METHOTREXATE INJECTION, BP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
28-11-2019

Aktiv ingrediens:

METHOTREXATE (METHOTREXATE SODIUM)

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

L01BA01

INN (International Name):

METHOTREXATE

Dosering :

20MG

Legemiddelform:

SOLUTION

Sammensetning:

METHOTREXATE (METHOTREXATE SODIUM) 20MG

Administreringsrute:

INTRA-ARTERIAL

Enheter i pakken:

0.8ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-03-10

Preparatomtale

                                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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