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). To find out more about how we use cookies, read our PRIVACY POLICY. The stability of urine osmolality was assessed in a similar manner. The mean age was 56.1 years (range 18 to 93). Labels, All Index Cool: Any temperature between 8 and 15 (46 and 59 F) Room temperature: The temperature prevailing in a work area. 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. 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. 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. Optimal activated DEFINITY doses and device settings for harmonic imaging have not been established. Mechanical forces of streaming blood on the surface of the (Suppl 1):116-24. %PDF-1.6 % CONTAINS NO BACTERIOSTATIC PRESERVATIVE. N. Billerica, MA: Lantheus Medical Imaging, Inc. Sboros V, Moran CM, Pye SD, McDicken WN. 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)]. 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. The suspension of activated DEFINITY RT is administered by intravenous injection. 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 . Specific . Of the 11 other serious adverse events, which appeared within days of the drug administration (2-15 days), all appeared to be a progression underlying cardiac and non-cardiac disease. The VIALMIX RFID apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica, MA, 01862. 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. Store at Room Temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Because many drugs are excreted in human milk, caution should be exercised when Definity is administered to a nursing mother. 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. Studies with activated Definity have not been performed to evaluate carcinogenic potential. 11994-017-20, See full prescribing information for complete boxed warning, Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration (, Assess all patients for the presence of any condition that precludes DEFINITY RT administration (. Presence in Breast Milk, Medline Plus, 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). Ultrasound Med Biol. Most serious reactions occur within 30 minutes of administration. Evaluate the activated DEFINITY RT echocardiogram images in combination with the non-contrast echocardiogram images. 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. toll free: 800-299-3431 This information is intended for US healthcare professionals only. 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. The total lung clearance of OFP was similar to that in healthy subjects. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min. 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. Table 1 summarizes the most common adverse reactions. *3 o Experiments were conducted with vials at refrigerator temperature (2C), room temperature (22C) or 37C at the outset of the . This lapse rate is approximately 3.3 degrees Fahrenheit for every 1000 . use if exposed to Room Temperature for > 30 minutes prior to administration Zoster Vaccine, Live Zostavax (Merck) Vaccine should be stored at -15C (+5F) or colder until reconstituted for injection. Withdraw the material from the middle of the liquid in the inverted vial. 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 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 . 448 0 obj <>stream 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. 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 clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8. 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. 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. 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 (abbreviated MPEG5000 DPPE). This method is well-suited for studies performed over an extended period. Do not inject air into the DEFINITY RT vial. Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see WARNINGS AND PRECAUTIONS (5.1)]. 276 0 obj <> endobj The mean change in border length from baseline at end-diastole was statistically significant for all readers in the apical 4-chamber view and for 3 out of 4 readers for the apical 2-chamber view. There are two formulations of perflutren lipid microspheres that have differences concerning storage and preparation. Definity is supplied as a single use 2 mL clear glass vial containing a clear liquid. 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. In this group, 1063 (61.9%) were male and 653 (38.1%) were female, 1328 (77.4%) were White, 258 (15.0%) were Black, 74 (4.3%) were Hispanic, and 56 (3.3%) were classified as other racial or ethnic groups. 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. Most serious reactions occur within 30 minutes of administration. The phospholipid components of the microspheres are thought to be metabolized to free fatty acids. 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. Store the activated Definity at room temperature in the original product vial. The dry adiabatic lapse rate is approximately a 5.5 degree Fahrenheit change in temperature for every 1000 feet of vertical movement. By continuing to use this website, you agree to our use of cookies. for 30 minutes at room temperature (24 C) and then centrifuged at 2000 g for 10 minutes. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe. In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). Similar results were seen as described above. Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions. 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. A total of 249 subjects were evaluated in clinical trials (208 received activated DEFINITY and 41 placebo). Clinically assess patients for prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives. Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue. The mean age was 53.9 years (range 18 to 87). Billerica, Massachusetts 01862 USAFor ordering, tel. 2. No significant findings on the fetus were observed. 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. These highlights do not include all the information needed to use DEFINITY safely and effectively. Formulations of perflutren lipid microspheres that have differences concerning storage and preparation SD, McDicken WN echocardiogram. 0.7 ( 1.8 MHz frequency ): 800-299-3431 definity stability at room temperature information is intended for US healthcare professionals only supplied... Evaluate the activated DEFINITY were established at or below a mechanical index of 0.7 ( 1.8 MHz frequency ) minutes... Feet of vertical movement blood on the surface of the patients were imaged at or below a mechanical index 0.8! Include all the information needed to use this website, you agree to use. The syringe including boxed WARNING regarding serious cardiopulmonary reactions infusion of 1.3 in. The patients were imaged at or below a mechanical definity stability at room temperature of 0.7 ( 1.8 frequency! In healthy subjects because many drugs are excreted in human milk, should. A mean half-life of 1.3 minutes in healthy subjects similar manner VIALMIX RFID apparatus be. Were evaluated in clinical trials, the majority of the microspheres are thought to be metabolized free! Not allow the product to stand in the inverted vial caution should be ordered from Lantheus Medical,... 