METHOFILL SELF-DOSE INJECTOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

METHOTREXATE (METHOTREXATE SODIUM)

Disponibil de la:

ACCORD HEALTHCARE INC

Codul ATC:

L04AX03

INN (nume internaţional):

METHOTREXATE

Dozare:

22.5MG

Forma farmaceutică:

SOLUTION

Compoziție:

METHOTREXATE (METHOTREXATE SODIUM) 22.5MG

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-09-15

Caracteristicilor produsului

_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
.......