Pulmotec tm crisol de g… – інструкція – Іспанія

Інструкція із застосування Pulmotec tm crisol de grafito para la preparacion de tecnegas para la inhalacion

Introduction

Prospect: information for the patient

PULMOTEC Crisol of graphite for the preparation of Technegas for inhalation equipment for radiopharmaceutical preparation

Pure high-grade graphite

Read this prospect thoroughly before this medication is administered to you, because it contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any questions, consult your nuclear physician, who will oversee the procedure.
If you experience any adverse effects, consult your nuclear physician, even if they are not listed in this prospect. See section 4.

1. What is PULMOTEC and what is it used for

This medication is solely for diagnostic use.

PULMOTEC, when present with sodium pertecnectate (Tc-99m) and heated to2550°Cin a high-purity argon atmosphere, produces a Technegas aerosol of carbon microparticles labeled with technetium (Tc-99m).

After inhaling Technegas, it is possible to record lung images.

Those images will help your doctor or nuclear medicine specialist observe if your lungs are abnormally ventilated. The use of Technegas is usually combined with the intravenous injection of another radiopharmaceutical agent to detect any abnormalities in pulmonary blood flow.

2. What you need to know before starting to use PULMOTEC

Warnings and precautions:

- Technegas is administered by qualified personnel specifically trained. Laws governing the use, possession, and handling of radioactive substances stipulate that this medication can only be used in hospitals or similar institutions.

Your doctor or the nuclear medicine specialist performing the procedure will tell you if you need to take any special precautions after using this medication.

If you have any doubts, consult your doctor or the nuclear medicine specialist performing 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 the nuclear medicine specialist will prescribe this procedure only if they consider the risk to be significantly less than the potential benefits.

Other medications and PULMOTEC:

No interactions with other medications have been reported to date.

Inform your nuclear medicine specialist if you are using or have recently used other medications, including those obtained without a prescription.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your nuclear medicine specialist before using this medication.

It is essential to inform your doctor or the nuclear medicine specialist if you have any possibility of pregnancy or if you are breastfeeding.

If you are pregnant:

The use of radiopharmaceuticals during pregnancy requires very special care.

Your doctor or the nuclear medicine specialist will only prescribe this procedure if they consider its benefits to outweigh the potential risk.

If you are breastfeeding:

If the use of Technegas is considered essential while you are breastfeeding, your doctor or the nuclear medicine specialist will ask you not to feed your child for 12 hours after its use, and to discard the milk produced during that time period.

Driving and operating machines

No studies have been conducted on the effect of this medication on the ability to drive or operate machines.

3. How to use PULMOTEC

Your doctor or nuclear medicine specialist will know how much Technegas you need to use to get an image that provides the necessary medical information. For adults, the usual inhaled dose is around 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 will be given oxygen for a few moments before inhaling the Technegas. There are several possible ways to use this product: to determine which method is best for you, you will be asked to try breathing through the mouthpiece without Technegas, and then repeat it with the mouthpiece connected to the Technegas generator.
If you feel uncomfortable using the medical product, you can remove the mouthpiece from your mouth between two Technegas inhalations.
To achieve a homogeneous distribution of the product in your lungs, you may need to use Technegas while lying down.
A series of 4 to 6 images is usually sufficient for your doctor or nuclear medicine specialist to obtain the necessary information.

If you use more PULMOTEC than you should:

A overdose is almost impossible. Doses are carefully prepared and verified.
If a overdose is suspected, your doctor or nuclear medicine specialist will ask you to drink plenty of liquid and urinate frequently.

If you have any other questions about using this medication, ask your doctor or the nuclear medicine specialist who will perform the procedure.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effect frequencies are defined as follows:
Very frequent	Affects more than 1 in 10 users
Frequent	Affects 1-10 in 100 users
Infrequent	Affects 1-10 in 1000 users
Rare	Affects 1-10 in 10,000 users
Very rare	Affects less than 1 in 10,000 users
Unknown	The frequency cannot be estimated from available data

Rare cases of dizziness, drowsiness, and nausea have been reported. It is believed that they may be related to a temporary decrease in blood oxygen, produced during the first inhalation of Technegas, which does not contain oxygen. This risk is minimized by administering oxygen before inhaling Technegas.
If you experience these effects, your doctor or nuclear medicine specialist will have you breathe normal air or administer oxygen.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of PULMOTEC

You will not need to obtain or conserve this medication for diagnostic use. The centre where the test is performed will do this.

The medication label states the appropriate conditions for conservation and the expiration date. Hospital staff will verify that the medication is stored in the established conditions and not used after its expiration date.

6. Contents of the packaging and additional 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 packaging:

Equipment for the preparation of radiopharmaceuticals.

Technegas is obtained by reheating the radioactive pertecnetate (99mTc) of sodium to2550°Cin a high-purity graphite crucible (a specific-shaped carbon object) in a crucible of PULMOTEC. Technegas is an aerosol (microscopic particles suspended in argon gas).

PULMOTEC crucibles of 135 µL

Five retractable containers (PVC – cardboard) with 10 PULMOTEC 135 µL crucibles per container in a cardboard box.

PULMOTEC crucibles of 300 µL

Five retractable containers (PVC-carton) with 10 300 µL crucibles per container of PULMOTEC in a cardboard box.

Marketing authorization holder and responsible for manufacturing:

Marketing authorization holder

CYCLOMEDICA IRELAND LTD

Unit A5 Calmount Business Park

Ballymount

Dublin 12

IRELAND

Responsible for manufacturing

Pharmapac Limited

Unit D1

Willow Drive

Naas Enterprise Park

Newhall

Naas

Co. Kildare

W91 E797

IRELAND

Last review date of this leaflet12/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

This information is intended solely for healthcare professionals:

Please consult the technical data sheet.