Ireland - English - HPRA (Health Products Regulatory Authority)

draximage (uk) limited - medronic acid - kit for radiopharmaceutical preparation - 10 milligrams per ampule

Ireland - English - HPRA (Health Products Regulatory Authority)

draximage (uk) limited - medronic acid - kit for radiopharmaceutical preparation - 10 milligrams per ampule

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

jubilant draximage inc., dba jubilant radiopharma - pentetic acid (unii: 7a314hqm0i) (pentetic acid - unii:7a314hqm0i) - pentetic acid 20 mg - draximage® dtpa, after radiolabeling with technetium tc 99m, is indicated for brain imaging in adults by intravenous administration. renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration. lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation. hypersensitivity to the active ingredient or to any component of the product [see warnings and precautions (5.1)]. risk summary limited available data with technetium tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. technetium tc 99m pentetate is transferred across the placenta (see data) . no animal reproductive studies have been conducted with technetium tc 99m pentetate. all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of

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

jubilant draximage inc - albumin aggregated (unii: 799c8vf17r) (albumin aggregated - unii:799c8vf17r) - albumin aggregated 2.5 mg - draximage maa, after radiolabeling with sodium pertechnetate tc 99m, is indicated for: - lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. - peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients. draximage maa is contraindicated in patients with: - severe pulmonary hypertension [see warnings and precautions (5.1)]. - a history of hypersensitivity to albumin human.reactions have included anaphylaxis [see warnings and precautions (5.2)] . risk summary   available data with technetium tc 99m albumin aggregated injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. animal reproduction studies with technetium tc 99m albumin aggregated have not been conducted radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. the radiation exposure to the fetus from technetium tc 99m albumin aggregated is expected to be low (less than 0.5 mgy) (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 are 2% to 4% and 15% to 20%, respectively. data human data no adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mgy, which represents less than 10 mgy fetal doses. risk summary technetium-99m is present in breast milk. there are no data on the effects of technetium tc 99m albumin aggregated on the breastfed infant or the effects on milk production. draximage maa is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower. based on clinical guidelines, exposure of technetium tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of technetium tc 99m albumin aggregated injection. the developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for draximage maa, any potential adverse effects on the breastfed child from technetium tc 99m albumin aggregated or from the underlying maternal condition. draximage maa, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). the safety profile of technetium tc 99m albumin aggregated injection in pediatric patients is similar to adults. the safety and efficacy of draximage maa have not been established for peritoneovenous shunt scintigraphy in pediatric patients.  no formal studies of draximage maa in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. in general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

draximage (uk) limited - tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate - kit for radiopharmaceutical preparation - 1 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

draximage (uk) limited - tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate - kit for radiopharmaceutical preparation - 1 milligram

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

global medical solutions australia pty limited t/a radpharm scientific - aggregated albumin, quantity: 2.5 mg; stannous chloride dihydrate, quantity: 0.1 mg; sodium chloride, quantity: 1.2 mg; albumin, quantity: 5 mg - powder - excipient ingredients: nitrogen; water for injections - technetium tc 99m albumin aggregated injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients. technetium tc 99m albumin aggregated injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (leveen) shunt patency.

Canada - English - Health Canada

jubilant draximage inc. dba jubilant radiopharma - medronic acid - powder for solution - 25mg - medronic acid 25mg - roentgenography

Canada - English - Health Canada

jubilant draximage inc. dba jubilant radiopharma - medronic acid - powder for solution - 10mg - medronic acid 10mg - roentgenography

Canada - English - Health Canada

jubilant draximage inc. dba jubilant radiopharma - sodium iodide 131 i - capsule - 3.7mbq - sodium iodide 131 i 3.7mbq - roentgenography