Gallium Citrate Ga-67

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.

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General A thorough knowledge of the normal distribution of intravenously administered Gallium Citrate Ga 67 Injection is essential in order to accurately interpret pathologic states. The finding of an abnormal gallium Ga-67 concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions. Gallium Citrate Ga 67 Injection is intended for use as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection. 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. As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper management and to ensure minimum radiation exposure to occupational workers. The vial contents are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether this drug affects fertility in males or females. Pregnancy Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 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 Mothers This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established.

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

Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 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.

This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.

Safety and effectiveness in pediatric patients below the age of 18 have not been established.