Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
PEFLURTEN
AMI TECHNOLOGIES LTD., ISRAEL
V09GX
SUSPENSION FOR INJECTION
PEFLURTEN 1.1 MG/ML
I.V
Required
LANTHEUS MEDICAL IMAGING INC., USA
OTHER CARDIOVASCULAR SYSTEM DIAGNOSTIC RADIOPHARMACEUTICALS
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.
2020-06-30
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 Lue koko asiakirja