Jubilant DraxImage Inc. dba Jubilant Radiopharma

Jubilant DraxImageModel I 131 - Sodium Iodide Capsule Diagnostic USP – Oral

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The capsules are composed of one opaque white half, while the other half is an opaque pink, yellow, orange, grey or green. The capsules are packaged in plastic vials containing 5 capsules and one desiccant packet. Each capsule contains 3.7 MBq (100 µCi) at time of calibration. The capsule will yield 2.03, 1.11, 0.61, or 0.33 MBq (55, 30, 16.5, or 9 µCi) according to the color-coded decay calendar, which assigns a color and capsule activity for each week of the year. You are invited to consult the color-coded decay calendar provided to help establish which colored capsule is required for your prescribed dose, or calculate correct dosage from the date and time of calibration provided on the container label.

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Sodium Iodide I-131 is indicated for use in performance of the radioactive iodide (RAI) uptake test to evaluate thyroid function. Diagnostic doses may also be employed in localizing metastases associated with thyroid malignancies.

Assessment of thyroid function and structure through the use of nuclear medicine procedures represents one of the most basic, valuable and still frequently used, techniques in ongoing nuclear medicine practices. The thyroid gland iodine uptake values reflect early phases of the thyroid hormone production relative to the overall thyroid gland function. Iodine uptake studies confirm the thyroid will take up iodine and determine how much.

Common indications for radionuclide thyroid imaging are to differentiate between various types of hypo- or hyperfunction, to assess nodularity and/or ectopic thyroid tissue or evaluation of thyroid cancer and possible metastases – especially after thyroid ablation or surgery.

Sodium iodide I-131 is indicated for the assessment & evaluation of thyroid function.

Sodium Iodide I-131 is contraindicated for use in women who are or may become pregnant. Iodine-131 may cause harm to the fetal thyroid gland when administered to pregnant women. Review of the literature has shown that transplacental passage of radioiodide may cause severe, and possibly irreversible, hypothyrodism in neonates. Use of Sodium Iodide I-131 in women of childbearing age should be deferred until the possibility of pregnancy has been ruled out. If this drug is administered to a woman with reproductive potential, the patient should be apprised of the potential hazard to a fetus.Product Insert