Sodium iodide (123I) Curium Pharma Spain 37 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml solution for injection

Sodium Iodide (123I)

Package leaflet:

1. What Ioduro (123I) de sodio Curium Pharma Spain 37 MBq/ml injectable and oral solution is and what it is used for
2. Before using Ioduro (123I) de sodio Curium Pharma Spain 37 MBq/ml injectable and oral solution
3. How to use Ioduro (123I) de sodio Curium Pharma Spain 37 MBq/ml injectable and oral solution
4. Possible side effects
5. How to store Ioduro (123I) de sodio Curium Pharma Spain 37 MBq/ml injectable and oral solution
6. Contents of the pack and other information

1. What Ioduro (123I) de sodio Curium Pharma Spain 37 MBq/ml solution for injection is and what it is used for

This medicine is for diagnostic use only.

It belongs to the group of medicines known as other radiopharmaceuticals for diagnosis of the cardiovascular system. When injected, it temporarily accumulates in the thyroid gland. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera, allowing an image known as a scintigram to be obtained. This scintigram will show precisely the location and distribution of the radiopharmaceutical in the organs and tumors where it accumulates, providing the physician with valuable information about the structure and function of the thyroid glands.

2. Before using Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution

Before this medicine is administered, it must be ensured that you are well hydrated.

Do not use Sodium Iodide (123I) Curium Pharma Spain:

• If you are breastfeeding.
• If you are allergic (hypersensitive) to the active substance or to any of the other components of sodium iodide (123I) Curium Pharma Spain.

Take special care with Sodium Iodide (123I) Curium Pharma Spain:

Sodium Iodide (123I) Curium Pharma Spain belongs to a group of medicines called radiopharmaceuticals and, therefore, its administration involves exposure to radiation (radioactivity) of relatively high dose in most patients (see “POSSIBLE ADVERSE EFFECTS”).

If you have kidney problems, the administered activity should be adjusted.

If you are under 18 years of age, because radiation exposure is proportionally higher than in adults.

Use of other medicines:

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may interfere with the proper functioning of sodium iodide (123I) Curium Pharma Spain:

• Antithyroid agents, carbimazole (and other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate, and various agents (anticoagulants, antihistamines, antiparasitics, penicillins, sulfonamides, tolbutamide, thiopentone) should generally be discontinued 1 week before administration of Sodium Iodide (123I) Curium Pharma Spain.
• Phenylbutazone should generally be discontinued 1–2 weeks before.
• Expectorants and vitamins, 2 weeks before.
• Natural or synthetic thyroid preparations (sodium thyroxine, sodium triiodothyronine, thyroid extract), 2–6 weeks before.
• Amiodarone, benzodiazepines, lithium, 4 weeks before.
• Iodine-containing skin disinfectants, 1–9 months before.
• Intravenous contrast agents, oral cholecystographic agents, and iodine-containing contrast media, up to 1 year before treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are a woman of childbearing potential (age when you can become pregnant), pregnancy must always be ruled out. If you experience a menstrual delay, you should assume you are pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure is kept to the minimum necessary to obtain the required clinical information. Alternative techniques that do not involve ionizing radiation should be considered.

If you are pregnant, you should not receive this medicine unless strictly necessary, because the fetus will be exposed to a small amount of radiation, or when the benefit to you outweighs the risk to the fetus.

If you are breastfeeding: Before administering Sodium Iodide (123I) Curium Pharma Spain to a mother who is breastfeeding, consideration should be given to reasonably delaying the examination until breastfeeding has ceased, and to whether the most appropriate radiopharmaceutical has been selected, taking into account the excretion of radioactivity into breast milk. If administration during breastfeeding is unavoidable, breastfeeding must be interrupted for 1.5–3 days after administration of this medicine, since in addition to iodine-123 it contains iodine-124 and iodine-125 as contaminants, and milk expressed during this period should be discarded. Consideration may be given to expressing and storing milk before administration of this product for later use. Breastfeeding may be resumed when the level of radioactivity in breast milk would result in a radiation dose to the infant not exceeding 1 mSv.

Driving and use of machines

Effects on the ability to drive or use machines are not expected following the use of this medicine.

Important information about some of the components of Sodium Iodide (123I) Curium Pharma Spain

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) Curium Pharma Spain 37 MBq/ml injectable solution

This medicine must be administered exclusively by authorized personnel, who will provide you with specific instructions at all times.

Your doctor will decide the amount of this medicine to be administered to you. This will be the minimum necessary quantity to obtain a scintigraphy scan of sufficient quality to provide the required information.

For detailed instructions on the proper administration/use of Sodium Iodide (123I) Curium Pharma Spain, see section 6.

If you consider the effect of Sodium Iodide (123I) Curium Pharma Spain to be too strong or too weak, inform your doctor or pharmacist.

If you are administered more Sodium Iodide (123I) Curium Pharma Spain than you should have received

Since this product is administered by a physician under strictly controlled conditions, overdose is highly unlikely.

However, if an excessive dose of this medicine is administered, the absorbed radiation dose should be minimized by increasing the elimination of the radiopharmaceutical from the body. To achieve this, you will be advised to empty your bladder frequently and gastrointestinal transit will be encouraged.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 5620420.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, sodium iodide (123I) may have adverse effects, although not everyone will experience them.

For all patients: exposure to ionizing radiation should be justified according to the expected medical objective, achieved with the lowest possible radiation dose received by the patient. Exposure to ionizing radiation is associated with cancer induction and the possibility of developing hereditary defects. The probability of these reactions occurring is low due to the low radiation doses received.

Isolated cases of allergic reactions have been reported, without more precise information on the frequency and details of such reactions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Iodide (123I) Sodium Curium Pharma Spain 37 MBq/ml injectable solution

Keep out of the reach and sight of children.

Prior to first opening, store the product at a temperature between 15°C and 25°C.

Storage must comply with national regulations regarding radioactive materials.

Storage must comply with national regulations regarding radioactive materials.

The shelf life of the capsule is 20 hours after the calibration date. The expiry date is indicated on the outer packaging.

Do not use Iodide (123I) Sodium Curium Pharma Spain after the expiry date stated on the container label.

After first opening, the shelf life is 8 hours when stored at 2–8°C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Iodide (123I) Sodium Curium Pharma Spain

• The active substance is sodium iodide (123I). 1 ml of injectable solution contains 37 MBq of sodium iodide (123I) at the date and time of calibration.
• The other components are sodium chloride, sodium hydrogen carbonate and water for injections.

Appearance of the medicinal product and contents of the pack

This medicine is presented as an injectable solution. It is supplied in multi-dose vials made of neutral glass type I according to Ph. Eur., with a 10 ml capacity, sealed with bromobutyl rubber stoppers coated with Teflon and aluminum overseals.

A vial contains 1, 2, 5 or 10 ml of injectable solution, corresponding to activities of 37 MBq, 74 MBq, 185 MBq and 370 MBq at the date and time of calibration.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Curium Pharma Spain S. A.
Avenida Doctor Severo Ochoa Nº 29
28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands

Date of the most recent revision of this summary: March/2016

This information is intended exclusively for physicians or healthcare professionals:

The complete package leaflet for Iodide (123I) Sodium Curium Pharma Spain is included as a section at the end of this summary, to provide physicians and healthcare professionals with scientific information and practical guidance on the administration and use of this radiopharmaceutical.

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