Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
GADOPENTETATE DIMEGLUMINE
JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
V08CA01
GADOPENTETIC ACID
469MG
SOLUTION
GADOPENTETATE DIMEGLUMINE 469MG
INTRAVENOUS
5/10/15/20ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0123846001; AHFS:
CANCELLED PRE MARKET
2022-05-17
JUBILANT DRAXIMAGE INC. MODULE 1 ADMINISTRATIVE GADOPENTETATE DIMEGLUMINE INJECTION, USP 1.3.1 PRODUCT MONOGRAPH 1 PRODUCT MONOGRAPH GADOPENTETATE DIMEGLUMINE INJECTION, USP 469 mg/mL (0.5 mmol/mL) For Intravenous Use THERAPEUTIC CLASSIFICATION Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) Jubilant DraxImage Inc. Date of Preparation: 16751 Trans Canada Hwy September 12, 2014 Kirkland, Quebec H9H 4J4 Canada http://www. draximage.com Submission Control No.: 160553 JUBILANT DRAXIMAGE INC. MODULE 1 ADMINISTRATIVE GADOPENTETATE DIMEGLUMINE INJECTION, USP 1.3.1 PRODUCT MONOGRAPH 2 TABLE OF CONTENTS 1.3.1 PRODUCT MONOGRAPH – NON-ANNOTATED ....... ERROR! BOOKMARK NOT DEFINED. PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 4 ACTION AND CLINICAL PHARMACOLOGY ...................................................................... 4 INDICATIONS AND CLINICAL USE ..................................................................................... 5 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS ............................................................................................................................... 6 _General ................................................................................................................................... 7_ _Nephrogenic Systemic Fibrosis (NSF) .................................................................................... 7_ _Hypersensitivity Reactions ...................................................................................................... 8_ _Injection Site Reactions........................................................................................................... 8_ _Sickle Erythrocytes.................................................................................................................. 9_ _Renal Impairment.................................................................... Perskaitykite visą dokumentą