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Gallium Citrate Ga 67 Injection
This information is intended for Canadian healthcare professionals only.
Gallium (Ga 67) Citrate 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 (Ga 67) chloride, 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 between 5.5 and 8.0 with hydrochloric acid and/or sodium hydroxide solution.
Gallium (Ga 67), with a half-life of 78.3 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% of 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.
Indication & Usage
Gallium (Ga 67) Citrate Injection may be useful to demonstrate the presence and extend 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 (Ga 67) Citrate Injection may be useful as an aid in detecting some acute inflammatory lesions.
Important risk information
Warnings and precautions
- Certain pathologic conditions may yield up to 40 percent false negative gallium (Ga 67) studies. Therefore, a negative study cannot be definitely interpreted as ruling out the presence of disease.
- Lymphocytic lymphoma frequently does not accumulate gallium (Ga 67) sufficiently for unequivocal imaging and the use of gallium with this histologic type of lymphoma is not recommended at this time.
- Gallium (Ga 67) localization cannot differentiate between tumor and acute inflammation and other diagnostic studies must be added to define the underlying pathology.
- Care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers.
- The user should follow the directions carefully and adhere to strict aseptic procedures.
- Radiopharmaceuticals should be used under the supervision of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
- Rare occurrences of allergic reactions, skin rash, and nausea have been reported in association with gallium (Ga 67) citrate use.
- Pregnant Women: Gallium (Ga 67) citrate should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.
- Nursing Women: This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breastfeedings for four (4) weeks following the administration of Gallium (Ga 67) Citrate Injection. Breast milk expressed within that time should be discarded.
- Pediatrics (0 – 16 years of age): Safety and effectiveness in pediatric patients below the age of 18 have not been established.
- Geriatrics (> 65 years of age): No data available.
Frequently asked questions
It may demonstrate the presence and extent of Hodgkin’s disease, lymphoma, and bronchogenic carcinoma. However, further studies should be done to determine final diagnosis.
Call Curium Pharmacovigilance / Product Monitoring Department at 866.789.2211
How is this product supplied
|Gallium Citrate Ga 67 Injection – 6 mCi/vial||1||Each||3mL||180G0CA||69945-180-06|
|Gallium Citrate Ga 67 Injection – 12 mCi/vial||1||Each||6mL||180M0CA||69945-180-12|