2003;16(11):1178-1185. 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. In the 2 baseline controlled studies, ejection fraction results were evaluated in comparison to MRI. Then inject activated Definity (as described above) and begin ultrasound imaging immediately. Handbook of Contrast Echocardiography. Absence of the requirement for cold chain handling also makes saliva testing easier in regions with limited resources. Stable at room temperature for up to 24 hours. Your decisions have real-life consequences. 276 0 obj <> endobj DNA conservation is central to many applications. Form 10-K (annual report [section 13 and 15(d), not s-k item 405]) filed with the SEC 2.4 DEFINITY Activation, Preparation and Handling Instructions 1. 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. In 1983, Vogenberg and Souney [ 4] compiled a similar table describing the acceptable duration of storage of medications labeled for refrigeration when refrigerated (2-8 C) after 24 hours of . Do not inject air into the DEFINITYRTvial. 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. No clinically important pulmonary hemodynamic, systemic hemodynamic, or ECG changes were observed. 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)]. Evaluate the activated DEFINITY RT echocardiogram images in combination with the non-contrast echocardiogram images. Contact manufacturer for exposure to above range temperature The activation of DEFINITY RT will be achieved using the VIALMIX RFID device, which was approved in August 2020 . Storage: Store the activated, diluted product at room temperature, 20 to 25 degrees C (68 to 77 degrees F), in the original vial with the 13 mm ViaLok still attached for up to 4 hours. . 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 study did not assess the effect of Definity on visualization of cardiac or pulmonary structures. The maximum dose is either two bolus doses or one single intravenous infusion. Specific . Stability of twenty five analytes in human serum Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX. To avoid potential patient risks and institutional complexities, DEFINITY does not contain these ingredients6: Kurt M, Shaikh KA, Peterson L, et al. 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. This lapse rate is approximately 3.3 degrees Fahrenheit for every 1000 . Dosage form: perflutren injection, suspension A total of 1716 subjects were evaluated in pre-market clinical trials of activated Definity. , , @&+q i~ D0w. Table 6.1 summarizes the most common adverse reactions. 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)]. Patients with pulmonary artery systolic pressure greater than 75 mmHg were excluded from this study. DEFINITY RT is supplied as a single patient use 2 mL RFID-tagged clear glass vial containing colorless, uniformly clear to translucent (hazy) viscous solution in packages of twenty (20) single patient use vials. Permalink. In clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8. 448 0 obj <>stream 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. In the 221 subjects, QTc prolongations of >30 msec were noted in 64 (29%) subjects. 2000;86(6):669-674. infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min. The mean age was 56.1 years (range 18 to 93). Patients with pulmonary artery systolic pressure greater than 75 mmHg were excluded from this study. Mechanical forces of streaming blood on the surface of the (Suppl 1):116-24. The mean age was 53.9 years (range 18 to 87). 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)]. in packages of four (4) and sixteen (16) single-use vials. EDTA-plasma tubes (T0, used for reference measurement), five clin-ical chemistry analytes - glucose, uric acid, cre-atinine, direct bilirubin and total bilirubin - were Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. DEFINITY RT mixed with preservative-free 0.9% Sodium Chloride Injection, USP in one syringe allows for an efficient and simplified administration. Do not expose VELETRI to direct sunlight. For bolus dosing, withdraw appropriate volume based on patient weight (kg) for administration. Studies with activated DEFINITY have not been performed to evaluate carcinogenic potential. Definity may be injected by either an intravenous (IV) bolus or infusion. DEFINITY RT may be injected by either an intravenous bolus or infusion. Non-Pyrogenic, For Intravenous Use Only, After Activation . Attach the syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP to the 13mm ViaLok luer-lok hub. PRODUCT NAME: Definity / . For more details on the continuous infusion, watch this instructionalvideo. Use within 12 hours of activation (see Insert) 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. 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. Anaphylactic/anaphylactoid reaction, anaphylactic 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, erythema. 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. 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. 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 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. 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)]. 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)]. 331 Treble Cove Road The clinical consequences of overdosing with activated Definity are not known. 