METHOTREXATE INJECTION, BP SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
28-11-2019
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Aktiv bestanddel:
METHOTREXATE (METHOTREXATE SODIUM)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
L01BA01
INN (International Name):
METHOTREXATE
Dosering:
20MG
Lægemiddelform:
SOLUTION
Sammensætning:
METHOTREXATE (METHOTREXATE SODIUM) 20MG
Indgivelsesvej:
INTRA-ARTERIAL
Enheder i pakken:
0.8ML
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0107545002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2015-03-10
Produktets egenskaber
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, BP
25 mg/mL methotrexate (as methotrexate sodium)
Single-Use Pre-Filled Syringes
Sterile
ANTIMETABOLITE AND ANTIRHEUMATIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite # 100
November 28, 2019
Montréal, Québec
H4P 2T4
Submission Control No.: 231323
_METHOTREXATE INJECTION, BP Product Monograph _
_Page 2 of 50 _
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
.......................................................................................................................................
13
DRUG
INTERACTIONS
.......................................................................................................................................
17
DOSAGE
AND
ADMINISTRATION....................................................................................................................
21
OVERDOSAGE
.....................................................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
31
STORAGE
AND
STABILITY
...............................................................................................................................
34
SPECIAL
HANDLING
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