METHOTREXATE INJECTION USP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible des:

PFIZER CANADA ULC

Codi ATC:

L01BA01

Designació comuna internacional (DCI):

METHOTREXATE

Dosis:

25MG

formulario farmacéutico:

SOLUTION

Composición:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

20ML/40ML/100ML/200ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2017-06-06

Fitxa tècnica

_Pr_
_METHOTREXATE INJECTION USP (methotrexate sodium) – Product
Monograph _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METHOTREXATE INJECTION USP
Methotrexate Injection
Solution (Preservative-Free), 10 mg/mL and 25 mg/mL methotrexate (as
methotrexate sodium), for
intravenous, intramuscular, intra-arterial, intrathecal and
intracerebroventricular use
Solution (with Preservative), 25 mg/mL methotrexate (as methotrexate
sodium), for intravenous,
intramuscular, intra-arterial use
USP
Antimetabolite and Antirheumatic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
[JAN 07, 1985]
Date of Revision:
MAR 01, 2024
Submission Control Number: 280068
_Pr_
_METHOTREXATE INJECTION USP (methotrexate sodium) – Product
Monograph _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
03/2024
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
.............