Prescribing Information

DYSPORT^® Powder for solution for injection (Clostridium botulinum type A toxin-haemagglutinin complex) 300 or 500 units

Prescribers should consult the Summary of Product Characteristics (SmPC) accessible at https://www.medicines.ie/ before treatment, to obtain more comprehensive information about Dysport. Presentation: Vials of 300 or 500 units (U) of Clostridium botulinum type A toxin-haemagglutinin complex. Powder for solution for injection. Indications: Symptomatic treatment of focal spasticity of: Upper limbs in adults, Lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (TBI), and dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients as well as focal spasticity affecting the upper limbs in paediatric cerebral palsy patients, ≥ 2 years. Symptomatic treatment of: Spasmodic torticollis, Blepharospasm, Hemifacial spasm and Severe primary hyperhidrosis of the axillae, which does not respond to topical treatment with antiperspirants or antihidrotics. Dysport is also indicated for the management of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who are regularly performing clean intermittent catheterisation. Administration: Dysport should only be administered by appropriately trained physicians. Reconstitute in sodium chloride injection B.P. (0.9 % w/v) to yield a concentration as follows: Adult and Paediatric Upper or Lower Limb spasticity: 100/200/500 units per ml; For spasticity in paediatric cerebral palsy patients, which is dosed using unit per body weight, further dilution may be required to achieve the final volume for injection. Blepharospasm, Hemifacial spasm and Axillary hyperhidrosis: 200 units per ml; Spasmodic torticollis: 500 units per ml. For further instruction on reconstitution see SmPC. The units (U) of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. Posology: Adult Upper and/or Lower Limb spasticity: Dosing in initial and sequential treatment sessions should be tailored to the individual. No more than 1 ml should generally be administered at any single injection site. Use of injection guiding techniques is recommended to target the injection sites. Injections may be repeated every 12-16 weeks or as required to maintain response, but not more frequently than every 12 weeks. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose and muscles to be injected. If treating both upper and lower limbs during the same treatment session, the total dose must not exceed 1500U. Upper Limb: In clinical trials, intramuscular (IM) injections of 500U, 1000U and 1500U doses were divided among selected muscles at a given treatment session (see SmPC). Clinical improvement may be expected 1 week after injection and may last up to 20 weeks. Lower Limb: In clinical trials, IM injections of 1000U and 1500U doses were divided among selected muscles (see SmPC). Total dose must not exceed 1500U. Dynamic equinus foot deformity due to focal spasticity in ambulant paediatric cerebral palsy patients: Dosing in initial and sequential treatment sessions should be tailored to the individual. Use of injection guiding techniques is recommended to target the injection sites. For treatment initiation, consideration should be given to start with a lower dose. Total dose should be divided between the affected spastic muscles of the lower limb(s). If possible, the dose should be distributed across more than 1 injection site in any single muscle. No more than 0.5 ml should be administered in any single injection site (see SmPC for recommended dosing). Max. total dose for unilateral lower limb injections must not exceed 15 U/kg or 30 U/kg for bilateral injections, per treatment session. In addition, total dose per treatment session must not exceed 30 U/kg or 1000 U, whichever is the lower. Clinical improvement may be expected within 2 weeks after injection. Repeat treatment should be administered when effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection. A majority of patients in clinical studies were retreated between 16-22 weeks; however, some patients had a longer duration of response, i.e. 28weeks. Focal spasticity of upper limbs in paediatric cerebral palsy patients: The maximum dose of Dysport administered per treatment session when injecting unilaterally must not exceed 16 U/kg or 640 U whichever is lower. When injecting bilaterally, the maximum Dysport dose per treatment session must not exceed 21 U/kg or 840 U, whichever is lower. The total dose administered should be divided between the affected spastic muscles of the upper limb(s). No more than 0.5 ml of Dysport should be administered in any single injection site (please see