Country: Canada
Language: English
Source: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
JAMP PHARMA CORPORATION
L01BA01
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
INTRA-ARTERIAL
2ML/40ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545002; AHFS:
CANCELLED POST MARKET
2022-11-14
JAMP-METHOTREXATE, METHOTREXATE INJECTION USP, 25 MG/ML UNPRESERVED PAGE 1 OF 69 PRODUCT MONOGRAPH Pr Jamp-METHOTREXATE Methotrexate Injection USP Unpreserved Methotrexate 25 mg/mL Sterile Solution ANTIMETABOLITE AND ANTIRHEUMATIC JAMP PHARMA CORPORATION DATE OF REVISION : September 25, 2019 1310 rue Nobel Boucherville, Québec Canada J4B 5H3 SUBMISSION CONTROL NO.: 230627 JAMP-METHOTREXATE, METHOTREXATE INJECTION USP, 25 MG/ML UNPRESERVED PAGE 2 OF 46 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 .......................................................................................................... 12 DRUG INTERACTIONS .......................................................................................................... 15 DOSAGE AND ADMINISTRATION ..................................................................................... 19 OVERDOSAGE ...................................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 28 STORAGE AND STABILITY.................................................................................................. 30 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 30 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 32 PART II: SCIENTIFIC INFORMATION ....................................... Read the complete document