Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
GADOTERATE MEGLUMINE
GUERBET
V08CA02
GADOTERIC ACID
376.9MG
SOLUTION
GADOTERATE MEGLUMINE 376.9MG
INTRAVENOUS
VIALS:5/10/15/20/60100ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0158590001; AHFS:
APPROVED
2016-11-25
_Product Monograph _ _DOTAREM Gadoterate meglumine injection _ _Page 1 of 42 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION DOTAREM Gadoterate Meglumine Injection Solution, 376.9 mg/mL, equivalent to 0.5 mmol/mL, Intravenous Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) Manufacturer: Guerbet BP 57400 95943 Roissy CdG Cedex FRANCE Importer: Methapharm Inc. 81 Sinclair Blvd Brantford, Ontario Canada N3S 7X6 Date of Initial Authorization: NOV 25, 2016 Date of Revision: July 5, 2023 Submission Control Number: 269429 _ _ _Product Monograph _ _DOTAREM Gadoterate meglumine injection _ _Page 2 of 42 _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, 7.1.1 Pregnant Women 07/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations ........................................................................................... 5 4.2 Recommended Dose an Baca dokumen lengkapnya