Renocis

Package leaflet: Information for the patient

RENOCIS 1 mg kit for radiopharmaceutical preparation

succimer
Please read this leaflet carefully before you are given this medicine, as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician who will supervise your examination.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or the nuclear medicine physician. See section 4. Contents of this leaflet:
  1. What RENOCIS is and what it is used for
  2. What you need to know before you are given RENOCIS
  3. How RENOCIS is administered
  4. Possible side effects
  5. How RENOCIS is stored
  6. Contents of the pack and other information

1. What RENOCIS is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Renocis contains succimer as the active substance.
Renocis is used after labeling with a radioactive solution of technetium (Tc) to obtain an injectable solution of technetium (Tc) succimer.
After injection, the technetium (Tc) succimer solution temporarily accumulates in the kidneys. Due to its radioactivity, it can be detected outside the body by a special camera, allowing images to be acquired. These images provide the necessary information about the structure and/or function of the kidneys.
Administration of Renocis involves exposure to a certain amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you should know before being given RENOCIS

RENOCIS must not be administered:

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

Warnings and precautions

Exercise particular caution with RENOCIS:

• if you suffer from allergies, as some cases of allergic reactions have been observed after administration of RENOCIS.
• if you are pregnant or think you might be pregnant (see the section “Pregnancy and breastfeeding” below).
• if you are breastfeeding (see the section “Pregnancy and breastfeeding” below).

Inform the nuclear medicine physician if any of the situations listed above apply to you. RENOCIS may not be suitable for you. The nuclear medicine physician will advise you accordingly.

Before receiving RENOCIS you must:

• Drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first few hours after the examination.

Children and adolescents
Inform the nuclear medicine physician if you are under 18 years of age.

Other medicines and RENOCIS
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription, as they may affect the quality of the images and the outcome of the examination. Your physician may advise you to discontinue treatment with the following medicines before the RENOCIS examination:

• ammonium chloride (used in the treatment of recurrent urinary tract infections),
• sodium bicarbonate (used to acidify blood and/or urine),
• mannitol (used to reduce intracranial pressure),
• certain medicines used to treat arterial hypertension, such as Angiotensin Converting Enzyme (ACE) inhibitors like captopril,
• certain chemotherapeutic agents such as methotrexate, cyclophosphamide, or vincristine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please consult your nuclear medicine physician before taking this medicine. Inform the nuclear medicine physician if you might be pregnant, have missed your period, or are breastfeeding, before receiving RENOCIS. In case of doubt, it is important to consult the nuclear medicine physician in charge of the examination.

If you are pregnant
It is advisable to avoid any examination using technetium (Tc) during pregnancy. Indeed, procedures involving radiopharmaceuticals may pose a risk to the fetus. The nuclear medicine physician will administer this product during pregnancy only if the expected benefit outweighs the potential risk.

If you are breastfeeding
Inform the nuclear medicine physician if you are breastfeeding. The physician may decide either to postpone the examination until the end of breastfeeding, or to ask you to stop breastfeeding until radioactivity has cleared from your body. Ask your nuclear medicine physician when you may resume breastfeeding. Generally, breastfeeding can resume 4 hours after injection.

Driving and using machines
It is considered unlikely that RENOCIS will affect your ability to drive or operate machinery.

RENOCIS contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially "sodium-free".

3. How to take RENOCIS

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Renocis will be used only in a specially controlled area. This product will be handled and administered exclusively by trained and qualified personnel competent to use it safely. These individuals will take particular care in the safe use of this product and will keep you informed of their actions.
The nuclear medicine physician in charge of the examination will determine the amount of technetium (Tc) succimer to be administered in your case. This will be the smallest quantity necessary to obtain the required information.
The recommended administered dose for an adult usually ranges between 30 and 120 MBq (MBq: megabecquerel, a unit used to express radioactivity).

Use in children and adolescents
The dose to be administered to a child or adolescent will be adjusted according to body weight.

Administration of Renocis and performance of the examination
This medicinal product will be injected into a vein in the arm.
A single injection is sufficient to provide your physician with the necessary information.

Duration of the examination
Your nuclear medicine physician will inform you about the usual duration of the examination.
Images may be acquired from 1 to 3 hours after injection. Additional images may occasionally be required up to 24 hours after injection.

After administration of Renocis, you will be asked to drink as much as possible and to urinate frequently to help eliminate the product from your body.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicinal product. Please consult your nuclear medicine physician if you have any questions.

If you receive more Renocis than you should
An overdose is practically impossible, as you will receive only a single dose of Renocis precisely determined by the nuclear medicine physician supervising the examination. However, in the event of an overdose, appropriate treatment will be administered.
If you have further questions about the use of this medicinal product, please consult the nuclear medicine physician supervising the examination for further information.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody experiences
them.
A few cases of allergic-type reactions have been reported, with an undefined frequency based on
available data.
This radiopharmaceutical product will deliver small amounts of ionising radiation, associated with a
very low risk of cancer and congenital abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or the
nuclear medicine physician. You may also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store RENOCIS

This medicine must not be stored by the patient. This medicine must be stored under the responsibility of a specialist in suitable premises. Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive materials.

6. Package contents and other information

What Renocis contains
The active substance is: succimer (dimercaptosuccinic acid).
The other components are: stannous chloride dihydrate, inositol, ascorbic acid, sodium hydroxide, under
nitrogen atmosphere.

Description of the appearance of Renocis and contents of the pack
Renocis is a kit for radiopharmaceutical preparation intended solely for healthcare professionals.
You must not store or handle this medicinal product.
Presentation: pack of 5 multidose vials.

Marketing Authorization Holder and Manufacturer
Curium Italy S.r.l
Via Nicola Piccinni 2
20131 Milano
Italy

Manufacturer
CIS bio international
R.N.306 – Saclay
B.P. 32
91192 Gif-sur-Yvette Cedex
France

Detailed information on this medicinal product is available on the website of the Italian Medicines Agency ( www.agenziafarmaco.gov.it ).

The following information is intended exclusively for healthcare professionals:
The complete product characteristics summary of RENOCIS is provided as a separate document, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC (Summary of Product Characteristics).