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.