ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Technetium Tc 99m Oxidronate affects fertility in males and females.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. During the 24 hours following injection, Technetium Tc 99m-labeled Technescan HDP is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans. Blood levels are about 10% of the injected dose at one hour post-injection and continue to fall to about 6%, 4% and 3% at 2, and hours, respectively. When measured at 24 hours following its administration, skeletal retention is approximately 50% of the injected dose. Technescan HDP exhibits its greatest affinity for areas of altered osteogenesis and actively metabolizing bone.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. None known.

DESCRIPTION SECTION.

DESCRIPTION. Technescan(TM) HDP is supplied as lyophilized powder, packaged under nitrogen in vials for intravenous administration after reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2o2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2o2H2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2o2H2O as active ingredients. In addition, each vial contains 0.84 mg gentisic acid as stabilizer and 30.0 mg sodium chloride. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. The pH of the reconstituted drug is between 4.0 and 5.5. The contents of the vial are sterile and non-pyrogenic.The chemical structure of oxidronate sodium is:This radiopharmaceutical diagnostic agent, when reconstituted with ADDITIVE-FREE sodium pertechnetate Tc 99m forms complex of unknown structure.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. General Instructions. The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq (0.20 mCi)/kg with range of 7.4 to 13 MBq (0.20 to 0.35 mCi)/kg. The recommended minimum total pediatric dose is 37 MBq (1.0 mCi). The maximum total dose injected into pediatric or adult patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed mg.Unit dose preparation instructions should be followed for pediatric patients. The radioactivity of each dose should be measured by suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed to hours post-injection.

GENERAL PRECAUTIONS SECTION.

General. The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc 99m solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of Technescan HDP Tc 99m.Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Oxidronate and are NOT to be administered directly to the patient. Technetium Tc 99m Oxidronate should be formulated within eight (8) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration. Technetium Tc 99m Oxidronate as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by specific training 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. To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Technescan HDP is supplied as lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2o2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2o2H2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2o2H2O. In addition, each vial contains 0.84 mg gentisic acid as stabilizer and 30.0 mg sodium chloride. Kits containing vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20o to 25oC (68o to 77oF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Curium and the Curium logo are trademarks of Curium company.(C)2018 Curium US LLC. All Rights Reserved.Manufactured by: Curium US LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0R12/2018CURIUM(TM).

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Technescan HDP Tc 99m is diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.

NURSING MOTHERS SECTION.

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

OVERDOSAGE SECTION.

Overdose. In the event of the administration of an overdose with Technescan HDP, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. Technescan(TM) HDP Kit for the Preparation of Technetium Tc 99m OxidronateSterile, Non-Pyrogenic, for IV Injection with Sodium Pertechnetate Tc 99mRx onlyEach vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2 2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2 2H2O), with 0.343 mg, maximum tin chloride [stannous and stannic] dihydrate as SnCl2 2H2O. In addition, each vial contains 0.84 mg gentisic acid (stabilizer) and 30.0 mg sodium chloride. The pH is adjusted with HCI and/or NaOH. Contents are lyophilized and sealed under nitrogen. Use within hours of preparation.Manufactured by:Curium US LLCMaryland Heights, MO 63043Made in USACURIUM(TM)A091V0R12/2018. Display Panel A091VO.

PRECAUTIONS SECTION.

PRECAUTIONS. General. The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc 99m solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of Technescan HDP Tc 99m.Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Oxidronate and are NOT to be administered directly to the patient. Technetium Tc 99m Oxidronate should be formulated within eight (8) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration. Technetium Tc 99m Oxidronate as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by specific training 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. To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours.. Carcinogenesis, Mutagenesis, Impairment of Fertility. No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Technetium Tc 99m Oxidronate affects fertility in males and females.. Pregnancy Category C. Animal reproduction studies have not been conducted with Technetium Tc 99m Oxidronate. It is also not known whether Technetium Tc 99m Oxidronate can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Technetium Tc 99m Oxidronate should be given to pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of woman of childbearing capability should be performed during the first few (approximately 10) 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.. Overdose. In the event of the administration of an overdose with Technescan HDP, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.

PREGNANCY SECTION.

Pregnancy Category C. Animal reproduction studies have not been conducted with Technetium Tc 99m Oxidronate. It is also not known whether Technetium Tc 99m Oxidronate can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Technetium Tc 99m Oxidronate should be given to pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

SPL UNCLASSIFIED SECTION.

PHYSICAL CHARACTERISTICS. Technetium Tc 99m decays by isomeric transition with physical half-life of 6.02 hours.Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 108, (1981).The principal photon that is useful for detection and imaging is listed in Table 1.Table 1. Principal Radiation Emission Data RadiationMean Percent/DisintegrationEnergy(keV)Gamma-289.07140.5.

WARNINGS SECTION.

WARNINGS. Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).