Страна: Канада
мова: англійська
Джерело: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
STRIDES PHARMA CANADA INC
L01BA01
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
INTRA-ARTERIAL
2ML/40ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545002; AHFS:
APPROVED
2013-12-03
PAGE 1 OF 47 PRODUCT MONOGRAPH PR METHOTREXATE INJECTION, USP Unpreserved 25 mg/mL methotrexate (as methotrexate sodium) Sterile Solution Intramuscular, intravenous, intra-arterial, intrathecal, and intracerebroventricular ANTIMETABOLITE AND ANTIRHEUMATIC Strides Pharma Canada Inc. 1565, Boul. Lionel-Boulet Varennes, Quebec J3X 1P7 Date of Revision: October 14, 2021 Submission Control No.: 254503 PAGE 2 OF 47 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 16 DOSAGE AND ADMINISTRATION ..................................................................................... 20 OVERDOSAGE ........................................................................................................................ 29 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 29 STORAGE AND STABILITY ................................................................................................. 32 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 33 PART II: SCIENTIFIC INFORMATION ........................................................................ Прочитайте повний документ