METOJECT SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

METHOTREXATE (METHOTREXATE SODIUM)

Commercializzato da:

MEDEXUS PHARMACEUTICALS INC.

Codice ATC:

L01BA01

INN (Nome Internazionale):

METHOTREXATE

Dosaggio:

10MG

Forma farmaceutica:

SOLUTION

Composizione:

METHOTREXATE (METHOTREXATE SODIUM) 10MG

Via di somministrazione:

INTRA-ARTERIAL

Confezione:

1ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0107545004; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2020-04-23

Scheda tecnica

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PRODUCT MONOGRAPH
Pr
METOJECT
®
methotrexate sodium solution for injection
methotrexate 10 mg/mL
Single-Use Pre-Filled Syringes
Sterile
THERAPEUTIC CLASSIFICATION
Antimetabolite and Antirheumatic
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Submission Control No.: 231322
Date of Revision:
December 10, 2019
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .......... Error! Bookmark not
defined.
SUMMARY PRODUCT INFORMATION ..................... ERROR! BOOKMARK NOT
DEFINED.
INDICATIONS AND CLINICAL USE ........................... ERROR!
BOOKMARK NOT DEFINED.
CONTRAINDICATIONS ...............................................
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WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS ................................................
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DRUG INTERACTIONS
..............................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 30
STORAGE AND STABILITY
......................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
....................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 34
PART II: SCIENTIFIC INFORMATION
............................................................................
35
PHARMACEUTICAL INFORMATION
.......................................................................
35
DETAILED PHARMACOLOGY
.................................................................................
36
TOXICOLOGY
.................................................