GALLIAPHARM

Package leaflet: Information for the patient

GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator
Gallium (Ga) chloride solution

This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. Patients can also help by reporting any suspected
adverse reactions that occur after administration of the medicine.
For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before the medicine is administered, 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, please consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, including those not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Leaflet contents:

1. What GalliaPharm is and what it is used for
2. Important information before administration of gallium (Ga) chloride solution obtained using GalliaPharm
3. How the gallium (Ga) chloride solution obtained using GalliaPharm is administered
4. Possible adverse reactions
5. How to store GalliaPharm
6. Contents of the pack and other information

1. What GalliaPharm is and what it is used for

GalliaPharm is a radiopharmaceutical product intended solely for diagnostic purposes.
It is a radiopharmaceutical product not intended for direct administration to patients.
GalliaPharm is a germanium (Ge)/gallium (Ga) radionuclide generator, a device used to obtain gallium (Ga) chloride solution.
The resulting gallium (Ga) chloride solution is used for radiolabelling, a technique in which a substance is labelled (radiolabelled) with a radioactive substance—in this case, Ga.
GalliaPharm is used to label specific medicinal products specifically developed and approved for use with the active substance: gallium (Ga) chloride.
These medicinal products act as carriers delivering radioactive Ga to the required site in the body. They may include compounds designed to detect specific types of cells in the body, including tumour (cancerous) cells. The small amount of administered radioactive compound can be detected from outside the body using special cameras, allowing images of the body to be obtained. Please refer to the Patient Information Leaflet of the medicinal product that will be radiolabelled with gallium (Ga) chloride.
The nuclear medicine physician will explain to the patient the nature of the examination to be performed using this product.
Use of a medicinal product labelled with Ga involves exposure to a low level of radioactivity. The treating physician and the nuclear medicine physician have determined that the clinical benefit to the patient from the procedure using the radiopharmaceutical outweighs the risk associated with radiation exposure.

2. Important information before using gallium (⁶⁷Ga) chloride solution obtained using

the product GalliaPharm
Gallium (⁶⁷Ga) chloride solution obtained using the product GalliaPharm must not be used

• if the patient is allergic to gallium (⁶⁷Ga) or to any of the other ingredients of this medicine (listed in section 6). When using a medicinal product labelled with ⁶⁷Ga, please read the contraindications information contained in the Patient Leaflet of the medicinal product to be radiolabelled.

Warnings and precautions
For warnings and precautions regarding the medicinal product labelled with ⁶⁷Ga, please refer to the Patient Leaflet of the medicinal product to be radiolabelled.
Children and adolescents
Patients under 18 years of age or parents of such patients should consult a nuclear medicine physician.
Gallium (⁶⁷Ga) chloride solution and other medicines
Please inform the nuclear medicine physician about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take, because they may interfere with image interpretation.
It is not known whether gallium (⁶⁷Ga) chloride solution interacts with other medicines, as appropriate studies have not been conducted.
For information on interactions related to the use of medicinal products labelled with ⁶⁷Ga, please refer to the Patient Leaflet of the medicinal product to be radiolabelled.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a nuclear medicine physician before receiving radiolabelled medicines using the product GalliaPharm.
The patient must inform the nuclear medicine physician before receiving radiolabelled medicines using the product GalliaPharm if there is any possibility she might be pregnant, if her menstrual period is delayed, or if she is breastfeeding.
In case of doubt, please consult the nuclear medicine physician supervising the procedure.
Pregnant women
The nuclear medicine physician will administer the medicine during pregnancy only if the expected benefit outweighs the potential risk.
Breastfeeding women
The patient will have to interrupt breastfeeding. The nuclear medicine physician will advise when breastfeeding can be resumed.
Driving and operating machinery
The medicinal product used in conjunction with GalliaPharm may affect the ability to drive and operate machinery. Please read the Patient Leaflet of this medicine carefully.

3. How to use the gallium (Ga) chloride solution prepared with the product

GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical
products. The GalliaPharm product will be used exclusively in designated controlled areas.
The product will be prepared and administered to the patient only by personnel who are
trained and qualified to perform these tasks safely. These individuals will take all necessary
precautions to ensure safe use of the product and will inform the patient about the actions
being taken.
The nuclear medicine physician supervising the procedure will determine the amount of
radiolabelled product using GalliaPharm to be administered in each individual case. This will
be the smallest dose necessary to achieve the desired outcome, depending on the final
product and its intended use. For more detailed information, please refer to the Patient
Information Leaflet of the medicinal product to be radiolabelled.
Administration of gallium (Ga) chloride solution and performance of the procedure
The patient will not receive gallium (Ga) chloride solution directly, but rather another
medicinal product radiolabelled with GalliaPharm. Gallium (Ga) chloride solution may only
be used in combination with another medicinal product specifically developed and approved
for conjugation (radiolabelling) with GalliaPharm. The patient will receive only the final
radiolabelled product.
Duration of the procedure
The nuclear medicine physician will inform the patient how long the procedure typically lasts
after administration of the radiolabelled medicinal product using GalliaPharm.
After administration of the radiolabelled medicinal product using GalliaPharm
The nuclear medicine physician will inform the patient whether any special precautions are
required following administration of the radiolabelled medicinal product using GalliaPharm.
For any questions, please contact the nuclear medicine physician.
Administration of a higher than recommended dose of the radiolabelled medicinal product using GalliaPharm
Overdose is unlikely, as the patient will receive a dose of the radiolabelled medicinal product
using GalliaPharm that is precisely controlled by the nuclear medicine physician supervising
the procedure. In the event of an overdose, appropriate treatment will be administered.
If you have any questions regarding the use of this product, please consult the nuclear
medicine physician supervising the procedure.

4. Possible adverse reactions

Like any medicinal product, the radiopharmaceutical prepared with GalliaPharm may cause adverse reactions, although not everyone will experience them.
Administration of the radiopharmaceutical prepared with GalliaPharm results in a small emission of ionizing radiation, carrying the lowest possible risk of cancer and hereditary defects.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician.
Adverse reactions can be reported directly to the Department for 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, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to improve the safety information available for this medicinal product.

5. How to store GalliaPharm product

The patient will not store this product. A specialist at the nuclear medicine facility is responsible
for its storage. Radioactive pharmaceutical products must be stored in accordance with
national regulations concerning the storage of radioactive materials.
The following information is intended for specialists only.
The radionuclide generator must not be used after the expiry date stated on the packaging
after: "EXP".
Do not disassemble the housing. Do not store at temperatures above 25°C.
The gallium (Ga) chloride solution obtained using the GalliaPharm product is intended for
immediate use.

6. Contents of the packaging and other information

What GalliaPharm contains
The active substance in GalliaPharm is gallium (Ga) chloride solution.
The other components are: titanium dioxide (column filler)
sterile ultrapure hydrochloric acid 0.1 mol/l (elution solution)

What GalliaPharm looks like and contents of the pack
The patient will not receive or prepare this product.

Marketing Authorisation Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

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

Information intended exclusively for medical professionals:

The complete Product Information for GalliaPharm is provided as a separate
document within the product packaging. Its purpose is to provide healthcare
professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical product.
The contents of the Product Information should be carefully reviewed.