Indium In 111 Oxyquinoline 1 mCi/mL
Indium In-111 Oxyquinoline · LIQUID · BWXT Medical Ltd.
Indium In 111 Oxyquinoline is a liquid containing indium in-111 oxyquinoline at 1 mCi/mL, taken intravenous. Manufactured by BWXT Medical Ltd..
Key Facts
- Brand Name
- Indium In 111 Oxyquinoline
- Generic Name
- Indium In-111 Oxyquinoline
- NDC Code (Product)
72536-0920- Manufacturer
- BWXT Medical Ltd.
- Strength
- 1 mCi/mL
- Dosage Form
- LIQUID
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA202586
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 09/27/2019
Recall History
No Recall HistoryFull Prescribing Information
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.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended adult (70 kg) dose of indium In 111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200 to 500 µCi. Indium In 111 Oxyquinoline Solution is intended for the radiolabeling of autologous leukocytes. The indium In 111 oxyquinoline labeled autologous leukocytes are administered intravenously. Imaging is recommended at approximately 24 hours post injection. Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required. Aseptic procedures and a shielded syringe should be employed in the withdrawal of Indium In 111 Oxyquinoline Solution from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient's dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.
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.
Contraindications
CONTRAINDICATIONS None known.
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.
Frequently Asked Questions
What is Indium In 111 Oxyquinoline used for?
Indium In 111 Oxyquinoline contains Indium In-111 Oxyquinoline. It is a liquid taken intravenous. Consult your doctor for specific uses.
Is Indium In 111 Oxyquinoline a controlled substance?
Indium In 111 Oxyquinoline is not classified as a controlled substance by the DEA.
What is the generic name for Indium In 111 Oxyquinoline?
The generic name for Indium In 111 Oxyquinoline is Indium In-111 Oxyquinoline. There are 1 other brand versions of Indium In-111 Oxyquinoline.
What is the NDC code for Indium In 111 Oxyquinoline 1 mCi/mL?
The NDC (National Drug Code) for Indium In 111 Oxyquinoline 1 mCi/mL is 72536-0920, listed by BWXT Medical Ltd..