APO-TIZANIDINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
25-10-2023
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Aktiv bestanddel:
TIZANIDINE (TIZANIDINE HYDROCHLORIDE)
Tilgængelig fra:
APOTEX INC
ATC-kode:
M03BX02
INN (International Name):
TIZANIDINE
Dosering:
4MG
Lægemiddelform:
TABLET
Sammensætning:
TIZANIDINE (TIZANIDINE HYDROCHLORIDE) 4MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Terapeutisk område:
CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS
Produkt oversigt:
Active ingredient group (AIG) number: 0135342001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2015-05-05
Produktets egenskaber
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PRODUCT MONOGRAPH
PR
APO-TIZANIDINE
TIZANIDINE HYDROCHLORIDE TABLETS USP
2 MG AND 4 MG TIZANIDINE
ANTISPASTIC AGENT
APOTEX INC
150 SIGNET DRIVE
TORONTO, ONTARIO
CANADA M9L 1T9
CONTROL NO.: 279972
DATE OF PREPARATION:
OCT
25,
2023
Page
2
of
27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................................
3
ADVERSE REACTIONS
........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................12
DOSAGE AND ADMINISTRATION
......................................................................................13
OVERDOSAGE
....................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
......................................................................14
STORAGE AND STABILITY
................................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................16
PART II: SCIENTIFIC INFORMATION .................................................................................17
PHARMACEUTICAL INFORMATION
..................................................................................17
CLINICAL TRIALS
..............................................................................................................18
DETAILED PHARMACOLOGY
..
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