FDA label ea9f7125-98b5-49c3-85b8-763915156ff0

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
8fc6228a-faf3-4ba7-80e1-ff56ae934383
SPL ID
ea9f7125-98b5-49c3-85b8-763915156ff0
Version
1
Effective date
2012-05-23
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:30

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

SIDE/ADVERSE EFFECTS At present, there are no known side/adverse effects associated with the use of diagnostic dosages of I-123 MIBG. PREPARATION FOR THIS TEST Special preparatory instructions may apply; patient should inquire in advance. Administration of potassium iodide or Lugol’s solution one day before administration of I-123MIBG and for 6 days after administration to prevent or reduce thyroid uptake of radioiodide contaminant. GENERAL DOSAGE INFORMATION Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate State agency, if required, or, outside the U.S., the appropriate authority. To minimize uptake of radioactive iodine by the thyroid, potassium iodide (SSKI, 60 mg twice a day) or Lugol's solution (1 drop three times a day) may be used, beginning at least 24 hours before and continuing for 6 days after administration of I-123 MIBG. Safety considerations for handling this radiopharmaceutical: Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. IOBENGUANE I-123 INJECTION Usual adult administered activity for diagnosis of tumors or medullary disease: Intravenous, 370 megabecquerels (10 millicuries) of I-123 mIBG, with a minimum specific activity of 740 megabecquerels to 1.3 gigabecquerels (20 to 35.6 millicuries) per mg (at time of calibration), administered over a period of fifteen to thirty seconds. Usual pediatric administered activity for diagnosis of tumors or medullary disease: In children up to 18 years of age, dosage must be individualized by physician. Usual geriatric administered activity: See usual adult administered activity. Thank you, AnazaoHealth Corporation

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.