Dysport is a muscle relaxant produced by Clostridium botulinum bacteria. It acts on the junctions between the nerves and muscles, preventing the release of one of the chemical messengers called acetylcholine from the nerve endings that would normally cause the muscle to contract. If the messenger is prevented from being released this results in a weakened muscle and helps to reduce some of the abnormal muscle contractions.

Dysport is used for the treatment of

Your doctor may have prescribed it for another reason. Ask your doctor if you have any questions why Dysport has been prescribed for you.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without prescription from your pharmacy, supermarket or health food shop.

Some medicines can interfere with the way Dysport works such as

These drugs must be used with caution if you are receiving Dysport. Your doctor will advise you accordingly.

Dysport contains a small amount of albumin that has been obtained from human blood. The risk of a viral infection cannot be eliminated completely when using human blood or products made from human blood.

Dysport should not be used in children except for the treatment of cerebral palsy. It is not recommended for the treatment of cerebral palsy in children under 2 years of age.

Use of Dysport is not recommended for the treatment of moderate to severe glabellar lines in patients under the age of 18.

A reduced dose may be appropriate in elderly patients where reduced muscle mass may exist.

Your doctor will advise you regarding the use of Dysport in pregnancy.

Use of Dysport during breastfeeding is not recommended.

Local weakness can be expected and there is a possibility of unexpected side effects such as generalized weakness. These effects can affect the ability to drive and use machines.

Your doctor will make up and give you the injection. For the injection, Dysport will be dissolved in 0.9% sodium chloride injection.

Your doctor will decide where to make the injections and for how long you need treatment. You will be given injections of your medicine in a clinic that specialises in treating your condition. The doctor who injects your medicine will have received training and be experienced in giving Dysport injections.

If you have arm spasticity post-stroke, your first dose of Dysport will be 500 -1000 units in total. The doctor will give a number of injections into each of up to five affected muscles in your arm. Injections will be given approximately every 16 weeks, or as required to maintain the response, but not more frequently than every 12 weeks. The maximum dose must not exceed 1000 units.

If you have spasmodic torticollis, your first dose of Dysport will be 250 - 500 units in total. Your doctor will give injections into a number of places in your neck, probably into the 2 or 3 of the neck muscles most affected by the condition. Your doctor will decide how much to give and which muscles to inject. You will be given injections approximately every 12 weeks depending on how long before the relaxing effect on the muscle wears off. The maximum dose must not exceed 1000 units.

If you are being treated for paediatric cerebral palsy, your first dose of Dysport will be 20 units /kg. The doctor will divide the amount between both calf muscles. If only one calf is affected by spasticity, the doctor will only give injections of 10 units /kg in this calf. Injections will be given approximately every 16 weeks, or as required to maintain the response, but not more frequently than every 12 weeks.

If you are being treated for blepharospasm affecting both eyes, your first dose will be approximately 40 units of Dysport per eye. The medicine will be injected just under the skin at certain sites around the eye. These sites and the exact amount needed will be decided by the doctor. Injections will be given approximately every twelve weeks when the relaxing effect on the muscles is wearing off. On the next visits the amount of Dysport given may be increased to 60, 80 or 120 units per eye if a longer duration of effect is required. The doctor will decide what dose to administer. If only one eye is affected by blepharospasm, the doctor will only give injections of Dysport around this eye.

If you are being treated for hemifacial spasm the doctor will give injections as for blepharospasm but on the affected side of your face only.

If you are being treated for glabellar lines, the recommended dose of Dysport is 50 units to be divided equally among 5 injection sites. Injection sessions may be repeated every 16 weeks. A 3 months minimum interval between 2 injection sessions is required.

Your doctor will decide when you will need your next injection and how much of the medicine will be injected.

Nothing will happen if you miss a scheduled appointment for your injection other than some of the spasm or muscle stiffness may return. Consult your doctor and he will decide when you need your next injection.

The relaxing effect will eventually wear off and the muscle movements will return to the way they were before treatment.

As it is given to you by your doctor who has received training on administration of Dysport, it is very unlikely that you will receive an overdose. However, if you are given too much Dysport, there is an increased risk of the medicine getting into the bloodstream and causing complications associated with oral botulinum poisoning. Paralysis of your muscles may occur and you may be placed on a respirator and other support systems if it affects your breathing. Contact the Poisons Information centre on 131126 if you believe you may have been given too much Dysport.

Along with its desired effects Dysport may cause unwanted effects because of a weakening of muscles near the injected muscle.

 

The most common side effects are:

Less commonly Dysport may cause itching.

Rarely skin rashes, including rashes at the injection site, and muscle weakness may be experienced.

 

The most common side effects include:

Rare side effects include: severe pain in the affected arm and a night time cough getting worse.

 

The most common side effects include:

Less common side effects are:

Rarely Dysport may cause breathing difficulties. These side effects may be expected to resolve within 2 to 4 weeks.

The most common side effects are:

Less commonly sleepiness has been reported.

 

The most common side effects include:

Less commonly the facial nerves may become paralysed. Rarely the edge of the eyelid may turn in towards the eyeball and the eye muscles may become paralysed, there may be a need to avoid bright lights.

Headache and injection site reactions are very common, including pain, bruising, itchiness, a feeling of pins and needles, redness and skin rash.

Common side effects include

Less common side effects include blurred or double vision, visual disturbances or disorders in eye movement.

Side effects resulting from distribution of the effects of Dysport to areas away from the site of injection have been reported (excessive muscle weakness, difficulty swallowing or pneumonia which in very rare cases may have been fatal). Hypersensitivity to Dysport has been reported occasionally.

Your medicine will be stored in a refrigerator (2°C - 8°C - do not freeze) at the clinic where the injections are carried out. It should not be used after the date marked on the label (expiry date).

It contains no antimicrobial agent. The product is for the treatment of one patient only on one occasion. Any remaining contents should be discarded appropriately by the clinic.

Each pack contains 1 vial of Dysport. Each vial contains a small pellet of white powder that must be mixed with sterile sodium chloride solution before injection.

Each vial of Dysport 300U contains 300 IPSEN units of Clostridium botulinum type A toxin-haemagglutinin complex as the active ingredient.

Each vial of Dysport 500U contains 500 IPSEN units of Clostridium botulinum type A toxin-haemagglutinin complex as the active ingredient.

These IPSEN units apply to Dysport only and are not the same for other medicines containing botulinum toxin. Dysport 300U and 500U both contain albumin and lactose.

If you have any further questions on your Dysport treatment, or are unsure of the information, please see your doctor, who will be able to assist you.