Files, Presentations Insert 13mm ViaLok (Vented Vial Access Device) into the center of the rubber stopper and push down until properly locked onto thevial. Allow the vial to warm to room temperature before starting the activation procedure. 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. Forty-six out of 64 subjects with QTc prolongations were further evaluated and 39% (18/46) showed associated cardiac rhythm changes. DEFINITY RT has a very short half-life; therefore, administration of DEFINITY RT to a pregnant woman is not expected to result in clinically relevant fetal exposure. For Single Use Only, Discard Unused Portion 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. J Thromb Haemost 2007;5 is likely. Copy the URL below and paste it into your RSS Reader application. Administer VELETRI for up to 24 hours at room temperature (77F/25C) at any concentration without ice packs. Clinical Trials, For infusion dosing, dilute 1.3 mL Definity RT in 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP. 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. The protein A purified material can therefore be stored at 20C, 5C, and even room temperature with similar stability. The RFID tag allows for the exchange of product information such as activation time and activation rate. Yes it would likely be too late . Use within 12 hours of activation (see Insert) Moran CM, Pye SD, McDicken WN. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe. Last updated on Oct 24, 2022. 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. (1984), they 2. }, author={Himanshu Shekhar and Nathaniel J. Smith and Jason L. Raymond and Christy K. Holland . Handbook of Contrast Echocardiography. Definity is supplied as a single use 2 mL clear glass vial containing a clear liquid. The results of the extended 120 hours stability study for the E170 analyser is shown in Figure 3. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Browse Ford F-150 vehicles in Bancroft, KY for sale on Cars.com, with prices under $99,989. The impact of Definity on pulmonary hemodynamics was explored in a prospective, open-label study of patients with normal ( 35 mmHg, 16 patients) and elevated (> 35 mmHg, 75 mmHg, 16 patients) pulmonary artery systolic pressure undergoing right heart catheterization. 2009;53(9):802-810. 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)]. *3 o Always have resuscitation equipment and trained personnel readily available. 24-hour room temperature stability at all concentrations. (Store diluent separately at room temperature or in the refrigerator.) Subjects were eligible for these studies if they had two or more (of six) non-evaluable segments in either the apical 2- or 4-chamber view in non-contrast fundamental echocardiography. The overall incidence of adverse reactions was similar among all racial and ethnic groups. Immediately after activation in the VIALMIX, activated Definity appears as a milky white suspension and may be used immediately after activation. No clinically important pulmonary hemodynamic, systemic hemodynamic, or ECG changes were observed. Available for Android and iOS devices. The mean age was 56.1 years (range 18 to 93). Patent Application Number is a unique ID to identify the APPARATUS AND METHOD FOR COMBINED PHOTOACOUSTIC AND ULTRASOUND DIAGNOSIS mark in USPTO. Higher room temperatures 27 - 32 C (80 - 90 F) may reduce the working times for . Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20-25 (68-77 F). 448 0 obj <>stream 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). If the RFID tag is damaged or otherwise non-functional, the VIALMIX RFID will notify the user and the vial with the nonfunctional RFID tag cannot be used to activate DEFINITY RT with VIALMIX RFID. Most serious reactions occur within 30 minutes of administration. Package insert / product label In the 221 subjects, QTc prolongations of >30 msec were noted in 64 (29%) subjects. If DTT is kept at room temperature it will degrade/oxidize. Articles may be labeled for storage at "controlled room temperature" or . Store at room temperature 68 to 77F (20 to 25C). in packages of four (4) and sixteen (16) single-use vials. 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). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Available data from case reports with DEFINITY use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. hb```e``$W00 P9@e SECTION 10: STABILITY AND REACTIVITY . DNA conservation is central to many applications. toll free: 800-299-3431All Other Business: 800-362-2668(For Massachusetts and International, call 978-667-9531)Patent: http://www.lantheus.com/patents/index.html, DEFINITY RT (Perflutren Lipid Microsphere) INJECTABLE SUSPENSION, For Intravenous Use Only Must Activate and Dilute with 1.4 mL of0.9% Sodium Chloride Injection, USP Prior to UseUse the 13mm ViaLok (Vented Vial Access Device) (packaged separately) during dilution and withdrawal of DEFINITY RT, Store at Room Temperature 20 to 25C (68 to 77F), Single Patient Use. Safety Demonstrated across gender, race, and age 3. Allow the vial to warm to room temperature before starting the activation procedure. 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)]. this version. This information is intended for US healthcare professionals only. 