Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
Ultra-TechneKow FM, Radionuclide Generator.
| Pharmaceutical Form |
|---|
|
Radionuclide generator. A lead-shielded radionuclide generator consisting of absorbed 99Mo in a glass column. A Type I glass vial contains a clear, colourless sterile aqueous solution as eluent. Type I, evacuated sterile glass vials for eluate collection and column drying are provided with the Generator, as well as a vial for protection of the eluate needle. 7 disinfection swabs. |
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours to technetium (99Tc) which, in view of its long half-life of 2.13 × 105 years can be regarded as quasi stable. A sterile generator contains the parent isotope 99Mo, adsorbed to an aluminium oxide column. The 99Mo on the column is in equilibrium with the formed daughter isotope 99mTc. The generators are supplied with the following 99Mo activity amounts:
At activity reference time:
| GBq | (mCi) | GBq | (mCi) |
|---|---|---|---|
| 2.15 | (58) | 17.20 | (465) |
| (116) | 21.50 | (581) | |
| (174) | 25.80 | (697) | |
| (232) | 30.10 | (814) | |
| (291) | 34.40 | (930) | |
| (349) | 43.00 | (1162) |
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Technetium ⁹⁹ᵐTc pertechnetate |
The pertechnetate ion distributes in the body similarly to the iodide ion, but is not organified. In contrast to the iodide ion, the pertechnetate is released unchanged from the thyroid gland. Pertechnetate concentrates in the thyroid gland, salivary glands, gastric mucosa and choroid plexus. It is used in nuclear medicine in several nuclear scanning procedures. |
| List of Excipients |
|---|
|
Sodium chloride |
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:
The first time an Ultra-TechneKow FM is supplied, it comes with:
Each Ultra-TechneKow FM is supplied with:
Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
PA 690/17/1
Date of first authorisation: 28 April 2000
Date of last renewal: 28 April 2010
| Drug | Countries | |
|---|---|---|
| ULTRA-TECHNEKOW FM | Austria, Estonia, Spain, France, Ireland, Poland, Singapore, United Kingdom |
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