Gallium Citrate Ga-67
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Questions & Answers
Side Effects & Adverse Reactions
None known.
Legal Issues
There is currently no legal information available for this drug.
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
Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive Gallium Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
History
There is currently no drug history available for this drug.
Other Information
Gallium Citrate Ga 67 Injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. Each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of Gallium Ga 67 on the calibration date as a complex formed from 8.3 nanograms gallium chloride Ga 67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution.
Gallium Ga 67, with a half-life of 78.26 hours, is cyclotron produced by the proton irradiation of enriched zinc. At the time of calibration the drug contains no more than 0.02% Gallium Ga 66 and no more than 0.2% Zinc Zn 65. The concentration of each radionuclidic impurity changes with time. At expiration, the drug contains no more than 0.001% Gallium Ga 66 and no more than 1.0% Zinc Zn 65. No carrier has been added.
Gallium Citrate has the following chemical structure:
Sources
Gallium Citrate Ga-67 Manufacturers
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Mallinckrodt Inc.
![Gallium Citrate Ga-67 Injection, Solution [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gallium Citrate Ga-67 | Mallinckrodt Inc.
The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection is 74 to 185 megabecquerels (2 to 5 millicuries). Gallium Citrate Ga 67 Injection is intended for intravenous administration only.
Approximately 10 percent of the administered dose is excreted in the feces during the first week after injection. Daily laxatives and/or enemas are recommended from the day of injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies.
Studies indicate the optimal tumor to background concentration ratios are often obtained 48 hours post injection. However, considerable biological variability may occur in individuals and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if contents are turbid.
Instructions for the handling of Gallium Citrate Ga 67:
Waterproof gloves should be used during the entire handling and administration procedure.
Using proper shielding, the vial containing the Gallium Citrate Ga 67 should be visually inspected to insure that it is free of particulate matter and discoloration prior to use.
Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation.
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