METHOTREXATE INJECTION, BP SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-11-2019
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
METHOTREXATE (METHOTREXATE SODIUM)
Fáanlegur frá:
PHARMASCIENCE INC
ATC númer:
L01BA01
INN (Alþjóðlegt nafn):
METHOTREXATE
Skammtar:
20MG
Lyfjaform:
SOLUTION
Samsetning:
METHOTREXATE (METHOTREXATE SODIUM) 20MG
Stjórnsýsluleið:
INTRA-ARTERIAL
Einingar í pakka:
0.8ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0107545002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2015-03-10
Vara einkenni
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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