Land: Canada
Språk: engelsk
Kilde: Health Canada
BACLOFEN
NOVARTIS PHARMACEUTICALS CANADA INC
M03BX01
BACLOFEN
2MG
SOLUTION
BACLOFEN 2MG
INTRATHECAL
5ML
Prescription
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0113246003; AHFS:
APPROVED
1997-06-03
_ _ _Page 1 of 40_ PRODUCT MONOGRAPH Pr LIORESAL ® INTRATHECAL (baclofen injection) 0.05 mg/mL, 0.5 mg/mL and 2 mg/mL For intrathecal injection and infusion only Antispastic Agent _ _ _ _ _ _ _ _ _ _ _ _ _ _ Novartis Pharmaceuticals Canada Inc. DATE OF PREPARATION: 385 Bouchard Blvd. September 13, 1994 Dorval, Quebec H9S 1A9 DATE OF REVISION: May 5, 2020 Submission Control No: 235751 LIORESAL is a registered trademark. _ _ _Page 2 of 40_ PRODUCT MONOGRAPH PR LIORESAL ® INTRATHECAL (baclofen injection) 0.05 mg/mL, 0.5 mg/mL and 2 mg/mL For intrathecal injection and infusion only THERAPEUTIC CLASSIFICATION Antispastic Agent CLINICAL PHARMACOLOGY The precise mechanisms of action of LIORESAL (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, LIORESAL Intrathecal 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. _ _ _Page 3 of 40_ PHARMACODYNAMICS OF LIORESAL INTRATHECAL: INTRATHECAL BOLUS: The onset of action is generally half an hour to one hour after administration of an intrathecal bolus dose. Peak antispast read_full_document