Data from FDA - Curated by EPG Health - Last updated 22 August 2017

Indication(s)

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

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Advisory information

contraindications
CONTRAINDICATIONS None known.
Special warnings and precautions
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 a pregnant woman or can affect reproduction capacity. Technetium Tc 99m Oxidronate 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. 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.
Adverse reactions
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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION General Instructions The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq (0.20 mCi)/kg with a 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 a pediatric or adult patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed 2 mg. Unit dose preparation instructions should be followed for pediatric patients. The radioactivity of each dose should be measured by a suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed 1 to 4 hours post-injection.
Pregnancy and lactation
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings.

More information

Category Value
Authorisation number NDA018321
Agency product number H852YK87WP
Orphan designation No
Product NDC 69945-091
Date Last Revised 04-04-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder MALLINCKRODT NUCLEAR MEDICINE LLC