METHOTREXATE SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

METHOTREXATE

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

L01BA01

INN (International Name):

METHOTREXATE

Dosering :

25MG

Legemiddelform:

SOLUTION

Sammensetning:

METHOTREXATE 25MG

Administreringsrute:

INTRA-ARTERIAL

Enheter i pakken:

2ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0107545002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2011-05-03

Preparatomtale

METHOTREXATE PRODUCT MONOGRAPH
PAGE 1 OF 47
PRODUCT MONOGRAPH
Pr
METHOTREXATE
Methotrexate Tablets USP
Methotrexate Injection USP
Antimetabolite
®T.M. Wyeth
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
DATE OF PREPARATION:
April 1, 2003
DATE OF REVISION:
April 21, 2011
SUBMISSION CONTROL NO: 144377, 144378
©
Pfizer Canada Inc.
METHOTREXATE PRODUCT MONOGRAPH
PAGE 2 OF 47
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................3
SUMMARY PRODUCT INFORMATION
............................................................................3
INDICATIONS AND CLINICAL
USE..................................................................................3
CONTRAINDICATIONS
.......................................................................................................4
WARNINGS AND
PRECAUTIONS......................................................................................6
ADVERSE
REACTIONS......................................................................................................16
DRUG INTERACTIONS
......................................................................................................19
DOSAGE AND
ADMINISTRATION..................................................................................22
OVERDOSAGE
....................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
................................................................30
STORAGE AND
STABILITY..............................................................................................32
SPECIAL HANDLING INSTRUCTIONS
...........................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................34
PART II: SCIENTIFIC
INFORMATION....................................................................................35
PHARMACEUTICAL
INFORMATION..............