DEFINITY SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PERFLUTREN

Διαθέσιμο από:

LANTHEUS MI CANADA INC

Φαρμακολογική κατηγορία (ATC):

V08DA04

INN (Διεθνής Όνομα):

MICROSPHERES OF PHOSPHOLIPIDS

Δοσολογία:

150MCL

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

PERFLUTREN 150MCL

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

1.5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER DIAGNOSTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2002-02-04

Αρχείο Π.Χ.Π.

_ _
_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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