PULMOTEC Kit for radiopharmaceutical preparation Ref.[27570] Active ingredients: Technetium ⁹⁹ᵐTc technegas

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Cyclomedica Ireland Ltd, Ulysses House (Third floor), Foley Street, Dublin 1, Ireland

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 patient to another. It is recommended to follow the pulmonary count rate during inhalation of Technegas, using a Anger camera equipped with a standard collimator (low energy, low/medium resolution), until a lung count rate of between 1.5 and 2 Kcps is obtained. Inhalation has then to be stopped. This corresponds for adults approximatively to 40 MBq of Technegas inhaled.

The activity to be administered to children is a fraction of the recommended activity for adults, according to the EANM Dosage Card (Paediatric and Dosimetry Committees EANM, 2008), and is given by the following calculation:

A[MBq]Administered Baseline Activity* x Multiple

* baseline activity = 70.0 MBq

Therefore recommended activity of sodium pertechnetate [Tc-99m] to be deposited in the crucible will vary between 100 MBq and 700 MBq for children following the table below:

Weight (kg)Activity administered (crucible loading activity) (MBq)
3100
4100
6119,7
8149,8
10189,7
12219,8
14249,9
16280
18310,1
20340,2
22370,3
24399,7
26429,8
28450,1
30480,2
32510,3
34540,4
36560
38590,1
40620,2
42639,8
44669,9
≥46700

Adequate quality images are obtained in children with a pulmonary count rate of 500-1000 cps in the lungs monitored as described for adults. It is recommended to follow the pulmonary count rate during inhalation of Technegas, using a Anger camera equipped with a standard collimator (low energy, low/medium resolution), until a lung count rate of between 0.5 and 1Kcps is obtained. Inhalation has then to be stopped.

Method of administration

Technegas is administered by inhalation, at most ten minutes after preparation, through the "Patient Administration Set". This contains a plastic tube, to be connected to the Technegas generator, fitted with a mouthpiece and a filter.

Staff should wear disposable gloves and are recommended to wear aprons and masks, especially when the patient has a productive cough.

It is recommended that the patient is instructed to breath through the mouth piece selected from one of the models of administration described below, chosen to match the patient's ability:

  1. Slow deep breathing from the residual functional capacity (end of calm expiration), followed by a 5-second breath-hold (recommended method).
  2. Normal breathing with deep inhalation without breath-holding.
  3. Rapid and deep inspiration from the residual functional capacity followed by a breath-hold of about 5 seconds at the end of the respiration.

Dyspnoeic patients may remove the mouthpiece between the inhalations of Technegas.

As the first inhalation of Technegas contains no oxygen, pre-oxygenation of the patient is recommended prior to inhalation of Technegas, especially for patients with respiratory failure.

To yield uniform apex-to-base deposition, it is recommended to perform the administration with the patient in the supine position.

Dosimetry

Technetium (Tc-99m) decays with the emission of gamma radiation with a mean energy of 140 KeV and a half-life of 6 hours, to technetium (Tc-99) which can be regarded as stable.

The biokinetic model for Technegas assumes that 95% of the inhaled material is deposited in the lungs with 5% in the main bronchii airways, with a biological half-time of 4 days. The material absorbed from the GI-tract is assumed to behave as orally administered 99mTc-pertechnetate (ICRP, 1987). (ICRP Publication 80)

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

OrganAdult15 years10 years5 years1 year
Adrenals0.00680.00910.0130.0200.034
Bladder0.000320.000450.000740.00120.0028
Bone surfaces0.00490.00630.00880.0140.026
Brain0.000250.000330.000580.000940.0015
Breast0.00670.00730.0130.0190.027
Gall bladder0.00230.00320.00550.00840.011
GI-tract     
Stomach0.00440.00620.00880.00130.022SI0.000870.00130.00220.00390.0078Colon0.00140.00190.00340.00590.012
ULI0.00190.00250.00460.00770.015
LLI0.000740.00100.00180.00340.0070
Heart0.0130.0170.0230.0320.048
Kidneys0.00200.00300.00460.00720.0013
Liver0.00570.00780.0100.0150.025
Lungs0.110.160.220.330.63
Muscles0.00280.00360.00490.00730.013
Oesophagus0.00820.0100.0150.0190.027
Ovaries0.000410.000550.00110.00200.0042
Pancreas0.00520.00730.0100.0160.028
Red bone marrow0.00330.00380.00500.00660.011
Salivary glands0.00280.00360.00630.00980.018
Skin0.00120.00130.00220.00330.0059
Spleen0.00480.00630.00930.0150.025
Testes0.0000610.0000910.000200.000330.0011
Thymus0.00820.0100.0150.0190.027
Thyroid0.00290.00390.00690.0110.020
Uterus0.000300.000460.000830.00160.0036
Remaining organs0.00270.00350.00470.00680.012
Effective dose (mSv/MBq)0.0150.0220.0310.0470.087

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.

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

For Pulmotec 135 microlitre crucibles: Five thermoformed blister packs (PVC – cardboard) of 10 PULMOTEC, 135 microlitre crucibles in a cardboard box.

For Pulmotec 300 microlitre crucibles: Five thermoformed blister packs (PVC – cardboard) of 10 PULMOTEC, 300 microlitre crucibles in a cardboard box.

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 in accordance with national regulations must therefore be taken.

Radioactive waste must be disposed of in accordance with national and international regulations.

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