Indium In-111 Oxyquinoline

Prescription

Nama merek: Indium in 111 Oxyquinoline

Bentuk Sediaan

Injection

Rute Pemberian

INTRAVENOUS

Produsen

Medi-Physics Inc. dba GE Healthcare.

About This Medication

DESCRIPTION Indium In 111 Oxyquinoline (oxine) Solution is a diagnostic radiopharmaceutical intended for radiolabeling autologous leukocytes. It is supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5 [sodium hydroxide and hydrochloric acid may be used to adjust the pH]. Each mL of the solution contains 37 MBq, 1 mCi of indium In 111 [no carrier added, >1.85 GBq/mcg indium (>50 mCi/mcg indium)] at calibration time, 50 mcg oxyquinoline, 100 mcg polysorbate 80, and 6 mg of HEPES (N-2-hydroxyethyl-piperazine-N'-2-ethane sulfonic acid) buffer in 0.75% Sodium Chloride Solution. The drug is intended to be used as a single-dose vial and contains no bacteriostatic agent. The radionuclidic impurity limit for indium 114m is not greater than 37 kBq, 1 µCi of indium 114m per 37 MBq, 1 mCi of indium In 111 at the time of calibration. The radionuclidic composition at expiration time is not less than 99.75% of indium In 111 and not more than 0.25% of indium In 114m/114. Chemical name: Indium In 111 Oxyquinoline. The precise structure of the indium In 111 oxyquinoline complex is unknown at this time. The empirical formula is (C 9 H 6 NO) 3 In 111.

Bahan Aktif

Bahan	Kekuatan
Indium In-111 Oxyquinoline	-

Indikasi & Penggunaan

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.

Dosis & Cara Pemberian

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.

Side Effects Overview

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.

Peringatan & Tindakan Pencegahan

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.

Kontraindikasi

CONTRAINDICATIONS None known.

Frequently Asked Questions

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 …

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 …

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 …

CONTRAINDICATIONS None known.

Indium In-111 Oxyquinoline is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Indium In-111 Oxyquinoline drug label (National Library of Medicine)
• openFDA — Indium In-111 Oxyquinoline label data (U.S. Food & Drug Administration)
• NDC Directory — Indium In-111 Oxyquinoline (FDA National Drug Code)

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Sumber data: DailyMed (NLM), openFDA, MFDS