M-METHOTREXATE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

METHOTREXATE (METHOTREXATE DISODIUM)

Dostępny od:

MANTRA PHARMA INC

Kod ATC:

L01BA01

INN (International Nazwa):

METHOTREXATE

Dawkowanie:

2.5MG

Forma farmaceutyczna:

TABLET

Skład:

METHOTREXATE (METHOTREXATE DISODIUM) 2.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Podsumowanie produktu:

Active ingredient group (AIG) number: 0107545001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2023-02-03

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
M-METHOTREXATE
Methotrexate Tablets USP
Tablets, 2.5 mg methotrexate (supplied as methotrexate disodium), Oral
USP
ATC CODE: L01BA01
ANTIMETABOLITE
Mantra Pharma Inc.
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3
SUBMISSION CONTROL NUMBER: 268193
_ _
_ _
Date of
Initial Authorization:
FEB 1, 2023
_M-METHOTREXATE Product Monograph_
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
...................................................................................
4
ADVERSE REACTIONS
...................................................................................................
12
DRUG INTERACTIONS
...................................................................................................
16
DOSAGE AND ADMINISTRATION
...............................................................................
20
OVERDOSAGE
..................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 24
STORAGE AND STABILITY
...........................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 27
PART II: SCIENTIFIC INFORMATION
...............................................................................
29
PHARMACEUTICAL INFORMATION
..........................................................................