METHOTREXATE INJECTION BP SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
30-10-2019
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Aktiv bestanddel:
METHOTREXATE (METHOTREXATE SODIUM)
Tilgængelig fra:
ACCORD HEALTHCARE INC
ATC-kode:
L01BA01
INN (International Name):
METHOTREXATE
Dosering:
25MG
Lægemiddelform:
SOLUTION
Sammensætning:
METHOTREXATE (METHOTREXATE SODIUM) 25MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
40ML
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0107545002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2018-04-12
Produktets egenskaber
Page 1 of 55
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PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITHOUT PRESERVATIVE
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITH PRESERVATIVE
Sterile Solution
Antimetabolite and Antirheumatic
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
October 30, 2019
Control No. 231320
Page 2 of 55
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_Pr_
_Methotrexate Injection BP, Product Monograph, Accord Healthcare Inc.
_
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
.......................................................................................................
14
DRUG INTERACTIONS
.......................................................................................................
19
DOSAGE AND ADMINISTRATION
...................................................................................
23
OVERDOSAGE
.....................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 35
STORAGE AND STABILITY
...............................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
............................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 39
PART
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