Baclofen Intrathecal Sintetica 0.5mg/ml Solution Injectable

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BACLOFEN

Available from:

Intega Sdn. Bhd.

INN (International Name):

BACLOFEN

Units in package:

20 ml x 1 Ampoules

Manufactured by:

Sintetica S.A.

Summary of Product characteristics

COMPOSITION
_BACLOFEN INTRATHECAL SINTETICA 0.05MG/ML SOLUTION INJECTABLE_:
1 ml of solution for injection contains 0.05 mg Baclofen.
1 ampoule of 1 ml contains 0.05 mg Baclofen.
_BACLOFEN INTRATHECAL SINTETICA 0.5MG/ML SOLUTION INJECTABLE_:
1 ml of solution for infusion contains 0.5 mg Baclofen.
1 ampoule of 20 ml contains 10 mg Baclofen.
_BACLOFEN INTRATHECAL SINTETICA 2MG/ML SOLUTION INJECTABLE: _
1 ml of solution for infusion contains 2 mg Baclofen.
1 ampoule of 5 ml contains 10 mg Baclofen.
1 ampoule of 20 ml contains 40 mg Baclofen._ _
DESCRIPTION
Solution for injection/infusion.
Clear and colourless solution in ampoules.
PHARMACODYNAMICS
Mechanism of action
Baclofen slows down mono- and polysynaptic reflex transmission in the
spinal
cord, by stimulating GABA
B
receptors.
_ _
Pharmacodynamics effects
The
chemical
structure
of
baclofen
is
analogous
to
that
of
gamma-
aminobutyric
acid
(GABA),
which
is
a
neurotransmitter
inhibitor.
Neuromuscular
transmission
is
not
altered
by
baclofen.
Baclofen
has
an
antinociceptive
action.
In
neurological
diseases
accompanied
by
musculoskeletal spasms, the properties of baclofen manifest not only
in the
form of an effect on reflex muscle contractions, but also as a marked
reduction
in the intensity of painful spasms and clonus.
_ _
Clinical efficacy and safety
Baclofen improves patient mobility, providing them with greater
autonomy,
and facilitates physiotherapy. Baclofen depresses the CNS in general,
causing
sedation, somnolence, as well as respiratory and cardiovascular
depression.
Baclofen Intrathecal Sintetica can be regarded as an alternative to
destructive
neurosurgical procedures. Baclofen, introduced directly into the
intrathecal
space, allows treatment of spasticity at doses at least 400 to 1,000
times lower
than they would be via the oral route.
_ _
Intrathecal bolus
The medicinal product usually starts to act half an hour to one hour
after
administration
of
a
single
intrathecal
dose.
The
peak
spasmolytic
effect
manifests around 4 hours post-dose and its action las