Sonne C, Xie F, Lof J, et al. Lantheus Holdings, Inc. 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. In a retrospective analysis, in a subset of subjects (n=12 to 47, depending on reader) having at least 2 adjacent segments non-evaluable on non-contrast imaging, activated DEFINITY converted a baseline non-evaluable image to an evaluable image in 58 to 91% of the patients, depending on the reader. Data on file, Lantheus Medical Imaging, Inc. Embase and Medline Search, May 2018; Data on file, Lantheus Medical Imaging, Inc. 2021 Millennium Research Group, Inc. All rights reserved. (1), DEFINITY RT may be injected by either an intravenous bolus or infusion. ), More about getting RSS News & Updates from DailyMed, N=Sample size 1716 subjects who received activated DEFINITY, n=Number of subjects reporting at least one Adverse Reaction, Total Number of Subjects with an Adverse Reaction, Central and peripheral nervous system disorder, 0.35 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, MANUFACTURE(11994-017) , ANALYSIS(11994-017), ANALYSIS(11994-017) , MANUFACTURE(11994-017) , PACK(11994-017) , LABEL(11994-017), 5 To obtain yields >90%, it is necessary to reconstitute the antibody within the . 9 Schering Corporation 800-222-7579 DEFINITY RT may be administered as a simple, straight bolus injection followed by a 0.9% Sodium Chloride Injection, USP flush to offer an easy, rapid image enhancement in small doses. The mean half-life of OFP in blood was 1.9 minutes. Last updated on Oct 24, 2022. Handbook of Contrast Echocardiography. The RFID tag allows for the exchange of product information such as activation time and activation rate. Becher H, Burns PN. Follow the preparation and storage procedures, as well as directions for activation of DEFINITY RT carefully and adhere to strict aseptic procedures during preparation. The activation of DEFINITY RT will be achieved using the VIALMIX RFID device, which was approved in August 2020 . Cool: Any temperature between 8 and 15 (46 and 59 F) Room temperature: The temperature prevailing in a work area. In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. Background Treatment decisions in children with inflammatory bowel disease (IBD) are increasingly based on longitudinal tracking of faecal calprotectin concentrations, but there is little known about the stability of this protein in stool. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. Each mL of the clear liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE), 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in Water for Injection. 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. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Before injection, this product must be activated and prepared according to the instructions outlined below. Evidence of genotoxicity was not found in the following studies with activated Definity: 1) bacterial mutagenesis assay (Ames assay), 2) in vitro mammalian mutagenesis assay, 3) in vitro human lymphocyte chromosome aberration assay, and 4) in vivo rat micronucleus assay. Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. All Other Business: 800-362-2668 0
Full instructions for use of VIALMIX RFID are provided on the VIALMIX RFID screen and User's Guide. SECTION 10: STABILITY AND REACTIVITY . . The attenuation coefficient of Definity at 37 C was as much as 5 dB higher than the attenuation coefficient measured at 25 C. OFP is a stable gas that is not metabolized. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Follow all manufacturers' guidelines and do not operate any part of the VIALMIX RFID with DEFINITY RT RFID-tagged vials within 6 inches (15 cm) of a pacemaker and/or defibrillator. The DEFINITY RT vial contains components that upon activation and dilution yield perflutren lipid microspheres. The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)--[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- -methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Activated DEFINITY RT (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. Place the activated vial in the upright position and remove the flip-top cap. Contrast Agent Stability: A Continuous B-Mode Imaging Approach. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. DEFINITYRT offers multiple dosing and administration options to meet patient- and practicespecific needs.1. Available for Android and iOS devices. Additionally, cooling the diluted UCA suspension from 37 C to 25 C accelerated the dissolution rate. Then inject activated Definity (as described above) and begin ultrasound imaging immediately. In clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8. The mean half-life of OFP in blood was 1.9 minutes. Store the activated Definity at room temperature in the original product vial. Research, browse, save, and share from 202 F-150 models in Bancroft, KY. For ordering, tel. To find out more about how we use cookies, read our PRIVACY POLICY. No adverse developmental outcomes were observed in animal reproduction studies with administration of activated DEFINITY in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see Data). 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. (5.1). In the two placebo-controlled studies a total of 123 subjects were randomized in 1:2 ratio to receive two IV bolus doses of either saline (placebo) or activated Definity 10 microL/kg (17 placebo vs. 33 activated Definity patients and 24 placebo vs. 49 activated Definity patients, respectively). Hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) [, One (1) 2 mL RFID-tagged vial - NDC (11994-017-01), Twenty (20) 2 mL RFID-tagged vials per kit - NDC (11994-017-20). DEFINITY RT [package insert]. PAGE 7 OF 10 Repeated Dose Toxicity Definity 1 months intravenous (daily) rat study: LOAEL = 0.1 A sterile syringe or cap should be attached to the Luer . Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. After activation, each vial contains a maximum of 1.2 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) octafluoropropane [see DESCRIPTION (11)]. The stability of urine osmolality was assessed in a similar manner. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. FOR SINGLE USE ONLY: Definity does not contain bacterial preservative. Add 1.4mL preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITYRT vial. The outcome measures in these studies included the blinded assessment of ejection fraction (EF), endocardial border length (EBL) obtained by direct measurement, and qualitative assessment of wall motion. 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. DEFINITY was administered intravenously to rabbits at doses of 0.1, 0.3, and 1.0 mL/kg (approximately, 1.6, 4.8, and 16 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 7 to day 19 of gestation. OFP gas binding to plasma proteins or partitioning into blood cells has not been studied. Do not administer Definity by intra-arterial injection [see CONTRAINDICATIONS (4)]. Do not inject air into the DEFINITY RT vial. By continuing to use this website, you agree to our use of cookies. The VIALMIX apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica, MA, 01862. This study did not assess the effect of DEFINITY on visualization of cardiac or pulmonary structures. OFP is a stable gas that is not metabolized. For customer orders call 1-800-299-3431. In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). Generic name: perflutren Each mL of the viscous solution contains 3.75 mg lipid blend (consisting of 0.225 mg DPPA, 2.005 mg DPPC, and 1.520 mg MPEG5000 DPPE), 517.5 mg propylene glycol, 631 mg glycerin, 0.370 mg anhydrous sodium acetate, and 0.030 mg glacial acetic acid. Allow the vial to warm to room temperature before starting the activation procedure. Half of the solution was stored in a Drug class: Ultrasound contrast media. Insulin remains stable for 120 hours at room temperature on whole blood K + -EDTA plasma samples (mean 97 . in packages of four (4) and sixteen (16) single-use vials. Other adverse reactions that occurred in 0.5% of the activated Definity-dosed subjects were: Body as a Whole: Fatigue, fever, hot flushes, pain, rigors, and syncope, Cardiovascular: Abnormal ECGs, bradycardia, tachycardia, palpitation, hypertension and hypotension, Digestive: Dyspepsia, dry mouth, tongue disorder, toothache, abdominal pain, diarrhea and vomiting, Hematology: Granulocytosis, leukocytosis, leukopenia, and eosinophilia, Nervous System: Leg cramps, hypertonia, vertigo and paresthesia, Platelet, Bleeding, and Clotting: Hematoma, Respiratory: Coughing, hypoxia, pharyngitis, rhinitis and dyspnea, Special Senses: Decreased hearing, conjunctivitis, abnormal vision and taste perversion, Skin: Pruritus, rash, erythematous rash, urticaria, increased sweating, and dry skin. 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