Sodium iodide (123I) GE Healthcare

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution

Sodium Iodide ( I)
Please read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist responsible for performing the examination.
• If you experience any side effects, even those not listed in this leaflet, inform the nuclear medicine specialist.

Contents of this leaflet:

1. What Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution is and what it is used for
2. What you need to know before you are given Sodio Ioduro (123I) GE Healthcare 37 MBq/mL injectable solution
3. How Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution is used
4. Possible side effects
5. How Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution is stored
6. Contents of the pack and other information

1. What Sodio Ioduro injectable solution is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only. It is used solely to help identify possible diseases.
Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution is a radiopharmaceutical. It is administered before a scan and helps a special device to visualise the inside of a part of your body.

• It contains an active substance called 'sodium iodide'.
• Once administered, it can be detected from outside your body by an imaging device used for diagnostic examination.
• The scan can help your doctor to see the thyroid gland and assess its function. Your nuclear medicine doctor will explain which part of your body will be examined. The use of Sodio Ioduro ( I) GE Healthcare 37 MBq/mL injectable solution involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist have determined that the clinical benefit you will obtain from the diagnostic procedure with this radiopharmaceutical outweighs the risk due to radiation exposure.

2. What you should know before being given Sodio Ioduro ( I) GE Healthcare 37 MBq/ml

Injectable solution
Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable solution must not be used:

• If you are allergic (hypersensitive) to sodium iodide ( I) or to any of the excipients of this medicine (listed in section 6). Do not take Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable solution if the above cases apply to you. If in doubt, speak with your nuclear medicine physician or nurse.

Warnings and precautions
Exercise particular caution with Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable
solution
Check with your nuclear medicine physician or nurse before being given Sodio Ioduro
( I) GE Healthcare 37 MBq/ml injectable solution

• if you are pregnant or think you may be pregnant
• if you have reduced kidney function
• if you are breastfeeding

Before administration of Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable
solution you must:
Drink plenty of fluids before undergoing the examination, so that you urinate as frequently as possible during the first hours after the examination.
Children and adolescents
Inform the nuclear medicine specialist if you are under 18 years of age.
Other medicines and Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable solution
Inform the nuclear medicine specialist or nurse if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal remedies.
This is because some medicines may interfere with Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution.
Before undergoing the examination, inform the nuclear medicine specialist if you are taking any of the following types of medicines, as they may interfere with your test results:

• anti-inflammatory drugs, such as phenylbutazone
• antithyroid drugs, such as carbimazole, propylthiouracil or methimazole
• expectorants, such as certain cough medicines
• salicylates, such as aspirin
• steroids (such as hydrocortisone, prednisolone or dexamethasone)
• benzodiazepines (such as diazepam, temazepam and nitrazepam)
• drugs used to treat thyroid disorders, such as sodium levothyroxine or sodium liotironine
• drugs taken before certain types of scans, such as perchlorate
• drugs used to treat infections, such as antiparasitics, penicillins, sulfonamides
• Amiodarone and antiarrhythmic drugs (used to treat irregular heartbeat)
• Lithium (used in the treatment of certain conditions, such as depression or mental disorders)
• Sodium nitroprusside (used to treat very high blood pressure)
• Sodium sulfobromophthalein (used to test liver function)
• Topical iodides (used to disinfect 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 sugar levels)
• Thiopental (used as a general anesthetic)
• drugs administered in hospital for X-rays or scans (intravenous contrast media, with or without iodine)
• vitamins If you are unsure whether any of the above situations apply to you, inform your nuclear medicine physician or nurse before taking Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your nuclear medicine specialist before being administered this medicine.
You must inform the nuclear medicine specialist before administration of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist performing the examination.
If you are pregnant
The nuclear medicine specialist will administer this medicine during pregnancy only if they determine that the expected benefit outweighs the risk.
If you are breastfeeding
Do not breastfeed after being administered Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution.
This is because small amounts of radioactivity may pass into breast milk.
If you are breastfeeding, the nuclear medicine specialist should wait until breastfeeding has ended before using Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution.
If waiting is not possible, the nuclear medicine specialist will ask you:

• to interrupt breastfeeding for 1.5–3 days, and
• to use infant formula for your baby, and
• to express (remove) breast milk and discard it. Your doctor will inform you when you can resume breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery are known.
Important information about Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution
When Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution is used, you are exposed to radioactivity.

