TECHNESCAN DTPA Kit, Powder for solution for injection Ref.[27726] Active ingredients: Technetium ⁹⁹ᵐTc pentetic acid

In adults the following administered doses are recommended (other doses may be justifiable):

For intravenous use:

• Measurement of glomerular filtration rate from plasma: 1.8-3.7 MBq.
• Measurement of glomerular filtration rate using gamma camera combined with sequential dynamic renal scanning: 37-370 MBq. Sequential scanning should begin immediately after injection. Optimal static imaging time is 1 hour post injection.
• Brain scanning: 185-740 MBq. For cerebral examinations static images are obtained 1 hour and, if necessary, several hours after injection. Sequential dynamic scanning should begin immediately after injection.

For inhalation:

• Lung ventilation imaging: 500-1000 MBq in nebuliser; 50-100 MBq in lung.

For oral use:

• Study of gastro-oesophageal reflux and gastric emptying: 10-20 MBq. Dynamic recording should be performed during the first minutes (up to 120 minutes for gastroduodenal transit).

Paediatric dose

The dose for children is adjusted according to body weight:

Paediatric dosage (MBq) = Adult dosage (MBq) x Child weight (kg) / 70

In some circumstances, dose adjustment according to surface area may be appropriate:

Paediatric dosage (MBq) = Adult dosage (MBq) x Child body surface (m²) / 1.73

In very young children (up to 1 year) a minimum dose of 20 MBq is necessary in order to obtain images of sufficient quality, when technetium (^99mTc) pentetate (DTPA) is used for kidney studies.

Radiation Dosimetry

(^99mTc) technetium decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours to (99Tc) technetium, which can be regarded as quasi stable. For this product the effective dose equivalent resulting from:

• An intravenous administered activity of 740 MBq to a patient with normal renal function is 4.7 mSv (per 70 kg individual).
• An inhalation (nebuliser) of 100 MBq is 0.7-7 mSv (per 70 kg individual).
• An oral administration of 20 MBq is 0.5 mSv (per 70 kg individual).

According to ICRP (International Commission of Radiological Protection) the radiation doses absorbed by the patients are the following:

Normal renal function
Absorbed dose per unit activity administered (mGy/MBq):

Abnormal renal function
Absorbed dose per unit activity administered (mGy/MBq):

The radiation doses given to man on administration by aerosol of ^99mTc DTPA are the following:
Absorbed dose per unit activity administered (mGy/MBq):

The radiation doses given to man on administration per os of ^99mTc
DTPA are the following (D.J. Gambini, R. Granier: Manuel pratique de Médecine Nucléaire):

In the event of the administration of a radiation overdose with technetium (^99mTc) pentetate (DTPA) the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding.

1 year.

After reconstitution, the product should be used within 8 hours. Store below 25°C.

Powder for solution for injection

Do not store above 25°C. Keep the vials in the outer carton.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Storage should be in accordance with national regulations for radioactive materials.

Carton box containing five 10 ml type 1 Ph.Eur. clear, colourless, borosilicate glass vials. The vials are closed with a bromobutyl rubber lyophilisation stopper sealed with an aluminium cap.

Any unused product or waste material should be disposed of in accordance with local requirements for radioactive materials.