METHOTREXATE INJECTION, USP SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

METHOTREXATE (METHOTREXATE SODIUM)

Dostępny od:

STRIDES PHARMA CANADA INC

Kod ATC:

L01BA01

INN (International Nazwa):

METHOTREXATE

Dawkowanie:

25MG

Forma farmaceutyczna:

SOLUTION

Skład:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Droga podania:

INTRA-ARTERIAL

Sztuk w opakowaniu:

2ML/40ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2013-12-03

Charakterystyka produktu

PAGE 1 OF 47
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, USP
Unpreserved
25 mg/mL methotrexate (as methotrexate sodium)
Sterile Solution
Intramuscular, intravenous, intra-arterial, intrathecal, and
intracerebroventricular
ANTIMETABOLITE AND ANTIRHEUMATIC
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Date of Revision:
October 14, 2021
Submission Control No.: 254503
PAGE 2 OF 47
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
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 33
PART II: SCIENTIFIC INFORMATION
........................................................................