METOJECT SUBCUTANEOUS SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

METHOTREXATE (METHOTREXATE SODIUM)

Tilgængelig fra:

MEDEXUS PHARMACEUTICALS INC.

ATC-kode:

L04AX03

INN (International Name):

METHOTREXATE

Dosering:

15MG

Lægemiddelform:

SOLUTION

Sammensætning:

METHOTREXATE (METHOTREXATE SODIUM) 15MG

Indgivelsesvej:

SUBCUTANEOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0107545005; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2016-05-17

Produktets egenskaber

_METOJECT_
_® _
_SUBCUTANEOUS_
(_Methotrexate Injection) _
_Page 1 of _45_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
METOJECT
® SUBCUTANEOUS
Methotrexate Injection
Solution, 7.5 mg / 0.15 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 10 mg / 0.2 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 12.5 mg / 0.25 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 15 mg / 0.3 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 17.5 mg / 0.35 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 20 mg / 0.4 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 22.5 mg / 0.45 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
Solution, 25 mg / 0.5 mL (50 mg/mL) methotrexate as methotrexate
sodium, single-use
pre-filled syringe for subcutaneous injection
House Standard
Immunosuppressant
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Submission Control Number:
251944
Date of Initial Approval:
May 17, 2016
Date of Revision:
December 7, 2021
_METOJECT_
_® _
_SUBCUTANEOUS_
(_Methotrexate Injection) _
_Page 2 of _45_ _
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions
12/2021
8. Adverse Reactions
12/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1 INDICATIONS
..................................................................................................................
4
1.1 Pediatrics
...................................................................................................................
4
1.2
Geriatrics......................................