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Feridex Product Information

FERIDEX I.V.®1 (ferumoxides injectable solution) is a super paramagnetic iron oxide used for magnetic resonance imaging (MRI). It was the first organ-specific MRI contrast agent available in the U.S. to detect and evaluate liver lesions. Controlled clinical studies show the agent improves contrast between normal and abnormal liver tissue seen on MRI. T2-weighted images provide the maximum contrast effect. FERIDEX I.V. can be used in conjunction with any currently available clinical MRI system, regardless of field strength.

Indications

FERIDEX I.V. is indicated for I.V. administration as an adjunct to MRI in adult patients to enhance the T2-weighted images used to detect and evaluate liver lesions.

Dosage and Administration

The recommended dosage of FERIDEX I.V. is 0.56 milligrams of iron (0.05 mL FERIDEX I.V.) per kilogram of body weight, that is diluted in 100 mL of 5% dextrose solution and given over 30 minutes. (See Drug Preparation Section.) The diluted drug is administered through a 5 micron filter at arate of 2 to 4 milliliters per minute.

FERIDEX I.V. should not be administered undiluted.

Drug Preparation

  1. The vial should be used at room temperature. Mix by inverting the vial 10 to 20 times.
  2. Draw up the appropriate dose of FERIDEX I.V. into a sterile syringe.
  3. Dilute FERIDEX I.V. by injecting it into 100 mL of 5% dextrose solution (D5W).
  4. The bag should be inverted two or three times to assure dilution.
  5. The drug product should be administered within 8 hours following dilution.

Imaging

Post-contrast imaging may begin immediately after the dose is infused and may be performed up to 3.5 hours after the end of the infusion. T2-weighted pulse sequences provide the maximum contrast effect.


1 FERIDEX I.V. is a registered trademark of and is marketed under a license from Advanced Magnetics, Inc. Cambridge, MA.

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