Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
botulinum toxin type B
Sloan Pharma S.a.r.l
M03AX01
botulinum toxin type B
Muscle relaxants
Torticollis
NeuroBloc is indicated for the treatment of cervical dystonia (torticollis).See section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type A.
Revision: 33
Withdrawn
2001-01-22
28 B. PACKAGE LEAFLET Medicinal product no longer authorised 29 PACKAGE LEAFLET: INFORMATION FOR THE USER NEUROBLOC 5000 U/ML SOLUTION FOR INJECTION BOTULINUM TOXIN TYPE B READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NeuroBloc is and what it is used for 2. What you need to know before you use NeuroBloc 3. How to use NeuroBloc 4. Possible side effects 5. How to store NeuroBloc 6. Contents of the pack and other information 1. WHAT NEUROBLOC IS AND WHAT IT IS USED FOR NeuroBloc injection works by reducing or stopping muscle contractions. It contains the active ingredient ‘Botulinum Toxin Type B’. NeuroBloc is used to treat an illness called cervical dystonia (torticollis). This is where you have contractions of your neck or shoulder muscles that you cannot control. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEUROBLOC DO NOT USE NEUROBLOC: - if you are allergic to Botulinum Toxin Type B or any of the other ingredients of NeuroBloc (listed in section 6) - if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis (Lou Gehrig's disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain) - if you have been experiencing shortness of breath or difficulty swallowing You must not be given NeuroBloc if any of the above applies to you. If you are not sure talk to your doctor or pharmacist. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using NeuroBloc: - if you have a bleeding problem such as haemophilia - if you have lung problems - if you have difficulty swallowing. This is because swallowing problems could make you breathe food or liquids i Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT NeuroBloc 5000 U/ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 5000 U Botulinum Toxin Type B. Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B. Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B. Each 2.0 ml vial contains 10,000 U Botulinum Toxin Type B. Produced in _Clostridium botulinum_ Serotype B (Bean Strain) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless to light yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NeuroBloc is indicated for the treatment of cervical dystonia (torticollis) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins. Restricted to hospital use only. Posology The initial dose is 10,000 U and should be divided between the two to four most affected muscles. Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit. Injections should be repeated as required to maintain good function and minimise pain. In long term clinical studies, the average dosing frequency was approximately every 12 weeks, however this may vary between subjects, and a proportion of patients maintained a significant improvement relative to baseline for 16 weeks or longer. The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient. For patients with reduced muscle mass the dose should be adjusted according to individual patient need. The potency of this medicinal product i Læs hele dokumentet