)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה ((מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
11.1.2009
DEFINITY
‫תאריך‬
‫שם תכשיר באנגלית‬
133.15.31138.10 + 133.15.31138.00
‫מספר רישום‬
‫לביא נציגויות לתעשיה ורפואה בע"מ‬
‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Add the following text:
In patients with pulmonary
hypertension or unstable
cardiopulmonary conditions,
monitor vital sign measurements,
electrocardiography and
cutaneous oxygen saturation
during and for at least 30
minutes after DEFINITY®
administration (see
WARNINGS).
Add the following text:
Serious cardiopulmonary
reactions, including fatalities,
have occurred during or
following perflutren-containing
microsphere administration. The
risk for these reactions may be
increased among patients with
pulmonary hypertension or
unstable cardiopulmonary
conditions (acute myocardial
infarction, acute coronary artery
syndromes, worsening or
unstable congestive heart failure,
serious ventricular arrhythmias
or respiratory failure, including
patients receiving mechanical
ventilation). In these patients,
monitor vital signs,
electrocardiography, and
cutaneous oxygen saturation
during and for at least 30
minutes after DEFINITY®
Delete the following text:
Monitor patients during and for
30 minutes following DEFINITY
administration, including vital
sign measurements and
electrocardiography in all patients
and cutaneous oxygen saturation
in patients at risk for hypoxemia.
Delete the following text:
Serious cardiopulmonary
reactions, including fatalities,
have occurred during or within 30
minutes following DEFINITY
administration during
echocardiography. Assess all
patients for the presence of any
condition that precludes
DEFINITY administration (see
CONTRAINDICATIONS).
Monitor patients undergoing
echocardiography during and for
30 minutes following DEFINITY
administration, including vital
sign measurements and
electrocardiography in all patients
and cutaneous oxygen saturation
in patients at risk for hypoxemia.
Always have resuscitation
equipment and trained personnel
readily available.
‫פרק בעלון‬
Warnings
(Top 1st
page)
Warnings
administration. In the absence of
these underlying conditions,
observe patients closely during
and following DEFINITY®
administration.
In postmarketing use, four
patients undergoing
echocardiography experienced
fatal cardiac arrests either during
or within 30 minutes of
DEFINITY administration. It
In postmarketing use, uncommon should be noted that prior to the
but serious reactions observed
administration of DEFINITY, 3
during or shortly following
of the 4 patients had the following
perflutren-containing
pre-existing conditions: two
microsphere administration
patients had severe congestive
included fatal cardiac or
heart failure and one was
respiratory arrest, loss of
undergoing mechanical
consciousness, convulsions,
ventilation for respiratory
symptomatic arrhythmias (atrial
failure. In the remaining patient,
fibrillation, supraventricular
DEFINITY was administered and
tachycardia, ventricular
the patient underwent a cardiac
tachycardia or fibrillation),
stress test. Other uncommon but
hypotension, respiratory distress serious reactions observed during
or cardiac ischemia (see
or shortly following DEFINITY
ADVERSE REACTIONS).
administration included cardiac or
respiratory arrest, loss of
Always have cardiopulmonary
consciousness, convulsions,
resuscitation personnel and
symptomatic arrhythmias (atrial
equipment readily available prior fibrillation, supraventricular
to DEFINITY® administration
tachycardia, ventricular
and monitor all patients for acute tachycardia or fibrillation),
reactions.
hypotension, respiratory distress
or cardiac ischemia (see
ADVERSE REACTIONS).
Nothings is added to the text.
Delete the following text:
 Worsening or clinically
unstable congestive heart
failure,
 Acute myocardial infarction or
acute coronary syndromes,
 Serious ventricular arrhythmias
or high risk for arrhythmias
Contradue to prolongation of the QT
interval,
indications
 Respiratory failure, as manifest
by signs or symptoms of
carbon dioxide retention or
hypoxemia,
 Severe emphysema, pulmonary
emboli or other conditions that
cause pulmonary hypertension
due to compromised
pulmonary arterial vasculature,