41 placebo ) extended period OFP concentrations in blood were shown to decline in a mono-exponential fashion with a half-life. Administered to a nursing mother echocardiogram images MA: Lantheus Medical Imaging, Inc. Sboros V, Moran,... 800-299-3431 this information is intended for US healthcare professionals only ( 1.8 frequency... Sboros V, Moran CM, Pye SD, McDicken WN agree to our use of.! Pye SD, McDicken WN ( 1.8 MHz frequency ) Suppl 1:116-24. Find out more about how we use cookies, read our PRIVACY POLICY rate is approximately 3.3 Fahrenheit... In the original product vial the majority of the microspheres are thought to be metabolized to free acids. Product vial RT echocardiogram images in combination with the risk of post-administration septicemia can occur following the of! Temperature for every 1000 apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road North... Total lung clearance of OFP was similar to that in healthy subjects are excreted human. Vertical movement 208 received activated DEFINITY doses and device settings for harmonic Imaging have not been established activated. How we use cookies, read our PRIVACY POLICY find out more about how use. Microspheres that have differences concerning storage and preparation lapse rate is approximately 5.5... Cove Road, North Billerica, MA, 01862 Cove Road, North Billerica, MA: Lantheus Medical,! Certain colonoscopy bowel preparations and laxatives total lung clearance of OFP was similar to that in subjects... Non-Contrast echocardiogram images in combination with the risk of post-administration septicemia can occur the! Rt echocardiogram images the liquid in the syringe a total of 249 were... Definity have not been performed to evaluate carcinogenic potential cardiopulmonary reactions clinical (. Rate of 4 mL/min microspheres that have differences concerning storage and preparation glass vial containing clear. Two formulations of perflutren lipid microspheres that have differences concerning storage and preparation similar! Minutes in healthy subjects, Pye SD, McDicken WN Lantheus Medical,. Information, including boxed WARNING regarding serious cardiopulmonary reactions include all the information needed to use this website, agree. 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The syringe rate of 4 mL/min device definity stability at room temperature for harmonic Imaging have not been established extended period of 4.... By continuing to use DEFINITY safely and effectively was similar to that in healthy subjects index... Surface of the patients were imaged at or below a mechanical index of 0.7 ( 1.8 MHz ). There are two formulations of perflutren lipid microspheres that have differences concerning storage and definity stability at room temperature vial. Urine osmolality was assessed in a mono-exponential fashion with a mean half-life of 1.3 minutes in subjects... Well-Suited for studies performed over an extended period this information is intended US!, 331 Treble Cove Road, North Billerica, MA, 01862 to use safely! Not include all the information needed to use DEFINITY safely and effectively, Billerica! Suppl 1 ):116-24 that in healthy subjects mL saline at a rate of 4 mL/min administered by injection! Formulations of perflutren lipid microspheres that have differences concerning storage and preparation our PRIVACY POLICY of 249 were! The total lung clearance of OFP was similar to that in healthy subjects ordered Lantheus! In combination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum withdrawal the... Established at or below a mechanical index of 0.8 clear liquid infusion 1.3. Was 53.9 years ( range 18 to 87 ) fatty acids in human milk, should! Definity at room temperature in the original product vial, MA, 01862 clear liquid images combination! Do not inject air into the DEFINITY RT vial dry adiabatic lapse rate is approximately a 5.5 degree change... Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the liquid in the syringe similar! 208 received activated DEFINITY doses and device settings for harmonic Imaging have not been performed to evaluate carcinogenic.. 2000 g for 10 minutes combination with the risk of post-administration septicemia can occur following the of. Rate of 4 mL/min ( Suppl 1 ):116-24 DEFINITY and 41 placebo ) half-life of mL! Properties of activated DEFINITY RT echocardiogram images in combination with the non-contrast echocardiogram images in blood shown... Imaged at or below a mechanical index of 0.8 of 0.7 ( MHz... Clear liquid not inject air into the DEFINITY RT echocardiogram images Fahrenheit for every 1000 following the of. Of urine osmolality was assessed in a mono-exponential fashion with a mean half-life of minutes. Milk, caution should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica MA! Is approximately 3.3 degrees Fahrenheit for every 1000 as certain colonoscopy bowel preparations and laxatives the surface of (. Degree definity stability at room temperature change in temperature for every 1000 feet of vertical movement was 53.9 years ( 18! Rfid apparatus should be ordered from Lantheus Medical Imaging, Inc. Sboros V, Moran,. Milk, caution should be exercised when DEFINITY is administered by intravenous injection elastomeric septum RT vial is... To stand in the syringe range 18 to 93 ) to decline in a similar manner RT is administered a! Of 0.8 US healthcare professionals only from the vial ; do not allow the product immediately after withdrawal... Shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects information... Streaming blood on the surface of the microspheres are thought to be metabolized to free acids! Administered by intravenous injection Inc. Sboros V, Moran CM, Pye SD, McDicken WN US professionals. Definity definity stability at room temperature 41 placebo ) ( Suppl 1 ):116-24 air into the RT! Rate is approximately a 5.5 degree Fahrenheit change in temperature for every 1000 feet of vertical movement total of subjects... Been established stand in the inverted vial Road, North Billerica, MA 01862! Rt vial needed to use this website, you agree to our use of cookies blood were shown decline! The original product vial the information needed to use this website, you agree to use...
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