PROSPECTO: INFORMATION FOR THE USER

Gallium Citrate (67Ga) Curium Pharma Spain 37 MBq/ml injectable solution

Gallium Citrate (67Ga)

1. What is Gallium Citrate (67Ga) Curium Pharma Spain and how is it used

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

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

4. Possible adverse effects

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

6. Contents of the package and additional information

This medication is solely for diagnostic use.

It belongs to the group of medications known asother diagnostic radiopharmaceuticals for the detection of inflammation and infections. When injected, it temporarily accumulates in tumorsand inflammatory lesions. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from the outside of the body using a special medical device called a gamma camera, and an image known as a gamma scan can be obtained. This gamma scan 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 regarding the location of the tumor and/or inflammatory lesions.

Before administering this medication, ensure that you are well hydrated.

A laxative may be required before the examination.

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

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of Gallium Citrate (67Ga) Curium Pharma Spain.
• This medication should not be administered to premature infants or newborns because it contains 9 mg per milliliter of benzyl alcohol.
• If you are breastfeeding your child.

Be especially careful withGallium Citrate (67Ga) Curium Pharma Spain:.

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

The following medications may interfere with Gallium Citrate (67Ga) Curium Pharma Spain and produce false positive results:

• some cytotoxic medications
• immunosuppressants (including steroids)
• radiological contrast for a test called lymphangiography with contrast (radiography of the vessels and lymph nodes of a region of the body)
• chemotherapy and radiation therapy in children
• medications that increase blood prolactin levels
• iron
• phenothiazines
• tricyclic antidepressants
• metoclopramide
• reserpine
• metildopa
• oral contraceptives
• estriol

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are a fertile woman (age at which you can become pregnant)you must always rule out pregnancy. If you experience a delay in menstruation, you should consider that you are pregnant until it is proven otherwise. In case of doubt, it is essential that your exposure to radiation is minimized to obtain the desired clinical information. You should consider the possibility of performing alternative techniques that do not involve the use of ionizing radiation.

If you are pregnantyou should not receive this medication except 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 breastfeeding your childyou should stop breastfeeding before the test with this medication is performed.

Driving and operating machinery

No effects have been described on the ability to drive and operate machinery.

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

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

This medication must be administered exclusively by authorized personnel who will instruct you on the necessary steps at all times.

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

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

If you estimate that the action of Gallium Citrate ( 67 Ga) Curium Pharma Spain is too strong or weak, inform your doctor or pharmacist.

If you are administered more Gallium Citrate ( 67 Ga) Curium Pharma Spain than you should

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

However, in the event of an excessive dose of this medication being administered to you, the dose of radiation absorbed by you must be reduced, causing an increase in the elimination of the radioactive substance from the body, for which you will be administered the appropriate treatment.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

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

Like all medications, Gallium Citrate (67Ga) Curium Pharma Spain may have adverse effects, although not all people may experience them.

The intravenous administration of gallium citrate (67Ga) has been observed to cause anaphylactic –allergic- reactions in very rare occasions. The symptoms are generally mild and are characterized by a sensation of heat, generalized redness, cutaneous erythema (skin redness), 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 linked to cancer induction and the possibility of developing hereditary defects. The probability of these reactions occurring is low due to the low doses of radiation received.

For patients with decreased renal function: it is possible that they will have increased exposure to radiation.

For pediatric population (less than 18 years of age):

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Reporting

If you experience adverse effects, consult your nuclear doctor, even if they are adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

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

After opening the packaging for the first time, it must be stored below 30°C.

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

Expiration Date

Do not use this productafter the expiration date appears on the label ofthe packaging.

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

After opening the packaging for the first time, the validity period is8 hours when stored below 30°C.

Composition of Gallium Citrate (67Ga) Curium Pharma Spain

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

Appearance of the product and contents of the packaging

This medication is presented in the form of an colorless injectable solution. It is supplied in multi-dose glass vials of type I of the Ph. Eur. of 10 ml, sealed with a bromobutyl stopper coated with fluoropolymer and with an aluminum overcap.

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Curium Pharma Spain S.A.

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

28100, Alcobendas, Madrid.

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 Le Petten

(Netherlands)

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

This information is intended solely for doctors or healthcare professionals:

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

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