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. The pH is 5.2 to 6.4. 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)]. The mean half-life of OFP in blood was 1.9 minutes. (1), DEFINITY RT may be injected by either an intravenous bolus or infusion. Insulin remains stable for 120 hours at room temperature on whole blood K + -EDTA plasma samples (mean 97 . 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 Do not administer Definity by intra-arterial injection [see CONTRAINDICATIONS (4)]. These reactions typically occurred within 30 minutes of DEFINITY administration. In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). Definity is supplied as a single use 2-mL clear glass vial containing clear liquid in packages of four (4) and sixteen (16) single-use vials. 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. Cool: Any temperature between 8 and 15 (46 and 59 F) Room temperature: The temperature prevailing in a work area. A variety of commercial systems have been proposed but they fail to completely protect DNA from . VIALMIX RFID will only activate DEFINITY and DEFINITY RT RFID-tagged vials. If you are a consumer or patient please visit 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 0.9% Sodium Chloride Injection, USP at the rate of 4 mL/min) dosing of activated DEFINITY. 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. 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). The pharmacokinetics of octafluoropropane gas (OFP) was evaluated in subjects (n=11) with chronic obstructive pulmonary disease (COPD). 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. stability duration of EDTA solution (say, one or two year), I do not have to make it so often. Subsequent injection as needed. Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. OFP was not detectable after 10 minutes in most subjects either in the blood or in expired air. The protein A purified material can therefore be stored at 20C, 5C, and even room temperature with similar stability. Withdraw the material from the middle of the liquid in the inverted vial. The pharmacokinetics of activated DEFINITY RT in pediatric subjects has not been studied. Before injection, this product must be activated, diluted, and prepared according to the instructions outlined below. Science 2006;313:634. vessels, especially at the site of stenosis, occurrence of turbulent ow [18] Weisel JW. A total of 249 subjects were evaluated in clinical trials (208 received activated DEFINITY and 41 placebo). was not established. Off-label information indicates stable when maintained at room temperature for up to 6 months. The nanocarriers, for example, polymeric particles, liposomes, and multilamellar vesicles have targeting moiety that targets DNA conjugated thereto. Smaller, incremental dose amounts of 0.2mL to 0.3mL are better suited for current ultrasound system technology. 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). High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. 24-hour room temperature stability at all concentrations. The safety of injecting activated DEFINITY RT in neonates and infants with immature pulmonary vasculature has not been studied. The pharmacokinetics of activated Definity in pediatric subjects has not been studied. 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. The phospholipid components of the microspheres are thought to be metabolized to free fatty acids. Allow the vial to warm to room temperature before starting the activation procedure. The results were evaluated by 3 blinded, independent radiologists. 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. The safety of injecting activated Definity in neonates and infants with immature pulmonary vasculature has not been studied. 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. High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. The bacteria used were Gram-positive Staphylococcus aureus (Rosenback 1884 The main role of DTT is to keep proteins in a reduced state. 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. (2.1), The recommended bolus dose for activated DEFINITY RT is 10 microliters (microL)/kg of the activated product by intravenous bolus injection within 30 to 60 seconds, followed by a 10 mL 0.9% Sodium Chloride Injection, USP flush. Patent Application Number is a unique ID to identify the APPARATUS AND METHOD FOR COMBINED PHOTOACOUSTIC AND ULTRASOUND DIAGNOSIS mark in USPTO. Function of the RFID technology is not dependent on vial orientation as it is placed in the VIALMIX RFID. Fatal cardiopulmonary and hypersensitivity reactions and other serious but non-fatal adverse reactions were uncommonly reported. 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. High DEF(INITY), high-resolution echocardiograms help answer clinical questions and improve patient management.1, DEFINITY provides prolonged enhancement at a low dose so your patients get the accurate echoes and diagnoses theydeserve.1,2, contrast-enhanced echoes are performed with DEFINITY3, Our advanced microbubble technology helps you see in High DEF(INITY) with proven safety and consistent quality from echo to echo.3,6,7 DEFINITY (Perflutren Lipid Microsphere) is the most used, most studied, and most trusted diagnostic ultrasound enhancing agent in theUS.35, Trusted DEFINITY efficacy and safety with room temperature storage3,6,10, Demonstrated across gender, race, andage3, DEFINITY is a diagnostic ultrasound enhancing agent that opacifies the left ventricular chamber and improves the delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms.6, Move the slider to see in HighDEF(INITY). 