Australia - English - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - perflutren, quantity: 1.1 mg/ml - injection, suspension - excipient ingredients: sodium chloride; propylene glycol; water for injections; dipalmitoylphosphatidylcholine; n-(methoxy-peg-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium; sodium dipalmitoylphosphatidate; glycerol; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - this medicinal product is for diagnostic use only. definity is indicated for use in patients in contrast-enhanced diagnostic ultrasound imaging to improve the characterization of focal lesions of the liver and kidney. definity is indicated for use in patients with suboptimal echocardiograms to provide opacification of cardiac chambers, improvement of left ventricular endocardial border delineation and assessment of regional wall at both rest and stress.

United States - English - NLM (National Library of Medicine)

lantheus medical imaging, inc. - perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - perflutren 6.52 mg in 1 ml - definity is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. definity is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (peg) [see warnings and precautions (5.2) and description (11)] . risk summary 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. definity has a very short half-life; therefore, administration of definity to a pregnant woman is not expected to result in clinically relevant fetal exposure. no adverse developmental outcomes were observed in animal reproduction studies with administration of activated definity in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see data) . all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data definity was administered intravenously to rats at doses of 0.1 ml/kg, 0.3 ml/kg, and 1 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. definity was administered intravenously to rabbits at doses of 0.1ml/kg, 0.3 ml/kg, and 1 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. no significant findings on the fetus were observed. risk summary there are no data on the presence of perflutren lipid microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for definity and any potential adverse effects on the breastfed infant from definity or from the underlying maternal condition. the safety and effectiveness of definity have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. use of definity for this indication is supported by evidence from adequate and well-controlled studies in adults [see clinical studies (14)] , a pharmacodynamic and safety study in 40 pediatric patients 1 month of age and older [see adverse reactions (6.1) and clinical pharmacology (12.2)] , and published studies in 149 patients 5 years to 24 years of age [see adverse reactions (6.1)] . of the total number of subjects in clinical trials of definity, 144 (33%) were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients.

United States - English - NLM (National Library of Medicine)

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. 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.

United States - English - NLM (National Library of Medicine)

lantheus medical imaging, inc. - perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - definity rt is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. definty rt is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (peg) [see warnings and precautions (5.2) and description (11)]. risk summary available data from case reports with definity rt use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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. no adverse developmental outcomes were observed in animal reproduction studies with administration of activated definity, another formulation of perflutren lipid microspheres, in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see data) . all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data definity was administered intravenously to rats at doses of 0.1ml/kg, 0.3 ml/kg, and 1 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. definity was administered intravenously to rabbits at doses of 0.1ml/kg, 0.3 ml/kg, and 1 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. no significant findings on the fetus were observed. risk summary there are no data on the presence of perflutren lipid microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for definity rt and any potential adverse effects on the breastfed infant from definity rt or from the underlying maternal condition. the safety and effectiveness of definity rt have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. use of definity rt for this indication is supported by evidence from adequate and well-controlled studies in adults [see clinical studies (14)] , a pharmacodynamic and safety study in 40 pediatric patients 1 month of age and older [see adverse reactions (6.1) and clinical pharmacology (12.2)] , and published studies in 149 patients 5 years to 24 years of age [see adverse reactions (6.1)] . of the total number of subjects in clinical trials of definity, 144 (33%) were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients.

European Union - English - EMA (European Medicines Agency)

lantheus eu limited - perflutren - echocardiography - contrast media - this medicinal product is for diagnostic use only.luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.

European Union - English - EMA (European Medicines Agency)

ge healthcare as - perflutren - echocardiography - contrast media - this medicinal product is for diagnostic use only.optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.optison should only be used in patients where the study without contrast enhancement is inconclusive.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - perflutren, quantity: 190 microgram/ml - injection, suspension - excipient ingredients: albumin; sodium chloride; n-acetyltryptophan; octanoic acid; sodium hydroxide; water for injections - other conditions: store vial upright. optison is indicated for use in patients with inclusive exchocardiograms to opacify the left ventricle and to improve the delineation to the left ventricular endocardial borders.

New Zealand - English - Medsafe (Medicines Safety Authority)

global medical solutions (nz) limited - perflutren 1.1 mg/ml - solution for injection - 1.1 mg/ml - active: perflutren 1.1 mg/ml excipient: colfosceril palmitate dibasic sodium phosphate monohydrate glycerol sodium dipalmitoylphosphatidate n-(methoxy-peg-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium monobasic sodium phosphate monohydrate propylene glycol sodium chloride water for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lantheus mi uk ltd - perflutren-containing lipid microspheres - solution for dispersion for injection - 150microlitre/1ml

Canada - English - Health Canada

lantheus mi canada inc - perflutren - suspension - 150mcl - perflutren 150mcl - other diagnostic agents