NeuroBloc
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-05-2023
Charakterystyka produktu
(SPC)
04-05-2023
Sprawozdanie z oceny publicznego
(PAR)
04-05-2023
Składnik aktywny:
botulinum toxin type B
Dostępny od:
Sloan Pharma S.a.r.l
Kod ATC:
M03AX01
INN (International Nazwa):
botulinum toxin type B
Grupa terapeutyczna:
Muscle relaxants
Dziedzina terapeutyczna:
Torticollis
Wskazania:
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.
Podsumowanie produktu:
Revision: 33
Status autoryzacji:
Withdrawn
Data autoryzacji:
2001-01-22
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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