البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
SANDOZ CANADA INCORPORATED
L01BA01
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
INTRA-ARTERIAL
50MG/2ML,500MG/20ML,1000MG/40ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545002; AHFS:
CANCELLED PRE MARKET
2018-08-01
_ _ _Methotrexate PF/SA Injection _ _Page 1 of 43_ PRODUCT MONOGRAPH PR METHOTREXATE PF/SA INJECTION methotrexate injection USP 25 mg/mL as 50 mg/2 mL 500 mg/20 mL 1000 mg/40 mL Antimetabolite and Antirheumatic Sandoz Canada Inc. 145, Jules-Léger Boucherville, Quebec J4B 7K8 Date of Revision: February 18, 2013 Submission Control No: 159589 _ _ _Methotrexate PF/SA Injection _ _Page 2 of 43_ 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 ............................................................................. 17 OVERDOSAGE ................................................................................................................ 26 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 27 STORAGE AND STABILITY ......................................................................................... 29 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 29 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 30 PART II: SCIENTIFIC INFORMATION ............................................................................... 31 PHARMACEUTICAL INFORMATION ......................................................................... 3 اقرأ الوثيقة كاملة