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PULMOTEC

Active substance(s): GRAPHITE / GRAPHITE / GRAPHITE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
PULMOTECTM
Graphite crucible for the preparation of Technegas inhalation.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
One crucible (high pure 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 technetium [Tc-99m], called Technegas.
For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Solid for inhalation powder.

4.

CLINICAL PARTICULARS

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)
3
4
6
8
10
12
14
16
18
20
22
24
26
28
30
32
34
36
38

Activity administered
(crucible loading activity)
(MBq)
100
100
119,7
149,8
189,7
219,8
249,9
280
310,1
340,2
370,3
399,7
429,8
450,1
480,2
510,3
540,4
560
590,1

40
42
44
≥ 46

620,2
639,8
669,9
700

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
inspiration.
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.

4.3

Contraindications
None known.

4.4

Special warnings and special precautions for use
Radiopharmaceuticals should be received, used and administered only by
authorized persons in designated clinical settings and receipt, storage, use,
transfer and disposal are subject to the regulations and appropriate licences of
the competent authorities.
Radiopharmaceuticals should be prepared in a manner which satisfies both
radiation safety and pharmaceutical quality requirements.
Technegas should be administered ten minutes at most after preparation.
A careful assessment of the risk/benefit ratio should be made before use of the
product in children, particularly since use of Technegas results in an increased
effective dose and absorbed organ doses in children (see 11. Dosimetry).

4.5

Interaction with other medicinal products and other forms of interactions
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 to be pregnant until
proven otherwise. Where uncertainty exists it is important that radiation
exposure should be the minimum consistent with achieving the desired clinical
information. Alternative techniques which do not involve ionising radiation
should be considered.
Radionuclide procedures carried out on pregnant women also involve radiation
doses to the foetus. Only imperative investigations should be carried out

during pregnancy when likely benefit exceeds the risks incurred by mother and
foetus.
Before administering a radioactive medicinal product to a mother who is
breast-feeding consideration should be given to whether the investigation
could be reasonably delayed until the mother has ceased breast-feeding and
whether the most appropriate radiopharmaceutical product has been chosen,
bearing in mind secretion in breast milk.
If the administration of this radioactive product is essential, breast feeding
must be interrupted for at least 12 hours and the expressed milk must be
discarded.

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 estimated from the available data

Rare cases of dizziness and nausea have been reported. These have been ascribed to hypoxia
which may occur during inhalation of Technegas which initially contains no oxygen.
If a patient shows signs of hypoxia, he/she should immediately be allowed to breathe air and,
if necessary, oxygen.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely
benefit. The activity administered must be such that the resulting radiation dose is as low as
reasonably achievable bearing in mind the need to achieve the diagnosis.
Exposure to ionising radiation can lead to cancer or development of hereditary defects. The
effective dose resulting from a inhaled activity of 40 MBq of this radiopharmaceutical being
only 0.6 mSv (70 kg adult), these adverse events can be expected with a very low probability.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.

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.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals; Technetium
(99mTc), inhalants.
ATC code: V09E A 02
In the concentrations used for diagnostic examinations, Technegas is an inert
suspension and has no pharmacological effect.

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 technetium-99m.
Part of the carbon micro-particles may be retained in the upper and central
airways and is greater in patients with airway obstruction. These particles are
cleared by ciliary action and, after swallowing, are eliminated through the
gastro-intestinal tract without absorption.

5.3

Preclinical safety data
Toxicological data on PULMOTECTM 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 of oral administration of solution of Technegas in rats showed that the
radioactivity remained almost exclusively in the gastro-intestinal tract.
No study of effects on reproductive functions, of a mutagenic and
carcinogenic potential has been carried out.

6.

PHARMACEUTICAL PARTICULARS

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 containers
Five thermoformed blister packs (PVC – cardboard) of 10 PULMOTECTM
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.

7.

MARKETING AUTHORISATION HOLDER
Cyclomedica Ireland Limited

Ulysses House
(Third Floor)
Foley Street
Dublin 1
Ireland

8.