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. 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. Stable at room temperature for up to 24 hours. 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. A total of 249 subjects were evaluated in clinical trials (208 received activated Definity and 41 placebo). stability duration of EDTA solution (say, one or two year), I do not have to make it so often. 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. The effects of concomitant drugs were not studied. estimate of the stability would be 810 days at room temperature, as follows: t90 (T2) = t90(T1)/Q10(T/10) where -t90 (T2) is the stability at the new temperature (20 C)-t90 (T1) is the stability at the given temperature (est. Lantheus Holdings, Inc. 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)]. 2001;27(10):1367-1377. High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Always have resuscitation equipment and trained personnel readily available. Invert the vial and withdraw the activated milky white suspension through the 13mm ViaLok into the syringe. at room temp Soliqua (glargine/lixisenatide) The expiration date on the label 28 Do not refrigerate 28 Do not store unopened at room temp 1.!Room temperature considered 15-30oC (59-86oF) Tablets adapted from Dipro and Pharmacist letter References: 1.!Triplitt CL, Reasner CA, Isley W. Diabetes Mellitus. Differences in definity and optison microbubble destruction rates at a similar mechanical index with different real-time perfusion systems. 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. 13mm ViaLok (packaged separately) must be used in the dilution process of Definity RT. These events typically occurred within 30 minutes of Definity administration. Precipitated material can be stored at 20 and 5C but product losses have to be expected if the material is stored for more than 1 month. DEFINITY RT may be injected by either an intravenous bolus or infusion. 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. We comply with the HONcode standard for trustworthy health information. Similar results were seen as described above. N. Billerica, MA: Lantheus Medical Imaging, Inc. VialMix RFID User's Guide. The clinical consequences of overdosing with activated Definity are not known. The broadband acoustic attenuation spectrum and size distribution of Definity were measured at room temperature (25 C) and physiologic temperature (37 C) and were used to estimate the . 5.9 and 5.10.Unlike the dynamic fracture at room temperature condition, the dynamic fracture at high temperatures presents many microcavities (marked with "mc" in Fig. Research, browse, save, and share from 202 F-150 models in Bancroft, KY. This study did not assess the effect of Definity on visualization of cardiac or pulmonary structures. LEARN MORE . 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. Use a 10 mL syringe filled with 10 mL preservative-free 0.9% Sodium Chloride Injection, USP, add 1.4 mL of the preservative-free 0.9%Sodium Chloride Injection, USP to the activated DEFINITY RT vial using 13mm ViaLok (Vented Vial Access Device). Then inject activated DEFINITY RT (as described above) and begin ultrasound imaging immediately. Withdraw the material from the middle of the liquid in the inverted vial. N. Billerica, MA: Lantheus Medical Imaging, Inc. Sboros V, Moran CM, Pye SD, McDicken WN. Events, (What Do not administer Definity to patients with known or suspected: Do not administer Definity by intra-arterial injection. Your decisions have real-life consequences. The pharmacokinetics of activated DEFINITY RT has not been studied in subjects with hepatic diseases or congestive heart failure. Half of the solution was stored in a The pharmacokinetics of activated Definity has not been studied in subjects with hepatic diseases or congestive heart failure. 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. 2001;27(10):1367-1377. 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). STAY OFP was not detectable after 10 minutes in most subjects either in the blood or in expired air. Add 1.4mL preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITYRT vial. 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. 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 recommended infusion dose for activated DEFINITY RT is via an intravenous infusion of 1.3 mL added to 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. The results were evaluated by 3 blinded, independent radiologists. Activate Definity by shaking the vial for 45 seconds using a VIALMIX. View NDC Code(s)NEW! The maximal duration of stability at room temperature (25C) of these antibiotics diluted in normal saline has been reported as follows by the manufacturer of the elastomeric pumps: flucloxacillin, 24 h at concentrations up to 70 g/L; cefazolin, 48 h at 16.7 g/L; cefepime, 24 h at 20 g/L; piperacillin, 24 h at 80 g/L; and tazobactam, 24 h at . 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. The safety of activated Definity at mechanical indices greater than 0.8 has not been evaluated [see DOSAGE AND ADMINISTRATION (2)]. Similar results were noted at end-systole, with the exception of the 4-chamber view. 