METHOTREXATE SUBCUTANEOUS SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

METHOTREXATE (METHOTREXATE SODIUM)

Dostupné s:

ACCORD HEALTHCARE INC

ATC kód:

L04AX03

INN (Mezinárodní Name):

METHOTREXATE

Dávkování:

15MG

Léková forma:

SOLUTION

Složení:

METHOTREXATE (METHOTREXATE SODIUM) 15MG

Podání:

SUBCUTANEOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2019-08-07

Charakteristika produktu

_METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METHOTREXATE 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
BP
Immunosuppressant
Accord Healthcare Inc.
3535 boul. St-Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Submission Control Number: 263562
Date of Initial Approval:
August 2, 2019
Date of Revision:
October 3, 2022
_METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions
10/2022
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
..........................................................................................................................
4
1.1
Pediatrics
...........................................................................................................................
4
1.2
Geriatrics