DEFINITY

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PEFLURTEN

MAH:

AMI TECHNOLOGIES LTD., ISRAEL

ATC_code:

V09GX

pharmaceutical_form:

SUSPENSION FOR INJECTION

composition:

PEFLURTEN 1.1 MG/ML

administration_route:

I.V

prescription_type:

Required

manufactured_by:

LANTHEUS MEDICAL IMAGING INC., USA

therapeutic_group:

OTHER CARDIOVASCULAR SYSTEM DIAGNOSTIC RADIOPHARMACEUTICALS

therapeutic_indication:

Echocardiography: Definity (perflutren injectable suspension) is indicated for contrast-enhanced ultrasound imaging of cardiac structures (ventricular chambers and endocardial borders) and function (regional wall motion) in adult patients with suboptimal echocardiograms. Abdominal ultrasound : Definity is also indicated for contrast-enhanced ultrasound imaging of the liver and kidneys in adult patients to improve the evaluation of pathology.

authorization_date:

2020-06-30

SPC

recommended dose and mode of administration and procedures of
activation of
DEFINITY
®
(perflutren injectable suspension) should be strictly adhered to.
DEFINITY
®
should be administered with caution in patients with a history of
drug allergies, asthma or hay fever, and multiple allergies.
The safety of microbubbles in patients on mechanical ventilation has
not been
established.
A specific analysis correlating the mechanical index values (0.3 to
1.9) used
in clinical trials with DEFINITY
®
with the observed cardiac disturbances is not
available. The safety of DEFINITY
®
at mechanical indices greater than 0.8 has not
been established. Users of diagnostic ultrasound devices should employ
exposures,
in any relevant mode, which are As Low As Reasonably Achievable
(ALARA).
High Ultrasound Mechanical Index: High Ultrasound Mechanical Index
(MI) values
may cause microspheres cavitation or rupture and in combination with
end systolic
triggering may induce premature ventricular contractions (PVC). In
addition,
end-systolic triggering with high MI has been reported to cause
ventricular
arrhythmias following administration of a microsphere product. In
clinical trials
with DEFINITY
®
, the majority of patients were imaged at or below a mechanical
index of 0.8. The safety of DEFINITY
®
at MI values greater than 0.8 or with the use
of high mechanical index end-systolic triggering has not been
evaluated.
A total of 1716 patients received DEFINITY
®
in clinical trials. The incidence of
treatment-related cardiovascular events was < 0.5% and included:
abnormal
ECGs, bradycardia, tachycardia, palpitation, hypertension, and
hypotension.
Two patients had treatment-related cardiac adverse events and
associated QTc
changes (1 increase and 1 decrease) of
≥
30 msec from baseline.
QTc Interval Prolongation: In 610 subjects (568 received DEFINITY
®
and 42
received placebo), ECG parameters after doses up to 40 FL/kg were
recorded for
up to 72 hours after the first bolus injection. QTc prolongation of
=30 msec was
noted in 70 (12.3