SmPC for full details). Focal spasticity of dynamic foot deformity and upper limbs in paediatric cerebral palsy patients: The dose of Dysport to be injected for concomitant treatment should not exceed a total dose per treatment session of 30 U/kg or 1000 U, whichever is lower (please see SmPC for full details). Spasmodic torticollis: The initial recommended dose is 500U IM as a divided dose into the 2 or 3 most active neck muscles. The split amongst muscles will vary according to the type of torticollis diagnosed (see SmPC). A lower dose may be appropriate if the patient is markedly underweight or in the elderly, where a reduced muscle mass may exist. Subsequent doses may be adjusted according to clinical response and side-effects observed. Doses within the range of 250 – 1000 units are recommended, although the higher doses may be accompanied by increase in side effects, particularly dysphagia (see ‘Side effects’). Relief of symptoms may be expected within 1 week after injection. Injections may be repeated approx. every 16 weeks, but not more frequently than every 12 weeks. Children: The safety and effectiveness of Dysport in the treatment of spasmodic torticollis in children has not been demonstrated. Blepharospasm and hemifacial spasm: The initial recommended dose is 40U per affected eye. Subsequently, if the response is insufficient from the initial treatment, the dose may be increased to 60U, 80U or up to 120U/eye. Max. dose must not exceed 120U/eye. Injections are given subcutaneously, medially and laterally into the junction between the preseptal and orbital parts of both the upper and lower orbicularis oculi muscles of each eye. Relief may be expected within 2-4 days with maximal effect within 2 weeks. Injections should be repeated as required to prevent recurrence of symptoms, but not more frequently than every 12 weeks. Children: The safety and effectiveness of Dysport in the treatment of blepharospasm and hemifacial spasm in children has not been demonstrated. Axillary hyperhidrosis: Initial recommended dose is 100U/axilla. Max. dose should not exceed 200U/axilla. Intradermal injections to be given at 10 sites i.e. to deliver 10U per site to equal 100U/axilla. Max. effect should be seen after 2 weeks. Injections should not be repeated more frequently than every 12 weeks. Urinary incontinence due to neurogenic detrusor overactivity (NDO): Recommended dose is 600 U but can be increased to 800 U in case of insufficient response, such as in patients with a severe disease presentation. Should be administered to patients who are regularly performing clean intermittent catheterisation. Total dose should be divided across 30 intradetrusor injections evenly distributed throughout the detrusor muscle, avoiding the trigone. Dysport is injected via a flexible or rigid cystoscope and each injection should be to a depth of approximately 2 mm with the delivery of 0.5 ml to each site. For the final injection, approximately 0.5 ml of sterile normal saline should be injected to ensure the full dose is delivered. Contraindications (See SmPC for full dosing information): Known hypersensitivity to any component of Dysport. Urinary tract infection at the time of treatment for the management of urinary incontinence due to neurogenic detrusor overactivity. Warnings and precautions: Side effects related to the spread of toxin, distant from the injection site, have been reported (see ‘Undesirable effects). Patients treated with therapeutic doses may present with excessive muscle weakness. The risk of occurrence of such side effects may be reduced by using the lowest effective possible dose and by not exceeding the maximum recommended dose. Exercise caution, with close medical supervision, in patients with subclinical/clinical evidence of marked defective neuromuscular transmission (e.g. myasthenia gravis), where excessive muscle weakness may occur, with therapeutic doses of Dysport. Patients with underlying neurological disorders are at increased risk of this side effect. Exercise caution when treating lower limb spasticity in adults especially in elderly patients, who may be at increased risk of fall. 