METHOTREXATE SUBCUTANEOUS SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

METHOTREXATE (METHOTREXATE SODIUM)

Inapatikana kutoka:

ACCORD HEALTHCARE INC

ATC kanuni:

L04AX03

INN (Jina la Kimataifa):

METHOTREXATE

Kipimo:

10MG

Dawa fomu:

SOLUTION

Tungo:

METHOTREXATE (METHOTREXATE SODIUM) 10MG

Njia ya uendeshaji:

SUBCUTANEOUS

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-08-07

Tabia za bidhaa

_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