SODIUM IODIDE (123I) GE HEALTHCARE 37 MBq/mL INJECTABLE SOLUTION

Introduction

Leaflet: Information for the patient

Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution.

Sodium Iodide (123I)

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

Contents of the leaflet

1. What Sodium Iodide (123I) is and what it is used for
2. What you need to know before using Sodium Iodide (123I)
3. How to use Sodium Iodide (123I)
4. Possible side effects
5. Storage of Sodium Iodide (123I)
6. Package contents and additional information

1. What is SODIUM IODIDE (123I) and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Sodium Iodide (123I) is used only to help identify diseases.

Sodium Iodide (123I) is a "radiopharmaceutical". It is administered before an examination and, with the help of a special camera, allows visualization of a part of the body.

• It contains an active ingredient called "sodium iodide".
• Once injected, it can be detected from outside the body by a special camera used in the examination.
• The examination can help the doctor see the thyroid gland and how it works.

The administration of Sodium Iodide (123I) involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using SODIUM IODIDE (123I)

Sodium Iodide (123I) should not be used

• if you are allergic to Sodium Iodide (123I) or any of the other components (listed in section 6).

Warnings and precautions

Be particularly careful with Sodium Iodide (123I):

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

Before administration of Sodium Iodide (123I)

Drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.

Children and adolescents

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

Use of Sodium Iodide (123I) with other medicines

Tell 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.

Before the examination, inform your doctor if you are using any of the following medicines.

• Anti-inflammatory medicines such as phenylbutazone.
• Anti-thyroid medicines, such as propylthiouracil or methimazole.
• Expectorants, such as cough medicines (used to remove mucus from the airways).
• Salicylates such as aspirin (used to treat pain or heart disease).
• Steroids, such as hydrocortisone, prednisolone, or dexamethasone.
• Benzodiazepines such as diazepam, temazepam, and nitrazepam (used to treat anxiety or sleep problems).
• Medicines used to treat thyroid disorders such as sodium levothyroxine or sodium liotrix.
• Medicines taken before some types of examinations such as perchlorate.
• Medicines used to treat infections such as antiparasitics, penicillins, sulfonamides.
• Amiodarone and medicines for irregular heart rhythm.
• Lithium (used to treat certain conditions such as depression or mental problems).
• Sodium nitroprusside (used to treat high blood pressure).
• Sodium sulfobromophthalein (used to evaluate liver function).
• Topical iodides (used to clean the skin before surgery).
• Anticoagulants (used to thin the blood).
• Antihistamines (used to treat or prevent allergic reactions).
• Tolbutamide (used in people with diabetes to lower blood glucose levels).
• Thiopental (used as a general anesthetic).
• Medicines administered in the hospital for X-rays or examinations (intravenous contrast media).
• Vitamins.

If you are unsure whether you are in any of the above circumstances, consult your doctor before using Sodium Iodide (123I).

Pregnancy, breastfeeding, and fertility

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

You must inform your nuclear medicine doctor before administration of Sodium Iodide (123I) 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 essential 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 benefit is expected to outweigh the risk.

If you are breastfeeding

Do not breastfeed if you use Sodium Iodide (123I). This is because small amounts of "radioactivity" may pass into breast milk. If you are breastfeeding, your doctor may wait until you finish breastfeeding before using Sodium Iodide (123I). If you cannot wait, your doctor may ask you to:

• interrupt breastfeeding for 1.5 to 3 days,
• use artificial milk to feed your child; and
• express and discard breast milk.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

Consult your doctor if you can drive or use machines after administration of Sodium Iodide (123I).

Sodium Iodide (123I) contains sodium:This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use SODIUM IODIDE (123I)

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Sodium Iodide (123I) 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 Sodium Iodide (123I) 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 3.7 to 14.8 MBq (MegaBecquerel, 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 Sodium Iodide (123I) and performance of the procedure

Sodium Iodide (123I) is administered by intravenous injection.

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

The examination is usually performed 3 to 6 hours after the injection.

Duration of the procedure

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

After administration of Sodium Iodide (123I), you must:

Urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after you are given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more Sodium Iodide (123I) than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Sodium Iodide (123I) by the nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any questions about the use of Sodium Iodide (123I) injectable solution, ask the 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.

Allergic reactions

If you experience an allergic reaction while you are in the hospital or clinic undergoing the examination, inform your doctor immediately. The signs may be:

• skin rash, itching, flushing
• swelling of the face
• difficulty breathing

If you experience any of the above side effects after leaving the hospital or clinic, go directly to the emergency department of the nearest hospital.

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

Reporting of side effects:

If you experience any side effects, contact your doctor or nurse, even if they are 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. Storage of SODIUM IODIDE (123I)

You will not need to store this medicine. This medicine is stored under the responsibility of specialists 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 Sodium Iodide (123I) after the expiration date stated on the label after EXP.

6. Package contents and additional information

Composition of Sodium Iodide (123I) injectable solution

• The active ingredient is Sodium Iodide (123I) 37 MBq/ml at the time and date of calibration
• The other components are acetic acid, sodium hydroxide, sodium thiosulfate, sodium bicarbonate, sodium chloride, and water for injectable preparations.

Appearance of the product and package contents

Sodium Iodide (123I) is supplied in a multidose glass vial closed with a Teflon-coated stopper and sealed with an aluminum cap. Each vial is placed in a lead container of suitable thickness.

Each vial contains between 0.5 ml and 10 ml of injectable solution. The activity range per vial is between 18.5 MBq and 370 MBq at the time and date of calibration

Marketing authorization holder and manufacturer

Marketing authorization holder

GE Healthcare Bio-Sciences, S.A.U.

C/ Gobelas, 35-37

28023 Madrid

Spain

Manufacturer

GE Healthcare B.V.

De Rondom 8

5612 AP Eindhoven

Netherlands

Date of last revision of this leaflet: July 2020

Other sources of information

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

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This information is intended only for doctors or healthcare professionals.

The complete technical data sheet of Sodium Iodide (123I) 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.