BACLOFEN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
20-08-2014
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Aktiv ingrediens:
BACLOFEN
Tilgjengelig fra:
APOTEX INC
ATC-kode:
M03BX01
INN (International Name):
BACLOFEN
Dosering :
10MG
Legemiddelform:
TABLET
Sammensetning:
BACLOFEN 10MG
Administreringsrute:
ORAL
Enheter i pakken:
100/250/500/1000
Resept typen:
Prescription
Terapeutisk område:
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0113246001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2014-08-23
Preparatomtale
Page 1 of 27
PRODUCT MONOGRAPH
BACLOFEN
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE August 18, 2014
TORONTO, ONTARIO
M9L 1T9
Control Number: 176430
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...............................................................................................
3
CLINICAL PHARMACOLOGY
......................................................................................................
3
INDICATIONS
..................................................................................................................................
5
CONTRAINDICATIONS
.................................................................................................................
5
WARNINGS
......................................................................................................................................
5
PRECAUTIONS
................................................................................................................................
7
ADVERSE REACTIONS
................................................................................................................
10
SYMPTOMS AND TREATMENT OF OVERDOSAGE
.............................................................. 13
DOSAGE AND ADMINISTRATION
............................................................................................
14
AVAILABILITY
.............................................................................................................................
15
CHEMISTRY AND PHARMACOLOGY
......................................................................................
17
TOXICOLOGY
...............................................................................................................................
18
TERATOLOGY AND REPRODUCTION STUDIES
....................................................................
20
SELECTED BIBLIOGRAPHY
...................................................................................................
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