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. Administer with caution to patients with pre-existing swallowing/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. Not to be used to treat spasticity in patients who have developed a fixed contracture. Careful consideration should be given before the injection of patients with a history of allergic reaction to a product containing botulinum toxin type A or in patients with prolonged bleeding times, infection/inflammation at the proposed injection site(s). Antibody formation to botulinum toxin has been noted rarely in patients receiving Dysport. Clinically, neutralising antibodies might be suspected by substantial deterioration in response to therapy and/or the need for consistent use of increased doses. Dysport should only be used to treat a single patient during a single session. Interactions: Drugs affecting neuromuscular transmission may potentiate the effect of botulinum toxin and should be used with caution. Fertility, pregnancy and lactation: Safety in pregnancy has not been demonstrated and Dysport should be used only if the benefit justifies any potential risk to the foetus. Exercise caution when prescribing to pregnant women. Use during lactation cannot be recommended. Studies in male and female rats have shown effects on fertility (see SmPC). Effects on ability to drive and use machines: May impair the ability to drive or operate machinery in case of adverse reactions such as muscle weakness and eye disorders. Undesirable effects: Undesirable effects related to spread of toxin distant from the injection site have been reported, such as dry mouth, excessive muscle weakness, dysphagia, aspiration/aspiration pneumonia, with fatal outcome (death) in some very rare cases. Hypersensitivity reactions have also been reported post-marketing. In general, the following ADRs (Adverse drug reactions) were reported in clinical trials, across all indications: Common: asthenia, fatigue, influenza like illness, injection site reactions. ADRs vary across the indications. Adult Upper Limb spasticity: Common: muscular weakness, musculoskeletal pain, pain in the extremity. Adult Lower Limb spasticity: Common: dysphagia, muscular weakness, myalgia, asthenia, fatigue, influenza-like illness, injection site reactions (pain, bruising, rash, pruritus), fall. When treating combined upper and lower spasticity in children aged 2 years or older refer to the posology section of the SmPC for the individual indication. The dose of Dysport to be injected for concomitant treatment should not exceed a total dose per treatment session of 30 U/kg or 1000 U, whichever is lower. Focal spasticity in paediatric cerebral palsy patients, two years of age or older: Dynamic equinus foot deformity due to focal spasticity: Common: myalgia, muscular weakness, urinary incontinence, influenza-like illness, injection site reaction (e.g. pain, erythema, bruising etc.), gait disturbance, fatigue, fall. Upper limbs in paediatric cerebral palsy patients: Common: Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Skin and subcutaneous tissue disorders. Adverse reactions: Muscular weakness, myalgia, Influenza-like illness, fatigue, injection site reactions (eczema, bruising, pain, swelling, rash), Asthenia, Rash. Spasmodic torticollis: Very common: dysphagia, dry mouth, muscle weakness; Common: dysphonia, dyspnoea, headache, dizziness, facial paresis, vision blurred, visual acuity reduced, neck pain, musculoskeletal pain or stiffness, myalgia, pain in extremity. Dysphagia appeared to be dose related and occurred most frequently following injection into the sternomastoid muscle. A soft diet may be required until symptoms resolve. Blepharospasm and hemifacial spasm: Very common: ptosis; Common: facial paresis, diplopia, dry eye, lacrimation increased, eyelid oedema. Axillary hyperhidrosis: Common: compensatory sweating. See SmPC for full side-effect profile including uncommon and rare events for each indication. Adverse Drug Reactions: Urinary tract infection, Bacteriuria, Headache, Hypoaesthesia, Constipation, Muscle weakness, Haematuria, Urinary retention, Urethral haemorrhage, Bladder haemorrhage, Erectile dysfunction, Pyrexia, Bladder pain, Autonomic dysreflexia. Overdose: Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. Patients should be monitored for several weeks for symptoms of systemic weakness or muscle paralysis. Pharmaceutical precautions: Unopened vials: Can be used following a single exposure to temperatures up to 25°C for up to 72 hours. Store at 2°C – 8°C. Do not freeze. Reconstituted solution: may be stored at 2°C – 8°C for up to 24 hours prior to use. Refer to the SmPC for further details on the reconstituted solution. Marketing authorisation numbers: 300U: PA 1613/002/002; 500U: PA 1613/002/001. MA Holder: Ipsen Pharma 70 rue Balard 75015 Paris France. Further information is available on request from: Ipsen Pharmaceuticals Limited, Blanchardstown Industrial Park, Blanchardstown, Dublin 15, Ireland. Tel: +353 1 809 8256. Dysport^® is a registered trademark.

Date of PI preparation: May 2026. Ref. DYS-IE-001019