Država: Kanada
Jezik: angleščina
Source: Health Canada
PERFLUTREN
LANTHEUS MI CANADA INC
V08DA04
MICROSPHERES OF PHOSPHOLIPIDS
150MCL
SUSPENSION
PERFLUTREN 150MCL
INTRAVENOUS
1.5ML
Prescription
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0142602001; AHFS:
APPROVED
2002-02-04
_ _ _DEFINITY (Perflutren Injectable Suspension) _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr DEFINITY® perflutren injectable suspension Suspension, 150 mcL/mL, Intravenous Ultrasound Contrast Media (ATCC: V08DA04) Lantheus MI Canada, Inc. 1111 Dr. Frederik-Philips Boulevard Montreal, QC Canada Date of Initial Authorization: FEB 16, 2002 Date of Revision: SEP 9, 2022 Submission Control Number: 263241 _ _ _ _ _DEFINITY (Perflutren Injectable Suspension) _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Immune 02/2021 7 WARNINGS AND PRECAUTIONS, Cardiovascular 09/2022 7 WARNINGS AND PRECAUTIONS, Hematologic 09/2022 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 ........................................................... 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ............ Preberite celoten dokument