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Technescan™ HDP Kit for the Preparation of Technetium Tc 99m Oxidronate

INDICATIONS AND USAGE

Technescan HDP Kit for the Preparation of Technetium Tc 99m Oxidronate is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

  • 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).
  • 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.
  • 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 insure 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.
  • To help reduce the radiation dose to the bladder, as well as other target organs, the patient should increase his or her fluid intake (unless medically contraindicated) and void as often as possible after the injection of Technetium Tc 99m Oxidronate for six hours after the imaging procedure.

ADVERSE REACTIONS

  • Serious adverse reactions may include hypersensitivity reactions.
  • Nausea and vomiting have infrequently been associated with Technetium Tc 99m Oxidronate.

USE IN SPECIFIC POPULATIONS

  • Breast feeding: should be discontinued because Technetium Tc 99m is excreted in human milk.

How Supplied

Distribution Direct
Expiration 8 hours after preparation
Shelf Life 12 months post manufacture
Storage Conditions Kit and reconstituted drug - controlled room temperature 20°C-25°C (68°F-77°F)

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, 30 vial 1 kit N091D0 00019909140
Kit, 5 vial 1 kit N091B0 00019909120

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What is the maximum amount of activity that can be added to the kit?300 mCi (volume 3-6 mL), see package insert for additional details.
What is the recommended pediatric dose?Per the package insert, the recommended pediatric dose is 7.4 MBq (0.2mCi)/kg with a range of 7.4 to 13 MBq (0.2mCi to 0.35mCi)/kg. The recommended minimum total pediatric dose is 37 MBq (1.0mCi). The maximum total dose injected into a pediatric patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed 2 mg. See package insert for full prescribing information.
What is the half-life?Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. For optimal results, imaging should be performed 1 to 4 hours post injection.
What is the expiration date after reconstitution?The expiration after reconstitution is 8 hours.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.