Pentetic acid

Cut the dried strip 2 cm from the solvent front end. The short piece is marked Part III and the long piece is marked Part IV . Count the pieces in a counter and determine the percentage of free pertechnetate according to the following formula: Figure 2 System B Diagram Step 6: Determine the radiochemical purity according to the following formula: Use Technetium Tc 99m pentetate injection only if the radiochemical purity is 90% or greater. eq1 Figure_1 eq2 figure2 step-6-formula 2.6 Radiation Dosimetry The estimated radiation absorbed dose to various organs from an intravenous injection of Tc 99m pentetate in patients with normal and abnormal renal function is shown respectively in Table 4 and Table 5 . [See table below.] [See table below.] Bone surfaces 6.0 7.1 11 15 28 Brain 2.8 3.5 5.7 9.1 16 Breast 2.3 3.0 4.2 6.8 13 Gallbladder wall 4.2 5.7 9.2 13 16 Gastrointestinal tract Esophagus 3.3 4.2 6.2 9.6 17 Stomach wall 3.8 5.0 7.9 11 19 Small intestine wall 4.5 5.6 8.5 13 22 Colon wall 4.5 5.8 8.7 13 22 Upper large intestine wall 4.3 5.6 8.1 13 21 Lower large intestine wall 4.9 6.1 9.5 13 23 Heart wall 3.7 4.7 7.0 10 18 Kidneys 7.7 9.2 13 19 32 Liver 3.7 4.6 7.1 11 19 Lungs 3.3 4.2 6.2 9.5 17 Muscles 3.2 4.0 6.1 9.1 17 Ovaries 5.0 6.2 9.2 14 23 Pancreas 4.3 5.3 8.0 12 21 Red marrow 3.4 4.2 6.4 9.3 16 Skin 2.2 2.6 4.2 6.7 12 Spleen 3.8 4.7 7.3 11 19 Testes 3.5 4.5 6.9 10 18 Thymus 3.3 4.2 6.2 9.6 17 Thyroid 3.4 4.2 6.7 11 19 Urinary bladder wall 21 27 39 50 66 Uterus 6.1 7.4 11 16 25 Remaining organs 3.3 4.1 6.3 9.7 17 Effective dose per unit activity (microSv/MBq) 4.6 5.8 8.7 13 21 The estimated radiation absorbed dose to various organs from the inhalation of Tc 99m Pentetate Injection is shown in Table 6 . [See table below.]

Administration Instructions Use aseptic technique for all drug preparation and handling. Visually inspect the Tc 99m labeled DRAXIMAGE ® DTPA injection after reconstitution for particulate matter prior to administration. Do not use or administer if there is evidence of foreign matter or the solution is not clear. Measure the patient dose by a radioactivity calibration system immediately prior to administration.

Intravenous Use Instruct the patient to increase fluid intake and to void frequently for the next 4 to 6 hours after Tc 99m labeled DRAXIMAGE ® DTPA administration by injection to minimize the radiation dose to the bladder. Inhalation Use Use the selected nebulizer in accordance with the manufacturer’s instructions. Instruct the patient to rinse their mouth and expectorate after Tc 99m labeled DRAXIMAGE ® DTPA administration by inhalation to minimize the radiation dose to the mouth and esophagus.

Instructions for Drug Preparation The prepared solution can either be administered via intravenous injection or aerosolized by nebulizer for inhalation use. Before reconstitution, inspect the integrity of the vial. Add 2 to 10 mL [maximum amount 18.5 gigabecquerels (500 mCi)] of sodium pertechnetate Tc 99m injection USP to the reaction vial.

The volume of pertechnetate added should be balanced by the removal of the same volume of air. Cover the vial shield and invert to mix the contents. Assay the preparation in a calibrator, record the radio assay information on the label with radiation warning symbol, and affix it to the reaction vial. After reconstitution, store the solution at 25 °C (77 °F) in a lead shield and discard after 12 hours; excursions permitted between 15 °C and 30 °C (59 °F and 86°F).

Allow the preparation to stand for 15 minutes before determining the radiochemical purity of Tc 99m labeled DRAXIMAGE ® DTPA injection. After reconstitution, do not vent the vial.