FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Feridex I.V. is indicated for I.V. administration as an adjunct to MRI (in adult patients) to enhance the T2 weighted images used in the detection and evaluation of lesions of the liver that are associated with an alteration in the RES.
History
There is currently no drug history available for this drug.
Other Information
Feridex I.V.® (ferumoxides injectable solution) is a sterile aqueous colloid of superparamagnetic iron oxide associated with dextran for intravenous (i.v.) administration as a magnetic resonance imaging contrast media. Chemically, ferumoxides is a non-stoichiometric magnetite, of average formula FeO1.44. Each milliliter of Feridex I.V. contains 11.2 milligrams of iron and 61.3 milligrams of mannitol at a pH of 5 to 9. The formulation also contains dextran (5.6– 9.1 mg/mL) and citrate (0.25–0.53 mg/mL). The osmolality is approximately 340 mOsm/kg; specific gravity is 1.04. Feridex I.V. is a black to reddish-brown aqueous colloid.
Sources
Feridex Manufacturers
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Bayer Healthcare Pharmaceuticals Inc.
Feridex | Bayer Healthcare Pharmaceuticals Inc.
DoseThe 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. (SeeDrug Preparation Section). The diluted drug is administered through a 5 micron filter at a rate of 2 to 4 milliliters per minute.
Feridex I.V. should not be administered undiluted.
Drug Preparation The vial should be used at room temperature. Mix by inverting the vial 10 to 20 times. Draw up the appropriate dose of Feridex I.V. into a sterile syringe. Dilute Feridex I.V. by injecting it into 100 mL of 5% dextrose solution (D5W). The bag should be inverted two or three times to assure dilution. The drug product should be administered within 8 hours following dilution. ImagingPost-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.
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