Baclofen Injection

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Baclofen 0.5 mg/mL

Disponible desde:

Medsurge Pharma Limited

Dosis:

10 mg/20mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Baclofen 0.5 mg/mL Excipient: Sodium chloride Water for injection

tipo de receta:

Prescription

indicaciones terapéuticas:

Indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, 20 mL Type 1 clear in outer cardboard carton - 1 dose units - 60 months from date of manufacture stored at or below 25°C. Do not freeze

Fecha de autorización:

2016-02-16

Información para el usuario

_MEDSURGE BACLOFEN INJECTION_ CMI NZ V2.0 (JANUARY 2022)
1
BACLOFEN INJECTION
_BACLOFEN SOLUTION FOR INTRATHECAL INJECTION _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Baclofen Injection. It
does
not
contain
all
the
available
information. It does not take the place of
talking to your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP-TO-DATE INFORMATION ON
THE MEDICINE. YOU CAN ALSO DOWNLOAD
THE
MOST
UP-TO-DATE
LEAFLET
FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you having Baclofen Injection against
the benefits they expect it will give you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again
WHAT BACLOFEN INJECTION
IS USED FOR
Baclofen Injection is used to reduce
tension in your muscles which causes
spasms.
These
spasms
happen
in
various
illnesses
such
as
multiple
sclerosis,
cerebral
palsy
and
other
diseases or injuries of the spinal cord or
brain.
Because this medicine reduces spasms
and the pain that goes with them, it
helps to make you more mobile. This
helps
you
to
manage
your
daily
activities
and
makes
physiotherapy
easier.
Baclofen Injection belongs to a group of
medicines called muscle relaxants. It
contains the active ingredient, baclofen,
in the form of an ampoule for injection.
It is used when medicines taken by
mouth do not work well enough or when
they cause too many side effects.
The solution in the ampoule is injected
into your back (spinal cord) using a
special
pump.
From
the
pump,
a
constant amount of baclofen goes into
your spinal cord through a tiny tube.
This medicine can be used for ad

Ficha técnica

BACLOFEN INJECTION
NEW ZEALAND DATA SHEET
Edition 3.0 (January 2022)
Page 1 of 21
BACLOFEN INJECTION
1 PRODUCT NAME
Baclofen Injection 0.05mg/1mL, solution for injection
Baclofen Injection 10mg/5mL, solution for injection
Baclofen Injection 10mg/20mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Baclofen 0.05mg/1mL (0.05mg/mL)
Baclofen 10mg/20mL (0.5mg/mL)
Baclofen 10mg/5mL (2mg/mL)
For the full list of excipients, see section _6.1 List of excipients_.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Baclofen solution for intrathecal Injection is indicated in patients
with severe chronic
spasticity
of spinal origin (associated with injury, multiple sclerosis, or other
spinal cord diseases) or of cerebral
origin who are unresponsive to orally administered antispastics
(including oral baclofen) and/or
who experience unacceptable side effects at effective
oral doses.
4.2
Dose and method of administration
Method of administration
Intrathecal administration of baclofen through an implanted delivery
system should
only
be
undertaken
by
physicians
with
the
necessary
knowledge
and
experience.
Specific instructions
for
implanting,
programming
and/or
refilling
the
implantable
pump are given by the pump
manufacturers, and must be strictly adhered to.
Dose
Baclofen solution for intrathecal Injection is intended for
administration in single bolus
test doses
(via spinal catheter or lumbar puncture) and, for chronic use, in
implantable
pumps suitable for
continuous administration of baclofen solution into the intrathecal
space.
For patients with spasticity due to head injury, it is recommended not
to proceed to long-term
Baclofen solution for intrathecal Injection therapy until the symptoms
of spasticity
are stable (i.e.
at least one year after the injury).
Establishment of the optimum dose schedule requires that each patient
undergoes an
initial
screening phase with test doses by intrathecal bolus, followed by a
very careful
individ