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What you need to know before you are given Botulinum Toxin Type A Do not use Botulinum Toxin Type A: If you are allergic to botulinum toxin type A or any of the other ingredients of this medicine listed in section 6.
Warnings and precautions: There are increased risks of having Botulinum Toxin Type A injections under any of these circumstances. Children and adolescents: For the treatment of spasticity associated with cerebral palsy in children, Botulinum Toxin Type A should only be used in children 2 years of age or over. Botulinum Toxin Type A is not indicated, for the treatment of glabellar lines and lateral canthal lines, in patients under the age of 18 years.
Other medicines and Botulinum Toxin Type A: Please tell your doctor if you are taking any antibiotics for an infection e. Some of these medicines may increase the effect of Botulinum Toxin Type A. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility: Botulinum Toxin Type A is not recommended during pregnancy, unless clearly necessary.
Page 2 of 9 Botulinum Toxin Type A is not recommended in breast-feeding women. Botulinum Toxin Type A may affect fertility, when given at high doses. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines: Botulinum Toxin Type A may cause muscle weakness or problems with your vision. If you experience any of these effects, do not drive or use any machines. How Botulinum Toxin Type A is given Your doctor will choose your dose of medicine and decide how often you need treatment. This will depend on what you are being treated for.
A vial of Botulinum Toxin Type A should be used only for you and only for a single treatment session. For treatment of muscle spasms in your arm and shoulder: The dose of Botulinum Toxin Type A will usually be between and units divided between the affected arm and shoulder muscles. Your muscle spasms should normally improve within 1 week. Injections will usually be given about every 12 to 16 weeks.
For treatment of muscle spasms in your leg: The dose of Botulinum Toxin Type A will usually be units and should not exceed this dose. The doctor may divide the amount between the affected leg muscles. For treatment of muscle spasms in your arm and leg: If you need to receive injections in your arm and leg in the same treatment session, your doctor may divide the dose between your arm and leg in line with the approved dose recommendations, but the overall dose must not exceed units.
For treatment of muscle spasms in your neck: The first dose of Botulinum Toxin Type A will usually be units divided into a number of places in the neck, probably into 2 or 3 of the neck muscles most affected by the condition. A smaller amount may be given to very underweight or elderly patients.
Your muscle spasms should improve within 1 week. Further injections - units will be given about every 16 weeks depending on how long the effect lasts or as required to maintain a response, but not more frequently than every 12 weeks. The maximum dose should not exceed units.
For treatment of muscle spasm around your eyes: The first injection will usually be 40 units per eye. The medicine will be injected just under the skin at various sites around the eye. If only one eye is affected, the doctor will only give injections of Botulinum Toxin Type A around this eye. Injections will be given about every 12 weeks depending on how long the effects last.
On the next visits, the amount of Botulinum Toxin Type A given may be increased to a maximum of units per eye. Page 3 of 9 For treatment of muscle spasm in your face: The doctor will give you injections on the side of your face that is affected. The first injection will usually be units. Your next injections of Botulinum Toxin Type A may be reduced to 80 or 60 units.
For treatment of muscle spasms in the legs of children with cerebral palsy: Children over 2 years: The dose is decided by your doctor. Botulinum Toxin Type A is injected into the affected muscles of the legs. Your doctor will repeat the treatment approximately every 16 - 22 weeks or as needed, but no more frequently than every 12 weeks.
Your doctor will prepare and give the injections. The units used for different botulinum toxin products are not the same. Botulinum Toxin Type A units are not interchangeable with other botulinum toxin products. The effect of the treatment should be noticeable within a few days after injection.
The interval between treatments with Botulinum Toxin Type A will be decided by your doctor. You should not have treatment more often than every 12 weeks. For treatment of excessive sweating of your armpits: The first dose will usually be units per armpit.
The doctor may divide this amount between the affected areas. Your symptoms should usually improve within 2 weeks and the effect can last for up to approximately 48 weeks. The amount of the next dose your doctor gives you, and when you will be given a further injection will depend on how you respond.
The minimum time between treatments is 12 weeks. The maximum dose you should be given is units per armpit. If you are given more Botulinum Toxin Type A than you need If you are given more Botulinum Toxin Type A than you need, muscles other than the ones that were injected may begin to feel weak.
This may not happen straight away. If this does happen, speak to your doctor immediately. Seek urgent medical help if you have difficulty breathing, swallowing or speaking. If you forget an injection of Botulinum Toxin Type A Nothing will happen if an injection is missed other than some of the spasm or muscle stiffness may return. Tell your doctor and he will decide when the next injection is needed.
If you stop taking Botulinum Toxin Type A Your muscle spasms will return to the way they were before treatment. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Botulinum Toxin Type A may in rare cases cause side effects away from its site of injection.
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