PMS-METHOTREXATE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
16-05-2019
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Aktiv bestanddel:
METHOTREXATE (METHOTREXATE DISODIUM)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
L01BA01
INN (International Name):
METHOTREXATE
Dosering:
2.5MG
Lægemiddelform:
TABLET
Sammensætning:
METHOTREXATE (METHOTREXATE DISODIUM) 2.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0107545001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2003-04-07
Produktets egenskaber
PRODUCT MONOGRAPH
PR
PMS-METHOTREXATE
Methotrexate Tablets USP
2.5 mg methotrexate (as methotrexate disodium)
ATC CODE: L01BA01
ANTIMETABOLITE
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
May 16, 2019
Montréal, Québec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 224788
_pms-METHOTREXATE Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................5
ADVERSE REACTIONS
....................................................................................................12
DRUG INTERACTIONS
.....................................................................................................16
DOSAGE AND
ADMINISTRATION.................................................................................20
OVERDOSAGE
...................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
...............................................................24
STORAGE AND STABILITY
............................................................................................26
SPECIAL HANDLING INSTRUCTIONS
..........................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
............................................................................29
CLINICAL
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