METHOTREXATE INJECTION BP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible depuis:

UMAN PHARMA INC

Code ATC:

L01BA01

DCI (Dénomination commune internationale):

METHOTREXATE

Dosage:

25MG

forme pharmaceutique:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Mode d'administration:

INTRA-ARTERIAL

Unités en paquet:

2ML

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:

2009-09-16

Résumé des caractéristiques du produit

_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
.