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

recordati rare diseases, inc. - succimer (unii: dx1u2629qe) (succimer - unii:dx1u2629qe) - succimer 100 mg - chemet is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45 mcg/dl. chemet is not indicated for prophylaxis of lead poisoning in a lead-containing environment; the use of chemet should always be accompanied by identification and removal of the source of the lead exposure. chemet should not be administered to patients with a history of allergy to the drug.

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

theragnostics inc - succimer (unii: dx1u2629qe) (succimer - unii:dx1u2629qe) - nephroscan, after radiolabeling with technetium tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adult and pediatric patients including term neonates. none risk summary available data with technetium tc 99m succimer 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 succimer have not been conducted. although all 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 succimer is expected to be low (less than 0.50 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 10mgy fetal doses. risk summary technetium tc 99m succimer is present in breast milk. there are no data on the effects of technetium tc 99m succimer on the breastfed infant or the effects on milk production. nephroscan is used for imaging in infants with renal disease; exposure to technetium tc 99m succimer via breast milk is expected to be lower. based on clinical guidelines, exposure of technetium tc 99m succimer 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 succimer injection. the developmental and health benefits of breastfeeding should be considered along with a mother's clinical need for nephroscan, any potential adverse effects on the breastfed child from technetium tc 99m succimer or from the underlying maternal condition. nephroscan, after radiolabeling with technetium tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in pediatric patients, including term neonates. use of nephroscan in this age group for this indication is supported by evidence from effectiveness established in adult studies and data from published pediatric studies supporting the safety and effectiveness of weight-based dosing of technetium tc 99m succimer injection in renal parenchymal imaging in pediatric patients including term neonates [see dosage and administration (2.3)] . the recommended amount of radioactivity in pediatric patients, 1.85 mbq/kg (0.05 mci/kg) with a range of 19 mbq to 74 mbq (0.5 mci to 2 mci), is based on published studies that used technetium tc 99m succimer for the evaluation of acute pyelonephritis, renal scarring, and split renal function in pediatric patients [see dosage and administration (2.2)] . hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium tc 99m succimer in pediatric patients [see warnings and precautions (5.1) and adverse reactions (6)] . clinical studies of technetium tc 99m succimer did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious usually administering the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with decreased renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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

special order - succimer - oral capsule - 300mg

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

special order - succimer - oral capsule - 100mg

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

global medical solutions australia pty limited t/a radpharm scientific - succimer, quantity: 1 mg - injection, powder for - excipient ingredients: inositol; ascorbic acid; stannous chloride - indications as at 25 september 1996: technetium (99mtc) succimer may be used as a static renal imaging pharmaceutical and is particularly suited for evaluation of renal cortex, deliniation of renal space occupying lesions, determination of intrarenal function, distribution and identification of ectopic renal sites.

Ireland - English - HPRA (Health Products Regulatory Authority)

curium netherlands b.v. - succimer - kit for radiopharmaceutical preparation - 1.2 milligram(s) - technetium (99mtc) compounds; technetium (99mtc) succimer

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - succimer - capsule - succimer 100 mg - all other therapeutic products

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

austin health - injection, powder for - excipient ingredients: succimer; stannous chloride; ascorbic acid; inositol; hydrochloric acid; sodium hydroxide - diagnostic agent when radiolabelled for renal cortical scintigraphy

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

imported (united states) - succimer - oral capsule - 100mg

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

imported (france) - succimer - oral capsule - 200mg