Patient Information Leaflet

RespiriScint, kit for the preparation of a radiopharmaceutical preparation
high-purity graphite
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult the nuclear medicine specialist supervising your examination.
If you experience any side effects, including any not listed in this leaflet, inform the nuclear medicine specialist immediately. See section 4.

Table of contents

What RespiriScint is and what it is used for
Important information before using RespiriScint
How to use RespiriScint
Possible side effects
How to store RespiriScint
Contents of the pack and other information

1. What RespiriScint is and what it is used for

This product is intended for diagnostic use only.
RespiriScint, when heated to 2550°C in a high-purity argon atmosphere in the presence of sodium pertechnetate (Tc), produces a radioactive aerosol of carbon microspheres labeled with technetium (Tc), known as Technegaz.
After inhalation of Technegaz, lung imaging can be performed.
This imaging allows the physician or nuclear medicine specialist to assess whether the patient's lungs are abnormally ventilated. Technegaz is usually used in conjunction with an intravenous injection of another radiopharmaceutical to detect any abnormalities in blood flow to the lungs.

2. Important information before using RespiriScint

Warnings and precautions

Technegaz is administered only by trained and qualified personnel in accordance with safe handling procedures. Regulations govern the use, possession, and handling of radioactive substances, and stipulate that this medicine may be used only in hospitals or similar controlled institutions. The physician or nuclear medicine specialist performing the examination will inform you whether special precautions are required after administration of this medicine. If in doubt, consult the physician or nuclear medicine specialist conducting the examination.
The use of Technegaz involves administration of a small amount of radioactive material. The risk associated with this exposure is very low. The physician or nuclear medicine specialist will recommend this examination only when potential benefits outweigh the risks.

RespiriScint and other medicines

No interactions with other medicinal products have been reported to date.
Inform your physician or nuclear medicine specialist about all other medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a child, consult a nuclear medicine specialist before using this medicine.
It is important to inform your physician or nuclear medicine specialist if there is any possibility of pregnancy or if you are breastfeeding.

If you are pregnant:

The use of radiopharmaceuticals during pregnancy requires special caution. Your physician or nuclear medicine specialist will recommend this examination only if the potential benefits outweigh the risks.

If you are breastfeeding:

If administration of Technegaz during breastfeeding is necessary, your physician or nuclear medicine specialist will advise you to interrupt breastfeeding for 12 hours after the examination and to express and discard breast milk during this period.

Before taking any medicine, consult your physician and/or the nuclear medicine specialist supervising the examination.

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

3. How to use RespiriScint

The attending physician or a nuclear medicine specialist 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.
Smaller doses are used in children and adolescents.

Technegas is administered by inhalation. Because the first inhalation does not contain oxygen, the patient may be given oxygen for a few moments before inhaling Technegas. There are several ways of using this medicine: to determine which method is best for the patient, the physician may first recommend a trial of breathing through the mouthpiece without Technegas, followed by repeating the procedure with the mouthpiece connected to the Technegas generator.
If the patient experiences discomfort during administration of the medicine, the mouthpiece may be removed from the mouth between two inhalations of Technegas.
To achieve uniform distribution of the medicine in the lungs, administration of Technegas in the supine position may be necessary.
Usually, a series of 4 to 6 images is sufficient for the attending physician or nuclear medicine specialist to obtain the required information.

Use of a higher than recommended dose of RespiriScint

Overdose is practically impossible. Doses are carefully prepared and checked.
In case of suspected overdose, the attending physician or nuclear medicine specialist will advise the patient to drink fluids and urinate frequently. If there are any further doubts regarding the use of this medicine, consult the attending physician or the nuclear medicine specialist supervising the examination.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of adverse reactions is defined as follows:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

Rare cases of dizziness, fainting, and nausea have been reported. These are believed to be caused by a temporary decrease in blood oxygen levels, which may occur during the first inhalation of Technegaz, which does not contain oxygen. This risk can be minimized by administering oxygen prior to inhalation of Technegaz.
If such symptoms occur in a patient, the attending physician or nuclear medicine specialist will allow the patient to breathe normal air or will administer oxygen.

Reporting of adverse reactions
If any adverse reactions occur, including any undesirable symptoms not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store RespiriScint

The medicine is not stored by the patient. Storage of the medicine is the responsibility of qualified
personnel at the nuclear medicine facility where the examination is performed.
Information on storage conditions and expiry date is provided on the medicine label. Hospital staff will ensure that the medicine is stored under the specified conditions and is not used after the expiry date.

6. Contents of the Package 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 components.

What RespiriScint looks like and contents of the pack
Kit for the preparation of a radiopharmaceutical. Technegas is obtained by heating radioactive sodium pertechnetate (Tc) to a temperature of 2550°C in a high-purity graphite crucible (a shaped piece of carbon). Technegas is formed as an aerosol (i.e. microscopic particles suspended in gaseous argon).

RespiriScint Crucible 135 µl: 5 thermoformed blister packs (PVC - cardboard), each containing 10 RespiriScint crucibles, 135 µl, in a cardboard box.
RespiriScint Crucible 300 µl: 5 thermoformed blister packs (PVC - cardboard), each containing 10 RespiriScint crucibles, 300 µl, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Information intended for medical professionals only:
Please refer to the Summary of Product Characteristics.