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

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands

Marketing authorization dates and numbers

PA 690/17/1

Date of first authorisation: 28 April 2000
Date of last renewal: 28 April 2010

Drugs

Drug Countries
ULTRA-TECHNEKOW FM Austria, Estonia, Spain, France, Ireland, Poland, Singapore, United Kingdom

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