MARKETING AUTHORISATION NUMBER
PL 18992/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/03/2010

10

DATE OF REVISION OF THE TEXT
10/07/2015

11

DOSIMETRY
Technetium (Tc-99m) decays with the emission of gamma radiation with a
mean energy of 140 Ke V 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)
Organ
Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI-tract
Stomach
SI
Colon
ULI
LLI
Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas
Red bone marrow
Salivary glands
Skin
Spleen
Testes
Thymus
Thyroid
Uterus
Remaining organs
Effective dose
(mSv / MBq)

12

Adult
0.0068
0.00032
0.0049
0.00025
0.0067
0.0023

15 years
0.0091
0.00045
0.0063
0.00033
0.0073
0.0032

10 years
0.013
0.00074
0.0088
0.00058
0.013
0.0055

5 years
0.020
0.0012
0.014
0.00094
0.019
0.0084

1 year
0.034
0.0028
0.026
0.0015
0.027
0.011

0.0044
0.00087
0.0014
0.0019
0.00074
0.013
0.0020
0.0057
0.11
0.0028
0.0082
0.00041
0.0052
0.0033
0.0028
0.0012
0.0048
0.000061
0.0082
0.0029
0.00030
0.0027

0.0062
0.0013
0.0019
0.0025
0.0010
0.017
0.0030
0.0078
0.16
0.0036
0.010
0.00055
0.0073
0.0038
0.0036
0.0013
0.0063
0.000091
0.010
0.0039
0.00046
0.0035

0.0088
0.0022
0.0034
0.0046
0.0018
0.023
0.0046
0.010
0.22
0.0049
0.015
0.0011
0.010
0.0050
0.0063
0.0022
0.0093
0.00020
0.015
0.0069
0.00083
0.0047

0.0013
0.0039
0.0059
0.0077
0.0034
0.032
0.0072
0.015
0.33
0.0073
0.019
0.0020
0.016
0.0066
0.0098
0.0033
0.015
0.00033
0.019
0.011
0.0016
0.0068

0.022
0.0078
0.012
0.015
0.0070
0.048
0.0013
0.025
0.63
0.013
0.027
0.0042
0.028
0.011
0.018
0.0059
0.025
0.0011
0.027
0.020
0.0036
0.012

0.015

0.022

0.031

0.047

0.087

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
Technegas is generated exclusively using the medical device called Technegas
generator. It is essential to follow the instructions described below to ensure proper
quality of the product inhaled. Handling of the Technegas generator is detailed in the
instruction manual for the medical device.
Technegas is produced by heating to 2550°C the PULMOTECTM crucible to which a
solution of sodium pertechnetate [Tc-99m] (Ph.Eur.), from a standard Technetium

(Tc-99m) Generator, is added and, dry-evaporated. The preparation of the Technegas
is performed under an atmosphere of inert argon of purity equal to at least 99.99 %.
1. Using forceps supplied with the Technegas Generator, remove the
PULMOTECTM crucible from its protective packaging and place it on a
glass watch or other suitable support.
2. Rinse only the hole of the PULMOTECTM crucible as follows: using a
needleless syringe, fill the hole of the crucible with ≥ 95 % ethanol and
empty it by turning up the crucible. Do NOT use methylated alcohol as it
may leave residues upon evaporation that could lead to pyrolysis
products in the Technegas generation stage.
3. Wear disposable gloves to prevent any eventual contamination during
the following operations.
4. Open the Technegas Generator drawer and, using forceps, insert the
wetted crucible between the support electrodes of the generator.
5. Rotate the crucible to ensure good electrical contact is made with the
support electrodes. Ensure the hole is upright.
6. Using a syringe and needle, load the crucible (note that the walls of the
crucible hole must be wet with ethanol) with 250 to 700 MBq of sodium
pertechnetate [Tc-99m], in a volume around 0.1 mL, so that the
meniscus is concave or flat and non convex. If the meniscus is convex,
draw back the excess of sodium pertechnetate [Tc-99m] using the
syringe.
7. Close the drawer of the Technegas Generator and proceed to evaporate
of sodium pertechnetate [Tc-99m] solution.
NOTE: At this stage of preparation, an additional load of sodium
pertechnetate [Tc-99m] may be introduced to obtain the desired activity.
To perform this, simply repeat the steps 6 and 7.
8. Proceed to the heating cycle to generate the Technegas.
9. Administer Technegas within 10 minutes of preparation, following the
instructions given above (cf. section 4.2).
10. PULMOTECTM is intended for single use. The Technegas Generator
machine breaks the crucible at the end of the synthesis to prevent
accidental re-use. Crucible fragments should be considered as
radioactive waste.
The Technegas generator includes several automatic security devices to ensure safe
and effective generation and delivery of the diagnostic agent.
The purge phase allows automatic elimination of air introduced during preparation
and check the chamber seal. The Technegas generator inhibits delivery of the
diagnostic agent if the maximum temperature is not reached or if the Technegas has
been prepared for more than 10 minutes.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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