Patient Information Leaflet

GalliaPharm 0.74 - 1.85 GBq radionuclide generator

Galium Chloride Solution (68Ga)

Read this leaflet carefully before receiving this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who will oversee the procedure.
• If you experience any side effects, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

1.What is GalliaPharm and what is it used for

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

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

4.Possible side effects

5.Storage of GalliaPharm

6.Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

This medication is a radiopharmaceutical that should not be administered directly to patients.

GalliaPharm is a radionuclide generator of germanium (68Ge) / gallium (68Ga), a device used to obtain a solution of gallium chloride (68Ga).

The gallium chloride (68Ga) solution is used for radioactive labeling, a technique in which a labeling (radioactive labeling) is performed with a radioactive compound, in this case the 68Ga.

GalliaPharm is used to label certain medications that have been developed and approved specifically for use with the active principle gallium chloride (68Ga). These medications act as carriers to carry the 68Ga radioactive to where it is needed. These can be substances designed to recognize a specific type of cell in the body, including cancer cells.The low amount of administered radioactivity can be detected outside the body using special cameras to obtain images of the body.Consult the prospectus of the medication to be labeled radiologically with gallium chloride (68Ga).The nuclear physician will explain what type of examination will be performed with this product.

The administration of a medication labeled with 68Ga involves receiving a small amount of radioactivity. Your doctor and the nuclear physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Do not administer the gallium chloride solution (68Ga) obtained with GalliaPharm

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

If you are using a medication marked with68Ga, you must read the information on contraindications in the prospectus of the medication that is going to be radiolabeled.

Warnings and precautions

For information related to special warnings and special precautions for the use of medications marked with68Ga, consult the prospectus of the medication that is going to be radiolabeled.

Children and adolescents

Inform your nuclear doctor if you or your child is under 18 years old.

Other medications and the gallium chloride solution (68Ga)

Inform your nuclear doctor if you are taking, have recently taken, or may need to take any other medicationsince some medicationsmay interfere with the interpretation of images.

It is not known whether the gallium chloride solution (68Ga) may interact with other medications since specific studies have not been conducted.

For information related to interactions associated with the use of medications marked with68Ga, consult the prospectus of the medication that is going to be radiolabeled.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your nuclear doctor before administering radiolabeled medications with GalliaPharm.

You must inform your nuclear doctor before administering radiolabeled medications with GalliaPharm if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult your nuclear doctor who will oversee the procedure in case of doubt.

If you are pregnant

Your nuclear doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

You will be asked to suspend breastfeeding. Ask your nuclear doctor when you can resume breastfeeding.

Driving and operating machinery

You may experience effects on your ability to drive and operate machinery due to the medication used in combination with GalliaPharm. Read the prospectus of that medication carefully.

There are strict rules for the use, handling, and disposal of radioactive pharmaceuticals. GalliaPharm will only be used in specially controlled areas.This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide the amount of radiolabeled medicationmarked withGalliaPharmto be used in your case. This will be the minimum amount necessary to obtain the desired information, depending on the final product and its intended use. For more information, read the prospectus of the medication to be radiolabeled.

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

You will not receive the gallium chloride solution (68Ga), but another product radiolabeled withGalliaPharm.The gallium chloride solution (68Ga)should only be used in combination with another medication that has been specifically developed and approved for use in combination (radiolabeled) with GalliaPharm. You will only receive the final radiolabeled product.

Procedure duration

Your nuclear physician will informyou about the usual duration of the procedure after administration of the radiolabeled medication with GalliaPharm.

After administering the radiolabeled medication withGalliaPharm:

The nuclear physician will inform you if you need to take special precautions after the radiolabeled medication with GalliaPharm has been administered to you. Consult your nuclear physician if you have any doubts.

If moreradiolabeled medication withGalliaPharmhas been administered than

It is unlikelyto experience an overdose, as you will only receive the radiolabeled medication with GalliaPharmaccurately controlledby the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use of this product, ask your nuclear physician overseeing the procedure.

Like all medications, the radiolabeled medication with GalliaPharm may produce adverse effects, although not all people will experience them.

The administration of the radiolabeled medication with GalliaPharm involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician, even if it is possible adverse effects that do not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

The radionuclide generator must not be used after the expiration date that appears on the packaging after “CAD”.

Do not remove the box. Do not store at a temperature above25°C.

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

Composition of GalliaPharm

The active principle is the gallium chloride solution (68Ga).

The other components are:Titanium dioxide (matrix)

Hydrochloric acid0.1 mol/lultrapure sterile(elution solution)

Appearance of GalliaPharm and contents of the packaging

You will not receive or handle this medication.

Marketing authorization holder and manufacturer

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str.10

13125 Berlin

Germany

Local representative:

NUCLIBER, S.A.

C/ Hierro, 33

28045 Madrid

Spain

Phone: +34 915 062 940

This medication is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet: 12/2019.

-----------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

The complete technical datasheet forGalliaPharmis 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

radioactive substance.

Please consult the technical datasheet[the technical datasheet must be included in the box].