ADREVIEW- iobenguane i-123 injection United States - English - NLM (National Library of Medicine)

adreview- iobenguane i-123 injection

medi-physics inc. - iobenguane i-123 (unii: p2th1xyz84) (iobenguane i-123 - unii:p2th1xyz84) - iobenguane i-123 2 mci in 1 ml - adreview is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. adreview is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (h/m) ratio of radioactivity uptake in patients with new york heart association (nyha) class ii or class iii heart failure and left ventricular ejection fraction (lvef) ≤ 35%. among these patients, adreview may be used to help identify patients with lower one and two year mortality risks, as indicated by an h/m ratio ≥ 1.6. limitations of use: in patients with congestive heart failure, adreview utility has not been established for: - selecting a therapeutic intervention or for monitoring the response to therapy; - using the h/m ratio to identify a patient with a high risk for death. adreview is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. risk summary radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. administration of an appropriate thyroid blocking agent is recommended before use of adreview in a pregnant woman to protect the woman and fetus from accumulation of i 123 [see dosage and administration (2.2) ]. there are no available data on adreview use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with iobenguane i 123. all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of adreview. adreview contains 10.3 mg/ml of benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 iodine 123 (i 123), the radionuclide in adreview, is present in human milk. there is no information on the effects on the breastfed infant or on milk production. advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after adreview administration in order to minimize radiation exposure to a breastfed infant. the safety and effectiveness of adreview have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma [see clinical studies (14.1)] . safety and effectiveness in pediatric patients below the age of 1 month or in any pediatric patient with congestive heart failure have not been established. serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. when administering adreview in infants consider the combined daily metabolic load of benzyl alcohol from all sources including adreview (contains 10.3 mg of benzyl alcohol per ml) and other drugs containing benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see warnings and precautions (5.3)] . in clinical studies of adreview in heart disease, 27% of subjects were 65-74 years of age and 17% of subjects were 75 years of age or 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. adreview is excreted by the kidneys, and the risks of adverse reactions, increased radiation dose, and occurrence of falsely negative imaging results, may be greater in patients with severely impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. consider assessment of renal function in elderly patients prior to adreview administration.

MIBG I-123 74 MBq/ml inj. sol. i.v. vial Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

mibg i-123 74 mbq/ml inj. sol. i.v. vial

curium belgium s.p.r.l.-b.v.b.a. - iobenguane sulfate 0,5 mg/ml; iobenguane (123 i) 74 mbq/ml - solution for injection - 74 mbq/ml - iobenguane (i-123) 74 mbq/ml; iobenguane sulfate 0.5 mg/ml - iobenguane (123i)

MIBGEN iobenguane[123I] sulfate 100MBq/mL injection Australia - English - Department of Health (Therapeutic Goods Administration)

mibgen iobenguane[123i] sulfate 100mbq/ml injection

australian nuclear science and technology organisation t/a ansto - iobenguane (123i) sulfate, quantity: 100 mbq/ml - injection, solution - excipient ingredients: monobasic sodium phosphate dihydrate; dibasic sodium phosphate; ascorbic acid; benzyl alcohol; water for injections - diagnostic scintigraphic localisation of phaeochromocytomas, paragangliomas (chemodectomas), ganglioneuroblastomas and ganglioneuromas. detection, staging and follow-up on therapy of neuroblastomas.

ADREVIEW SOLUTION Canada - English - Health Canada

adreview solution

ge healthcare canada inc - iobenguane 123 i - solution - 74mbq - iobenguane 123 i 74mbq - roentgenography

I 123 MIBG META IODOBENZYLGUANIDINE- i 123 mibg injection, powder, lyophilized, for solution United States - English - NLM (National Library of Medicine)

i 123 mibg meta iodobenzylguanidine- i 123 mibg injection, powder, lyophilized, for solution

anazaohealth corporation - iobenguane sulfate i-123 (unii: 23x1185wbo) (iobenguane i-123 - unii:p2th1xyz84) - iobenguane is indicated as a radioactive isotope diagnosing for adrenomedullary disorders and neuroendocrine tumors. tumors, adrenal medulla (diagnosis): i-123 mibg is used for diagnostic imaging of the adrenal medulla, for the evaluation and localization of intra- and extra-adrenal pheochromocytomas, paragangliomas, and neuroblastomas, as well as for localization of metastatic lesions from these tumors. i-123 mibg can also be used for confirmation of diagnosis of pheochromocytoma when catecholamine determination tests are unclear. tumors, carcinoid (diagnosis): i-123 mibg scintigraphy is used as screening procedures for suspected carcinoid tumors, especially those of intestinal origin. hyperplasia, adrenal medulla (diagnosis): i-123 mibg is used in the evaluation of the adrenal medulla for disorders such as medullary hyperplasia in patients at risk of developing medullary disease (e.g., multiple endocrine neoplasia [men type 2, men type 3]). carcinoma, thyroid (diagnosis): i-123 mibg is used for diagnostic i

Adreview 74 MBq/ml inj. sol. i.v. vial Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

adreview 74 mbq/ml inj. sol. i.v. vial

ge healthcare bv-srl - iobenguane sulfate 8e-005 g/g; iobenguane (123 i) 74 mbq/ml - solution for injection - 74 mbq/ml - iobenguane (i-123) 74 mbq/ml - iobenguane (123i)

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

mibgen

ansto t/a ansto health - iobenguane(123i) sulfate; iobenguane [123i] sulfate; iobenguane sulfate [123i] -

IODINE-123 META IODOBENZYLGUANIDINE SOLUTION Canada - English - Health Canada

iodine-123 meta iodobenzylguanidine solution

edmonton radiopharmaceutical centre (alberta health services) - iobenguane 123 i - solution - 185mbq - iobenguane 123 i 185mbq

AdreView [I-123] 74MBq/1ml solution for injection vials United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

adreview [i-123] 74mbq/1ml solution for injection vials

ge healthcare ltd - iobenguane [i-123] - solution for injection - 74mbq/1ml

AdreView [I-123] 111MBq/1.5ml solution for injection vials United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

adreview [i-123] 111mbq/1.5ml solution for injection vials

ge healthcare ltd - iobenguane [i-123] - solution for injection - 74mbq/1ml