SINTETICA BACLOFEN INTRATHECAL baclofen 10 mg/20 mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

baclofen, Quantity: 0.5 mg/mL

Available from:

Boucher & Muir Pty Ltd

INN (International Name):

Baclofen

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intrathecal

Units in package:

1 ampoule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SINTETICA BACLOFEN 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.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-03-10

Patient Information leaflet

SINTETICA BACLOFEN
INTRATHECAL
_INTRATHECAL INJECTION_
_Baclofen_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given Sintetica
Baclofen Intrathecal.
This leaflet answers some common
questions about Sintetica Baclofen
Intrathecal. It does not contain all the
available information. The most up-
to-date Consumer Medicine
Information can be downloaded from
www.ebs.tga.gov.au.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of giving you Sintetica
Baclofen Intrathecal against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT SINTETICA
BACLOFEN INTRATHECAL IS
USED FOR
Sintetica Baclofen 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.
Sintetica Baclofen Intrathecal
belongs to a group of medicines
called muscle relaxants. It contains
the active ingredient, baclofen, in a
solution for injection or infusion. 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 canal)
using a special pump. From the
pump, a constant amount of baclofen
goes into the space surrounding your
spinal cord through a tiny tube.
This medicine can be used for adults
and for children aged four years or
older.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
S

Summary of Product characteristics

SINTETICA BACLOFEN INTRATHECAL
1
AUSTRALIAN PRODUCT INFORMATION
SINTETICA BACLOFEN INTRATHECAL
BACLOFEN
SOLUTION FOR INTRATHECAL INJECTION
1
NAME OF THE MEDICINE
Baclofen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sintetica Baclofen Intrathecal contains 50 microgram baclofen per 1 mL
ampoule (50
microgram/mL), 10 mg baclofen per 20 mL ampoule (500 microgram/mL), 10
mg baclofen
per 5 mL ampoule (2 mg/mL) and 40 mg baclofen per 20 mL ampoule (2
mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sintetica Baclofen Intrathecal is a solution for intrathecal injection
and intrathecal infusion.
It is a clear, colourless solution.
Sintetica Baclofen Intrathecal does not contain preservatives.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sintetica Baclofen 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
Sintetica Baclofen Intrathecal 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
Sintetica Baclofen Intrathecal therapy until the symptoms of
spasticity are stable (i.e. at least
one year after the injury).
SINTETICA BACLOFEN INTRATHECAL
2
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 clos