Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
SANDOZ CANADA INCORPORATED
L01BA01
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
INTRA-ARTERIAL
2ML/20ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545002; AHFS:
CANCELLED POST MARKET
2023-07-28
_ _ _Methotrexate Injection USP _ _Page 1 of 48_ PRODUCT MONOGRAPH PR METHOTREXATE INJECTION USP 25 mg / mL methotrexate (as methotrexate sodium) Sterile Solution Antimetabolite and Antirheumatic Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, Quebec J4B 1E6 Date of Revision: September 16, 2019 Submission Control No: 231325 _ _ _Methotrexate Injection USP _ _Page 2 of 48_ 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 ................................................................................................. 14 DRUG INTERACTIONS ................................................................................................. 17 DOSAGE AND ADMINISTRATION ............................................................................. 21 OVERDOSAGE ............................................................................................................... 28 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 28 STORAGE AND STABILITY ......................................................................................... 31 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION .............................................................................. 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 DETAILED PHARMACOLOGY Přečtěte si celý dokument