METOJECT SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METHOTREXATE (METHOTREXATE SODIUM)

Διαθέσιμο από:

MEDEXUS PHARMACEUTICALS INC.

Φαρμακολογική κατηγορία (ATC):

L01BA01

INN (Διεθνής Όνομα):

METHOTREXATE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

METHOTREXATE (METHOTREXATE SODIUM) 10MG

Οδός χορήγησης:

INTRA-ARTERIAL

Μονάδες σε πακέτο:

1ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2020-04-23

Αρχείο Π.Χ.Π.

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_Page 1 of _50_ _
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
.................................................