TECHNESCAN HDP Powder for solution Ref.[10994] Active ingredients: Technetium ⁹⁹ᵐTc oxidronic acid

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.

Radiation dosimetry

The estimated absorbed radiation doses from an intravenous injection of Technetium Tc 99m-labeled Technescan HDP are shown in Table 4.

Table 4. Estimated Absorbed Radiation Dose^*:

^* Based on data in MIRD Dose Estimate Report No. 14. Bladder initially voided at 2.0 hours and then every 4.8 hours thereafter.
^** See Dosage and Administration section.

Preparations for use

All procedures should be conducted using waterproof gloves. Use shielded syringe during transport and administration of Tc 99m solutions.

1. Remove plastic disc from Technescan HDP vial and cleanse top by swabbing with alcohol. Note: If dose is for a single adult patient or for a pediatric patient, see unit dose preparation method below.
2. Place vial in lead vial shield. Add 3 to 6 mL of sodium pertechnetate Tc 99m solution and secure with a fitted lead cover. In choosing the amount of Tc 99m radioactivity to be used, the number of doses desired, the activity of each dose [recommended adult dose is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi)] and radioactive decay must be taken into account. The recommended maximum amount of Tc 99m radioactivity to be added to the vial is 11.1 gigabecquerels (300 mCi). Note: The contents of the vial are now radioactive. Maintain adequate shielding using the lead vial shield and fitted lead cover during the life of the radioactive preparation.
3. Shake the vial gently, for approximately 30 seconds, to ensure complete dissolution.
4. Record the time, date of preparation and the activity of the Tc 99m labeled Technescan HDP on the radioassay information label and affix to the vial.
5. Use within eight (8) hours of preparation. Refrigeration of the radiolabeled complex is not necessary. Discard unused material in accordance with Nuclear Regulatory Commission or Agreement State regulations pertaining to the disposal of radioactive wastes.

Unit dose preperation

Preparing a dose for a single adult patient or for a pediatric patient

To minimize volume injected and to ensure optimum solution concentration, reconstitute the vial contents in 3 to 6 mL of sterile, non-pyrogenic normal saline containing no preservatives. Shake the vial gently for approximately 30 seconds to assure complete dissolution, withdraw and discard all but approximately 1 mL of the solution. Add appropriate amount of sodium pertechnetate Tc 99m for a single adult dose or for one or more pediatric doses and shake gently. Proceed with steps 4 and 5. No more than 1480 MBq (40 mCi) should be added to the vial when preparing multiple pediatric doses. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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.