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PULMOTEC

Active substance(s): GRAPHITE

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PULMOTEC

Cyclomedica Ireland Ltd

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Patient in/ormation leaflet

Read all of this leaflet carefully before you start
using this medicine.




Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor or the specialist in nuclear medicine.
Ifany of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or the specialist in
nuclear medicine who will perform the
investigation.

In th is lea flet:
1. WHAT PULMOTEC IS AND WHAT IT IS USED
FOR?
2. BEFORE YOU USE PULMOTEC
3. HOW WILL PULMOTEC BE USED?
4. POSSIBLE SIDE EFFECTS
5. HOW WILL PULMOTEC BE STORED?
6. FURTHER INFORMATION

1. WHAT PULMOTEC IS AND WHAT IT IS USED
FOR.
This medicine is for diagnostic use only.
PULMOTEC, when in the presence of sodium
pertechnetate (Tc-99m) and heated to 2550°C in an
atmosphere of high purity argon, produces an aerosol of
carbon micro-particles labelled with technetium (Tc­
99m), called Technegas.
After inhalation ofTechnegas, imaging of the lungs can
be recorded .
These images help your doctor or the specialist in
nuclear medicine to see whether your lungs are
abnormally ventilated. The use of Technegas is
generally combined with the injection in your veins of
another radiopharmaceutical agent to detect any
abnormality in the blood flow to the lungs .

2. BEFORE YOU USE PULMOTEC

Graphite crucible for the
preparation ofthe suspension
for Teclmegas inhalation
High purity graphite

- The use of Tech neg as involves the administration of a

tiny amount of radioactivity.

The risk arising from this use is very small. Your doctor

or the specialist in nuclear medicine will prescribe this

procedure only if he or she considers that this risk is

greatly outweighed by the potential benefits.


Taking other medicines:

No interaction with other medicines known to date.

Please tell your doctor or the specialist in nuclear

medicine if you are taking or have recently taken other

medicines, including medicines without prescription.


Pregnancy and breast-feeding:

It is important to tell your doctor or the specialist in

nuclear medicine if there is any possibility you might be

pregnant, or if you are breast-feeding.

- The use of a radiopharmaceutical during pregnancy

requires very special care.

Your doctor or the specialist in nuclear medicine will

prescribe this procedure only if he or she considers that

its benefits outweigh the risk incurred.

- If the use of Technegas proves essential while you are

breast-feeding, your doctor or the specialist in nuclear

medicine will ask you not to breast-feed for 12 hours

after use, and to discard the milk produced during that

time.

Ask your doctor and lor the specialist in nuclear

medicine who will perform the investigation for advice

before taking any medicine.


Driving and using machines:

No studies have been done on the effect of this medicine

on driving or using machines.


3. HOW WILL PULMOTEC BE USED?:

- Your doctor or the specialist in nuclear medicine will

know how much Technegas you will need to use to get

an image that gives the required medical information .

For adults, the usual inhaled dose is about 40 MBq.

The becquerel (Bq) is a unit of radioactivity. MBq

means megabecquerel.

For children lower doses are used.


Take special care with PULMOTEC:
- Technegas is administered by specially-trained,
qualified staff. Laws governing the use, possession and
handling of radioactive substances stipulate that this
medicine may only be used in hospitals or similar
institu ti ons.
Your doctor or the specialist in nuclear medicine who
will perform the investigation will tell you if you need
to take any special precautions after using this medicine.
If in any doubt, please ask your doctor or the specialist
in nuclear medicine who will perform the investigation
for advice

PIL-UK-150301

- Technegas is inhaled. As the first inhalation contains
no oxygen, oxygen may be given to you for a few
moments before you inhale the Technegas. There are
several possible ways to use this product: to determine
which way is best in your case you will be asked first to
try breathing through the mouthpiece with no
Technegas, and then to repeat this with the mouthpiece
connected to the Technegas generator.
- If you experience discomfort when using the medicine,
you may take the mouthpiece out of your mouth
between two inhalations of Techneg as.

1/2

- To get an even distribution of the medicine in your

lungs, you may have to use Technegas in a lying-down

position.

- A series of 4 to 6 images is usually enough for your

doctor or the specialist in nuclear medicine to get the

required information.


If you used more PULMOTEC than you should:

- An overdose is practically impossible. The doses are

carefully prepared and checked.

- If an overdose is suspected, your doctor or the

specialist in nuclear medicine will ask you to drink a lot

and urinate frequently.

If you have any further questions on the use of this

product, ask your doctor or specialist in nuclear

medicine who will perform the investigation.

4. POSSIBLE SIDE EFFECTS
Like all medicines, PULMOTEC, can cause side effects,
a Ih
t ouglh not everylbd
0 ly gets t hem.
The frequencies for undesirable effects are defined as
follows:
Very common A ffects more than 1 user in 10
Common
Affects I to 10 users in 100
Uncommon
Affects 1 to 10 users is 1,000
Rare
Affects 1 to 10 users in 10,000
Very rare
Affects less than 1 user un J 0,000
Not known
Frequency cannot be estimated from
the available data
- Rare cases of giddiness and nausea have been
reported. These are thought to be caused by a temporary
drop in oxygen in the blood, which can happen during
the first inhalation of Technegas, which contains no
oxygen. This risk is minimised by giving oxygen before
inhaling Technegas.
- If you feel these effects, the doctor or the specialist in
nuclear medicine will let you breathe normal air or give
you oxygen.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leat1et. You can also report side
effects directly via the Yellow Card Scheme
at www.mhra.gov.uk/yellowcard . By reporting side
effects, you can help provide more information on the
safety of this medicine.

What PULMOTEC contains:
The active substance is high purity graphite:
1.340 g per one crucible

There is no other ingredient.


What PULMOTEC looks like and contents of the
pack:
Kit for radiopharmaceutical preparation.
Solid for inhalation powder.
The Technegas is obtained by heating the radioactive
agent sodium pertechnetate 9m Tc) to 2550 °C in a high
purity graphite crucible (a piece of carbon with a
specific shape). Technegas is an aerosol (microscopic
particles suspended in argon gas).

e

Five thermoformed blister packs (PVC - cardboard) of
10 Pulmotec crucibles in a cardboard box.

Marketing authorisation holder:
CYCLOMEDICA IRELAND Ltd
Ulysses House
Foley Street
Dublin 1
IRELAND
Manufacturers
Pharmapac Limited
Unit L2
Toughers Business Park
New Hall
Naas
Co. Kildare
Ireland
This leaflet was last revised in 03/2015

The following information is intended for medical or

healthcare professionals only:

See the summary of product characteristics.


5. HOW WILL PULMOTEC BE STORED?
You will not have to get or store this medicine for
diagnostic. The qualified staff of the nuclear medicine
center where is performed this investigation, will do
this .
The label on the medicine states the proper storage
conditions and the expiry date. The hospital staff will
make sure the medicine is stored in the conditions stated
and is not used after its expiry date.
6. FURTHER INFORMATION
PIL·UK·150301

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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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