Respiriscint

Package Leaflet: Information for the Patient

RespiriScint,a kit for the preparation of a radiopharmaceutical preparation
high-purity graphite

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Consult a specialist doctor in nuclear medicine supervising the examination if advice or additional information is needed.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the specialist doctor in nuclear medicine. See section 4.

Table of Contents of the Leaflet

• 1. What is RespiriScint and what is it used for
• 2. Important information before using RespiriScint
• 3. How to use RespiriScint
• 4. Possible side effects
• 5. How to store RespiriScint
• 6. Package contents and other information

1. What is RespiriScint and what is it used for

This product is intended for diagnostic purposes only.
RespiriScint, when heated to a temperature of 2550°C in an atmosphere of high-purity ultraclean argon in the presence of sodium pertechnetate (Tc), produces an aerosol of carbon microparticles labeled with technetium (Tc), called Technegas.
After inhalation of Technegas, lung imaging can be performed.
Using imaging, the treating physician or the specialist doctor in nuclear medicine will be able to assess whether the patient's lungs are ventilated improperly. The use of Technegas is usually combined with the intravenous administration of another radiopharmaceutical agent to detect any abnormalities in blood flow to the lungs.

2. Important information before using RespiriScint

Warnings and precautions

• Technegas is administered by trained and qualified personnel. There are regulations governing the use, possession, and handling of radioactive substances, which state that this medicine may only be used in hospitals or similar controlled institutions. The treating physician or the specialist doctor in nuclear medicine who performs the examination will inform the patient whether any special precautions are necessary after using this medicine. In case of any doubts, consult the treating physician or the specialist doctor in nuclear medicine who performs the examination.
• The use of Technegas involves the administration of a small amount of a radioactive agent. The risk associated with such use is very small. The treating physician or the specialist doctor in nuclear medicine will only recommend this examination if they consider that the potential benefits outweigh the risk.

RespiriScint and other medicines

No interactions with other medicines have been reported so far.
Tell the treating physician or the specialist doctor in nuclear medicine about all other medicines the patient is taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a specialist doctor in nuclear medicine before using this medicine.
It is important to inform the treating physician or the specialist doctor in nuclear medicine if there is any possibility of pregnancy or if the patient is breastfeeding.
In the case of pregnancy:

• The use of a radiopharmaceutical during pregnancy requires special caution. The treating physician or the specialist doctor in nuclear medicine will only recommend this examination if they consider that the benefits outweigh the risk. In the case of breastfeeding:
• If the use of Technegas during breastfeeding is necessary, the treating physician or the specialist doctor in nuclear medicine will recommend that the patient stop breastfeeding for 12 hours after the examination and discard the breast milk during this time. Before using any medicine, consult the treating physician or the specialist doctor in nuclear medicine supervising the examination.

Driving and using machines

No studies have been conducted on the effects of this medicine on driving or using machines.

3. How to use RespiriScint

The treating physician or the specialist doctor in nuclear medicine will decide what dose of Technegas should be used in the patient to obtain an image containing the required medical information.
In adults, the usual inhaled dose is approximately 40 MBq.
Becquerel (Bq) is a unit of measurement of radioactivity. MBq means megabecquerel.
Lower doses are used in children and adolescents.

• Technegas is administered by inhalation. Since the first inhalation does not contain oxygen, the patient may be given oxygen for a few moments before inhaling Technegas. There are several possibilities for using this medicine: to determine which method is best for the patient, the doctor will first recommend a trial of breathing through a mouthpiece without Technegas, and then repeat this procedure with the mouthpiece connected to the Technegas generator.
• If the patient feels discomfort during the use of the medicine, they may remove the mouthpiece from their mouth between two inhalations of Technegas.
• To achieve even distribution of the medicine in the lungs, it may be necessary to use Technegas in a lying position.
• Usually, a series of 4 to 6 images is sufficient for the treating physician or the specialist doctor in nuclear medicine to obtain the required information.

Using a higher dose of RespiriScint than recommended

• Overdose is practically impossible. Doses are carefully prepared and checked.
• In case of suspected overdose, the treating physician or the specialist doctor in nuclear medicine will recommend that the patient drink fluids and urinate frequently. If there are any further doubts about the use of this medicine, consult the treating physician or the specialist doctor in nuclear medicine supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common
may occur in more than 1 in 10 patients
Common
may occur in less than 1 in 10 patients
Uncommon
may occur in less than 1 in 100 patients
Rare
may occur in less than 1 in 1000 patients
Very rare
may occur in less than 1 in 10,000 patients
Frequency not known
frequency cannot be estimated from the available data

• Rare cases of dizziness, drowsiness, and nausea have been reported. It is believed that they are caused by a temporary drop in oxygen levels in the blood, which may occur during the first inhalation of Technegas, which does not contain oxygen. This risk can be minimized by administering oxygen before inhaling Technegas.
• If the patient experiences such symptoms, the treating physician or the specialist doctor in nuclear medicine will allow the patient to breathe normal air or administer oxygen.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C 02-222 Warsaw, Tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store RespiriScint

The medicine is not stored by the patient. The storage of the medicine is the responsibility of the qualified personnel of the nuclear medicine center where the examination is performed.
Information on storage conditions and expiration date can be found on the medicine label. The hospital staff will ensure that the medicine is stored in the specified conditions and not used after the expiration date.

6. Package contents and other information

What RespiriScint contains

• The active substance is high-purity graphite (99.9%): 1.340 g in one crucible;
• There are no other ingredients.

What RespiriScint looks like and what the package contains

A kit for the preparation of a radiopharmaceutical preparation.
Technegas is obtained by heating radioactive sodium pertechnetate (Tc) to a temperature of 2550°C in a crucible with high-purity graphite (a piece of carbon of a specific shape). Technegas is produced in the form of an aerosol (i.e., microscopic particles suspended in argon gas).
RespiriScint crucible 135 µl
5 thermoformed blister packs (PVC - cardboard) containing 10 RespiriScint crucibles, 135 µl in a cardboard box.
RespiriScint crucible 300 µl
5 thermoformed blister packs (PVC - cardboard) containing 10 RespiriScint crucibles, 300 µl in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cyclomedica Ireland Limited
A5 Calmount Business Park
Ballymount, D12 XA06 Dublin
Ireland
[email protected]
tel +353 1 405 0506

Importer

Pharmapac Ltd
Unit D1, Willow Drive
Naas Enterprise Park, Newhall
W91 E797 Naas, Co. Kildare
Ireland

Date of last update of the leaflet:

Information intended for healthcare professionals only:
See the Summary of Product Characteristics.