Lioresal Intrathecal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Baclofen 2 mg/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Baclofen 2 mg/mL

Dosage:

10 mg/5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Baclofen 2 mg/mL Excipient: Nitrogen Sodium chloride Water for injection

Units in package:

Ampoule, glass, Colourless type I glass ampoule, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Polpharma Pharmaceuticals Works SA

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Colourless type I glass ampoule - 5 mL - 3 years from date of manufacture stored at or below 30°C

Authorization date:

2008-04-24

Patient Information leaflet

__________________________________________________________________________________________________
Lioresal

Intrathecal
1
LIORESAL
 INTRATHECAL
_Baclofen 0.05 mg/1 mL Solution for Intrathecal Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lioresal Intrathecal.
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 Lioresal
Intrathecal 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 LIORESAL
INTRATHECAL IS USED FOR
Lioresal Intrathecal 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.
Lioresal Intrathecal 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, around
yourspinal cord. This medicine can
be used for adults and for children
a

Summary of Product characteristics

NEW ZEALAND DATA SHEET
LIORESAL
®
INTRATHECAL Solution for injection
Page 1 of 16
LIORESAL
® INTRATHECAL
BACLOFEN
0.05MG/1ML SOLUTION FOR INTRATHECAL INJECTION
1. PRODUCT NAME
Lioresal
®
Intrathecal 0.05 mg/mL solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lioresal Intrathecal is a solution for intrathecal injection. It
contains no preservatives.
One ampoule of 1 mL contains 0.05 mg baclofen (0.05 mg/mL).
3. PHARMACEUTICAL FORM
Lioresal ampoules containing 0.05 mg/mL are available for
administering low-dose bolus
injections during the screening phase.
Lioresal Intrathecal contains no preservatives.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lioresal Intrathecal 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
DOSAGE
Lioresal Intrathecal is intended for administration in single bolus
test doses (via spinal catheter
or lumbar puncture).
For patients with spasticity due to head injury, it is recommended not
to proceed to long-term
Lioresal Intrathecal 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 individual dose
titration prior to maintenance therapy. This is due to the great
variability in the effective
individual therapeutic dose.
Patients must be monitored closely in a fully equipped and staffed
environment during the
screening phase and dose-titration period. Resuscitative equipment
should be available for
immediate use in case of life-threatening or intolerable adverse
reactions.
SCREENING PHASE
Prior to initiation of chronic infusion of intrathecal bac