BACLOFEN-10 TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
10-03-2021
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Aktiv bestanddel:
BACLOFEN
Tilgængelig fra:
PRO DOC LIMITEE
ATC-kode:
M03BX01
INN (International Name):
BACLOFEN
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
BACLOFEN 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500
Recept type:
Prescription
Terapeutisk område:
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Produkt oversigt:
Active ingredient group (AIG) number: 0113246001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2019-01-15
Produktets egenskaber
Page 1 of 27
PRODUCT MONOGRAPH
PR
BACLOFEN – 10
PR
BACLOFEN – 20
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 10, 2021
Laval, Quebec
H7L 3W9
Control Number: 248887
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...........................................................................................................................
3
CLINICAL PHARMACOLOGY
....................................................................................................................................
3
INDICATIONS
...............................................................................................................................................................
5
CONTRAINDICATIONS
...............................................................................................................................................
5
WARNINGS
...................................................................................................................................................................
5
PRECAUTIONS
............................................................................................................................................................
9
ADVERSE REACTIONS
.............................................................................................................................................12
SYMPTOMS AND TREATMENT OF OVERDOSAGE
..........................................................................................14
DOSAGE AND ADMINISTRATION
..........................................................................................................................15
AVAILABILITY
..............................................................................................................................................................17
CHEMISTRY AND PHARMACOLOGY
....................................................................................................................18
PHARMACOLOGY
.........
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