GALLIUM CITRATE (67Ga) CURIUM PHARMA SPAIN 37 MBq/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gallium citrate (67Ga) Curium Pharma Spain 37 MBq/ml solution for injection

Gallium citrate (67Ga)

Contents of the pack:

1. What is Gallium citrate (67Ga) Curium Pharma Spain and what is it used for

2. What you need to know before you use Gallium citrate (67Ga) Curium Pharma Spain

3. How to use Gallium citrate (67Ga) Curium Pharma Spain

4. Possible side effects

5. Storage of Gallium citrate (67Ga) Curium Pharma Spain

1. Contents of the pack and further information

1. What is Gallium citrate (67Ga) Curium Pharma Spain and what is it used for

This medicinal product is for diagnostic use only.

It belongs to a group of medicines called other diagnostic radiopharmaceuticals for the detection of inflammation and infections. When injected, it temporarily accumulates in tumors and inflammatory lesions. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera, and an image known as a scintigram can be obtained. This scintigram will show exactly the location and distribution of the radiopharmaceutical in the tumor or in the inflammatory lesions where it accumulates, providing the doctor with valuable information about the location of the tumor and/or inflammatory lesions.

2. What you need to know before you use Gallium citrate (67Ga) Curium Pharma Spain

Before administering this medicine, you should ensure that you are well hydrated.

Administration of a laxative may be necessary before the examination.

Do not use Gallium citrate (67Ga) Curium Pharma Spain:

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Gallium citrate (67Ga) Curium Pharma Spain.
• This medicinal product should not be administered to premature or newborn infants because it contains 9 mg per milliliter of benzyl alcohol.
• If you are breastfeeding.

Be careful with Gallium citrate (67Ga) Curium Pharma Spain:

• When this medicine is administered to you, it involves exposure to small amounts of radiation. Although your doctor will always consider the potential risks and benefits.
• If you have reduced kidney function, as it is possible that your exposure to radiation may increase.
• If you are under 18 years of age because exposure to radiation is proportionally greater than in adults. Additionally, it will only be used if the doctor considers that there are no other alternative diagnostic methods because the experience of use is limited.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The following medicines may interfere with Gallium citrate (67Ga) Curium Pharma Spain and cause false positive results:

• some cytotoxic medicines
• immunosuppressants (including steroids)
• radiological contrast for a test called lymphography with contrast (radiography of the vessels and lymph nodes of a region of the body)
• chemotherapy and radiotherapy in children
• medicines that increase blood prolactin levels
• iron
• phenothiazines
• tricyclic antidepressants
• metoclopramide
• reserpine
• methyldopa
• oral contraceptives
• estilbestrol

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are a woman of childbearing age (age at which you can become pregnant)you should always rule out pregnancy. If you experience a delay in your menstrual period, you should think you are pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure is minimal and necessary to obtain the desired clinical information. The possibility of performing alternative techniques that do not involve the use of ionizing radiation should be considered.

If you are pregnantyou should not receive this medicine unless in exceptional circumstances when the benefit to you outweighs the risk to the fetus because the fetus will receive a small amount of radiation.

If you are breastfeedingyou should stop breastfeeding before undergoing the test with this medicine.

Driving and using machines

No effects on the ability to drive and use machines have been described.

Important information about some of the components of Gallium citrate (67Ga) Curium Pharma Spain.

This medicine contains less than 1 mmol (23 mg) of sodium per dose; it is essentially "sodium-free".

3. How to use Gallium citrate (67Ga) Curium Pharma Spain

This medicine should be administered exclusively by authorized personnel who will indicate the instructions to follow at all times.

Your doctor will decide the amount of this medicine that will be administered to you. This will be the minimum amount necessary to obtain a scintigram with the necessary quality to provide the required information.

For detailed instructions on the correct administration/use of Gallium citrate (67Ga) Curium Pharma Spain, see section 6.

If you think the action of Gallium citrate (67Ga) Curium Pharma Spain is too strong or too weak, tell your doctor or pharmacist.

If you are given too much Gallium citrate (67Ga) Curium Pharma Spain

Since this product is administered by a doctor under strict control conditions, any overdose is very unlikely.

However, in the event that you are administered an excessive dose of this medicine, the absorbed radiation dose should be reduced by increasing the elimination of the radiopharmaceutical from the body, for which you will receive the appropriate treatment.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gallium citrate (67Ga) Curium Pharma Spain can cause side effects, although not everybody gets them.

It has been observed that the intravenous administration of gallium citrate (67Ga) causes anaphylactic reactions - allergic - in very rare cases. The symptoms are generally mild and are characterized by a feeling of heat, generalized redness, cutaneous erythema (redness of the skin), pruritus (itching), and/or urticaria (skin condition characterized by hives, papules, and pruritus among other symptoms and signs).

For all patients: exposure to ionizing radiation should be justified based on the expected medical objective, obtained with the minimum possible dose of radiation received by the patient. Exposure to ionizing radiation is associated with the induction of cancer and the possibility of developing hereditary defects. The probability of these reactions occurring is low due to the low doses of radiation received.

In patients with reduced renal function: it is possible that their exposure to radiation may increase.

In the pediatric population (under 18 years of age):

• It should be taken into account that the received dose is proportionally greater than in adults.
• This medicine may cause toxic reactions and allergic reactions in children under 3 years of age.

If you think any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience side effects, talk to your nuclear medicine doctor, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gallium citrate (67Ga) Curium Pharma Spain

Keep out of the sight and reach of children.

Before opening the pack for the first time, the product should be stored at a temperature below 25°C.

After opening the pack for the first time, it should be stored below 30°C.

Storage should be carried out in accordance with national regulations on radioactive materials.

Expiration date

Do not use this product after the expiration date stated on the pack.

Before opening the pack for the first time, the validity period of this product is 16 days from the date of production.

After opening the pack for the first time, the validity period is 8 hours stored below 30°C.

6. Contents of the pack and further information

Composition of Gallium citrate (67Ga) Curium Pharma Spain

• The active substance is gallium citrate (67Ga). Each milliliter of the solution for injection contains 37 MBq of gallium citrate (67Ga) at the date and time of calibration.
• The other components are sodium chloride, sodium citrate dihydrate, benzyl alcohol, and water for injections. This medicine contains 9 mg per milliliter of benzyl alcohol and 2.83 mg of sodium ion.

Appearance of the product and contents of the pack

This medicine is presented as a colorless solution for injection. It is supplied in multidose glass vials type I Ph. Eur. of 10 ml, sealed with a bromobutyl rubber stopper coated with fluoropolymer and with an aluminum overseal.

It is available in packs of 1 vial containing 2.2 or 3.3 or 5.5 ml of the solution for injection, which corresponds to an activity of 82, 123, or 205 MBq at the date and time of calibration.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, N. º 29, 3º-2

28100, Alcobendas, Madrid.

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 Le Petten

(Netherlands)

Date of the last revision of this leaflet:05/2020.

This information is intended only for healthcare professionals:

The full technical data sheet of Gallium citrate (67Ga) Curium Pharma Spain is included as a section at the end of this leaflet, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/