País: Canadá
Língua: inglês
Origem: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
ACCORD HEALTHCARE INC
L04AX03
METHOTREXATE
10MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 10MG
SUBCUTANEOUS
100
Prescription
Active ingredient group (AIG) number: 0107545005; AHFS:
APPROVED
2022-09-15
_Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection _ _Page 1 of 44_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR METHOFILL SELF-DOSE INJECTOR Methotrexate Injection Solution, 7.5 mg/0.15 mL, 10 mg/0.20 mL, 12.5 mg/0.25 mL, 15 mg/0.30 mL, 17.5 mg/0.35 mL, 20 mg/0.40 mL, 22.5 mg/0.45 mL, and 25 mg/0.50mL [each corresponding to 50 mg/mL methotrexate (as methotrexate sodium)], in a single-dose prefilled auto-injector for subcutaneous use Sterile BP Immunosuppressant Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, QC H9H 5B9 Canada Date of Initial Authorization: SEP 14, 2022 Submission Control Number: 254599 _Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection _ _Page 2 of 44_ TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................... 4 1 INDICATIONS ................................................................................................................... 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 5 4.1 Dosing Considerations .............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4.4 Administration ....... Leia o documento completo