To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or, Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration, Assess all patients for the presence of any condition that precludes DEFINITY RT administration, Table 1 New-Onset Adverse Reactions Occurring in 0.5% of All DEFINITY-Treated Subjects, Table 3 MEAN (SD) ENDOCARDIAL BORDER LENGTH (CM) BY BOTH APICAL 2- AND 4-CHAMBER VIEWS AT END-SYSTOLE AND END-DIASTOLE BY STUDY, EVALUABLE SUBJECTS, All Drug Impairment of male or female fertility was not observed in rats and rabbits treated with activated DEFINITY at doses up to 24 and 15 times the human dose based on body surface area (in rats and rabbits respectively). In this group, 154 (61.8%) were male and 95 (38.2%) were female; 183 (73.5%) were White, 38 (15.3%) were Black, 21 (8.4%) were Hispanic, and 7 (2.8%) were classified as other racial or ethnic groups. Contrast agent stability: a continuous B-mode imaging approach. Cold: Any temperature not exceeding 8C (46 F). In clinical trials, the overall incidence of adverse reactions was similar for the <65 year age group and the 65 year age group. After activating the contents of the vial in a VIALMIX, each mL of the milky white suspension contains a maximum of 1.2 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) octafluoropropane. . Handbook of Contrast Echocardiography. The safety of activated Definity with the use of end-systolic triggering has not been evaluated. Definity/Perflutren Lipid Microspheres Intravenous Inj Susp: 2mL. The overall incidence of adverse reactions was similar among all racial and ethnic groups. Report Adverse STAY Activated DEFINITYRT may be used for up to 4 hours from the time of dilution, stored at room temperature in the product vial with the ViaLok attached. To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. In an open administration, crossover trial, 64 patients were randomized to receive both bolus (10 microL/kg) and infusion (1.3 mL activated Definity in 50 mL saline at the rate of 4 mL/min) dosing of activated Definity. Fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing. It is essential to follow directions for activation of Definity carefully and to adhere to strict aseptic procedures during preparation. DEFINITY RT does not contain bacterial preservative. J Am Coll Cardiol. Higher room temperatures 27 - 32 C (80 - 90 F) may reduce the working times for . DNA-targeted nanocarriers for encapsulating an active agent and delivering it to extracellular DNA are provided. Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. Table 1 summarizes the most common adverse reactions. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. However, OFP protein binding is expected to be minimal due to its low partition coefficient into whole blood. Based on the rapid clearance of this drug, advise nursing mothers to pump and discard breast milk once after treatment [see CLINICAL PHARMACOLOGY (12)]. The following serious adverse reactions are described elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. DEFINITY RT may be injected by either an intravenous bolus or infusion. Illumina. DEFINITY RT- perflutren injection, suspension, 11994-017-01, (5.1). Immediately after VIALMIX RFID activation, but no more than 15 minutes, place the activated vial in the upright position and remove the flip top cap. Of these, 144 (8.4%) had at least one adverse reaction (Table 1). The overall incidence of adverse reactions was similar between males and females. The safety of injecting activated Definity in neonates and infants with immature pulmonary vasculature has not been studied. Do not administer Definity by intra-arterial injection [see CONTRAINDICATIONS (4)]. . A fresh urine sample was divided amongst 11 non-sterile, plastic 5mL tubes containing no additives. Withdraw the material from the middle of the liquid in the inverted vial. Activated Definity (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Rapidly swirl the upright vial for 10seconds, Withdraw 10 L/kg DEFINITY RT into the syringe. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. The pH is 6.2-6.8. Advise patients to inform their healthcare provider if they develop any symptoms of hypersensitivity after DEFINITY RT administration, including rash, wheezing, or shortness of breath. The Definity vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures. A temperature maintained thermostatically that encompasses the usual and customary working environment of 20C to 25C (68F to 77F) that allows for brief deviations between 15C and 30C (59F to 86F) that are experienced in pharmacies, hospitals, and warehouses. A sterile syringe or cap should be attached to the Luer . Form 10-K (annual report [section 13 and 15(d), not s-k item 405]) filed with the SEC In clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8. These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias [see Warnings and Precautions (5.1, 5.2)]. DEFINITY was administered intravenously to rats at doses of 0.1, 0.3, and 1.0 mL/kg (approximately 0.8, 2.4, and 8 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 6 to day 17 of gestation. A sterile syringe or cap should be attached to the Luer fitting on the ViaLok until use. The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions [see ADVERSE REACTIONS (6)]. After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound device at 0.8 or below [see Warnings and Precautions (5.4)]. PubMed, Attach the syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP to the 13mm ViaLok luer-lok hub. The pH is 5.2 to 6.4. OFP gas binding to plasma proteins or partitioning into blood cells has not been studied. Biochemical Data Summary. temperature excursion: Date and time Storage unit temperature (including minimum/maximum temperatures during the time of the event, if available) Room temperature, if available Name of the person completing the report General description of the event (i.e., what happened) If using a digital data logger (DDL), determine Assay of antibacterial activity. Administer VELETRI for up to 24 hours at room temperature (77F/25C) at any concentration without ice packs. *3 o 2.4 DEFINITY Activation, Preparation and Handling Instructions 1. J Am Soc Echocardiogr. In a crossover trial of 64 patients randomized to both bolus and infusion, the duration of clinically useful contrast enhancement for fundamental imaging was approximately 3.4 minutes after a 10 microL/kg bolus and was approximately 7.1 minutes during the continuous infusion of 1.3 mL activated Definity in 50 mL saline at a rate of 4 mL/min. Add 1.4 mL of preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITY RT vial. To obtain yields >90%, it is necessary to reconstitute the antibody within the . Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. The pharmacokinetics of activated Definity has not been studied in subjects with hepatic diseases or congestive heart failure. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula: DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula: DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula: MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and the following structural formula: Prior to activation, the DEFINITY RT vial contains 6.52 mg/mL octafluoropropane in the headspace which is confirmed by positive IR spectroscopic testing in every vial. The mean change in border length from baseline at end-systole was statistically significant for 3 out of 4 readers for the apical 4-chamber view and for 2 out 4 readers for the apical 2-chamber view. Reproduction, distribution, transmission or publication is prohibited. The safety of bolus and infusion dosing in combination or in sequence, has not been studied. Files, All Mapping In the baseline controlled studies, a total of 126 (67 in study A and 59 in study B) subjects received a bolus dose of 10 microL/kg activated DEFINITY. For customer orders call 1-800-299-3431. Last updated on Oct 24, 2022. Withdraw the material from the middle of the liquid in the inverted vial. Of the total number of subjects in clinical trials of Definity, 144 (33%) were 65 and over. See Full Prescribing Information for instructions on preparation and administration. 11994-017-20, See full prescribing information for complete boxed warning, Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration (, Assess all patients for the presence of any condition that precludes DEFINITY RT administration (. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG [see Adverse Reactions (6.2) and Description (11)]. Because many drugs are excreted in human milk, caution should be exercised when Definity is administered to a nursing mother. Insert the 13mm ViaLok (Vented Vial Access Device) into the center of the rubber stopper and push down until properly engaged and locked onto the vial. Activated DEFINITY and activated DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardialborder. Do not administer DEFINITY RT by intra-arterial injection. To be minimal due to its low partition coefficient into whole blood ethnic groups higher room temperatures 27 - C! % ) were 65 and over ( 8.4 % ) were 65 and over may be by. 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