ULTRA-TECHNEKOW FM Radionuclide generator Ref.[27727] Active ingredients: Technetium ⁹⁹ᵐTc pertechnetate

Sodium pertechnetate (^99mTc) is normally administered intravenously at activities which vary widely according to the clinical information required and the equipment employed. Pre-treatment of patients with thyroid blocking agents or reducing agents may be necessary for certain indications. Recommended activities are as follows:

Adults and the elderly

Thyroid scintigraphy: 18.5-80 MBq. Scintigraphy performed 20 minutes after intravenous injection.

Salivary gland scintigraphy: 40 MBq. Scintigraphy performed immediately after intravenous injection and at regular intervals up to 15 minutes.

Meckel’s diverticulum scintigraphy: 400 MBq. Scintigraphy performed immediately after intravenous injection and at regular intervals up to 30 minutes.

Brain scintigraphy: 370-800 MBq. Rapid sequential images are taken immediately within the first minute after intravenous administration; static images 1 to 4 hours later. Thyroid and choroid plexus should be blocked to avoid non-specific ^99mTc uptake.

Cardiac and vascular scintigraphy: 740-925 MBq. Red cells are labelled invivo or in-vitro by pre-treating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images over 30 minutes.

Gastrointestinal bleeding: 740-925 MBq. Red cells are labelled in-vivo or in-vitro by pre-treating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images at appropriate intervals for up to 24 hours.

Lacrimal dust scintigraphy: 2-4 MBq each eye. Drops are instilled into the eye and dynamic images are taken over 2 minutes, followed by static images at appropriate intervals over 20 minutes.

Children

The activity for administration to children may be calculated from the recommendeds range of adult activity and adjusted according to body weight or surface area. However, the Paediatric Task Group of EANM recommend that the activity to be administered to a child should be calculated from the body weight according to the following table:

Fraction of adult dose:

In very young children (up to 1 year) a minimum dose of 20 MBq (10 MBq in thyroid scintigraphy) for direct administration or 80 MBq for red blood cell labelling is necessary in order to obtain images of sufficient quality.

Dosimetry

According to ICRP 53, the radiation doses absorbed by a patient following direct administration of sodium pertechnetate (^99mTc) are as follows:

(I) Without pre-treatment with blocking agent

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

(II) With pre-treatment with blocking agent

Absorbed dose per unit activity (mGy/MBq) when blocking agents are given:

The effective dose equivalent resulting from an administered activity of 800 MBq sodium pertechnetate (^99mTc) is 10.4 mSv. Following pre-treatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (^99mTc) results in an effective dose equivalent of 4.24 mSv.

(III) The radiation doses absorbed by a patient following intravenous injection of ^99mTc labelled red blood cells are as follows

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

The effective dose equivalent resulting from an administration of 925 MBq ^99mTc-labelled red blood cells is 7.86 mSv.

(IV) The radiation dose absorbed by the lens of the eye following administration of sodium pertechnetate (^99mTc) for lacrimal duct scintigraphy is estimated to be 0.038 mGy/MBq. This results in an effective dose equivalent of less than 0.01 mSv for an administered activity of 4 MBq.

In the event of the administration of a radiation overdose with sodium pertechnetate (^99mTc), the absorbed dose should be reduced where possible by increasing the elimination of the radionuclide from the body. Measures to reduce possible harmful effects include frequent voiding of urine and promotion of diuresis and faecal excretion. Very little supportive treatment can be undertaken in the event of an overdose of ^99mTc-labelled red blood cells since elimination is dependent on the normal haemolytic process.

The expiry date for this product is 9 days after activity reference time. The eluate can be used for 8 hours. Expiry date for the eluent is 3 years after manufacture; expiry date for both TechneVials and sterile vial is 1 year after manufacture.

Do not store above 25°C. Do not refrigerate. Generators must be kept in an UltraTechneKow Safe (with at least 57 mm of lead protection) or behind an adequate laboratory shield. The eluate must be stored at 2-8°C. Eluent vial, TechneVials and sterile vial must be stored below 25°C. Storage should be in accordance with national regulations for radioactive materials.

Generator

The generator consists of a cartridge containing an aluminiumoxide column charged with ⁹⁹Mo and locked between two filters. One side of the cartridge is connected to the shielded, sterile supply needle in the eluent holder. The other side is connected to the similarly shielded, sterile outlet needle in the elution station. A second sterile needle in the eluent holder serves to eliminate the underpressure in the eluent vial under sterile conditions. The generator column is shielded by 28 to 56 mm of lead, depending on the ⁹⁹Mo activity. The shielded generator with the built-in station and the eluent holder are packed in an hermetically sealed tin, which is also the package. Elution occurs by placing the eluent vial on the needles in the eluent holder, followed by complete or partial filling of evacuated vials.

Elution yield:

• 80% (vials of 11 and 25 ml)
• 75% (vial of 5 ml).

The first time an Ultra-TechneKow FM is supplied, it comes with:

• 1 TechneVial shield or UltraVial Shield
• 1 Sterile vial shielding, unless supplied with the UltraTechneKow Safe.

Each Ultra-TechneKow FM is supplied with:

• 7 TechneVials, sterile, evacuated vials of 5, 11 or 25 ml
• 1 Sterile vial is provided with the elution set.
• 1 Eluent vial, 100 ml of sterile, physiological salt solution
• 7 Disinfection swabs
• 7 Labels with the radioactivity symbol.

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