GALLIAPHARM 2.59 GBq RADIOPHARMACEUTICAL GENERATOR

Introduction

Patient Information: Summary of Product Characteristics

GalliaPharm 2.59GBq Radionuclide Generator

Gallium (68Ga) chloride solution

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine specialist who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What GalliaPharm is and what it is used for
2. What you need to know before the gallium (68Ga) chloride solution obtained with GalliaPharm is used
3. How to use the gallium (68Ga) chloride solution obtained with GalliaPharm
4. Possible side effects
5. Storage of GalliaPharm
6. Package contents and further information

1. What GalliaPharm is and what it is used for

GalliaPharm is a germanium (68Ge)/gallium (68Ga) radionuclide generator, a device used to obtain a gallium (68Ga) chloride solution. The gallium (68Ga) chloride solution is a substance that is handled by specialized doctors (nuclear medicine specialists) and pharmacists who have the necessary training to work with radioactive materials. The gallium (68Ga) chloride solution is not intended for direct use in patients, but it is used for radiolabeling, a technique in which a substance is labeled (radiolabeled) with a radioactive compound, in this case, 68Ga.

Only medicines that have been specifically developed and approved for radiolabeling with 68Ga are subjected to the radiolabeling procedure with gallium (68Ga) chloride solution. These radiolabeled medicines can recognize and bind to specific types of cells in the body and carry the radioactive 68Ga to these cells. The small amount of radioactivity present in the radiolabeled medicine can be detected from outside the body using special cameras. This can help your doctor with diagnosis. For more information, see the summary of product characteristics of the medicine that will be radiolabeled with gallium (68Ga) chloride solution.

Your nuclear medicine specialist will explain the type of examination that will be performed in more detail.

The use of a medicine radiolabeled with 68Ga involves receiving a small amount of radioactivity. Your doctor and nuclear medicine specialist have considered that the clinical benefit you will gain from the procedure with the medicine radiolabeled with 68Ga outweighs the risk of radiation.

2. What you need to know before the gallium (68Ga) chloride solution obtained with GalliaPharm is used

The gallium (68Ga) chloride solution obtained with GalliaPharm must not be administered

• if you are allergic to gallium (68Ga) chloride solution or to any of the other components of this medicine (listed in section 6).

If you are using a medicine radiolabeled with 68Ga, you should read the information about contraindications included in the summary of product characteristics of the medicine that will be radiolabeled.

Warnings and precautions

For information on special warnings and precautions for the use of medicines radiolabeled with 68Ga, see the summary of product characteristics of the medicine that will be radiolabeled.

Children and adolescents

Tell your nuclear medicine specialist if you or your child are under 18 years old.

Other medicines and the gallium (68Ga) chloride solution

Tell your nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as some medicines may interfere with the interpretation of images by your doctor.

It is not known if the gallium (68Ga) chloride solution can interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (68Ga) chloride solution, but a medicine that has been combined (radiolabeled) with a gallium (68Ga) chloride solution.

For information on other medicines in combination with the use of medicines radiolabeled with 68Ga, see the summary of product characteristics of the radiolabeled medicine.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine specialist for advice before you are given medicines radiolabeled with 68Ga.

If there is any possibility that you may be pregnant, if you have missed a period, or if you are breast-feeding, tell your nuclear medicine specialist before the administration of medicines radiolabeled with 68Ga.

In case of doubt, it is important that you consult your nuclear medicine specialist who will be supervising the procedure.

If you are pregnant

Your nuclear medicine specialist will only give you this radiolabeled medicine during pregnancy if the expected benefit outweighs the risk.

If you are breast-feeding

You will be asked to stop breast-feeding. Ask your nuclear medicine specialist when you can restart breast-feeding.

Driving and using machines

Medicines radiolabeled with 68Ga may affect your ability to drive and use machines. Read the summary of product characteristics of those medicines carefully.

