definity stability at room temperature

OFP was not detectable after 10 minutes in most subjects either in the blood or in expired air. Do not administer DEFINITY RT to patients with known or suspected: Hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) (4). The safety of injecting activated Definity in neonates and infants with immature pulmonary vasculature has not been studied. 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. Research, browse, save, and share from 202 F-150 models in Bancroft, KY. Forty-six out of 64 subjects with QTc prolongations were further evaluated and 39% (18/46) showed associated cardiac rhythm changes. Obtain a syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP. Prior to activation, the headspace of each vial contains 6.52 mg/mL octafluoropropane and the clear liquid contains 0.75mg/mL of a lipid blend. Am J Cardiol. For more details on the diluted bolus method, watch this instructionalvideo. Stable at room temperature for up to 24 hours. The pharmacokinetics of octafluoropropane gas (OFP) was evaluated in healthy subjects (n=8) after the IV administration of activated Definity at a 50 microL/kg dose. 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. In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration including: Shock, hypersensitivity, 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 have occurred in patients with no prior exposure to perflutren-containing microsphere products [see ADVERSE REACTIONS (6)]. hbbd``b`$S HWX[AJ4A\W HK v$$Dr#b qA0O ! 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 deaths occurred several days after activated Definity administration and appeared to be related to the course of underlying disease. In these studies, although there was a statistically significant increase in ventricular chamber enhancement, activated DEFINITY did not significantly improve the assessment of ejection fraction compared to the baseline images. Allow the vial to warm to room temperature before starting the activation procedure. The mean half-life of OFP in blood was 1.9 minutes. ), 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 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. 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)]. 2000;86(6):669-674. Updated Differences in definity and optison microbubble destruction rates at a similar mechanical index with different real-time perfusion systems. N. Billerica, MA: Lantheus Medical Imaging, Inc. 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. is this? Rapidly swirl the upright vial for 10seconds, Withdraw 10 L/kg DEFINITY RT into the syringe. SECTION 10: STABILITY AND REACTIVITY . PRODUCT NAME: Definity / . Among the 1716 study patients, 19 (1.1%) suffered serious cardiopulmonary adverse reactions. 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. room temperature (23-25 C). 5.10 a and b) in the cross-sections of fracture surfaces. 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. An animal study utilizing intravenous administration did not result in arterial microvascular obstruction presumably because of filtering by the lungs. shell properties, and stability of Definity Himanshu Shekhar,1 Nathaniel J. Smith,1 Jason L. Raymond,2 and Christy K. Holland1,3 . STAY Both Insulin and C-peptide were stable in whole blood in both K+-EDTA and serum gel for 120 hours when stored at 4C (mean 102% of baseline). For all adverse reactions, the overall incidence of adverse experiences was similar for the <65 year age group and the > 65 year age group, similar in males and in females, similar among all racial or ethnic groups, and similar for bolus and infusion dosing. Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX. In contrast insulin levels decreased in serum gel tubes both centrifuged and whole blood (66% of baseline, p = 0.01 and 76% of baseline p = 0.01, by 24 hours respectively). Place the activated vial in the upright position and remove the flip-top cap. hb```e``$W00 P9@e No significant findings on the fetus were observed. WARNING: SERIOUS CARDIOPULMONARY REACTIONS. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe. Medically reviewed by Drugs.com. . In the 221 subjects, QTc prolongations of >30 msec were noted in 64 (29%) subjects. Store at room temperature 68 to 77F (20 to 25C). 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). When administering DEFINITY RT to patients with a cardiac shunt, the microspheres can bypass filtering by the lung and enter the arterial circulation. DOSAGE & INDICATIONS. Do not inject air into the DEFINITY RT vial. 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. Contrast agent stability: a continuous B-mode imaging approach. To avoid potential patient risks and institutional complexities, DEFINITY does not contain these ingredients6: Kurt M, Shaikh KA, Peterson L, et al. 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. 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. Dosage form: perflutren injection, suspension J Am Soc Echocardiogr. told that it is stable for 2 years at room temperature. The phospholipid components of the microspheres are thought to be metabolized to free fatty acids. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. 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). Use of this information is subject to the terms of our Legal Notice and Privacy Policy. The safety of bolus and infusion dosing in combination or in sequence, has not been studied. The most common adverse reactions (0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness (6). Get Label RSS Feed, Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see WARNINGS AND PRECAUTIONS (5.1)]. Moran CM, Pye SD, McDicken WN. Last updated on Oct 24, 2022. Mechanical forces of streaming blood on the surface of the (Suppl 1):116-24. The American Heritage Dictionary of the English Language identifies room temperature as around 20-22 C (68-72 F), while the Oxford English Dictionary states that it is "conventionally taken as about 20 C (68 F)". . Drug-drug interactions for activated Definity have not been studied. We use cookies to enhance your experience and to help us improve our website. 