Barnascan 3000 MBq/ml solution for injection

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who supervises the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

This medicine is a radiopharmaceutical intended solely for diagnostic use.

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

After a small amount of BARNASCAN 3000 MBq/ml is injected, medical images obtained using a special camera will allow the physician to visualize and determine the location or progression of your disease.

2. What you need to know before starting to use Barnascan 3000 MBq/ml

BARNASCAN 3000 MBq/ml must 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

Talk to your nuclear medicine physician before receiving BARNASCAN 3000 MBq/ml:

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

Inform your nuclear medicine physician in the following cases:

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

Before administration of BARNASCAN 3000 MBq/ml you must:

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

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age.

Use of BARNASCAN 3000 MBq/ml with other medicines

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

• any medicine that may alter blood glucose (glycaemia) levels, 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 drink

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

Your physician must measure your blood glucose level before administering the medicine, since, in fact, high blood glucose levels (hyperglycaemia) may interfere with the interpretation of the images by your nuclear medicine physician.

Pregnancy and breastfeeding

You must inform the nuclear medicine physician before administration of BARNASCAN 3000 MBq/ml if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important that you consult your nuclear medicine physician supervising the procedure.

If you are pregnant

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

If you are breastfeeding

You must stop breastfeeding your child for 12 hours after the injection and discard any milk expressed during this period.

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

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

Driving and using machines

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

BARNASCAN 3000 MBq/ml contains sodium

Patients on low-sodium diets 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 injectable solution

This medicine contains 0.5% v/v ethanol (alcohol); this small amount corresponds to less than 100 mg per dose.

3. How to use Barnascan 3000 MBq/ml

There are strict regulations regarding the handling, use, and disposal of radiopharmaceuticals. BARNASCAN 3000 MBq/ml will only be used in specially controlled areas and will be handled and administered exclusively by trained and qualified personnel experienced in the safe use of such products. These individuals will take special care in the safe use of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of BARNASCAN 3000 MBq/ml to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The dose generally recommended for administration in adults ranges between 100 and 400 MBq (depending on the patient's body weight, the type of imaging camera used, 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 administered dose will be adjusted according to body weight.

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

BARNASCAN 3000 MBq/ml is administered intravenously.

A single injection is sufficient to perform the procedure required by your physician.

After the injection, you must remain completely at rest, without reading or talking. In addition, you will be offered a drink and asked to empty your bladder immediately before starting the procedure.

During image acquisition, you must remain completely still. You must not move or speak.

Duration of the procedure

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

BARNASCAN 3000 MBq/ml is administered as a single intravenous injection 45 to 60 minutes before image acquisition. The actual imaging process takes between 30 and 60 minutes.

After receiving BARNASCAN 3000 MBq/ml, you should:

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

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

An overdose is unlikely, as you will receive a single precisely controlled dose of BARNASCAN 3000 MBq/ml determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. Specifically, your nuclear medicine physician may recommend drinking plenty of fluids to facilitate the elimination of BARNASCAN 3000 MBq/ml from the body (since the primary route of elimination for this medicinal product is renal, i.e., via urine).

If you have any further questions about the use of BARNASCAN 3000 MBq/ml, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicinal product may produce adverse effects, although not everyone will experience them.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Your physician has considered that the clinical benefit you will obtain from the radiopharmaceutical test outweighs the risk associated with radiation exposure.

If you experience any adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your physician or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicinal product.

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 appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

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

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

6. Contents of the container and other information

Composition of BARNASCAN 3000 MBq/ml

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

Appearance of the product and contents of the container

The activity per vial ranges between 900 MBq and 30000 MBq at the time and date of calibration.

Marketing Authorization 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

Date of the most recent review of this summary: March 2014.

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for BARNASCAN 3000 MBq/ml is included as a separate document in the product packaging, providing additional scientific and practical information for healthcare professionals on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics (the Summary of Product Characteristics must be included in the package).