3. How to use the gallium (68Ga) chloride solution obtained with GalliaPharm

The use, handling, and disposal of radiopharmaceuticals are subject to very strict rules. GalliaPharm will only be used in special controlled areas. The production of the gallium (68Ga) chloride solution, as well as the radiolabeling of a specific carrier medicine and the administration of a medicine radiolabeled with 68Ga, will be carried out exclusively by persons who are properly trained and qualified to use it safely. These persons will take special care in the safe use of this medicine and will inform you of their actions.

Your nuclear medicine specialist who will be supervising the procedure will decide on the amount of radiolabeled medicine to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Administration of the gallium (68Ga) chloride solution and performance of the procedure

You will not be given the gallium (68Ga) chloride solution, but another medicine that has been combined (radiolabeled) with a gallium (68Ga) chloride solution.

Duration of the procedure

Your nuclear medicine specialist will inform you about the usual duration of the procedure with the radiolabeled medicine. For more information, see the summary of product characteristics of the radiolabeled medicine.

After administration of the radiolabeled medicine with gallium (68Ga) chloride solution

Your nuclear medicine specialist will inform you if you need to take special precautions after you have been given the radiolabeled medicine. Ask your nuclear medicine specialist if you have any doubts.

If you have been given more radiolabeled medicine with gallium (68Ga) chloride solution than you should, or if you have received a direct injection of gallium (68Ga) chloride solution by accident

It is unlikely that an overdose or accidental direct injection of a gallium (68Ga) chloride solution will occur, because you will only receive the radiolabeled medicine under the precise control of your nuclear medicine specialist who will be supervising the procedure. Nevertheless, in the event of an overdose or accidental direct injection, you will receive appropriate care.

If you have any further questions on the use of this medicine, ask your nuclear medicine specialist who will be supervising the procedure.

4. Possible side effects

Like all medicines, the radiolabeled medicine can cause side effects, although not everybody gets them.

After administration of the radiolabeled medicine, you will be given low amounts of ionizing radiation with minimal risk of cancer and congenital anomalies.

For more information on possible side effects, see the summary of product characteristics of the radiolabeled medicine.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of GalliaPharm

You will not need to store this medicine. This medicine is stored under the responsibility of your nuclear medicine specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

This information is intended only for healthcare professionals.

The radionuclide generator must not be used after the expiry date stated on the container after «EXP».

Do not dismantle the box.

The gallium (68Ga) chloride solution obtained with GalliaPharm must be used immediately.

6. Package contents and further information

Composition of GalliaPharm

• The active substances are germanium (68Ge) and gallium (68Ga) chloride dissolved in sterile ultrapure hydrochloric acid at a concentration of 0.1 mol/l. The germanium (68Ge) is irreversibly trapped within the radionuclide generator and decays into its daughter nuclide (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• The other components are: Titanium dioxide (matrix)

Sterile ultrapure hydrochloric acid at a concentration of 0.1 mol/l (eluate solution)

A radionuclide generator is supplied with:

1. 1 PP container containing the eluate, 250 ml of sterile ultrapure hydrochloric acid at a concentration of 0.1 mol/l (including a separate hanger for PP vials; PP: polypropylene)
2. 1 ventilated puncture device (ABS: acrylonitrile butadiene styrene/PE: polyethylene)
3. 2 1/16” male LUER adapters (PEEK)
4. 2 tubes (60 cm) (PEEK)
5. 1 tube (40 cm) (PEEK)
6. 1 tube (20 cm) (PEEK)
7. 3 1/16” 10-32 Fingertight connectors (PEEK)
8. 1 1/16” M6 Fingertight connector (PEEK)
9. 1 key block (TPX: polymethylpentene/HDPE: high-density polyethylene)
10. 1 male LUER connector (PP)

Appearance and package contents

You will not receive or handle this medicine.

Marketing authorization holder and manufacturer

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10

13125 Berlin

Germany

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The summary of product characteristics of this medicine can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

The full summary of product characteristics of GalliaPharm is provided in a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

See the summary of product characteristics or the package leaflet.