• Your doctor will always evaluate the potential risks and benefits before administering the medicine. Ask your doctor if you have any questions.

This medicine contains less than 1 mmol of sodium (23 mg) per dose and can therefore be considered 'essentially' sodium-free.

3. How Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution will be used only in designated controlled areas.
This product will be handled and administered to you exclusively by trained and qualified personnel experienced in its safe use.

• Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution will always be used in a hospital or clinic. The staff will ensure that the product is used safely and will inform you about the measures taken. The nuclear medicine specialist responsible for performing the examination will determine the amount of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution to be used in your case. The minimum necessary dose required to obtain the desired information will be administered. The usual administered amount in an adult ranges between 3.7 MBq and 14.8 MBq. (The megabecquerel is the unit of measurement of radioactivity).

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to the child's body weight.
Administration of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution and
performance of the procedure:
Sodio Ioduro injectable solution is administered intravenously.
The usual dose is:

• A single injection. Imaging is usually performed between 3 and 6 hours after injection.

Duration of the procedure
The nuclear medicine specialist will inform you about the duration of the procedure.
After receiving Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution,
you must:

• Avoid close contact with infants and pregnant women.
• Urinate as frequently as possible to eliminate the product from your body.

The nuclear medicine specialist will inform you if any special precautions need to be followed after receiving this medicinal product. If you have any questions, contact the nuclear medicine specialist.
If you have been administered more Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable
solution than intended:
Overdosage is unlikely, as you will receive a single, carefully controlled dose of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution, administered under the supervision of the specialist performing the examination. However, in the event of an overdose, appropriate treatment will be provided.
If you have any questions about the use of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution, please consult the nuclear medicine specialist responsible for performing the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you experience an allergic reaction while you are in hospital or at a clinic undergoing the procedure, inform the doctor or nurse immediately.
Signs may include:

• skin rash, itching, or hot flushes
• swelling of the face
• difficulty breathing.

Other side effects include
Not known – frequency cannot be estimated from the available data

• nausea, vomiting
• itching, skin rash, and urticaria.

If any of the side effects listed above occur after you have left the hospital or clinic, go directly to the emergency department of the nearest hospital.
This radiopharmaceutical will emit a small amount of ionizing radiation, with a minimal risk of developing cancer or hereditary abnormalities.
If you experience any side effect, contact your nuclear medicine physician.
This also applies to any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your nuclear medicine specialist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution is stored

Do not store this medicine. This medicine must be stored under the responsibility of a specialist in suitable premises. Storage must comply with current regulations concerning radioactive materials.
Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution must not be used after the expiry date stated on the packaging.
The following information is intended for specialists only.
This medicine may be used up to 36 hours from the calibration time stated on the label.
Store this medicine at a temperature below 25°C. Do not freeze. Store in the original lead container or in an equivalent shielded container.
After opening, store in a refrigerator (2°C–8°C) and use within one working day.
Sodio Ioduro injectable solution must not be used after the expiry date printed on the carton after EXP.
Keep Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution out of the reach and sight of children.
The product label includes the correct storage conditions and the batch expiry date.
Hospital staff must ensure that the product is correctly stored and disposed of, and that it is not used after the expiry date stated on the label.

6. Package contents and other information

What Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution contains

• The active substance is Sodium Iodide (I). Each ml of Sodium Iodide (I) injectable solution contains 37 MBq (the megabecquerel is the unit used to measure radioactivity) of Sodium Iodide [(I)].
• The other components are: glacial acetic acid, sodium hydroxide, sodium thiosulfate, sodium bicarbonate, sodium chloride, and water for injections.

Description of the appearance of Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution and
package contents
Sodium Iodide injectable solution is supplied in a single glass vial containing a variable amount of injectable solution ranging from 0.5 mL to 10 mL.

Marketing Authorization Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano
Italy

Manufacturer
GE Healthcare B.V.
De Rondom 8
5612 AZ Eindhoven
The Netherlands

This summary of product characteristics was last approved on

The following information is intended exclusively for the physician or healthcare personnel:
The complete Summary of Product Characteristics (SmPC) for Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution is provided as a separate document within the package, aimed at providing healthcare professionals with additional scientific and practical information on the administration, dosage, and use of this medicinal product.
Please refer to the SmPC (the SmPC must be included in the package).