PMS-METHOTREXATE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

METHOTREXATE (METHOTREXATE DISODIUM)

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

L01BA01

INN (Nama Antarabangsa):

METHOTREXATE

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

METHOTREXATE (METHOTREXATE DISODIUM) 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2003-04-07

Ciri produk

PRODUCT MONOGRAPH
PR
PMS-METHOTREXATE
Methotrexate Tablets USP
2.5 mg methotrexate (as methotrexate disodium)
ATC CODE: L01BA01
ANTIMETABOLITE
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
May 16, 2019
Montréal, Québec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 224788
_pms-METHOTREXATE Product Monograph _
_Page 2 of 42_
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
.....................................................................................................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
................................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
............................................................................29
CLINICAL