In patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts phospholipid-encapsulated microspheres can bypass the pulmonary particle-filtering mechanisms and directly enter the arterial circulation resulting in microvascular occlusion and ischemia. If not used within 5 minutes the microspheres should be resuspended by rapidly swirling the upright vial for 10 seconds before the product is withdrawn in a syringe. In a crossover trial of 64 patients randomized to both bolus and infusion using DEFINITY, 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 0.9% Sodium Chloride Injection, USP at a rate of 4 mL/min. 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. The targeting moiety that targets DNA is typically an antibody, or variant, fragment, or fusion protein derived therefrom that binds . If not used immediately, the activated, diluted DEFINITY RT can be stored at room temperature 20 to 25C (68 to 77F) in the original product vial with the 13mm ViaLok still attached for up to 4 hours. 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)]. These physical acoustic properties of activated Definity provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography. No deaths or serious adverse reactions were reported, suggesting that these reactions are unlikely to occur at a rate of more than 0.3% when Definity is used according to recommendations. Research, browse, save, and share from 202 F-150 models in Bancroft, KY. After activating the contents of the vial in a VIALMIX RFID and diluting with 1.4 mL of preservative-free 0.9% Sodium Chloride, Injection, USP, each mL of the milky white suspension contains 0.045 mg DPPA, 0.401 mg DPPC, 0.304 mg MPEG5000 DPPE, 0.074 mg anhydrous sodium acetate, 0.006 mg glacial acetic acid, a maximum of 1.2 1010 perflutren lipid microspheres, and about 80 microL/mL (0.65 mg/mL) octafluoropropane. However, because product labeling was insufficient regarding room-temperature stability and pharmacists were not routinely able to predict stability based on the . The mean age was 56.1 years (range 18 to 93). We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. told that it is stable for 2 years at room temperature. The total lung clearance of OFP was similar to that in healthy subjects. OFP concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects. The microsphere particle size parameters are listed in Table 11.1 below: Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. Store the activated Definity at room temperature in the original product vial. A sterile syringe or cap should be attached to the Luer . 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. There were 26 serious adverse events and 15 (0.9%) subjects discontinued because of an adverse event. Amgen 800-772-6436 Formoterol (Foradil) Prior to dispensing, refrigerate at 36 to 46 F (2 to 8C). For more details on the continuous infusion, watch this instructionalvideo. (5.1). Your decisions have real-life consequences. See Full Prescribing Information for instructions on preparation and administration. this version. Definity (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent. Clinically assess patients for prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives. DEFINITY RT is supplied as a single patient use 2 mL RFID-tagged clear glass vial containing a colorless, uniformly clear to translucent (hazy) viscous solution in packages of twenty (20) single patient use vials. Distributed ByLantheus Medical Imaging331 Treble Cove RoadN. Off-label information indicates stable when maintained at room temperature for up to 6 months. N. Billerica, MA: Lantheus Medical Imaging, Inc. Cold: Any temperature not exceeding 8C (46 F). Among the 1716 study patients, 19 (1.1%) suffered serious cardiopulmonary adverse reactions. The VIALMIX apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica, MA, 01862. In postmarketing use, serious hypersensitivity reactions were observed during or shortly following perflutren-containing microsphere administration including: Anaphylaxis, with manifestations that may include death, shock, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEFINITY RT and any potential adverse effects on the breastfed infant from DEFINITY RT or from the underlying maternal condition. J Thromb Haemost 2007;5 is likely. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for acute reactions. Then inject activated Definity (as described above) and begin ultrasound imaging immediately. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. There are two formulations of perflutren lipid microspheres that have differences concerning storage and preparation. The rate of infusion should be initiated at 4 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute. Files, Presentations Specific . 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. Differences in definity and optison microbubble destruction rates at a similar mechanical index with different real-time perfusion systems. Store at Room Temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP . Left ventricular chamber enhancement after an activated Definity dose of 10 microL/kg was significantly increased from baseline compared to placebo in both views at the mid-ventricular and apical levels at end-diastole. Invert the vial and withdraw the activated milky white suspension using the Intellipin (Dispensing Pin) or 18 to 20 gauge syringe needle. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). When handling small quantities in a clinical setting, good room ventilation is desirable. Patients receiving activated Definity should be instructed to inform their healthcare provider if they: Distributed By Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. ECG parameters for doses up to 10 microL/kg were monitored in 221 subjects at multiple time points from 1 hour to 72 hours after the first bolus injection. Additionally, cooling the diluted UCA suspension from 37 C to 25 C accelerated the dissolution rate. (1), DEFINITY RT may be injected by either an intravenous bolus or infusion. *3 o Function of the RFID technology is not dependent on vial orientation as it is placed in the VIALMIX RFID. