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.

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.

European Union - English - EMA (European Medicines Agency)

alexion europe sas - asfotase alfa - hypophosphatasia - other alimentary tract and metabolism products, - strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

Israel - English - Ministry of Health

alexion pharma israel ltd - asfotase alfa - solution for injection - asfotase alfa 100 mg / 1 ml - asfotase alfa - strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

Israel - English - Ministry of Health

alexion pharma israel ltd - asfotase alfa - solution for injection - asfotase alfa 40 mg / 1 ml - asfotase alfa - strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

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

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

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

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

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

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

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

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

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

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 100 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; monobasic sodium phosphate monohydrate; water for injections - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.