Pulmotec TM graphite crucible for the preparation of technegas for inhalation
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
PULMOTEC Graphite crucible for the preparation of Technegas for inhalation radiopharmaceutical preparation kit
High-purity graphite
Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your nuclear medicine physician, who will supervise the procedure.
- If you experience any adverse effects, consult your nuclear medicine physician, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What PULMOTEC is and what it is used for
- What you need to know before using PULMOTEC
- How to use PULMOTEC
- Possible adverse effects
- How to store PULMOTEC
- Contents of the pack and other information
1. What PULMOTEC is and what it is used for
This medicine is for diagnostic use only.
PULMOTEC, in the presence of sodium pertechnetate (Tc-99m) and heated to 2550°C in a high-purity argon atmosphere, produces a radioactive aerosol of carbon microparticles labeled with technetium (Tc-99m), known as Technegas.
After inhaling Technegas, images of the lungs can be recorded.
These images will help your doctor or nuclear medicine specialist assess whether your lungs are abnormally ventilated. Technegas is usually used in combination with the intravenous injection of another radiopharmaceutical agent to detect any abnormalities in pulmonary blood flow.
2. What you need to know before using PULMOTEC
Warnings and precautions:
- Technegas is administered by specially trained qualified personnel. Regulations governing the use, possession, and handling of radioactive substances stipulate that this medicine may only be used in hospitals or similar institutions.
Your doctor or the nuclear medicine specialist performing the procedure will inform you whether you need to take special precautions after receiving this medicine.
If you have any doubts, consult your doctor or the nuclear medicine specialist who will perform the procedure.
- The use of Technegas involves the administration of a small amount of radioactivity.
The risk associated with its use is very small. Your doctor or nuclear medicine specialist will prescribe this procedure only if they consider that the risk is considerably outweighed by the potential benefits.
Other medicines and PULMOTEC:
To date, no interactions with other medicines are known.
Inform your nuclear medicine doctor if you are currently using or have recently used any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before using this medicine.
It is important that you inform your doctor or the nuclear medicine specialist if there is any possibility that you are pregnant or if you are breastfeeding.
If you are pregnant:
The use of radiopharmaceuticals during pregnancy requires special care.
Your doctor or nuclear medicine specialist will prescribe this procedure only if they consider that the benefits outweigh the potential risk.
If you are breastfeeding:
If the use of Technegas is considered essential while you are breastfeeding, your doctor or nuclear medicine specialist will instruct you not to breastfeed your child for 12 hours after administration, and to discard the milk produced during that period.
Driving and using machines:
No studies have been conducted on the effect of this medicinal product on the ability to drive or operate machinery.
3. How to use PULMOTEC
Your doctor or the nuclear medicine specialist will determine how much Technegas you need to inhale in order to obtain an image providing the necessary medical information. For adults, the usual inhaled dose is approximately 40 MBq.
The becquerel (Bq) is a unit of radioactivity. MBq means megabecquerel.
Lower doses are used for children.
- Technegas is inhaled. Since the first inhalation does not contain oxygen, you must be supplied with oxygen for a short period before inhaling the Technegas. There are several possible ways to use this product: to determine the best method for you, you will first be asked to breathe through the mouthpiece without Technegas, and then repeat the process with the mouthpiece connected to the Technegas generator.
- If you feel discomfort while using the medicinal product, you may remove the mouthpiece from your mouth between two inhalations of Technegas.
- To achieve a homogeneous distribution of the medicinal product in your lungs, it may be necessary for you to inhale Technegas while lying down.
- A series of 4 to 6 images is usually sufficient for your doctor or the nuclear medicine specialist to obtain the necessary information.
If you use more PULMOTEC than you should:
- An overdose is practically impossible. Doses are carefully prepared and verified.
- If an overdose is suspected, your doctor or the nuclear medicine specialist will ask you to drink plenty of fluids and to urinate frequently.
If you have any further questions about the use of this medicine, ask your doctor or the nuclear medicine specialist who will perform the procedure.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequencies of adverse effects are defined as follows: | |
Very frequent | Affects more than 1 in 10 users |
Frequent | Affects 1–10 in 100 users |
Uncommon | Affects 1–10 in 1,000 users |
Rare | Affects 1–10 in 10,000 users |
Very rare | Affects fewer than 1 in 10,000 users |
Not known | Frequency cannot be estimated from the available data |
- Rare cases of dizziness, lightheadedness, and nausea have been reported. These are believed to be related to a temporary decrease in blood oxygen levels caused by the first inhalation of Technegas, which does not contain oxygen. This risk is minimized by administering oxygen prior to inhaling Technegas.
- If you experience these effects, the doctor or nuclear medicine specialist will let you breathe normal air or will administer oxygen.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of PULMOTEC
You will not have to obtain or store this diagnostic medicine. It will be handled by the facility where the test is performed.
The medicine's label specifies the appropriate storage conditions and the expiration date. Hospital staff will ensure that the medicine is stored under the specified conditions and is not used after its expiration date.
6. Package contents and other information
Composition of PULMOTEC:
- The active substance is high-purity graphite (99.9%): 1.340 g in each crucible
- There are no other excipients.
Appearance of the product and contents of the pack:
Radiopharmaceutical preparation kit.
Technegas is obtained by reheating the radioactive agent sodium pertecnetate (99mTc) to 2550 °C in a high-purity graphite crucible (a carbon object of specific shape). Technegas is an aerosol (microscopic particles suspended in argon gas).
PULMOTEC crucibles of 135 µL
Five shrink-wrapped packs (PVC – cardboard) containing 10 crucibles of 135 µL per pack of PULMOTEC in a cardboard box.
PULMOTEC crucibles of 300 µL
Five shrink-wrapped packs (PVC-cardboard) containing 10 crucibles of 300 µL per pack of PULMOTEC in a cardboard box.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
CYCLOMEDICA IRELAND LTD
Unit A5 Calmount Business Park
Ballymount
Dublin 12
IRELAND
Manufacturer
Pharmapac Limited
Unit D1
Willow Drive
Naas Enterprise Park
Newhall
Naas
Co. Kildare
W91 E797
Ireland
Date of latest revision of this leaflet: 12/2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
This information is intended for healthcare professionals only:
Please consult the Summary of Product Characteristics.