Pulmotec

Package leaflet: Information for the user

PULMOTEC, graphite crucible for the preparation of the inhalation suspension Technegas
High-purity graphite
Please read all of this leaflet carefully before you are given this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, including those not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Contents of this leaflet:

1. What PULMOTEC is and what it is used for
2. What you need to know before PULMOTEC is used
3. How PULMOTEC is used
4. Possible side effects
5. How PULMOTEC is stored
6. Contents of the pack and other information

1. What PULMOTEC is and what it is used for

This medicinal product is for diagnostic use only.
PULMOTEC, in the presence of sodium pertechnetate ( Tc) and heated to 2550°C in an ultra-pure argon atmosphere, generates an aerosol of technetium-99m-labeled carbon micro-particles, known as Technegas.
After inhalation of Technegas, imaging of the lungs can be performed.
These images allow the physician or nuclear medicine specialist to assess whether lung ventilation is abnormal. The use of Technegas is generally combined with another radiopharmaceutical agent, which is administered intravenously to evaluate for abnormalities in pulmonary blood flow.

2. What you need to know before PULMOTEC is used

Warnings and precautions

• Technegas must be administered by qualified personnel specifically trained for this purpose. Laws regulating the use, possession, and transport of radioactive substances stipulate that this medicine may only be used in hospitals or similar facilities. The treating physician or nuclear medicine specialist performing the examination will determine whether the patient needs to take any special precautions after receiving the medicine. If in doubt, consult the physician or nuclear medicine specialist who will perform the examination.
• The use of Technegas involves the administration of a small amount of radioactivity. The risk associated with this use is very low. Your doctor or nuclear medicine specialist will prescribe this procedure only if they consider that the potential benefits greatly outweigh the risks involved.

Other medicines and PULMOTEC:
No interactions with other medicines are currently known.
Inform your nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, if you suspect you might be pregnant, or if you are planning a pregnancy, please consult your nuclear medicine physician before being given this medicine.
It is important to inform your treating physician or nuclear medicine specialist if you are pregnant or breastfeeding.

If you are pregnant:
The use of radiopharmaceuticals during pregnancy requires particular caution. Your treating physician or nuclear medicine specialist will prescribe this procedure only if they consider that the benefits outweigh the risks involved.

If you are breastfeeding:
If the use of Technegas is considered essential during this period, your physician or nuclear medicine specialist will instruct you to interrupt breastfeeding for a period of 12 hours after administration and to discard the milk produced during this time.

Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive vehicles or operate machinery.

3. How PULMOTEC is used

The doctor or nuclear medicine specialist knows the amount of Technegas required to obtain an image providing the necessary medical information. In adults, the usual inhaled dose is approximately 40 MBq. The becquerel (Bq) is the unit of measurement for radioactivity. MBq means megabecquerel.
Children are administered lower doses.

• Technegas is administered by inhalation. Since the first inhalation does not contain oxygen, the patient may be pre-oxygenated for a few seconds before inhaling Technegas. There are different methods of administration: to determine the most suitable method for the individual case, the patient will first be asked to breathe through the mouthpiece without Technegas, then to breathe again with the mouthpiece connected to a Technegas generator.
• If discomfort occurs during administration of the medicine, the mouthpiece may be removed from the mouth after every two inhalations of Technegas.
• To achieve homogeneous distribution of the medicine in the lungs, it is advisable to use Technegas while lying down.
• A series of 4–6 images is generally sufficient for the doctor or nuclear medicine specialist to obtain the necessary information.

If you use more PULMOTEC than you should:

• Exceeding the recommended dose is practically impossible, as doses are carefully prepared and controlled.
• In case of suspected overdose, the treating physician or nuclear medicine specialist will ask the patient to drink plenty of fluids and to urinate frequently.

If you have any doubts about the use of PULMOTEC, consult the doctor or nuclear medicine specialist who will perform the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

• Rare cases of nausea, mild mental confusion, and dizziness have been reported, attributed to transient hypoxia that may occur at the moment of the first inhalation of Technegas, a substance initially devoid of oxygen. This risk is minimized by pre-oxygenating the patient prior to Technegas inhalation.
• If the patient experiences any of these effects, the attending physician or nuclear medicine specialist will ask the patient to breathe normally or will administer oxygen.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store PULMOTEC

The acquisition and storage of this medicinal product for diagnostic use is the responsibility of qualified personnel in the nuclear medicine department where the examination is performed, and not of the patient.
The label on the medicinal product indicates the appropriate storage conditions and the expiry date. Hospital staff will ensure that the medicinal product is stored under the indicated conditions and is not used after the expiry date.

6. Contents of the pack and other information

What PULMOTEC contains

• The active substance is high-purity graphite: 1.340 g per crucible.
• No other ingredients.

Description of the appearance of PULMOTEC and contents of the pack:
Kit for radiopharmaceutical preparation.
Solid powder for inhalation.
Technegas is produced by heating the radioactive agent Sodium pertechnetate (99mTc) at 2550°C within a high-purity graphite crucible (a piece of coal with a specific shape). Technegas is an aerosol (microscopic particles suspended in argon).

For PULMOTEC crucibles of 135 µL:
Packs consisting of 5 thermoformed blisters (PVC – cardboard) containing 10 PULMOTEC crucibles of 135 µL, housed in a cardboard box.

For PULMOTEC crucibles of 300 µL:
Packs consisting of 5 thermoformed blisters (PVC – cardboard) containing 10 PULMOTEC crucibles of 300 µL, housed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
CYCLOMEDICA IRELAND LTD
Unit A5 Calmount Business Park
Ballymount
Dublin 12
Ireland

Manufacturer:
Pharmapac Ltd
Unit L2
Willow Drive
Naas Enterprise Park
Newhall, Naas
Co. Kildare
W91 AR29
Ireland

The following information is intended for medical or healthcare professionals only: refer to the product characteristics summary.