RENOCIS 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

RENOCIS 1 mg kit for radiopharmaceutical preparation

Succimer

Read this package leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. See Section 4.

Contents of the package leaflet

1. What RENOCIS is and what it is used for
2. What you need to know before using RENOCIS
3. How to use RENOCIS
4. Possible side effects
5. Storage of RENOCIS
6. Contents of the pack and further information

1. What RENOCIS is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

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

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

2. What you need to know before using RENOCIS

RENOCIS must not be used

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

Warnings and precautions

Be particularly careful with RENOCIS:

• If you have an allergic disease, as cases of allergic reactions have been reported with this type of examination.
• If you are pregnantor think you may be pregnant.
• If you are breastfeeding.
• If you have kidney disease.

Consult your nuclear medicine doctor if you are in any of the above situations. Renocis may not be suitable for you. Your nuclear medicine doctor 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 few hours after the examination.

Children and adolescents:

Tell your nuclear medicine doctor if you are under 18 years old.

Using RENOCIS with other medicines

Tell your nuclear medicine doctor if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription, as some medicines may interfere with the interpretation of the images.

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

• Ammonium chloride(used to treat recurrent urinary infections)
• Sodium bicarbonate(a medicine that reduces blood or urine acidity)
• Mannitol(used to reduce intracranial pressure)
• Certain hypertension medicines(known as angiotensin-converting enzyme inhibitors, such as captopril)
• Anticancer medicines, such as methotrexate, cyclophosphamide, and vincristine

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before using this medicine.

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

In case of doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

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

If you are breastfeeding

If you are breastfeeding, inform your nuclear medicine doctor, as they may delay the examination until you finish breastfeeding or ask you to interrupt breastfeeding for a while.

Your doctor will tell you when you can restart breastfeeding, which usually occurs 4 hours after injection. You should discard the milk expressed during this time.

Driving and using machines

It is considered unlikely that Renocis will affect your ability to drive or use machines.

RENOCIS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to use RENOCIS

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Renocis will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel to use it safely. These people will take special safety measures for the safe use of this medicine and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of technetium (99mTc) succimer to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended amount to administer to an adult is between 30 and 120 MBq (MBq: Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

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

Administration of Renocis and performance of the procedure

Renocis is administered by injection into a vein in the arm.

A single injection is sufficient to perform the procedure your doctor needs.Duration of the procedure

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

The examinations can take from one to three hours after injection. In some cases, it may be necessary to perform additional examinations up to 24 hours after injection.

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

Your nuclear medicine doctor will indicate if you need to take special precautions after being given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more RENOCIS than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Renocis from your nuclear medicine doctor. However, in case of overdose, you will receive the appropriate treatment.

If you have any questions about the use of Renocis, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Reporting of side effects

If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of RENOCIS

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities.

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

The following information is intended only for the specialist.

Do not use Renocis after the expiry date stated on the label after CAD.

6. Contents of the pack and further information

Composition of RENOCIS

• The active substance 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 and pack contents

Renocis is a kit for radiopharmaceutical preparation that will only be used by healthcare professionals. This medicine is presented as a white powder. It is supplied in 15 ml colorless glass type I Ph.Eur. multidose vials, sealed with a chlorobutyl rubber stopper and an aluminum overseal.

A pack contains 5 vials, each with 1 mg.

Presentation:kit of 5 multidose vials.

Marketing authorization holder and manufacturer:

CIS bio international

RN 306 - Saclay

B.P. 32

F-91192 Gif sur Yvette Cedex

France.

You can request more information about this medicine from the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Date of last revision of this package leaflet:October 2018

This information is intended only for doctors or healthcare professionals:

The complete technical data sheet of RENOCIS is included as a detachable section at the end of this package leaflet in the product packaging, in order to provide healthcare professionals with further scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.