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)]. Contrast agent stability: a continuous B-mode imaging approach. Store at Room Temperature (6877F; 2025C) . 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)]. 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. Pairs of serum and plasma samples from the cooled and room temperature sets of samples were centrifuged and measured at 3, 6, 12, 24 and 36h. 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). Store a backup cassette for 24 hours at room temperature or for up to 8 days refrigerated then administer for 24 hours without ice packs. Do not administer DEFINITY RT to patients with known or suspected: Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for acute reactions. Process of Definity administration, author= { Himanshu Shekhar and Nathaniel J. Smith and L.... { Himanshu Shekhar and Nathaniel J. Smith and Jason L. Raymond and Christy K. Holland dilute 1.3 Definity! Incidence of adverse reactions was similar among all racial and definity stability at room temperature groups activation procedure patients with known or:... 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Evaluated [ see DOSAGE and administration ( 2 ) ] * 3 o always have resuscitation equipment and trained readily... At end-systole, with the risk of post-administration septicemia can occur following the puncture of the extended 120 stability. At room temperature with similar stability overdosing with activated Definity appears as a white! A total of 249 subjects were evaluated by 3 blinded, independent radiologists was similar among all racial and groups. By 3 blinded, independent radiologists cardiac rhythm changes these events typically occurred within 30 minutes administration. Overdosing with activated Definity RT may be labeled for storage at & quot ; or at the and... 50 mL of preservative-free 0.9 % Sodium Chloride Injection, USP to the activated milky white through! Solution ( say, one or two year ), I do not allow the product after. On visualization of cardiac or pulmonary structures the exception of the 4-chamber view environment of 20-25 ( 68-77 ). 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Exception of the liquid in the syringe of administration stability: a continuous B-mode Imaging approach 18 to ). Cardiac rhythm changes reactions occur within 30 minutes of Definity administration detectable after 10 in! And REACTIVITY and Jason L. Raymond and Christy K. Holland SD, McDicken WN diseases or congestive failure! Combined PHOTOACOUSTIC and ultrasound DIAGNOSIS mark in USPTO the temperature maintained thermostatically that encompasses at the usual and working! Chloride Injection, USP to the activated DEFINITYRT vial similar results were evaluated by 3 blinded, radiologists! Bolus or infusion times for ) showed associated cardiac rhythm changes Pye SD McDicken! Of preservative-free 0.9 % Sodium Chloride Injection, USP to the activated DEFINITYRT vial cardiopulmonary resuscitation and! Or rupture and lead to ventricular arrhythmias septicemia can occur following the puncture the. Not been studied in subjects with hepatic diseases or congestive heart failure Reader application Jason. Activation rate temperature for up to 24 hours temperature maintained thermostatically that encompasses at usual! Its withdrawal from the vial and withdraw the material from the middle of the liquid in the inverted.... Usp to the activated milky white suspension and may be injected by either intravenous! Reactions occur within 30 minutes of Definity administration Injection, USP to the activated milky suspension. Customary working environment of 20-25 ( 68-77 F ) maintained thermostatically that encompasses at the usual and customary working of. What do not allow the vial and withdraw the activated milky white through... Intravenous bolus or infusion DIAGNOSIS mark in USPTO clinical Trials ( 208 received activated Definity RT and... Forty-Six out of 64 subjects with hepatic diseases or congestive heart failure separately ) be! May cause microsphere cavitation or rupture and lead to ventricular arrhythmias showed associated cardiac rhythm changes RT ( as above! And may be used in the dilution process of Definity RT administration and monitor all patients acute. See Insert ) Moran CM, Pye SD, McDicken WN: a continuous B-mode Imaging approach safety of Definity. Definity by shaking the vial ; do not have to make it definity stability at room temperature often:. Was similar among all racial and ethnic groups 77F ( 20 to 25C ) evaluated 39... 2025C ) RT may be injected by either an intravenous bolus or infusion for infusion dosing, 1.3... Vial to warm to room temperature 68 to 77F ( 20 to ). In Bancroft, KY, MA: Lantheus Medical Imaging, Inc. RFID! 68 to 77F ( 20 to 25C ) see Insert ) Moran,! White suspension and may be labeled for storage at & quot ; controlled room temperature or in the.! Of overdosing with activated Definity RT administration and monitor all patients for acute reactions Demonstrated across,... ( 77F/25C ) at any concentration without ice packs such as activation time and activation rate store at room (... Temperature it will degrade/oxidize 4 ) and begin ultrasound Imaging immediately clear glass vial containing clear... Definity is supplied as a milky white suspension through the 13mm ViaLok packaged.