BACTHECAL baclofen 10 mg/20 mL intrathecal solution for injection ampoule

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

baclofen, Quantity: 10 mg

थमां उपलब्ध:

Medsurge Pharma Pty Ltd

INN (इंटरनेशनल नाम):

Baclofen

फार्मास्यूटिकल फॉर्म:

Injection, solution

रचना:

Excipient Ingredients: water for injections; sodium chloride

प्रशासन का मार्ग:

Intrathecal

पैकेज में यूनिट:

1 ampoule

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Visual Identification: Colourless, clear solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2015-08-07

सूचना पत्रक

CMI EDITION 4.0 OCTOBER 2020
1
BACTHECAL
_BACLOFEN _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Bacthecal. 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.
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
Bacthecal
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 BACTHECAL IS USED
FOR
Bacthecal 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.
Bacthecal
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 adults
and
for
children
aged
four
years
or
older.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY THIS
MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose.
This medi

उत्पाद विशेषताएं

BACTHECAL
PRODUCT INFORMATION
Edition 4.0 – October 2020
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
BACTHECAL
BACLOFEN (0.05MG/ML, 0.5MG/ML, 2MG/ML) SOLUTION FOR
INTRATHECAL INJECTION AMPOULE
1
NAME OF THE MEDICINE
Baclofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baclofen 0.05mg/1mL (0.05mg/mL)
Baclofen 10mg/20mL (0.5mg/mL)
Baclofen 10mg/5mL (2mg/mL)
It contains no preservatives.
For the full list of excipients, see _Section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Solution for intrathecal injection and intrathecal infusion.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
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).
BACTHECAL
PRODUCT INFORMATION
Edition 4.0 – October 2020
Page 2 of 25
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-titratio