METOJECT SUBCUTANEOUS SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

METHOTREXATE (METHOTREXATE SODIUM)

Disponível em:

MEDEXUS PHARMACEUTICALS INC.

Código ATC:

L04AX03

DCI (Denominação Comum Internacional):

METHOTREXATE

Dosagem:

12.5MG

Forma farmacêutica:

SOLUTION

Composição:

METHOTREXATE (METHOTREXATE SODIUM) 12.5MG

Via de administração:

SUBCUTANEOUS

Unidades em pacote:

1/4/12 SYR (0.25ML/SYR)

Tipo de prescrição:

Prescription

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2016-05-17

Características técnicas

_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......................................