Gallium (67GA) citrate Curium Netherlands

Package leaflet: Information for the patient

Gallio (⁶⁷Ga) citrate Curium Netherlands 37 MBq/ml solution for injection

gallium (⁶⁷Ga) citrate
Please read 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 questions, ask the nuclear medicine physician who will supervise your examination.
• If you experience any adverse reaction, contact the nuclear medicine physician. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Gallium (⁶⁷Ga) citrate Curium Netherlands is and what it is used for
2. What you need to know before you are given Gallium (⁶⁷Ga) citrate Curium Netherlands
3. How Gallium (⁶⁷Ga) citrate Curium Netherlands is used
4. Possible side effects
5. How to store Gallium (⁶⁷Ga) citrate Curium Netherlands
6. Contents of the pack and other information

1. What is Gallium (67Ga) Citrate Curium Netherlands and what is it used for?

This medicinal product is a radiopharmaceutical for diagnostic use only.
Gallium (67Ga) Citrate Curium Netherlands is used in combination with other imaging techniques to obtain images (scans) of:
various types of tumours in adults and children over one month of age
inflammatory conditions, particularly in the lungs, in adults.
Images (scans) of the radioactive substance can be obtained using a special type of camera. This can be performed externally on the body. This scan shows the distribution of radioactivity in the organs and body. Furthermore, it provides the physician with important information regarding organ function and structure.
The use of Gallium (67Ga) Citrate Curium Netherlands involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you should know before being administered Gallium (⁶⁸Ga) Citrate Curium

Netherlands
Do not use Gallium (⁶⁸Ga) Citrate Curium Netherlands

• if you are allergic to gallium (⁶⁸Ga) citrate or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or suspect you might be pregnant
• if you are breastfeeding
• in patients under 18 years of age, unless they have been diagnosed with cancer
• in newborns and premature infants (up to 4 weeks of age) due to the presence of benzyl alcohol. If any of these conditions apply to you, please speak with your nuclear medicine physician.

Warnings and precautions
Talk to your nuclear medicine physician before receiving Gallium (⁶⁸Ga) Citrate Curium Netherlands:

• if you have reduced kidney function;
• if you have reduced liver function.
  Your doctor will inform you whether any special precautions are necessary after administration of this medicine. Contact your nuclear medicine physician if you have any questions.

Before administration of Gallium (⁶⁸Ga) Citrate Curium Netherlands, it is necessary to

• drink plenty of water before the start of the examination, so as to urinate as frequently as possible during the first hours after the scan.

Children and adolescents
Particular caution is required in children and adolescents under 18 years of age due to potential radiation exposure to growing bone epiphyses and haematopoietic tissues.

Other medicines and Gallium (⁶⁸Ga) Citrate Curium Netherlands
Inform your nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, including those obtained without prescription, as they could interfere with image interpretation.
The following medicines may affect the gallium (⁶⁸Ga) citrate scan:

• medicines for the treatment of mental disorders containing active substances ending in “azine”, such as phenothiazines
• some medicines for the treatment of cancer
• iron therapy
• medicines for the treatment of depression: amitriptyline, imipramine, or similar substances
• medicines used to suppress the immune system, including corticosteroids
• contrast agents
• metoclopramide: a medicine used to treat nausea and vomiting
• reserpine: a medicine used to treat hypertension
• methyldopa: a medicine used to treat hypertension or heart problems
• oral contraceptive pill: an oral medicine to prevent pregnancy
• stilbestrol: a medicine used to treat prostate cancer

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding you must inform your nuclear medicine specialist before receiving Gallium (⁶⁸Ga) Citrate Curium Netherlands.
If you are pregnant
This medicine MUST NOT be used if you are pregnant.
If you are breastfeeding
This medicine MUST NOT be used if you are breastfeeding. Inform your doctor if you are breastfeeding, as he or she may decide to postpone the scan until you have stopped breastfeeding.
Your doctor may also ask you to stop breastfeeding and avoid close contact with your baby for 3 days after the injection.

Driving and using machines
It is considered unlikely that the injection of Gallium (⁶⁸Ga) Citrate Curium Netherlands will affect your ability to drive or operate machinery.

Gallium (⁶⁸Ga) Citrate Curium Netherlands contains sodium and benzyl alcohol
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially “sodium-free”.
This medicine contains 9 mg/ml of benzyl alcohol, which may cause allergic reactions. Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems (known as “gasping syndrome”) and death in young children (see contraindications).

3. How Gallio (Ga) citrato Curium Netherlands is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Gallio (Ga) citrato Curium Netherlands will be used only in designated and controlled areas. This product will be handled and administered exclusively by trained and qualified personnel who are skilled in its safe use. These individuals will take special precautions to ensure the safe use of the product and will inform you about the procedures they carry out.

The nuclear medicine physician responsible for the examination will determine the amount of Gallio (Ga) citrato Curium Netherlands to be used in your case. The smallest necessary amount required to obtain the desired diagnostic information will be administered.

The usually recommended administered activity for an adult ranges between 40 – 260 MBq (megabecquerel, the unit used to express radioactivity).

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to the child's body weight.

Administration of Gallio (Ga) citrato Curium Netherlands and procedure performance
Gallio (Ga) citrato Curium Netherlands is administered via intravenous injection.
One single injection is sufficient to perform the examination requested by the physician.

Additionally, your doctor may recommend a laxative to improve the detection of intestinal inflammatory lesions. Special attention will be paid if you are an insulin-dependent diabetic.

Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.

After receiving Gallio (Ga) citrato Curium Netherlands, you must:
urinate frequently to help eliminate the product from your body;
avoid close contact with young children and pregnant women for 3 days following the injection.

Your nuclear medicine physician will inform you if you need to take any specific precautions after receiving this medicinal product. Contact your nuclear medicine physician if you have any questions.

If you have received more Gallio (Ga) citrato Curium Netherlands than you should have
An overdose is unlikely, as you will receive only a single dose of Gallio (Ga) citrato Curium Netherlands, carefully controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.

If you have further questions about the use of Gallio (Ga) citrato Curium Netherlands, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody will experience them.
Allergic reactions may occur, with symptoms such as: feeling of warmth, generalized flushing, cutaneous erythema, itching and/or urticaria.
Symptoms are generally mild, and their frequency is unknown (cannot be estimated from available data).
This radiopharmaceutical involves exposure to low amounts of ionizing radiation, with a low risk of developing tumours or hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the website "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Gallio (67Ga) citrate Curium Netherlands

Do not store this medicinal product. It is stored under the responsibility of a specialist in suitable premises.
Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive products.

6. Package contents and other information

What Gallio (67Ga) citrate Curium Netherlands contains

• The active substance is gallium (67Ga) citrate: 1 millilitre contains 37 MBq/mL.
• The excipients are: sodium citrate dihydrate, benzyl alcohol, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the appearance of Gallio (67Ga) citrate Curium Netherlands and package contents
This medicinal product is a clear, colourless solution.
The pack contains 1 multidose glass vial. Each vial is enclosed in a lead shielding container of appropriate thickness.
Gallio (67Ga) citrate Curium Netherlands is supplied in vials containing 2.2 mL (82 MBq), 3.3 mL (123 MBq), or 5.5 mL (205 MBq).

Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands

The following information is intended for healthcare professionals only:
The full Summary of Product Characteristics (SmPC) for Gallio (67Ga) citrate Curium Netherlands is provided as a separate document within the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. Please refer to the SmPC of Gallio (67Ga) citrate Curium Netherlands.