JEANATOPE Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Iso-Tex Diagnostics, Inc.
Λέξεις κλειδιά
50914-7732
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1. Description
Jeanatope 1-125 (Iodinated 1-125 Albumin Injection) is a sterile, nonpyrogenic, aqueous solution for intravenous use. Each milliliter provides approximately 10 mg protein (normal human serum albumin), ...
2. Clinical Pharmacology
Following intravenous injection, radioiodinated serum albumin is uniformly distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. Labeled albumin ...
3. Indications and Usage
Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume.
4. Contraindications
At present there are no known contraindications to the use of this preparation.
5. Warnings
Radiopharmaceuticals should not be administered to patients who are pregnant or to nursing mothers unless the expected benefit to be gained outweighs the potential hazards. Since I-125 is excreted in human ...
6. Precautions
In the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and occupational workers consistent with proper patient management.
7. Adverse Reactions
Although the immunological properties of serum albumin are believed to be virtually unaltered by the iodinated process, there is a theoretical possibility that allergic reactions may occur in patients ...
10. Dosage and Administration
<em>Radioiodinated serum albumin is administered intravenously</em>. When a procedure such as a blood volume determination is to be repeated, the total dosage administered in any one week should not exceed ...
11. How Supplied
Jeanotope (Iodinated I-125 Albumin Injection USP) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 3.7 megabequerels/10.0 ml (100 microcuries/10.0 ...