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. The activated DEFINITY RT may be used for up to 4 hours from the time of dilution, with the 13mm ViaLok still attached, but only after the microspheres are resuspended by rapidly swirling the upright vial for 10 seconds. Articles may be labeled for storage at "controlled room temperature" or . Octafluoropropane is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. stability at room temperature and -20 C. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for hypersensitivity reactions. A sterile syringe or cap should be attached to the Luer fitting on the ViaLok until use. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying conditions. This method is well-suited for studies performed over an extended period. DEFINITY RT may be injected by either an intravenous bolus or infusion. had no data to evaluate the stability of this drug during continuous infusion in a tropical country. Assay of antibacterial activity. The unactivated vial contains a colorless, uniformly clear to translucent (hazy), viscous, sterile, non-pyrogenic solution, which upon activation with the aid of a VIALMIX RFID and dilution with 0.9% Sodium Chloride Injection, USP, provides a homogeneous, hypertonic, milky white injectable suspension of perflutren lipid microspheres. Also, in 13 to 37% of the patients, depending on the reader, activated DEFINITY was found to obscure the wall motion rendering the image non-evaluable. In clinical trials, the overall incidence of adverse reactions was similar for the <65 year age group and the 65 year age group. 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)]. N. Billerica, MA: Lantheus Medical Imaging, Inc. Sboros V, Moran CM, Pye SD, McDicken WN. @article{Shekhar2018EffectOT, title={Effect of Temperature on the Size Distribution, Shell Properties, and Stability of Definity{\textregistered}. Sonne C, Xie F, Lof J, et al. See full prescribing information for DEFINITY. 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, and the following structural formula: Prior to VIALMIX activation, the Definity vial contains 6.52 mg/mL octafluoropropane in the headspace. The incubation of authen-tic allicin and the aqueous garlic extract was performed at 4-42 C, using a water bath or just in temperature-controlled room (at 4 and 37 C) for 30d or less. The mean age was 56.1 years (range 18 to 93). The stability of platelet counts according to the 1 CV lower CVI, higher CVI, BV DES2014, EFLM 2019b, and IQMH methods was extended to 240 min when stored at room temperature and the stability of PDW and plateletcrit as determined by all tested methods were extended to 240 min when stored at 4C. DEFINITY RT is a modified formulation of DEFINITY that allows both storage and shipment at room temperature (DEFINITY's previously approved formulation requires refrigerated storage). The outcome measure for assessing the effectiveness of activated DEFINITY was the blinded assessment of improvement in ventricular chamber enhancement (measured by videodensitometry at end-diastole and end-systole). The activation of DEFINITY RT will be achieved using the VIALMIX RFID device, which was approved in August 2020 . 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 example, if I modelled the compound $\ce{BaSr(FeO3)2}$, I could compare its potential energy with that of the possible decompositions such as $\ce{SrFeO3}$ & $\ce{BaFeO3}$ and make a judgement on the . . attenuation spectrum and size distribution of Definity were measured at room temperature (25 C) and physiological temperature (37 C), and were used to estimate the viscoelastic shell . Administer slowly over 30 to 60 seconds. 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. 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). STAY It is essential to follow directions for activation of Definity carefully and to adhere to strict aseptic procedures during preparation. PubMed, These physical acoustic properties of activated DEFINITY RT provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography. June 22, 2021. 331 Treble Cove Road A total of 1716 subjects were evaluated in pre-market clinical trials of activated Definity. Invert the vial and withdraw the activated milky white suspension using the Intellipin (Dispensing Pin), the PINSYNC (Vented Vial Adapter 13mm), or 18 to 20 gauge syringe needle. After activation and dilution with 0.9% Sodium Chloride Injection, USP, each vial contains a maximum of 1.2 1010 perflutren lipid microspheres, and about 80 microL/mL (0.65 mg/mL) octafluoropropane [see Description (11)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions and/or with pre-existing PEG hypersensitivity [see Adverse Reactions (6.2)]. Contrast Agent Stability: A Continuous B-Mode Imaging Approach. Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20-25 (68-77 F). Activate Definity by shaking the vial for 45 seconds using a VIALMIX. Farooq W 2005-07-17 15:53:24 UTC. Obtain a syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP. is this? In the primary serum and K. 3. OFP gas binding to plasma proteins or partitioning into blood cells has not been studied. Invert the vial and withdraw the activated milky white suspension using the Intellipin (Dispensing Pin) or 18 to 20 gauge syringe needle. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Ultrasound in Med & Biol. 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. J Am Soc Echocardiogr. Store at Room Temperature (6877F; 2025C), Attach ViaLok Add 1.4mL preservative-free Sodium Chloride Injection,USP, VIALMIX RFID delivers precise activation, providing predictable, quality images from study to study1-3. CONTAINS NO BACTERIOSTATIC PRESERVATIVE. 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)]. Events, There were 15 discontinuations reported with a mean age of 41.5 years. However, OFP protein binding is expected to be minimal due to its low partition coefficient into whole blood. Fatal cardiopulmonary and anaphylactoid events and other serious but non-fatal adverse reactions were uncommonly reported. This information is intended for US healthcare professionals only. . If necessary, a second 10 microliters (microL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. 293 0 obj <>/Filter/FlateDecode/ID[<316805100FC3334C9C0FC2F3BB8F54E7><1904E91B490DF245BC538048FE28EB0F>]/Index[276 173]/Info 275 0 R/Length 97/Prev 159940/Root 277 0 R/Size 449/Type/XRef/W[1 2 1]>>stream 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. 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