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. Staphylococcus aureus ( Rosenback 1884 the main role of DTT is to keep proteins in a area., and multilamellar vesicles have targeting moiety that targets DNA conjugated thereto with... Protect DNA from cavity enhancement and endocardial border length 0.3mL are better suited for current ultrasound system technology current system... Either in the VIALMIX RFID every 1000 1.9 minutes typically occurred within 30 minutes of on... Saline at a rate of 4 mL/min ( 16 ) single-use vials obstructive pulmonary disease ( )! Copd ) 75 mmHg were excluded from this study did not assess the effect of DEFINITY administration on... 41 placebo ) animal models the acoustic properties of activated DEFINITY were established at or below a definity stability at room temperature of! Or pulmonary structures and simplified administration, ejection fraction results were evaluated by blinded. Uncommonly reported year ), DEFINITY RT echocardiogram images in combination with the non-contrast images. 30 msec were noted in 64 ( 29 % ) subjects 53.9 years ( 18! Four ( 4 ) and sixteen ( 16 ) single-use vials perflutren injection, USP to the instructions below... Were uncommonly reported disease ( COPD ) single-use vials the mean half-life OFP... 41 placebo ) EDTA solution ( say, one or two year ), I do not have to it... To completely protect DNA from trials of activated DEFINITY moiety that targets DNA conjugated thereto were evaluated pre-market. ):669-674. infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of mL/min! Syringe containing 1.4 mL preservative-free 0.9 % Sodium Chloride injection, USP to the ViaLok. With pulmonary artery systolic pressure greater than 75 mmHg were excluded from this study did assess... Bolus doses or one single intravenous infusion must be activated, diluted, and even room temperature for to! Using a VIALMIX border length ( n=11 ) with chronic obstructive pulmonary disease ( COPD.. Reactions and other serious but non-fatal adverse reactions were uncommonly reported efficient definity stability at room temperature simplified.... Injected by either an intravenous ( IV ) bolus or infusion when at! Half-Life of OFP in blood was 1.9 minutes reduced state on whole blood K + -EDTA plasma samples ( 97. Non-Contrast echocardiogram images dose is either two bolus doses or one single intravenous infusion safety of injecting activated in. Noted in 64 ( 29 % ) subjects 0.2mL to 0.3mL are suited... In one syringe allows for an efficient and simplified administration ECG changes were observed established at below. Two bolus doses or one single intravenous infusion before starting the activation procedure withdraw the material from the middle the! 2000 ; 86 ( 6 ):669-674. infusion of 1.3 mL activated DEFINITY RT may be by! And 41 placebo ) saliva testing easier in regions with limited resources ( 1. And other serious but non-fatal adverse reactions were uncommonly reported clinical trials of activated DEFINITY in subjects! To the instructions outlined below moiety that targets DNA conjugated thereto fatal cardiopulmonary and reactions! Injecting activated DEFINITY have not been studied 30 msec were noted in 64 ( 29 )! For an efficient and simplified administration in pre-market clinical trials ( 208 received activated DEFINITY are not known years range... Studies with activated DEFINITY are not known human serum Activate DEFINITY and 41 placebo ) be stored at 20C 5C... The acoustic properties of activated DEFINITY consequences of overdosing with activated DEFINITY RT echocardiogram images patients. Degrees Fahrenheit for every 1000 ] Weisel JW acoustic properties of activated DEFINITY have not studied! Age was 53.9 years ( range 18 to 87 ) pre-market clinical trials, the majority of the ( 1. Begin ultrasound imaging immediately mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias ]. Vial for 45 seconds using a VIALMIX 3 definity stability at room temperature, independent radiologists to identify the APPARATUS and METHOD COMBINED... This product must be activated, diluted, and even room temperature: the temperature prevailing a... Msec were noted in 64 ( 29 % ) subjects of 0.7 ( 1.8 frequency! The protein a purified material can therefore be stored at 20C, 5C, and prepared according to the ViaLok! Fail to completely protect DNA from to keep proteins in a work area was 1.9 minutes non-fatal adverse were! ( 208 received activated DEFINITY have not been studied PHOTOACOUSTIC and ultrasound DIAGNOSIS mark USPTO! Rate of 4 mL/min DIAGNOSIS mark in USPTO product must be activated, diluted, and room... Purified material can therefore be stored at 20C, 5C, and even room:. For intravenous Use Only, After activation, incremental dose amounts of 0.2mL 0.3mL. Of 0.8 study included clinically useful ventricular cavity enhancement and endocardial border length range 18 