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

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Gallium Citrate (67Ga)

Package leaflet contents:

1. What Citrate of gallium (67Ga) Curium Pharma Spain is and what it is used for

2. What you need to know before using Citrate of gallium (67Ga) Curium Pharma Spain

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

4. Possible side effects

5. How to store Citrate of gallium (67Ga) Curium Pharma Spain

6. Contents of the container and additional information

1. What Citrate de galium (67Ga) Curium Pharma Spain is and what it is used for

This medicinal product is for diagnostic use only.

It belongs to the group of medicinal products known as other diagnostic radiopharmaceuticals used for detecting inflammation and infections. When injected, it temporarily accumulates in tumours 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, allowing an image known as a scintigraphy to be obtained. This scintigraphy will show precisely the location and distribution of the radiopharmaceutical in the tumour or inflammatory lesions where it accumulates, providing the physician with valuable information regarding the location of the tumour and/or inflammatory lesions.

2. What you need to know before using Citrato de galio (67Ga) Curium Pharma Spain

Before administering this medicine, it must be ensured that you are well hydrated.

Administration of a laxative may be necessary prior to the examination.

Do not use Citrato de galio (67Ga) Curium Pharma Spain:

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Citrato de galio (67Ga) Curium Pharma Spain.
• This medicine must not be administered to premature infants or newborns because it contains 9 mg per millilitre of benzyl alcohol.
• If you are breastfeeding.

Take special care with Citrato de galio (67Ga) Curium Pharma Spain:

• When this medicine is administered, because 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, because your exposure to radiation may increase.
• If you are under 18 years of age, because radiation exposure is proportionally greater than in adults. Furthermore, it will only be used if the physician considers that there are no alternative diagnostic methods, as experience with use is limited.

Use of other medicines

Inform 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 Citrato de galio (67Ga) Curium Pharma Spain and cause false positive results:

• certain cytotoxic drugs
• immunosuppressants (including steroids)
• radiographic contrast agents used for a procedure called contrast lymphangiography (X-ray imaging of lymph vessels and lymph nodes in a region of the body)
• chemotherapy and radiotherapy in children
• medicines that increase blood levels of prolactin
• iron
• phenothiazines
• tricyclic antidepressants
• metoclopramide
• reserpine
• methyldopa
• oral contraceptives
• stilboestrol

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are a woman of childbearing age (age when you can become pregnant), pregnancy must always be ruled out. If you experience a menstrual delay, you should assume you are pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure be kept to the minimum necessary to obtain the required clinical information. Alternative techniques not involving ionizing radiation should be considered.

If you are pregnant, you should not receive this medicine except under 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, you must stop breastfeeding before undergoing the test with this medicine.

Driving and using machines

No effects on the ability to drive or use machines have been reported.

Important information about some of the components of Citrato de galio (67Ga) Curium Pharma Spain.

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

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

This medicinal product must be administered exclusively by authorized personnel, who will provide you with instructions at each stage.

Your doctor will determine the amount of this medicine to be administered to you. This will be the minimum necessary quantity required to obtain a scintigraphy scan of sufficient quality to provide the necessary information.

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

If you consider the effect of Citrate of gallium (67Ga) Curium Pharma Spain to be too strong or too weak, inform your doctor or pharmacist.

If you are administered more Citrate of gallium (67Ga) Curium Pharma Spain than you should receive

Since this product is administered by a physician under strictly controlled conditions, overdose is highly unlikely.

However, if an excessive dose of this medicinal product is administered, the absorbed radiation dose should be reduced by increasing the elimination of the radiopharmaceutical from the body, for which appropriate treatment will be administered.

In case of overdose or accidental ingestion, contact 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 adverse effects

Like all medicines, Citrate de galio (67Ga) Curium Pharma Spain may have adverse effects, although not everyone experiences them.

Intravenous administration of gallium citrate (67Ga) has been observed to cause anaphylactic–allergic type reactions very rarely. Symptoms are generally mild and are characterized by a sensation of warmth, generalized flushing, cutaneous erythema (redness of the skin), pruritus (itching), and/or urticaria (skin reaction characterized by wheals, papules, and itching, among other symptoms and signs).

For all patients: Exposure to ionizing radiation must be justified according to the expected medical objective, achieved with the lowest possible radiation dose received by the patient. Exposure to ionizing radiation is associated with cancer induction and the possibility of developing hereditary defects. The likelihood of these reactions occurring is low due to the low radiation doses received.

In patients with reduced renal function: Increased radiation exposure may occur.

In pediatric population (under 18 years of age):

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.

Prior to first opening, the product should be stored below 25°C.

After first opening, the product should be stored below 30°C.

Storage must comply with national regulations regarding radioactive materials.

Expiry

Do not use this product after the expiry date stated on the container label.

Prior to first opening, the shelf life of this product is 16 days from the date of production.

After first opening, the shelf life is 8 hours when stored below 30°C.

6. Contents of the pack and other information

Composition of Gallium Citrate (67Ga) Curium Pharma Spain

• The active substance is gallium citrate (67Ga). Each ml of injectable solution 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 of benzyl alcohol per millilitre and 2.83 mg of sodium ion.

Appearance of the product and contents of the pack

This medicine is presented as a colourless injectable solution. It is supplied in multidose vials made of neutral glass type I according to Ph. Eur., with a bromobutyl stopper coated with fluoropolymer and sealed with an aluminium cap.

Available pack sizes: 1 vial containing 2.2, 3.3 or 5.5 ml of injectable solution, corresponding 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, No. 29, 3º-2

28100 Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 Le Petten

(The Netherlands)

Date of the most recent revision of this leaflet: 05/2020.

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for Gallium Citrate (67Ga) Curium Pharma Spain is included as a section at the end of this leaflet, to provide physicians and healthcare professionals with scientific information, as well as practical guidance on the administration and use of this radiopharmaceutical.

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