Dysport

/ Medison

Arm spasticity: The recommended dose is 1000 units in total, distributed amongst the following five muscles:
The sites of injection should be guided by standard locations used for electromyography, although actual location of the injection site will be determined by palpation. All muscles except the biceps brachii (BB) should be injected at one site, whilst the biceps should be injected at two sites. The maximum dose administered must not exceed 1000 units. The starting dose should be lowered if there is evidence to suggest that this dose may result in excessive weakness of the target muscles, such as for patients whose target muscles are small, where the BB muscle is not to be injected or for patients who require concomitant injections into other muscle groups. Injections may be repeated approximately every 16 weeks, or as required to maintain a response, but not more frequently than every 12 weeks.
Children: The safety and effectiveness of the product in the treatment of post- stroke arm spasticity in children have not been demonstrated.
Paediatric cerebral palsy spasticity: The initial recommended dose is 20 units/kg body weight given as a divided dose between both calf muscles. If only one calf is affected, a dose of 10 units/kg body weight should be used. The maximum dose administered must not exceed 30 units/kg or 1000 units, whichever is the lower. The use of electromyography (EMG) is not routine clinical practice but may assist in identifying the most active muscles.Clinical improvement may be expected within two weeks after injection. Injections may be repeated approximately every 16 weeks or as required to maintain response, but not more frequently than every 12 weeks. Consideration should be given to lowering this starting dose if there is evidence to suggest that this dose may result in excessive weakness of the target muscles, such as for patients whose target muscles are small or patients who require concomitant injections to other muscle groups. Following evaluation of response to the starting dose subsequent treatment may be titrated within the range 10 units/kg and 30 units/kg divided between both legs. Administration should primarily be targeted to the gastrocnemius, although injections of the soleus and injection of the tibialis posterior should also be considered.
For full details see prescribing information.

Treatment of dynamic equinus foot deformity due to spasticity in ambulant pediatric cerebral palsy patients, 2 years of age or older; spasmodic torticollis in adults; blepharospasm in adults; hemifacial spasm in adults; treatment of spasticity of the arm post-stroke; axillary hyperhydrosis; treatment of moderate to severe glabellar lines.

Pregnancy. Hypersensitivity to any constituent of the formulation. Generalized disorders of muscle activity such as myasthenia gravis, when aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used, in the presence of infection at injection site.

The recommended dosages and frequencies of administration should not be exceeded. Physicians should be familiar with electromyographic technique when injecting Botox for the treatment of strabismus. During administration for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred from needle penetration into the orbit. Reduced blinking following the injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulceration. Botox is a treatment of focal spasticity that has only been studied in association with usual standard of care regimens, and is not intended as a replacement for these treatment modalities.

Localized pain, tenderness and/or bruising, local weakness represents the expected pharmacological action of botulinum toxin. Excessive doses may cause paralysis in muscles distant to the injection site. In the treatment of blepharospasm, the most commonly reported side effects are ptosis, tearing and irritation. Ecchymosis occurs easily in soft eyelid tissues. Diffuse skin rash and local swelling of the eyelid skin, reduced blinking. In the treatment of hemifacial spasm: Blurring of vision, facial droop, dizziness, and tiredness. In the treatment of spasmodic torticollis: Dysphagia, pain and soreness at the injection site, local weakness and symptomatic general weakness/malaise. In strabismus treatment: Spatial disorientation, double vision, or past-pointing. Extraocular muscles adjacent to injection site are often affected, causing ptosis or verticle deviation.
For full details see prescribing information.

The effects of botulinum toxin may be potentiated by drugs interfering either directly or indirectly with neuromuscular function (e.g. aminoglycosides, curare-like non-depolarising blockers) and such drugs should be used with caution in patients treated with botulinum toxin.

Pregnancy: There are limited data from the use of Clostridium botulinum type A toxin-haemagglutinin complex in pregnant women. Studies in animals have shown reproductive toxicity at high doses causing maternal toxicity. Dysport should be used during pregnancy only if the benefit justifies any potential risk to the fœtus. Caution should be exercised when prescribing to pregnant women.
Lactation: It is not known whether Clostridium botulinum type A toxin-haemagglutinin complex is excreted in human milk. The excretion of Clostridium botulinum type A toxinhaemagglutinin complex in milk has not been studied in animals. The use of Clostridium botulinum type A toxin-haemagglutinin complex during lactation cannot be recommended.

Excessive doses may produce distant and profound neuromuscular paralysis. Overdose could lead to an increased risk of the neurotoxin entering the bloodstream and may cause complications associated with the effects of oral botulinum poisoning (e.g. dysphagia and dysphonia). Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. There is no specific antidote; antitoxin should not be expected to be beneficial and general supportive care is advised. In the event of overdose the patient should be medically monitored for any signs and/or symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment should be instigated if necessary. Symptoms of overdose may not present immediately following injection. Should accidental injection or oral ingestion occur, the patient should be medically supervised for several weeks for signs and/or symptoms of excessive muscle weakness or muscle paralysis.