Label: information for the patient

RENOCIS 1 mg kit for radiopharmaceutical preparation

Succimer

Read this label carefully before this medication is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is overseeing the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See Section 4

1. What is RENOCIS and how is it used

2. What you need to know before starting to use RENOCIS

3. How to use RENOCIS

4. Possible adverse effects

5. Storage of RENOCIS

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

The active principle of Renocis is succimer. Renocis is used in combination with a radioactive solution of technetium (99mTc) to form a technetium (99mTc) succimer solution for injection.

When injected, the technetium (99mTc) succimer accumulates temporarily in the kidneys. Due to its radioactivity, it can be detected from the outside of the body using a special camera and images, known as gamma scans, can be obtained. These explorations provide valuable information about the structure or functioning of the kidneys.

The use of Renocis involves exposure to certain amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

RENOCIS should not be used

• If you are allergic to succimer or any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with RENOCIS:

• If you havean allergic disease, as cases of allergic reactions with this type of examination have been reported.
• If you arepregnantor believe you may be pregnant.
• If you are in thelactation period.
• If you havekidney disease.

Consult your nuclear medicine specialist if you are in any of the situations mentioned above. It may be that Renocis is not suitable for you. Your nuclear medicine specialist will give you the necessary instructions.

Before administration of Renocis you must:

Drink plenty of water before starting the examination so that you urinate as frequently as possible during the first hours after the examination.

Children and adolescents:

Inform your nuclear medicine specialist if you are under 18 years old.

Use of RENOCIS with other medications:

Inform your nuclear medicine specialist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, as some medications may interfere with the interpretation of images.

Your doctor or nuclear medicine specialist may recommend that you stop taking the following medications before the procedure with Renocis:

• Ammmonium chloride(used in the treatment of recurrent urinary tract infections)
• Sodium bicarbonate(a medication that reduces blood or urine acidity)
• Manitol(used to reduce intracranial pressure)
• Certainblood pressure medications(called angiotensin-converting enzyme inhibitors [ACEIs], such as captopril
• Cancer medications,such as methotrexate, cyclophosphamide, and vincristine

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you believe you may be pregnant, consult your nuclear medicine specialist before using this medication.

You must inform your nuclear medicine specialistbefore administration of Renocisif there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

It is essential to consult your nuclear medicine specialist who will oversee the procedure.

If you are pregnant

It is recommended to avoid the examination with technetium (99mTc) during pregnancy as it may pose risks to the fetus. Your nuclear medicine specialist will administer this product during pregnancy only if the expected benefit outweighs the risks.

If you are breastfeeding

If you are breastfeeding, inform your nuclear medicine specialist, as you may need to delay the examination until you have finished breastfeeding or ask to interrupt breastfeeding for a period of time.

Your doctor will indicate when you can resume breastfeeding, which usually occurs 4 hours after the injection. You should discard the milk expressed during that time period.

Driving and operating machinery

It is considered unlikely that Renocis will affect your ability to drive or operate machinery.

RENOCIS contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radioactive medications. Renocis will only be used in specially controlled areas. This medication will only be handled and administered by qualified and trained personnel to ensure safe use. These individuals will take special safety measures to ensure safe use of this medication and will inform you of their actions.

The nuclear physician overseeing the procedure will decide on the amount of technetium (99mTc) chelate to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for normal administration to an adult typically ranges from 30 to 120 MBq (MBq: Megabequerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the dose to be administered will be adjusted according to their body weight.

Administration of Renocis and procedure performance

Renocis is administered via an injection into a vein in the arm.

One injection is sufficient to perform the procedure your physician needs.Procedure duration

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

Scans may take anywhere from one to three hours after the injection. In some cases, additional scans may be necessary up to 24 hours after the injection.

After Renocis administration, you will be asked to drink as much as possible and urinate frequently to eliminate the product from your body.

Your nuclear physician will instruct you on any special precautions you may need to take after receiving this medication. Consult your nuclear physician if you have any nuclear-related questions.

If you have been administered more RENOCIS than you should

It is unlikely to experience an overdose, as you will receive a single, precisely controlled dose of Renocis from the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment.

If you have any questions about the use of Renocis, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

There have been reported cases of allergic reactions, with an unknown frequency.

Reporting Adverse Effects

If you experience any type of adverse effect, consult a nuclear medicine specialist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in suitable facilities.

The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use Renocis after the expiration date that appears on the label after CAD

Composition of RENOCIS

• The active principle is succimer (dimercaptosuccinic acid).
• The other components are: tin(II) chloride dihydrate (E-512), inositol, ascorbic acid (E-300), sodium hydroxide (E-524) and nitrogen (E-941).

Appearance of the product and contents of the packaging

Renocis is a set of reagents for radio-pharmaceutical preparation that will only be used by healthcare professionals. This medication is presented in the form of white powder. It is supplied in multi-dose vials of type I, colorless, stretched glass of 15 ml, sealed with a rubber stopper of chlorobutyl and with an aluminum overcap.

One package contains 5 vials with 1 mg each.

Presentation:a set of 5 multi-dose vials.

Holder of the marketing authorization and responsible for manufacturing:

CIS bio international

RN 306 - Saclay

B.P. 32

F-91192 Gif sur Yvette Cedex

France.

For more information about this medication, please contact the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tel.: 91 4841989

Date of the last review of this prospectus:October 2018

This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet of RENOCIS is included as a detachable section at the end of this prospectus 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.