DEFINITY SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PERFLUTREN

Tersedia dari:

LANTHEUS MI CANADA INC

Kode ATC:

V08DA04

INN (Nama Internasional):

MICROSPHERES OF PHOSPHOLIPIDS

Dosis:

150MCL

Bentuk farmasi:

SUSPENSION

Komposisi:

PERFLUTREN 150MCL

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

1.5ML

Jenis Resep:

Prescription

Area terapi:

OTHER DIAGNOSTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0142602001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2002-02-04

Karakteristik produk

_ _
_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
............