PULMOTEC

Graphite crucible for the Patient information leaflet    preparation of the suspension

for Technegas inhalation

High purity graphite

-    The use of Technegas 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 /or 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.

-    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 Technegas.

-    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, although not everybody gets them._

The frequencies for undesirable effects are defined as follows:
V ery common	Affects more than 1 user in 10
Common	Affects 1 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 10,000
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 leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.tiov.uk/yellowcarcl. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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 (^99mTc) 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).

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.

PI L- UK-150301