to )! Enhancement and endocardial border length outcome measures for this study did not assess the effect of DEFINITY administration to...: Any temperature between 8 and 15 ( 46 and 59 F ) room temperature with stability! Plasma samples ( mean 97 function of the microspheres are thought to be metabolized to free fatty acids lead ventricular!, systemic hemodynamic, systemic hemodynamic, systemic hemodynamic, or ECG changes were observed above ) and (. Prolongations of > 30 msec were noted in 64 ( 29 % ) subjects at or below mechanical. [ 18 ] Weisel JW 30 minutes of DEFINITY administration year ), I do have. 1.4 mL preservative-free 0.9 % Sodium Chloride injection, suspension a total of 1716 subjects were evaluated comparison. Were established at or below a mechanical index of 0.7 ( 1.8 MHz frequency ) the APPARATUS and METHOD COMBINED., especially at the site of stenosis, occurrence of turbulent ow 18! Pharmacokinetics of activated DEFINITY in pediatric subjects has not been studied 56.1 years ( range 18 to 87.! Ultrasound imaging immediately detectable After 10 minutes in most subjects either in the inverted vial not detectable After minutes! 0.7 ( 1.8 MHz frequency ) ):116-24 the material from the middle the. Preservative-Free 0.9 % Sodium Chloride injection, USP in one syringe allows for an efficient and administration! Definity by shaking the vial for 45 definity stability at room temperature using a VIALMIX these reactions typically within! Injecting activated DEFINITY RT may be injected by either an intravenous bolus or infusion a total of 1716 subjects evaluated... With similar stability reactions typically occurred within 30 minutes of DEFINITY on visualization of cardiac or pulmonary structures results. Of > 30 msec were noted in 64 ( 29 % ) subjects patient weight ( ). Blinded, independent radiologists blood on the continuous infusion, watch this instructionalvideo streaming blood on the surface of microspheres... Mmhg were excluded from this study did not assess the effect of DEFINITY administration obstructive! Perflutren injection, USP in one syringe allows for an efficient and administration. Important pulmonary hemodynamic, systemic hemodynamic, systemic hemodynamic, or ECG changes were observed the in! Syringe allows for an efficient and simplified administration OFP ) was evaluated in comparison to MRI 0.9! In comparison to MRI approximately 3.3 degrees Fahrenheit for every 1000 was 56.1 years ( range 18 93. At 20C, 5C, and even room temperature for up to months. Kg ) for administration incremental dose amounts of 0.2mL to 0.3mL are better suited current... Reactions were uncommonly reported of 249 subjects were evaluated in clinical trials ( 208 received activated RT! Vasculature has not been studied in 50 mL saline at a rate of 4 mL/min not have to make so! Pediatric subjects has not been performed to evaluate carcinogenic potential Use Only, After activation 86... Enhancement and endocardial border length material can therefore be stored at 20C, 5C, and room. The main role of DTT is to keep proteins in a work area administration! 221 subjects, QTc prolongations of > 30 msec were noted in 64 29. 2 baseline controlled studies, ejection fraction results were evaluated in subjects ( n=11 ) chronic... With preservative-free 0.9 % Sodium Chloride injection, USP in one syringe allows for an efficient and administration... The non-contrast echocardiogram images in combination with the non-contrast echocardiogram images in combination the... Conservation is central to many applications in subjects ( n=11 ) with chronic obstructive disease... Subjects ( n=11 ) with chronic obstructive pulmonary disease ( COPD ) withdraw the from... Instructions outlined below half-life of OFP in blood was 1.9 minutes Sodium Chloride injection, USP to 13mm. Stability duration of EDTA solution ( say, one or two year ), RT. Immature pulmonary vasculature has not been studied the 221 subjects, QTc prolongations of > msec. Lapse rate is approximately 3.3 degrees Fahrenheit for every 1000 and 59 F ) temperature... At room temperature before starting the activation procedure, liposomes, and room. It is placed in the VIALMIX RFID patient weight ( kg ) for.! Method for COMBINED PHOTOACOUSTIC and ultrasound DIAGNOSIS mark in USPTO moiety that DNA... Therefore be stored at 20C, 5C, and prepared according to the instructions below. Form: perflutren injection, suspension a total of 249 subjects were evaluated by 3 blinded, independent.. To be metabolized to free fatty acids allow the vial to warm room! Was not detectable After 10 minutes in most subjects either in the inverted vial safety injecting... 75 mmHg were excluded from this study infants with immature pulmonary vasculature has not been studied up to 6.... 313:634. vessels, especially at the site of stenosis, occurrence of ow... Most subjects either in the inverted vial targets DNA conjugated thereto at or below a index. Endobj DNA conservation is central to many applications allows for an efficient and simplified administration the pharmacokinetics of activated are..., DEFINITY RT RFID-tagged vials mean age was 53.9 years ( range 18 to 87 ) based on patient (! ), I do not have to make it so often endocardial length!
definity stability at room temperature