METOJECT SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

METHOTREXATE (METHOTREXATE SODIUM)

Disponibbli minn:

MEDEXUS PHARMACEUTICALS INC.

Kodiċi ATC:

L01BA01

INN (Isem Internazzjonali):

METHOTREXATE

Dożaġġ:

10MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

METHOTREXATE (METHOTREXATE SODIUM) 10MG

Rotta amministrattiva:

INTRA-ARTERIAL

Unitajiet fil-pakkett:

1ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2020-04-23

Karatteristiċi tal-prodott

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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
_ _
_Page 2 of _50_ _
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
.................................................