PULMOTEC Kit for radiopharmaceutical preparation (2020)
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Περιεχόμενα
1. Name of the medicinal product
PULMOTEC Graphite crucible for the preparation of Technegas inhalation.
2. Qualitative and quantitative composition
One crucible (high purity graphite) 1.340 g which, heated to 2550°C, under ultra pure argon in the presence of sodium pertechnetate [Tc-99m], produces an aerosol of carbon micro-particles labelled with ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. Solid for inhalation powder.
4.1. Therapeutic indications
For diagnostic use only. Scintigraphy of alveolar spaces, in particular in the context of the diagnosis of pulmonary embolism.
4.2. Posology and method of administration
The recommended activity of sodium pertechnetate [Tc-99m] to be deposited in the crucible is between 250 and 700 MBq for adults. The activity present in the lungs after each inhalation varies from one ...
4.3. Contraindications
None known.
4.4. Special warnings and precautions for use
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations ...
4.5. Interaction with other medicinal products and other forms of interaction
None known. No interaction studies in vitro or in vivo with inhaled or any medicinal drugs have been performed.
4.6. Pregnancy and lactation
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed ...
4.7. Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8. Undesirable effects
The frequencies for undesirable effects are defined as follows: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1000 to <1/100, Rare ≥1/10000 to <1/1000, Very rare <1/10000, Not known Cannot be ...
4.9. Overdose
An overdose of carbon cannot happen. In case of radioactivity overdose, there is no way of increasing the elimination of radiopharmaceutical product and reducing the radiation exposure.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Diagnostic radiopharmaceuticals; Technetium (<sup>99m</sup>Tc), inhalants <b>ATC code:</b> V09EA02 In the concentrations used for diagnostic examinations, Technegas is ...
5.2. Pharmacokinetic properties
After inhalation, Technegas is absorbed on the walls of pulmonary alveoli and remains in the lungs. There is no intra vascular clearance and elimination of radioactivity is by the physical decay of the ...
5.3. Preclinical safety data
Toxicological data on PULMOTEC are not available. A single administration of inhaled radioactivity of 5.5 MBq in a rat was well tolerated with most of the radioactivity inhaled found in the lung. Studies ...
6.1. List of excipients
None.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Four years. Technegas should be used within 10 minutes after preparation.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
<u>For Pulmotec 135 microlitre crucibles:</u> Five thermoformed blister packs (PVC – cardboard) of 10 PULMOTEC, 135 microlitre crucibles in a cardboard box. <u>For Pulmotec 300 microlitre crucibles:</u> ...
6.6. Special precautions for disposal and other handling
The administration of radiopharmaceuticals creates risks for other persons from external radiation in particular for the chest or by contamination from vomiting and sputum. Radiation protection precautions ...
7. Marketing authorization holder
Cyclomedica Ireland Ltd, Ulysses House (Third floor), Foley Street, Dublin 1, Ireland
8. Marketing authorization number(s)
PA1034/001/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29<sup>th</sup> September 2000 Date of last renewal: 23<sup>rd</sup> February 2010
10. Date of revision of the text
June 2020
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