Patient Information Leaflet

BARNASCAN 3000 MBq/ml injectable solution

Fludesoxiglucosa (18F)

Read this leaflet carefully before you receive 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 doctor who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

This medication is a radiocontrast agent for diagnostic use only.

The active principle contained in BARNASCAN 3000 MBq/ml is fludesoxiglucosa (18F) and is designed for the acquisition of diagnostic images of certain body parts.

Once a small amount of BARNASCAN 3000 MBq/ml is injected, medical images obtained with a special camera will allow the doctor to obtain images and determine the location or progression of your disease.

BARNASCAN 3000 MBq/ml should not be used

• if you are allergic (hypersensitive) to BARNASCAN 3000 MBq/ml or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Speak to your nuclear medicine doctor before receiving BARNASCAN 3000 MBq/ml:

• if you are diabetic and your diabetes is currently uncontrolled
• if you have an infection or inflammatory disease
• if you have kidney problems

Inform your nuclear medicine doctor in the following cases:

• if you are pregnant or think you may be pregnant
• if you are breastfeeding

Before the administration of BARNASCAN 3000 MBq/ml you must:

• drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.
• avoid all intense physical activity
• be fasting for at least 4 hours

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old

Use of BARNASCAN 3000 MBq/ml with other medicines

Inform your nuclear medicine doctor if you are taking, have taken recently or may need to take any other medicine, as some medicines may interfere with the interpretation of the images by your doctor:

• any medicine that may cause a change in blood sugar concentration (glucose), such as anti-inflammatory medicines (corticosteroids), medicines for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (epinephrine, norepinephrine, dopamine…)
• glucose
• insulin
• medicines used to increase blood cell production

Use of BARNASCAN 3000 MBq/ml with food and drinks

You must fast for at least four hours before receiving this medicine. You should drink a lot of water and avoid consuming liquids containing sugars.

Your doctor should measure your glucose level before administering the medicine, as high blood glucose levels (hyperglycemia) may make it difficult for your nuclear medicine doctor to interpret the images.

Pregnancy and breastfeeding

You must inform your nuclear medicine doctor before the administration of BARNASCAN 3000 MBq/ml if there is any possibility of pregnancy, if you have a delayed period or if you are breastfeeding.

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

If you are pregnant

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

If you are breastfeeding

You should stop breastfeeding your child for 12 hours after the injection and discard the milk expressed during that period.

The decision to resume breastfeeding should be made in consultation with the nuclear medicine specialist who will supervise the procedure.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your nuclear medicine doctor before receiving this medicine.

Driving and operating machines

It is considered unlikely that BARNASCAN 3000 MBq/ml will affect your ability to drive or operate machines.

BARNASCAN 3000 MBq/ml contains sodium

Patients with low-sodium diets should note that this medicine contains 23 mg (1 mmol) of sodium per dose.

Important information about some of the components of BARNASCAN 3000 MBq/ml injectable solution

This medicine contains 0.5% v/v of ethanol (alcohol), which corresponds to less than 100 mg per dose.

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. BARNASCAN 3000 MBq/ml 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 on the amount of BARNASCAN 3000 MBq/ml to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult ranges from 100 to 400 MBq (depending on the patient's body mass, the type of camera used to obtain images, and the image acquisition mode) The MegaBecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

In children and adolescents, the dose to be administered will be adjusted according to their body weight.

Administration of BARNASCAN 3000 MBq/ml and procedure performance

BARNASCAN 3000 MBq/ml is administered intravenously.

One injection is sufficient to perform the procedure your doctor needs.

After the injection, you must remain completely at rest, without reading or speaking. You will also be offered a drink and asked to urinate immediately before starting the procedure.

During image acquisition,you must remain completely at rest. Do not move or speak.

Procedure duration

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

BARNASCAN 3000 MBq/ml is administered as a single injection in a vein 45 to 60 minutes before image acquisition. The image acquisition with the camera lasts between 30 and 60 minutes.

After administration of BARNASCAN 3000 MBq/ml, you must:

• avoid direct contact with small children and pregnant women for 12 hours after the injection
• urinate frequently to eliminate the product from your body

If you have been administered more BARNASCAN 3000 MBq/ml than you should

It is unlikely to have an overdose because you will receive a controlled and precise dose of BARNASCAN 3000 MBq/ml supervised by the nuclear physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment. Specifically, your nuclear physician may recommend that you drink a lot of water to facilitate the elimination of BARNASCAN 3000 MBq/ml from your body (since the main route of elimination of this medication is renal, i.e., through urine).

If you have any other questions about the use of BARNASCAN 3000 MBq/ml, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Your doctor has taken into account that the clinical benefit you will obtain from the test with the radiopharmaceutical outweighs the risk due to radiation.

If you experience adverse effects, consult your nuclear medicine doctor, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use BARNASCAN 3000 MBq/ml after the expiration date appearing on the label of the container: 14 hours from the date and time of manufacture.

Do not use BARNASCAN 3000 MBq/ml if visible signs of deterioration are observed.

Composition of BARNASCAN 3000 MBq/ml

• The active principle is fludesoxiglucosa (18F). Each ml of injectable solution contains 3000 MBq of fludesoxiglucosa (18F) at the time and date of calibration.
• The other components are: Sodium chloride, sodium dihydrogen phosphate, ethanol, and water for injection preparations.

Appearance of the product and contents of the packaging

The activity per vial oscillates between 3000 MBq and 30000 MBq at the time and date of calibration.

Holder of the marketing authorization

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé 100

08950 Esplugues de Llobregat

Barcelona

Spain

Responsible for manufacturing

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé 100

08950 Esplugues de Llobregat

Barcelona

Spain

Local representative

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat

Barcelona

Spain

The detailed information of this medicine is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

Last review date of this prospectus: March 2014.

This information is intended solely for doctors or healthcare professionals:

The complete technical file of BARNASCAN 3000 MBq/ml is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical file (the technical file must be included in the box).