Sodium iodide (123I) GE Healthcare 37 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Sodium Iodide (123I)

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, ask 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 Sodium Iodide (123I) is and what it is used for
2. What you need to know before being given Sodium Iodide (123I)
3. How Sodium Iodide (123I) is administered
4. Possible side effects
5. How to store Sodium Iodide (123I)
6. Contents of the pack and other information

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

This medicine is a radiopharmaceutical intended solely for diagnostic use.

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

Sodium iodide (123I) is a "radiopharmaceutical." It is administered before a scan and, with the aid of a special camera, enables visualization inside a specific part of the body.

• It contains an active substance called "sodium iodide."
• Once injected, it can be detected from outside the body by a special camera used during the scan.
• The scan may help the physician to visualize the thyroid gland and assess its function.

Administration of sodium iodide (123I) involves receiving a small amount of radioactivity. Your physician and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

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

Sodium iodide (123I) must not be used

• if you are allergic to sodium iodide (123I) or to any of the other ingredients (listed in section 6).

Warnings and precautions

Exercise special caution with sodium iodide (123I):

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

Before administration of sodium iodide (123I), you should:

Drink plenty of water before starting the procedure to ensure frequent urination during the first few hours after completion.

Children and adolescents

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

Use of sodium iodide (123I) 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 images.

Before the scan, inform your physician if you are taking any of the following medicines:

• Anti-inflammatory drugs such as phenylbutazone.
• Antithyroid drugs, such as propylthiouracil or methimazole.
• Expectorants, such as cough medicines (used to clear 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 disorders).
• Medicines used to treat thyroid disorders such as sodium levothyroxine or sodium liotironine.
• Medicines used before certain types of scans, 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 disorders).
• Sodium nitroprusside (used to treat high blood pressure).
• Sodium sulfobromophthalein (used to assess 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 hospital for X-rays or scans (intravenous contrast agents).
• Vitamins.

If you are unsure whether any of the above apply to you, consult your physician before using sodium iodide (123I).

Pregnancy, breastfeeding, and fertility

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

You must inform your nuclear medicine physician before administration of sodium iodide (123I) if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

If in doubt, it is important to consult your supervising nuclear medicine physician.

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

Do not breastfeed while using sodium iodide (123I). This is because small amounts of "radioactivity" may pass into breast milk. If you are breastfeeding, your physician may wait until you have stopped breastfeeding before using sodium iodide (123I). If waiting is not possible, your physician may ask you to:

• interrupt breastfeeding for 1.5 to 3 days,
• use infant formula to feed your baby; and
• express and discard your breast milk.

Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and use of machines

Consult your physician about whether you may drive or operate machinery after administration of sodium iodide (123I).

Sodium iodide (123I) contains sodium: This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially "sodium-free".

3. How to use SODIUM IODIDE (123I)

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Sodium iodide (123I) will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of sodium iodide (123I) to be used in your case. This amount will be the minimum necessary to obtain the required information.

The generally recommended administered quantity for an adult ranges between 3.7 and 14.8 MBq (Megabecquerels, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered amount will be adjusted according to 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 required by your physician.

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

Duration of the procedure

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

After administration of sodium iodide (123I), you should:

Urinate frequently to eliminate the product from your body.

The nuclear medicine physician will inform you if you need to take special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more sodium iodide (123I) than you should have received

An overdose is unlikely, as you will receive a single precisely controlled dose of sodium iodide (123I) determined by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be provided.

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

Allergic reactions

If you have an allergic reaction while in hospital or clinic undergoing the examination, inform your doctor immediately. Signs may include:

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

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 kept under the responsibility of specialists in suitable facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

The following information is intended for specialists only.

Do not use Sodium Iodide (123I) after the expiry date stated on the label following EXP.

6. Contents of the container and other information

Composition of Sodium Iodide (123I) injectable solution

• The active substance is sodium iodide (123I) 37 MBq/ml at the date and time 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 contents of the container

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

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

The Netherlands

Date of the most recent revision of this summary: July 2020

Other sources of information

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

This information is intended for healthcare professionals only.

The full summary of product characteristics for Sodium Iodide (123I) 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.