NeuroBloc 5000 U/ml Solution for Injection
Botulinum Toxin Type B
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
- 1. What NeuroBloc is and what it is used for
- 2. Before you are given NeuroBloc
- 3. How you will be given NeuroBloc
- 4. Possible side effects
- 5. How to store NeuroBloc
- 6. Further Information
What Neurobloc Is And What It Is Used For
NeuroBloc is a toxin produced by bacteria called Clostridium botulinum.
NeuroBloc reduces the release of the ‘chemical messenger’, acetylcholine, which is made by nerves and tells your muscles to contract. If nerves are prevented from releasing this messenger, abnormal muscle contractions may be reduced or completely stopped.
NeuroBloc is used to treat cervical dystonia (torticollis). If you have cervical dystonia, you experience contractions of the neck and/or shoulder muscles that you cannot control.
Before You Are Given Neurobloc
You should not receive/be given NeuroBloc
- if you are allergic to any of the ingredients in this medicine
- if you suffer from a disease of the nerves or muscles especially one causing muscle weakness
- if you are pregnant or breast-feeding
In these cases, please tell your doctor.
Take special care with NeuroBloc and tell you doctor
- if you suffer from a bleeding disorder such as haemophilia
- when you are receiving medication such as warfarin, to prevent your blood clotting
- if you have lung problems
- if you have any difficulty swallowing before or after your NeuroBloc injection. Rarely severe swallowing problems can result in breathing food or liquids into your lungs and cause pneumonia which might be fatal.
NeuroBloc is not approved for use in children. You should not normally be given NeuroBloc if you are under 18 years old.
Taking other medicines
Please tell your doctor if you are taking antibiotics for an infection. If you are going to have an operation, please tell your doctor if you have been given NeuroBloc as it can interfere with medicines you may be given before a general anaesthetic.
Also inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Pregnancy and breast feeding
Generally, you should not be given NeuroBloc if you are pregnant or breast-feeding, this is because there is not enough information about the use of NeuroBloc in patients who are pregnant and it is not known if breast milk contains NeuroBloc in nursing mothers treated with the medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel tired, have any loss of sensation or blurred vision take care when driving or operating machinery.
Important information about some of the ingredients of NeuroBloc
The medicinal product contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc, i.e. essentially "sodium free".
How You Will Be Given Neurobloc
Your doctor will decide how much NeuroBloc to give you. The dose will usually be 10,000 Units, but it can be higher or lower, depending on your doctor’s decision and your response to any previous injections of NeuroBloc.
If you have the impression that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
NeuroBloc will be injected into your neck and/or shoulder muscles, depending on which ones are causing the problem. Your doctor will decide into which muscles to inject NeuroBloc and may inject part of the dose into different places in the muscles.
The effects of NeuroBloc will usually wear off after approximately 12 to 16 weeks. Your doctor will decide when you need another injection and how much to give you.
You can continue injections of NeuroBloc as long as it gives you relief from your symptoms.
If you are given more NeuroBloc than you need, some of your muscles that were not injected may feel weak. If this happens you should speak to your doctor immediately. Tell your doctor immediately if you have difficulty breathing. If he/she is unavailable seek emergency assistance.
If you forget to visit your doctor to receive your injection
The effects of NeuroBloc will gradually wear off and the abnormal muscle contractions may come back.
Possible Side Effects
Like all medicines, NeuroBloc can cause side effects, although not everybody gets them. You may feel pain at the place where you had the injection but this should wear off after a few minutes.
Effects may be seen in other areas than where you have received the injection and may occur days to weeks after injection. You may find that your mouth feels dry and/or that swallowing becomes difficult or experience a shortness of breath. In rare cases difficulty in swallowing may be severe and choking is possible. If you develop new or worsening swallowing difficulty, choking or breathing problems seek medical help immediately.
You may also notice one or more of the following effects after injection:
Very common reported side effects (likely to occur in more than 1 in 10 patients)
- dry mouth
- difficulty swallowing
- headache
Common reported side effects (likely to occur in fewer than 1 in 10 patients)
- weakness, pain or muscle stiffness around your body
- neck pain
- indigestion
- changes in the taste of your food and drink
- changes in the sound of your voice
- blurred vision
- drooping of the upper eyelid
- vomiting
- constipation
- flu-like symptoms
- loss of strength or energy
It is also possible that torticollis (turning of your head which you cannot control) could become worse after you have had your injection.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Neurobloc
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the container in the outer carton in order to protect from light.
For the purpose of ambulatory use, the product may be removed from the refrigerator for one single period of up to 3 months at a temperature not above 25°C without exceeding the expiry date. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
The date at which the product was taken out of the refrigerator should be mentioned on the outer carton.
Any unused solution should be discarded.
Due to the special nature of NeuroBloc, used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements.
Further Information
What NeuroBloc contains
- The active substance is Botulinum Toxin Type B. One ml contains 5000 U Botulinum Toxin Type B.
- The other ingredients are disodium succinate, sodium chloride, human serum albumin (containing sodium caprylate and sodium acetyltryptophanate as excipients), hydrochloric acid (for pH adjustment) and water for injections.
What NeuroBloc looks like and contents of the pack
NeuroBloc is a clear and colourless to pale yellow solution supplied in a glass vial that contains 0.5ml
(2500Units), 1.0ml (5000 Units) or 2.0ml (10,000 Units) of solution for injection.
Marketing Authorisation holder:
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
This leaflet was last approved in July 2009
No comments:
Post a Comment