Technetium Tc-99m

The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux Nasolacrimal Drainage System Imaging (dacryoscintigraphy) Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux

None.

Radiation risks associated with the use of Sodium Pertechnetate Tc 99m are greater in pediatric patients than in adults and, in general, the younger the patient the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit risk assessments involving pediatric patients. Long-term cumulative radiation exposure may be associated with an increased risk of cancer. Only use generator eluant specified for use with the Ultra-Technekow ™ V4 Generator. Do not use any other generator eluant or saline from any other source.

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 radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from time of generator elution. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Sodium Pertechnetate Tc 99m may affect fertility in males or females. Pregnancy In animal reproductive studies, Sodium Pertechnetate Tc 99m (as free pertechnetate) has been shown to cross the placental barrier. It is not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Pertechnetate Tc 99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards. Ideally, examinations using radiopharmaceutical drug products – especially those elective in nature – of women of childbearing capability should be performed during the first ten days following the onset of menses. Nursing Mothers Technetium Tc-99m is excreted in human milk during lactation, therefore, formula-feedings should be substituted for breast-feedings. Pediatric Use See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS .

Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m.

In animal reproductive studies, Sodium Pertechnetate Tc 99m (as free pertechnetate) has been shown to cross the placental barrier. It is not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Pertechnetate Tc 99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards. Ideally, examinations using radiopharmaceutical drug products – especially those elective in nature – of women of childbearing capability should be performed during the first ten days following the onset of menses.

Technetium Tc-99m is excreted in human milk during lactation, therefore, formula-feedings should be substituted for breast-feedings.

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS .