IRABGLU 370 MBq/mL INJECTABLE SOLUTION

Introduction

Leaflet:information for the patient

IRABGLU 370 MBq/ml injectable solution

Fludesoxyglucose (18F)

Read this leaflet carefully before this medicine is administered to you, 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 supervises the procedure.

• If you experience side effects, consult your nuclear medicine doctor who supervises the procedure, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What IRABGLU is and what it is used for
2. What you need to know before starting to use IRABGLU
3. How to use IRABGLU
4. Possible side effects

5 Conservation of

1. Package contents and additional information

1. What IRABGLU is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

Once a small amount of IRABGLU 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 starting to use IRABGLU

IRABGLU must not be used:

• if you are allergic (hypersensitive) to IRABGLU or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 pregnant
• If you are breastfeeding

Before administration of IRABGLU, you must:

• 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

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

Use of IRABGLU with other medicines

Inform your nuclear medicine doctor if you are taking, have recently taken, 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 modification in blood sugar concentration (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.

Use of IRABGLU with food and drinks

You must fast for at least 4 hours before receiving this medicine. You should drink plenty of water and avoid consuming liquids that contain sugars.

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

Pregnancy and breastfeeding

You must inform your nuclear medicine doctor before administration of IRABGLU if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding.

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

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

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

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

Driving and using machines

It is considered unlikely that IRABGLU will affect your ability to drive and use machines.

IRABGLU contains sodium and ethanol

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

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

3. How to use IRABGLU

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. IRABGLU will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who supervises the procedure will decide 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 amount for administration to an adult ranges from 100 to 400 MBq (depending on the patient's body weight, the type of camera used for image acquisition, and the mode of image acquisition). 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 IRABGLU and performance of the procedure

IRABGLU is administered intravenously.

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

After the injection, you must 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 image acquisition, you must remain completely at rest.Do not move or speak.

Duration of the procedure

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

IRABGLU 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 IRABGLU, 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 IRABGLU than you should

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

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

4. Possible side effects

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

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

Reporting of side effects:

If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of IRABGLU

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 the specialist.

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

Do not use IRABGLU if you notice visible signs of deterioration.

6. Package contents and additional information

Composition of IRABGLU

• The active ingredient is fludesoxyglucose (18F).

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

The other components are sodium chloride 0.9%, disodium citrate sesquihydrate, trisodium citrate dihydrate, hydrochloric acid 2N, absolute ethanol, and water for injectable preparations.

Appearance of the product and package contents

The activity per vial ranges from 370 MBq to 3700 MBq at the date and time of calibration.

Marketing authorization holder and manufacturer

Institut Radiofarmàcia Aplicada de Barcelona, S.L.

c/Doctor Aiguader, 88 Planta -1

08003 Barcelona

933 160 983

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

Date of last revision of this leaflet:March 2018

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This information is intended only for doctors or healthcare professionals:

The complete technical data sheet 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 data sheet [the technical data sheet must be included in the box].