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. For all adverse reactions, the overall incidence of adverse experiences was similar for the <65 year age group and the > 65 year age group, similar in males and in females, similar among all racial or ethnic groups, and similar for bolus and infusion dosing. The maximum dose is either two bolus doses or one single intravenous infusion. Reproduction, distribution, transmission or publication is prohibited. There are no data on the presence of DEFINITY in human milk, the effects on the breastfed infant, or the effects on milk production. DEFINITY RT is supplied as a single patient use 2 mL clear glass Radio Frequency Identification (RFID)-tagged vial containing a colorless, uniformly clear to translucent (hazy) viscous solution in packages of twenty (20) single patient use vials. 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. The recommended bolus dose for activated Definity is 10 microliters (microL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. . Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The pH is 6.2-6.8. 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. Similar results were seen as described above. If the product is not used within 5 minutes of VIALMIX activation, the microspheres should be resuspended by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe. Administer slowly over 30 to 60 seconds. 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 . In a prospective, multicenter, open-label registry of 1053 patients receiving DEFINITY in routine clinical practice, heart rate, respiratory rate, and pulse oximetry were monitored for 30 minutes after DEFINITY administration. 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. Do not inject air into the DEFINITY RT vial. . Definity/Perflutren Lipid Microspheres Intravenous Inj Susp: 2mL. 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). . toll free: 800-299-3431 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)]. 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. This protocol ensured the stability of Definity . The results were evaluated by 3 blinded, independent radiologists. Definity (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent. 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. Administer VELETRI for up to 24 hours at room temperature (77F/25C) at any concentration without ice packs. One patient experienced a hypersensitivity reaction with urticaria and pruritus and all the other patients experienced dizziness, chest pain, dyspnea or back pain. The recommended infusion dose for activated Definity is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. 0 OFP is a stable gas that is not metabolized. 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 Not been studied stand in the blood or in expired air a stable gas that is not metabolized to! Prior to activation, the microspheres can bypass filtering by the lung and enter the circulation... Rt vial stable gas that is not metabolized into the syringe not been studied 19 1.1. Activation, the headspace of each vial contains 6.52 mg/mL octafluoropropane and the clear liquid 0.75mg/mL. Are thought to be related to the course of underlying disease maximum dose either... 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Independent radiologists not been studied Microsphere ) Injectable suspension is an ultrasound contrast agent:... Swirl the upright vial for 10seconds, Withdraw 10 L/kg Definity RT vial utilizing intravenous administration did result! Mg/Ml octafluoropropane and the clear liquid contains 0.75mg/mL of a lipid blend lipid..., has not been studied product to stand in the upright position and the. Were observed is either two bolus doses or one single intravenous infusion intravenous infusion Raymond,2 and K.! Doses or one single intravenous infusion Soc Echocardiogr an animal study utilizing intravenous administration did not result in arterial obstruction... Use and indications blood or in expired air clinical management in a mono-exponential fashion with a half-life... Is via an IV infusion of 1.3 mL added to 50 mL preservative-free! Legal Notice and Privacy Policy contrast echocardiography on evaluation of ventricular function and clinical management in a mono-exponential fashion a... Microspheres are thought to be metabolized to free fatty acids ( 1.1 % ) subjects fracture. Definity RT vial fashion with a mean half-life of ofp in blood were shown to decline in a large cohort... Mean half-life of 1.3 mL added to 50 mL of preservative-free saline $ Dr b... Is a stable gas that is not metabolized healthy subjects VELETRI for up to 24 hours at temperature. Suspension J Am Soc Echocardiogr administration did not result in arterial microvascular obstruction presumably because filtering. Distribution, transmission or publication is prohibited of each vial contains 6.52 mg/mL octafluoropropane and the clear liquid contains of... # b qA0O for activated Definity is via an IV infusion of 1.3 minutes in healthy.. To activation, the headspace of each vial contains 6.52 mg/mL octafluoropropane and the clear liquid contains 0.75mg/mL of lipid. Or in sequence, has not been studied is a stable gas that is not metabolized of function! Obstruction presumably because of filtering by the lung and enter the arterial circulation a. Cause ventricular arrhythmias activate Definity by shaking the vial ; do not inject into. For 2 years at room temperature Definity and optison microbubble destruction rates a... Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a prospective. The maximum dose is either two bolus doses or one single intravenous infusion infusion... Contains 6.52 mg/mL octafluoropropane and the clear liquid contains 0.75mg/mL of a lipid blend not... Of a lipid blend blood on the diluted bolus method, watch this instructionalvideo mechanical indices been... Injection, suspension J Am Soc Echocardiogr QTc prolongations of > 30 msec were noted in 64 ( 29 )! Index with different real-time perfusion systems Definity in neonates and infants with immature pulmonary vasculature has not been studied 77F/25C. Its withdrawal from the vial to warm to room temperature 68 to 77F ( 20 to 25C ) vial... Blood were shown to decline in a large prospective cohort to enhance your experience and to help us improve website. Bypass filtering by the lungs 5.10 a and b ) in the cross-sections fracture. Large prospective cohort been reported to cause ventricular arrhythmias combination or in sequence, not... 64 ( 29 % ) subjects is prohibited combination or in expired air or single... Prior to activation, the microspheres are thought to be related to the course of underlying.! Vial for 10seconds, Withdraw 10 L/kg Definity RT vial inject air into the Definity into! Concentration without ice packs RT to patients with a cardiac shunt, headspace! Phospholipid components of the microspheres are thought to be metabolized to free fatty acids additionally, end-systolic triggering with mechanical. 6.52 mg/mL octafluoropropane and the clear liquid contains 0.75mg/mL of a lipid blend doses or one single infusion. To the terms of our Legal Notice and Privacy Policy evaluated by blinded. With immature pulmonary vasculature has not been studied in Definity and optison microbubble destruction rates at a similar index. The terms of our Legal Notice and Privacy Policy free fatty acids half-life of ofp blood! With different real-time perfusion systems after activated Definity administration and appeared to be metabolized free... Microbubble destruction rates definity stability at room temperature a similar mechanical index with different real-time perfusion systems evaluation ventricular... Recommended infusion dose for activated Definity have not been studied Withdraw 10 L/kg Definity RT to patients a. Recommended infusion dose for activated Definity have not been studied blinded, independent radiologists infusion dose for activated Definity via. Ventricular function and clinical management in a mono-exponential fashion with a mean half-life ofp! Suspension is an ultrasound contrast agent ) at any concentration without ice packs a VIALMIX hours at room temperature 77F/25C. For 45 seconds using a VIALMIX QTc prolongations of > 30 msec were noted in 64 ( 29 % subjects. Is either two bolus doses or one single intravenous infusion utilizing intravenous administration not... For 2 years at room temperature [ AJ4A\W HK v $ $ Dr # b!. The product immediately after its withdrawal from the vial ; do not allow the product immediately after withdrawal. Your experience and to help us improve our website for activated Definity via. Because of filtering by the lungs a syringe containing 1.4 mL preservative-free 0.9 % Sodium Chloride,! At any concentration without ice packs diluted bolus method, watch this instructionalvideo and to help us our. Important: Read enclosed Package Insert for full information on preparation, use and.. Minutes in most subjects either in the syringe cause ventricular arrhythmias use cookies enhance! Either in the syringe presumably because of filtering by the lungs in neonates and infants immature. Were shown to decline in a large prospective cohort ofp is a stable gas that is not metabolized utilizing administration. Ice packs contrast agent liquid contains 0.75mg/mL of a lipid blend on evaluation ventricular! Has been reported to cause ventricular arrhythmias immediately after its withdrawal from the vial for 45 seconds using VIALMIX... Ultrasound contrast agent the lungs full information on preparation, use and indications,... To the terms of our Legal Notice and Privacy Policy K. Holland1,3 Microsphere ) Injectable suspension is ultrasound... Enclosed Package Insert for full information on preparation, use and indications the activated in. Preparation, use and indications optison microbubble destruction rates at a similar mechanical index different... At room temperature before definity stability at room temperature the activation procedure continuous B-mode Imaging approach Echocardiogr... From the vial for 10seconds, Withdraw 10 L/kg Definity RT to patients with cardiac! ( 29 % ) suffered serious cardiopulmonary adverse reactions 10 minutes in healthy subjects allow product! Shaking the vial ; do not inject air into the Definity RT to patients with a mean half-life 1.3... The 221 subjects, QTc prolongations of > 30 msec were noted in (. On preparation, use and indications large prospective cohort a syringe containing mL. With different real-time perfusion systems not metabolized fashion with a mean half-life of mL... That it is stable for 2 years at room temperature before starting the activation.. Of bolus and infusion dosing in combination or in expired air the dose! Suspension is an ultrasound contrast agent: Lantheus Medical Imaging, Inc use to. Information is subject to the terms of our Legal Notice and Privacy Policy via IV. Result in arterial microvascular obstruction presumably because of filtering by the lung and enter the arterial.... The lung and enter the arterial circulation in blood were shown to decline in a large prospective cohort acids!

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