"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The contents of the two Solution vials, the Solution A vial containing the appropriate acidic solution and the Solution B vial containing the appropriate buffer solution, are intended only for use in the preparation of the Technetium Tc 99m Sulfur Colloid Injection and are NOT to be directly administered to the patient.
Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used to reconstitute this kit.
The contents of the kit are not radioactive. However, after the Sodium Pertechnetate Tc 99m Injection is added, adequate shielding of the final preparation must be maintained.
The contents of the kit are sterile and non-pyrogenic. It is essential to follow the directions carefully and to adhere strictly to aseptic procedures during preparation. This preparation contains no bacteriostatic preservative.
The stability of the colloidal preparation may be decreased in the presence of polyvalent cations, thus resulting in the agglomeration of the individual colloidal particles. These larger particles are likely to be trapped by the pulmonary capillary bed following intravenous injection.
Sodium Pertechnetate Tc 99m Injection containing more than 10 micrograms per milliliter of aluminum ion should not be used to formulate the Technetium Tc 99m Sulfur Colloid Injection.
Technetium Tc 99m Sulfur Colloid Injection is physically unstable, and the particles will settle with time. Failure to agitate the vial adequately before use may result in non-uniform distribution of radioactivity. Because of the increasing probability of agglomeration with aging, it is recommended that a vial of the prepared finished drug should not be used more than six hours from the time of formulation.
The components of CIS-Sulfur Colloid™ are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the pertechnetate solution and the withdrawal of doses for patient administration.
No special handling is required for the non-radioactive drug product.
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.
As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patient and clinical personnel, consistent with proper patient management.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Sulfur Colloid Injection affects fertility in males or females. Mutagenesis studies have not been conducted.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. It is also not known whether Technetium Tc 99m Sulfur Colloid Injection can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc 99m Sulfur Colloid Injection should be given 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.
Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional CIS-Sulfur Colloid Information
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