Labeling:information for the patient

IRABGLU 370 MBq/ml injectable solution

Fludesoxiglucosa (18F)

Read this labeling carefully before this medicine is administered,because it contains important information for you.

• Keep this labeling, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.

-If you experience any adverse effects,consult your nuclear medicine physician who is supervising the procedure,evenifthey are not listed in this labeling. See section 4.

1.What IRABGLU is and how it is used

2.What you need to knowbeforestarting touse IRABGLU

3.How to use IRABGLU

4.Possible adverse effects

5Storage of

6.Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

The active ingredient contained in IRABGLU is fludesoxiglucosa (18F) and is designed for the acquisition of diagnostic images of certain parts of the body.

Once a small amount of IRABGLU 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.

IRABGLUshould not be used :

• if you are allergic (hypersensitive) to IRABGLU or to any of the other ingredients ofthis medication (listed in section 6).

Warnings and precautions

Speak with your nuclear medicine doctor before receiving IRABGLU:

• 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
• if you are breastfeeding

Before administration of IRABGLU 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 IRABGLU withother medications

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

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

Use ofIRABGLU with foodsand drinks

You must fast for at least 4 hours before receiving this medication. You should drink a lot of water and avoid consuming liquids with sugar.

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

Pregnancy and lactation

You should inform your nuclear medicine doctor before administering IRABGLU if there is any possibility of pregnancy, if you have a delayed period or if you are breastfeeding.

In case of doubt, it is essential to consult with your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medication 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 any 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 medication.

Driving and operating machinery

It is unlikely that IRABGLU will affect your ability to drive and operate machinery.

IRABGLU contains sodium and ethanol

Patients on low-sodium diets should note that this medication contains 35.4 mg (1.54 mmol) of sodium per dose.

This medication contains a maximum of 0.17% V/V of ethanol (alcohol), which corresponds to 16.7 mg per dose.

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. IRABGLU will be used exclusively in special 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 who supervises the procedure will decide on the amount of IRABGLU 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

The dose to be administered will be adjusted according to the child's or adolescent's body weight.

Administration of IRABGLU and procedure

IRABGLU 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.You must not move or speak.

Procedure duration

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

IRABGLU is administered as a single injection in a vein between 45 and 60 minutes before image acquisition. The image acquisition with the camera lasts between 30 and 60 minutes.

After administration of IRABGLU, you must:

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

If you have been administered more IRABGLU than you should

It is unlikely to have an overdose because you will receive a controlled and precise dose of IRABGLU supervised by the nuclear physician who oversees 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 IRABGLU from your body (since the main route of elimination of this medication is renal, that is, through urine).

If you have any other questions about the use of IRABGLU, ask the nuclear physician who supervises the procedure.

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

The administration of this radioactive substance 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 radioactive substance outweighs the risk due to radiation.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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 suitable facilities. Radioactive medication storage will be performed in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use IRABGLU after the expiration date shown on the packaging.

Do not use IRABGLU if visible signs of deterioration are observed.

Composition of IRABGLU

• The active principle is fludesoxiglucosa (18F).

Each ml of injectable solution contains 370 MBq of fludesoxiglucosa (18F) at the time and date of calibration.

The other components are sodium chloride 0.9%,Sodium citrate dihydrate, Trisodium citrate dihydrate, Hydrochloric acid 2 N,absolute ethanol and water for injection preparations.

Appearance of the product and contents of the packaging

The activity per vial oscillates between 370 MBq and 3700 MBq at the time and date of calibration.

Holder of the marketing authorization and responsible manufacturer

Institut Radiofarmàcia Aplicada de Barcelona, S.L.

c/Doctor Aiguader, 88 Ground floor

08003 Barcelona

933 160 983

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

Last review date of this prospectus:March 2018

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This information is intended solely for doctors or healthcare professionals:

The complete technical file of IRABGLU 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].