Indium in 111 Oxyquinoline
Generic: INDIUM IN-111 OXYQUINOLINE
Basic Information
Manufacturer
Medi-Physics Inc. dba GE Healthcare.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
4c52c904-8137-4b10-8a85-d9b96c2d8a00
Indications & Usage
INDICATIONS AND USAGE Indium In 111 Oxyquinoline Solution is indicated for radiolabeling autologous leukocytes.
Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures.
The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.
Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation of patients with a high clinical probability of an abscess in a known location.
Ultrasound or computed tomography may provide a better anatomical delineation of the infectious process and information may be obtained more quickly than with labeled leukocytes.
If localization by these techniques is successful, labeled leukocytes should not be used as a confirmatory procedure.
If localization or diagnosis by these methods fails or is ambiguous, indium In 111 oxyquinoline labeled leukocyte imaging may be appropriate.
Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures.
The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.
Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation of patients with a high clinical probability of an abscess in a known location.
Ultrasound or computed tomography may provide a better anatomical delineation of the infectious process and information may be obtained more quickly than with labeled leukocytes.
If localization by these techniques is successful, labeled leukocytes should not be used as a confirmatory procedure.
If localization or diagnosis by these methods fails or is ambiguous, indium In 111 oxyquinoline labeled leukocyte imaging may be appropriate.
Warnings
WARNINGS The content of the vial of Indium In 111 Oxyquinoline Solution is intended only for use in the preparation of indium In 111 oxyquinoline labeled autologous leukocytes, and is not to be administered directly.
Autologous leukocyte labeling is not recommended in leukopenic patients because of the small number of available leukocytes.
Due to radiation exposure, indium In 111 oxyquinoline labeled leukocytes could cause fetal harm when administered to pregnant women.
If this radiopharmaceutical is used during pregnancy, the patient should be informed of the potential hazard to the fetus.
Indium In 111 oxyquinoline labeled autologous leukocytes should be used only when the benefit to be obtained exceeds the risks involved in children under eighteen years of age owing to the high radiation burden and the potential for delayed manifestation of long-term adverse effects.
Autologous leukocyte labeling is not recommended in leukopenic patients because of the small number of available leukocytes.
Due to radiation exposure, indium In 111 oxyquinoline labeled leukocytes could cause fetal harm when administered to pregnant women.
If this radiopharmaceutical is used during pregnancy, the patient should be informed of the potential hazard to the fetus.
Indium In 111 oxyquinoline labeled autologous leukocytes should be used only when the benefit to be obtained exceeds the risks involved in children under eighteen years of age owing to the high radiation burden and the potential for delayed manifestation of long-term adverse effects.
Adverse Reactions
ADVERSE REACTIONS Sensitivity reactions (urticaria) have been reported.
The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes.
The possibility of delayed adverse reactions has not been studied.
The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes.
The possibility of delayed adverse reactions has not been studied.