BACLOFEN INJECTION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BACLOFEN

זמין מ:

STERIMAX INC

קוד ATC:

M03BX01

INN (שם בינלאומי):

BACLOFEN

כמות:

10MG

טופס פרצבטיות:

SOLUTION

הרכב:

BACLOFEN 10MG

מסלול נתינה (של תרופות):

INTRATHECAL

יחידות באריזה:

20ML

סוג מרשם:

Prescription

איזור תרפויטי:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

leaflet_short:

Active ingredient group (AIG) number: 0113246005; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2014-05-02

מאפייני מוצר

PRODUCT MONOGRAPH
PR
BACLOFEN INJECTION
0.05 mg/mL, 0.5 mg/mL, and 2 mg/mL
For intrathecal injection and intrathecal infusion only
ANTISPASTIC AGENT
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
DATE OF REVISION:
May 5, 2021
CONTROL NO.: 246780
Page 2 of 29
PRODUCT MONOGRAPH
PR
BACLOFEN INJECTION
0.05 mg/mL, 0.5 mg/mL, and 2 mg/mL
For intrathecal injection and intrathecal infusion only
THERAPEUTIC CLASSIFICATION
Antispastic Agent
CLINICAL PHARMACOLOGY
The precise mechanisms of action of baclofen as an antispastic agent
are not fully understood.
Baclofen
inhibits
both
monosynaptic
and
polysynaptic
reflex
transmission
at the spinal level,
possibly
by
decreasing
excitatory
neurotransmitter
release
from
primary
afferent
terminals.
Actions at supraspinal sites may also contribute to its clinical
effect. Baclofen is an analogue of
the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and
may exert its effects by
stimulation of the GABA
B
receptor subtype.
Baclofen has been shown to have general Central Nervous System (CNS)
depressant properties
as indicated by the production of sedation with tolerance, somnolence,
ataxia, and respiratory
and cardiovascular depression. A dose-dependent inhibitory effect on
erectile function has been
shown in men through GABA
B
receptor stimulation.
In neurological diseases associated with spasm of the skeletal
muscles, baclofen injection may
have beneficial action on reflex muscle contractions, painful spasm,
automatism, hyperreflexia,
trismus, and clonus. Neuromuscular transmission is not affected by
baclofen. Baclofen may also
reduce pain associated with spasticity.
PHARMACODYNAMICS OF BACLOFEN INJECTION:
INTRATHECAL BOLUS:
The onset of action is generally half an hour to one hour after
administration of an intrathecal
bolus dose. Peak antispastic effect is seen at approximately 4 hours
after dosing and effects may
last 4 to 8 hours. Onset, peak response, and duration of action vary
with individual patients
depending on the dose and severity of symptoms.
CONTIN