GALLIAPHARM 1.11 GBq RADIONUCLIDE GENERATOR

Introduction

Package Leaflet: Information for the Patient

GalliaPharm 1,11GBq Radionuclide Generator

Gallium (68Ga) chloride solution

Read all of this leaflet carefully before you receive 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, consult your nuclear medicine specialist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is GalliaPharm and what is it used for
2. What you need to know before you start using the gallium (68Ga) chloride solution obtained with GalliaPharm
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 is GalliaPharm and what is it 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 is a substance whose handling is the responsibility of specialized physicians (nuclear medicine specialists) and pharmacists with the necessary training to work with radioactive materials. The gallium (68Ga) chloride is not intended for direct use in patients, but 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. These radiolabeled medicines can recognize and bind to specific types of body cells and carry the radioactive 68Ga to these body 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 package leaflet of the medicine to be radiolabeled with gallium (68Ga) chloride.

Your nuclear medicine specialist will explain the type of examination to 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 receive from the procedure with the medicine radiolabeled with 68Ga outweighs the risk of radiation.

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

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

• if you are allergic to gallium (68Ga) chloride 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 on contraindications included in the package leaflet of the medicine to be radiolabeled.

Warnings and Precautions

For information on special warnings and precautions for the use of medicines radiolabeled with 68Ga, see the package leaflet of the medicine to 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 no specific studies have been conducted. You will not receive an injection of gallium (68Ga) chloride, 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 package leaflet of the radiolabeled medicine.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before you are given medicines radiolabeled with 68Ga.

If there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding, inform your nuclear medicine specialist before 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 administer this radiolabeled medicine with 68Ga 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

Effects on the ability to drive and use machines may occur due to the use of medicines radiolabeled with 68Ga. Read the package leaflets 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 the exclusive responsibility of properly trained and qualified personnel to use it safely. These personnel will take special care in the safe use of this medicine and will inform you of their actions.

The nuclear medicine specialist supervising the procedure will decide the amount of radiolabeled medicine with 68Ga 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 administered 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 medicine radiolabeled with 68Ga. For more information, see the package leaflet of the radiolabeled medicine.

After Administration of the Medicine Radiolabeled with Gallium (68Ga) Chloride Solution

Your nuclear medicine specialist will inform you if you need to take special precautions after you have been administered the medicine radiolabeled with 68Ga. Consult your nuclear medicine specialist if you have any doubts.

If You Have Been Administered More Medicine Radiolabeled with Gallium (68Ga) Chloride Solution Than You Should, or If You Have Received a Direct Injection of Gallium (68Ga) Chloride Solution Accidentally

It is unlikely that an overdose or accidental direct injection of a gallium (68Ga) chloride solution will occur, because you will only receive the medicine radiolabeled with 68Ga under the precise control of the nuclear medicine specialist supervising the procedure. Nevertheless, in case of overdose or accidental direct injection, you will receive the necessary attention.

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

4. Possible Side Effects

Like all medicines, the medicine radiolabeled with 68Ga can cause side effects, although not everybody gets them.

After administration of the medicine radiolabeled with 68Ga, you will be administered low amounts of ionizing radiation with minimal risk of cancer and congenital anomalies.

For more information on possible side effects, see the package leaflet of the radiolabeled medicine.

Reporting of Side Effects

If you experience any side effects, consult your nuclear medicine specialist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included 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 the specialist in suitable premises. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

This information is intended only for the specialist.

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 (TPX: polymethylpentene/HDPE: high-density polyethylene)
10. 1 male LUER union (PP)

Appearance of the Product and Package Contents

You will not receive or handle this medicine.

Marketing Authorisation 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 package leaflet of this medicine can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

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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 package leaflet.