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

anazaohealth corporation - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - tetrofosmin 0.35 mg - tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function. physical half-life & target organs the physical half-life of technetium, tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 kev. dose calculations were performed using the standard mird method (mird pamphlet no.1 (rev),society of nuclear medicine, 1976). effective dose equivalents (ede) were calculated in accordance with icrp 53 (ann. icrp 18 (1-4),1988) and gave values of 8.61 × 10-3 msv/mbq and 1.12 × 10-2 msv/mbq after exercise and rest, respectively. there are no known contraindications for this preparation.

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

medi-physics inc. dba ge healthcare - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - tetrofosmin 1.38 mg - myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. myoview is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. none. risk summary there are no data with technetium tc99m tetrafosmin use in pregnant women to inform any drug associated risks. animal reproduction studies with technetium tc99m tetrofosmin have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc99m tetrafosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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. risk summary technetium tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). there are no data available regarding the effects of technetium tc99m tetrofosmin on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for myoview and any potential adverse effects on the breastfed child from myoview or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium tc99m tetrofosmin administration. safety and effectiveness in pediatric patients have not been established. of 2,300 subjects in clinical studies of myoview, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. no overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

anazaohealth corporation - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function. physical half-life & target organs the physical half-life of technetium, tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 kev. dose calculations were performed using the standard mird method (mird pamphlet no.1 (rev),society of nuclear medicine, 1976). effective dose equivalents (ede) were calculated in accordance with icrp 53 (ann. icrp 18 (1-4),1988) and gave values of 8.61 × 10-3 msv/mbq and 1.12 × 10-2 msv/mbq after exercise and rest, respectively. there are no known contraindications for this preparation.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

rotop pharmaka gmbh - tetrofosmin (bis)tetrafluoroborate 0,34 mg - eq. tetrofosmin 0,23 mg - kit for radiopharmaceutical preparation - 0,23 mg - tetrofosmin (bis)tetrafluoroborate 0.34 mg - technetium (99mtc) tetrofosmin

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - tetrofosmin (as tetrofosmin sulphosalicylate) - injection, powder, for solution - 0.23 mg/vial - tetrofosmin (as tetrofosmin sulphosalicylate) 0.23 mg/vial

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

medi-physics inc. dba ge healthcare - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. myoview is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. none. risk summary there are no data with technetium tc99m tetrofosmin use in pregnant women to inform any drug associated risks. animal reproduction studies with technetium tc99m tetrofosmin have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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. risk summary technetium tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). there are no data available regarding the effects of technetium tc99m tetrofosmin on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for myoview and any potential adverse effects on the breastfed child from myoview or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium tc99m tetrofosmin administration. safety and effectiveness in pediatric patients have not been established. of 2,300 subjects in clinical studies of myoview, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. no overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

ge healthcare australia pty ltd - tetrofosmin, quantity: 0.23 mg; stannous chloride dihydrate, quantity: 0.03 mg - injection, solution - excipient ingredients: sodium bicarbonate; sodium gluconate; disodium sulfosalicylate - myoview is indicated as an adjunct in the diagnosis of ischaemic heart disease infarction.

Ireland - English - HPRA (Health Products Regulatory Authority)

ge healthcare limited - tetrofosmin - kit for radiopharmaceutical preparation - 230 microgram - technetium (99mtc) tetrofosmin

Israel - English - Ministry of Health

eldan electronic instruments co ltd - tetrofosmin - lyophilized powder for solution for injection - tetrofosmin 0.23 mg/vial - technetium (99mtc) tetrofosmin - indicated as an adjunct in the diagnosis and localization of myocardial ischaemia or infarction. myoview is indicated as an adjunct to the initial assessments (e.g. palpation mammography or alternative imaging modalities and/or cytology) in characterisation of malignancy of suspected breast lesions where all these other recommended tests were inconclusive.

Malta - English - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - tetrofosmin - kit for radiopharmaceutical preparation solution for injection - tetrofosmin 230 µg - diagnostic radiopharmaceuticals