Galliad

Package leaflet: Information for the patient

Galliad, 0.74–1.85 GBq, radionuclide generator
Gallium chloride solution (⁶⁸Ga)
Please read this leaflet carefully before receiving the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions about the use of this medicine, please consult the nuclear medicine physician who will supervise the procedure.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Table of contents

1. What Galliad is and what it is used for
2. Important information before using the gallium chloride (⁶⁸Ga) solution obtained with Galliad
3. How to use the gallium chloride (⁶⁸Ga) solution obtained with Galliad
4. Possible side effects
5. How to store Galliad
6. Contents of the pack and other information

1. What Galliad is and what it is used for

This medicine is a radiopharmaceutical product and is not intended for direct administration
to patients.
Galliad is a germanium (⁶⁸Ge)/gallium (⁶⁸Ga) radionuclide generator, which allows the production of
gallium chloride (⁶⁸Ga) solution.
The obtained gallium chloride (⁶⁸Ga) solution is used for radiolabelling, a technique in which
a substance is labelled (radiolabelled) with a radioactive compound, in this case ⁶⁸Ga.
Galliad is used to label certain medicinal products that have been specifically developed and approved for
use with the active substance gallium chloride (⁶⁸Ga). These medicinal products act as carriers delivering
radioactive ⁶⁸Ga to specific target sites in the body. These may include substances designed to detect
specific types of cells in the body, including tumour (cancer) cells. The small amount of radiation emitted can be detected outside the body using special cameras.
Please refer to the package leaflet of the medicinal product when it is to be radiolabelled with gallium chloride (⁶⁸Ga).
The nuclear medicine physician will explain what type of examination will be performed using this product.
The use of a ⁶⁸Ga-labelled medicinal product involves exposure to small amounts of radiation. Your referring physician and the nuclear medicine physician have determined that the clinical benefits of the procedure using this radiopharmaceutical product outweigh the risks associated with radiation exposure.

2. Important information before using the gallium chloride (Ga) solution obtained with the medicinal product

Galliad
Do not use the gallium chloride (Ga) solution obtained with the medicinal product
Galliad,

• if the patient is allergic to gallium chloride (Ga) or to any of the other ingredients of this medicine (listed in section 6). When using Ga-labelled medicinal products, please refer to the contraindications information contained in the package leaflet supplied with the medicinal product intended for radiolabelling.

Warnings and precautions
Information regarding special warnings and special precautions for use related to Ga-labelled medicinal products can be found in the package leaflet supplied with the medicinal product intended for radiolabelling.
Children and adolescents
If the patient is under 18 years of age (or the child is under 18 years of age), please consult a nuclear medicine physician.
Gallium chloride (Ga) solution and other medicines
Inform the nuclear medicine physician about all medicines currently taken, recently taken, or expected to be taken in the future, as they may affect image interpretation.
It is not known whether gallium chloride (Ga) may interact with other medicines, as appropriate studies have not been conducted.
Information regarding interactions related to the use of Ga-labelled medicinal products can be found in the package leaflet supplied with the medicinal product intended for radiolabelling.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a nuclear medicine physician before administration of radiolabelled medicinal products using Galliad.
Before administration of radiolabelled medicinal products using Galliad, inform the nuclear medicine physician about the possibility of pregnancy, missed menstrual period, or breastfeeding.
In case of doubt, consult the nuclear medicine physician who will supervise the procedure.
If the patient is pregnant
The nuclear medicine physician will administer this medicinal product during pregnancy only if the expected benefits outweigh the risks to the fetus.
If the patient is breastfeeding
The patient will be asked to discontinue breastfeeding. Please consult the nuclear medicine physician regarding when breastfeeding may be resumed.
Driving and operating machinery
The medicinal product used with Galliad may affect the ability to drive and operate machinery. Please read the patient package leaflet of this medicinal product carefully.

3. How to use the gallium chloride (Ga) solution obtained using the medicine Galliad

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products.
Galliad will be used exclusively in designated controlled areas. The product will be handled and administered
to the patient only by trained and qualified personnel experienced in the safe use of such medicinal products.
These individuals will exercise particular caution to ensure safe use of this medicine and will inform the user of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of radiolabelled medicinal product using Galliad to be administered to a specific patient. This will be the smallest quantity necessary to achieve the appropriate diagnostic result, depending on the medicinal product to be labelled and its intended use. For further information, please refer to the patient leaflet of the medicinal product to be radiolabelled.

Administration of the gallium chloride (Ga) solution obtained using Galliad and the course of the procedure
The patient will not receive the gallium chloride (Ga) solution itself, but another medicinal product radiolabelled using Galliad.
The gallium chloride (Ga) solution must be used only in combination with another medicinal product specifically developed for use after labelling (radiolabelling) with Galliad. The patient will receive only the final radiolabelled medicinal product.

Duration of the procedure
The nuclear medicine physician will inform the patient about the standard duration of the procedure following administration of the radiolabelled medicinal product using Galliad.

After administration of the radiolabelled medicinal product using Galliad
The nuclear medicine physician will advise the patient whether special precautions are necessary after receiving the radiolabelled medicinal product using Galliad. If you have any questions, please contact the nuclear medicine physician.

Administration of a higher than recommended dose of the radiolabelled medicinal product using Galliad
Overdose is unlikely, as the patient will receive the radiolabelled medicinal product using Galliad only under the strict supervision of a nuclear medicine physician overseeing the procedure. However, in the event of an overdose, appropriate treatment will be administered.

If you have any questions regarding the use of this product, please speak with the nuclear medicine physician who will supervise the procedure.

4. Possible adverse reactions

The radiopharmaceutical labeled with Galliad, like any other medicinal product, may cause adverse reactions, although not everyone will experience them.
After administration of the radiopharmaceutical labeled with Galliad, it will deliver small amounts of ionizing radiation with minimal risk of cancer and heritable abnormalities.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform the nuclear medicine physician. 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
PL-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 enables further accumulation of safety information regarding the use of this medicinal product.

5. How to store Galliad

Storage of this medicinal product will not be necessary. Responsibility for storage lies with
the medical personnel at the respective facility. Storage of radiopharmaceuticals must be
carried out in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for medical
personnel:
The radionuclide generator must not be used after the expiry date indicated on the container after
"EXP".
Do not disassemble the plastic housing. Do not store at temperatures
above 25°C.
The gallium chloride (Ga) solution obtained using the Galliad medicinal product should be used immediately.

6. Contents of the pack and other information

What Galliad contains
The active substance is gallium chloride solution (Ga).
The other components are:
Titanium dioxide (E 171) (matrix)
Sterile hydrochloric acid 0.1 N (elution solution)

What Galliad looks like and contents of the pack
Obtaining or handling this medicine by the patient is not required.

Marketing Authorisation Holder and Manufacturer
IRE ELiT
Avenue de l’Espérance 1
6220 Fleurus
Belgium
E-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area
under the following names:

Information intended exclusively for medical or healthcare professionals:

The full SmPC (Summary of Product Characteristics) for the Galliad radionuclide generator 0.74–1.85 GBq is supplied as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Please consult the SmPC.