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Gallium Citrate Ga 67 Injection

INDICATIONS AND USAGE

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.

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.
  • The use of gallium with lymphocytic lymphoma is not recommended at this time because it does not accumulate Gallium Ga 67 sufficiently for unequivocal imaging.
  • 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 the patient consistent with proper management and to insure minimum radiation exposure to occupational workers.
  • The user should follow the directions carefully and adhere to strict aseptic technique.
  • Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

ADVERSE REACTIONS

  • Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.

USE IN SPECIFIC POPULATIONS

  • Pregnancy C: should only be given if clearly needed. Not studied in pregnancy.
  • Gallium Citrate Ga 67 is known to be excreted in human milk therefore formula feedings should be substituted for breast feedings.
  • Safety and efficacy has not yet been established in pediatrics (<18 years of age).

How Supplied

Distribution Direct
Calibration Day Thursday of each week
Shelf Life Wednesday following calibration
Storage Conditions Controlled room temperature 20-25°C (68-77°F)

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Vial, 12 mCi activity 1 each 6 mL N180M0 00019918012
Vial, 6 mCi activity 1 each 3 mL N180G0 00019918006

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What diseases might Gallium Citrate Ga 67 Injection be useful in helping to identify? 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.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.