ULTRA-TECHNEKOW FM Radionuclide generator (2019)
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Περιεχόμενα
1. Name of the medicinal product
Ultra-TechneKow FM, Radionuclide Generator.
2. Qualitative and quantitative composition
Technetium (<sup>99m</sup>Tc) is produced by means of a (<sup>99</sup>Mo/<sup>99m</sup>Tc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours ...
3. Pharmaceutical form
Radionuclide generator. A lead-shielded radionuclide generator consisting of absorbed <sup>99</sup>Mo in a glass column. A Type I glass vial contains a clear, colourless sterile aqueous solution as eluent. ...
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. The eluate from the generator (Sodium Pertechnetate (<sup>99m</sup>Tc) Injection Ph. Eur.) may be used as a reagent for labelling of various carrier compounds ...
4.2. Posology and method of administration
Sodium pertechnetate (<sup>99m</sup>Tc) is normally administered intravenously at activities which vary widely according to the clinical information required and the equipment employed. Pre-treatment of ...
4.3. Contraindications
None known.
4.4. Special warnings and precautions for use
Radiopharmaceutical agents should be used only by qualified personnel with the appropriate government authorisations for the use and manipulations of radionuclides. This radiopharmaceutical may be received, ...
4.5. Interaction with other medicinal products and other forms of interaction
Drug interactions have been reported in brain scintigraphy where there can be increased uptake of (<sup>99m</sup>Tc) pertechnetate in the walls of cerebral ventricles as a result of methotrexate-induced ...
4.6. Pregnancy and lactation
<sup>99m</sup>Tc (as free pertechnetate) has been shown to cross the placental barrier. When it is necessary to administer radioactive medicinal products to a woman of childbearing potential, information ...
4.7. Effects on ability to drive and use machines
Effects on ability to drive and use machines have not been described.
4.8. Undesirable effects
Allergic reactions have been reported following intravenous injection of sodium pertechnetate (<sup>99m</sup>Tc) and include urticaria, facial oedema, vasodilation, pruritus, cardiac arrythmias and coma. ...
4.9. Overdose
In the event of the administration of a radiation overdose with sodium pertechnetate (<sup>99m</sup>Tc), the absorbed dose should be reduced where possible by increasing the elimination of the radionuclide ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Various Thyroid diagnostic Radiopharmaceuticals <b>ATC code:</b> V09FX01 No pharmacological activity has been observed in the range of doses administered for diagnostic ...
5.2. Pharmacokinetic properties
The pertechnetate ion has similar biological distribution to iodide and perchlorate ions, concentrating temporarily in salivary glands, choroid plexus, stomach (gastric mucosa) and in the thyroid gland, ...
5.3. Preclinical safety data
There is no information on acute, subacute and chronic toxicity from single or repeated dose administration. The quantity of sodium pertechnetate (<sup>99m</sup>Tc) administered during clinical diagnostic ...
6.1. List of excipients
Sodium chloride Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
6.3. Shelf life
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 ...
6.4. Special precautions for storage
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 ...
6.5. Nature and contents of container
Generator The generator consists of a cartridge containing an aluminiumoxide column charged with <sup>99</sup>Mo and locked between two filters. One side of the cartridge is connected to the shielded, ...
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
8. Marketing authorization number(s)
PA 690/17/1
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28 April 2000 Date of last renewal: 28 April 2010
10. Date of revision of the text
September 2011
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