METHOTREXATE INJECTION, BP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

L01BA01

DCI (Dénomination commune internationale):

METHOTREXATE

Dosage:

20MG

forme pharmaceutique:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 20MG

Mode d'administration:

INTRA-ARTERIAL

Unités en paquet:

0.8ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-03-10

Résumé des caractéristiques du produit

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