PMS-METHOTREXATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHOTREXATE (METHOTREXATE SODIUM)

Available from:

PHARMASCIENCE INC

ATC code:

L04AX03

INN (International Name):

METHOTREXATE

Dosage:

12.5MG

Pharmaceutical form:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 12.5MG

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-07-18

Summary of Product characteristics

_pms-METHOTREXATE INJECTION page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
PMS-METHOTREXATE INJECTION
Methotrexate 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
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Quebec, H4P 2T4
Submission Control Number: 268544
Date of Initial Authorization:
July 14, 2023
_pms-METHOTREXATE INJECTION page 2 of 51 _
RECENT MAJOR LABEL CHANGES
_None at the time of authorization _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................................
4
1
INDICATIONS
.............................................................................................................................................
4
1.1
PEDIATRICS
.....................................................................................................................................
4
1.2
GERIATRICS
.....................................................................................................................................
4
2
CONTRAINDICATIONS
......................................