Dysport 300 IU 1 Vial

Powder for solution for injection (SC, IM):   Vials, unit boxes.

Excipients (common): 20% human albumin solution, lactose monohydrate.
Dysport Speywood units are preparation specific and are not interchangeable with other botulinum toxin preparations.

The concentration of the reconstituted Dysport solution is expressed in Speywood Units.

Given the lack of harmonization of unit systems for the various commercially available botulinum toxins, extreme caution should be exercised if it becomes necessary to switch from one pharmaceutical company’s botulinum toxin to another pharmaceutical company’s botulinum toxin.

Adverse reactions related to the spread of the toxin away from the administration site have been reported ( see Adverse reactions ). Patients treated at therapeutic doses may experience excessive muscle weakness. The risk of such adverse reactions can be reduced by using the lowest effective dose and not exceeding the maximum recommended dose.

Very rare cases of death sometimes following dysphagia, pneumonia (including but not limited to: dyspnea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported after treatment with botulinum toxin type A or B.

Dysport should be administered with caution to patients with a history of swallowing or respiratory disorders because diffusion of the toxin into the involved muscles may aggravate these disorders. Aspiration pneumonitis has been observed in rare cases and represents a risk in patients with chronic respiratory disorders.

Dysport should only be used with caution and under close medical supervision in patients with clinical or subclinical marked impairment of neuromuscular transmission (e.g., myasthenia gravis). These patients may have an increased sensitivity to products such as Dysport, which may lead to excessive muscle weakness.

The existence of a history of neurogenic facial damage (facial paralysis, polyradiculoneuritis) requires, during the first injection, the use of doses equal to a quarter of the recommended dose ( see Dosage and Method of Administration ).

Patients with blepharospasm may have been sedentary for a very long time. Therefore, during treatment with botulinum toxin, it is necessary to advise them to resume activity gradually.

Decreased blinking due to injection of botulinum toxin into the orbicularis oculi muscle can lead to prolonged corneal exposure, persistent epithelial damage, and corneal ulceration, especially in patients with facial paralysis. In this case, preventive and curative measures should be taken.

Cases of dry eye have been reported with the use of Dysport in the periocular areas ( see Adverse Reactions ). It is important to pay particular attention to this adverse effect because dry eye may predispose to corneal disorders. Protective drops, ointments, occlusion of the eye with a bandage, or other means may be necessary to prevent corneal disorders.

As with any intramuscular injection, Dysport should only be injected if strictly necessary, in patients with prolonged bleeding times or infection/inflammation at the injection site.

In case of atrophy of the targeted muscle, special precautions should be taken. Cases of muscle atrophy have been reported after the use of botulinum toxin ( see Adverse reactions ).

Autonomic dysreflexia associated with the treatment procedure for neurological detrusor overactivity may occur.This product contains a small amount of human albumin. The risk of transmission of viral infection cannot be completely excluded after use of human blood or blood derivatives.

Antibodies to botulinum toxin have been rarely observed in patients treated with Dysport. Clinically, neutralizing antibodies are suspected if there is a decreased response to treatment and/or a need for continued dose increases.

Pediatric population:

In dynamic equinus foot deformity in children with cerebral palsy, an initial precise functional assessment must be carried out in a specialized environment. It allows:

• to assess the relevance of the indication:
  • predominant spasticity;
  • absence of muscle weakness sometimes masked by hypertonia. This weakness could be aggravated by an injection of botulinum toxin;
  • absence of significant fixed retraction or post-surgical scar making botulinum toxin injection unnecessary;
• to determine the different components of the treatment (physiotherapy, wearing splints, etc.);
• to adapt the treatment according to clinical development.

. In general, the dose used in these cases was higher than that recommended ( see Adverse Reactions ).

Treatment of pediatric patients with severe neurological impairment, dysphagia, or a history of aspiration pneumonia or lung disease requires extreme caution.

Pregnancy:
Animal studies have not shown direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development, except at very high doses that are toxic to the mother ( see Preclinical safety ). Dysport 300 IU 1 Vial

The risks of muscle weakness and vision disturbances may, if they occur, temporarily impair the ability to drive vehicles and operate machinery.

Excessive doses can cause profound neuromuscular paralysis at a later stage.

Overdose may increase the risk of the neurotoxin entering the bloodstream and may lead to complications associated with botulinum syndrome (e.g., dysphagia and dysphonia). Respiratory resuscitation may be necessary if excessive doses cause paralysis of the respiratory muscles.

Symptoms of overdose may not necessarily occur immediately after injection.

Intramuscular administration (striated muscles)

In a chronic toxicity study in rats (up to 12 U/animal), no systemic toxicity was observed. Reproductive toxicity studies in pregnant rats and rabbits administered daily intramuscular injections of Clostridium botulinum hemagglutinin-toxin A complex at doses of 79 U/kg and 42 U/kg, respectively, did not result in embryo-fetal toxicity. In rats, the observed decrease in male and female fertility was due to the decrease in the number of matings due to muscle paralysis secondary to the administration of high doses. Dysport 300 IU 1 Vial

In a juvenile toxicity study, rats treated weekly from weaning to  postnatal day 21 and up to week 13 ^, used  as an animal model of children from 2 years of age to young adults (11 administrations over 10 weeks, up to a total dose of approximately 33 U/kg) did not show adverse effects on postnatal growth (including skeletal) and development of reproductive, neurological and neurobehavioral functions.

Store in the refrigerator (between +2°C and +8°C).

Do not freeze.

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