METHOTREXATE INJECTION BP SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
14-09-2009
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Aktiv bestanddel:
METHOTREXATE (METHOTREXATE SODIUM)
Tilgængelig fra:
UMAN PHARMA INC
ATC-kode:
L01BA01
INN (International Name):
METHOTREXATE
Dosering:
25MG
Lægemiddelform:
SOLUTION
Sammensætning:
METHOTREXATE (METHOTREXATE SODIUM) 25MG
Indgivelsesvej:
INTRA-ARTERIAL
Enheder i pakken:
2ML
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0107545002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2009-09-16
Produktets egenskaber
_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 1 of 43_
_ _
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, BP 25 MG/ML
Sterile
Antimetabolite and Antirheumatic
Uman Pharma Inc.
Date of Preparation: September 2, 2009
100, boul. de l’Industrie
Candiac, QC, J5R 1J1
Canada
Control No. 132325
_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 2 of 43_
_ _
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
........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
26
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 27
STORAGE
AND
STABILITY
...............................................................................................
29
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL
INFORMATION
.
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