NeuroBloc 5,000units1ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Botulinum toxin type B

Available from:

Eisai Ltd

ATC code:

M03AX01

INN (International Name):

Botulinum toxin type B

Dosage:

5000unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090300; GTIN: 5036330100665

Patient Information leaflet

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 into your lungs, which could then cause very
serious pneumonia
GE

Summary of Product characteristics

OBJECT 1
NEUROBLOC 5000 U/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 04-Apr-2018 | Eisai Ltd
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 po