BARNASCAN 3000 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

BARNASCAN 3000 MBq/ml Solution for Injection

Fludeoxyglucose (18F)

Read all of 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 further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is BARNASCAN 3000 MBq/ml and what is it used for
2. What you need to know before you start using BARNASCAN 3000 MBq/ml
3. How to use BARNASCAN 3000 MBq/ml
4. Possible side effects
5. Storage of BARNASCAN 3000 MBq/ml
6. Contents of the pack and further information

1. What is Barnascan 3000 MBq/ml and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

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

2. What you need to know before you start using Barnascan 3000 MBq/ml

BARNASCAN 3000 MBq/ml must not be used

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

Warnings and precautions

Talk 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

Tell your nuclear medicine doctor in the following cases:

• if you are pregnant or think you may be pregnant
• if you are breast-feeding

Before administration of BARNASCAN 3000 MBq/ml you should:

• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.
• avoid intense physical activity
• fast for at least 4 hours

Children and adolescents

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

Using BARNASCAN 3000 MBq/ml with other medicines

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

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

Using BARNASCAN 3000 MBq/ml with food and drinks

You should fast for at least four hours before receiving this medicine. You should drink plenty of water and avoid consuming liquids that contain sugars.

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

Pregnancy and breast-feeding

You should inform your nuclear medicine doctor before administration of BARNASCAN 3000 MBq/ml if there is any possibility that you may be pregnant, if you have a delayed period or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

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

If you are breast-feeding

You should stop breast-feeding your child for 12 hours after the injection and discard the milk expressed during this period.

The decision to resume breast-feeding should be taken in agreement with the specialist in nuclear medicine who will supervise the procedure.

If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine.

Driving and using machines

BARNASCAN 3000 MBq/ml is unlikely to affect your ability to drive or use machines.

BARNASCAN 3000 MBq/ml contains sodium

Patients on a low-sodium diet should be aware that this medicine contains 23 mg (1 mmol) of sodium per dose.

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

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

3. How to use Barnascan 3000 MBq/ml

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. BARNASCAN 3000 MBq/ml will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These people will take special care to use this product safely and will inform you of their actions.

The nuclear medicine doctor who is supervising the procedure will decide 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 recommended amount to administer to an adult is between 100 and 400 MBq (depending on the patient's body weight, the type of camera used for image acquisition, and the acquisition mode). The MegaBecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

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

Administration of BARNASCAN 3000 MBq/ml and performance of the procedure

BARNASCAN 3000 MBq/ml is administered by intravenous injection.

A single injection is sufficient to perform the procedure that your doctor needs.

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

During the acquisition of images, you will have to remain completely at rest. You should not move or talk.

Duration of the procedure

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

BARNASCAN 3000 MBq/ml is administered as a single injection into a vein between 45 and 60 minutes before image acquisition. The image acquisition itself lasts between 30 and 60 minutes.

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

• 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 given more BARNASCAN 3000 MBq/ml than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of BARNASCAN 3000 MBq/ml from your nuclear medicine doctor. However, in case of overdose, you will receive the appropriate treatment. In particular, your nuclear medicine doctor may recommend that you drink plenty of water to facilitate the elimination of BARNASCAN 3000 MBq/ml from your body (since the main route of elimination of this medicine is renal, i.e., in the urine).

If you have any further questions about the use of BARNASCAN 3000 MBq/ml, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Your doctor has considered that the clinical benefit you will get from the test with the radiopharmaceutical outweighs the risk due to radiation.

If you experience side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet.

Reporting of side effects

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

5. Storage of Barnascan 3000 MBq/ml

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for specialists.

Do not use BARNASCAN 3000 MBq/ml after the expiry date stated on the label of the pack: 14 hours from the date and time of manufacture.

Do not use BARNASCAN 3000 MBq/ml if you notice visible signs of deterioration.

6. Contents of the pack and further information

Composition of BARNASCAN 3000 MBq/ml

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

Appearance of the product and contents of the pack

The activity per vial ranges from 3000 MBq to 30000 MBq at the date and time of calibration.

Marketing Authorisation Holder

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

C/ Josep Anselm Clavé 100

08950 Esplugues de Llobregat

Barcelona

Spain

Manufacturer

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

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

Date of last revision of this leaflet: March 2014.

This information is intended only for healthcare professionals:

The full technical specifications of BARNASCAN 3000 MBq/ml are 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 specifications (the technical specifications must be included in the box).