PRECAUTIONS
General
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.
Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine.
In order to obviate or minimize the possibility of contamination and of increased fragility of the labeled red blood cells, sterile techniques should be employed throughout the collection, labeling, rinsing, suspending, and injection of red blood cells. In addition, the number of washes and transfers should be kept to a minimum and only sterile, non-pyrogenic isotonic diluent should be employed throughout the labeling procedure.
Radiopharmaceuticals should be used only by 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or whether this agent may impair fertility in males or females.
Pregnancy: Teratogenic Effects
Category C
Animal reproduction studies have not been conducted with Sodium Chromate Cr 51 Injection. It is also not known whether this agent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. A suspension of chromium 51-labeled red blood cells containing Sodium Chromate Cr 51 Injection and Bracco A-C-D Solution Modified (Anticoagulant Citrate Dextrose Solution Modified) should be administered to a pregnant woman only if clearly needed.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Nursing Mothers
Caution should be exercised when Sodium Chromate Cr 51 Injection is administered to a nursing woman since chromium 51 is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
Pediatric Use
Safety of the chromium 51-labeled suspension of red blood cells in children has not been established.
|