ELUCIREM 0.5 mmol/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Elucirem 0.5 mmol/ml Solution for Injection

gadopiclenol

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on how to report side effects.

Read all of 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 further questions, ask your doctor, radiologist or pharmacist.
• If you get any side effects, talk to your doctor or radiologist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Elucirem and what is it used for
2. What you need to know before you are given Elucirem
3. How Elucirem is given
4. Possible side effects
5. Storage of Elucirem
6. Contents of the pack and other information

1. What is Elucirem and what is it used for

Elucirem is a contrast medium that improves the contrast of images obtained during magnetic resonance imaging (MRI) examinations. Elucirem contains the active substance gadopiclenol.

It improves the visualization and delineation of abnormal structures or lesions in certain parts of the body and helps to differentiate between healthy and diseased tissue.

It is used in adults and children (from 2 years of age).

It is given as an injection into a vein. This medicine is only for diagnostic use and will only be administered by healthcare professionals with experience in the clinical practice of magnetic resonance imaging.

2. What you need to know before you are given Elucirem

Elucirem must not be given

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

Warnings and precautions

Tell your doctor, radiologist or pharmacist before you are given Elucirem:

• if you have had a previous reaction to any contrast agent,
• if you have asthma,
• if you have a history of allergy (such as hay fever, hives),
• if your kidneys do not work properly,
• if you have had seizures or are being treated for epilepsy,
• if you have any heart or blood vessel disease,

In all these cases, your doctor will decide whether the planned examination is possible or not. If you are given Elucirem, your doctor or radiologist must take the necessary precautions and administer it under close supervision.

Your doctor or radiologist may decide to perform a blood test to check the proper functioning of your kidneys before deciding to use Elucirem, especially if you are 65 years of age or older.

Other medicines and Elucirem

Tell your doctor, radiologist or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor, radiologist or pharmacist if you are receiving or have recently received medicines for heart or blood pressure problems, such as beta-blockers, vasoactive substances, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists.

Pregnancy and breastfeeding

Pregnancy

Ask your doctor or radiologist if you are pregnant or think you may be pregnant, as Elucirem should not be used during pregnancy unless it is strictly necessary.

Breastfeeding

Ask your doctor or radiologist if you are breastfeeding.

Your doctor will assess whether you should continue breastfeeding or interrupt it until 24 hours after receiving Elucirem.

Driving and using machines

Elucirem has a negligible influence on the ability to drive and use machines. However, if you feel unwell after the examination, you should not drive or use machines.

Elucirem contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 15 ml vial; it is essentially "sodium-free".

3. How Elucirem is given

A healthcare professional will inject Elucirem into your vein with a small needle. Elucirem can be injected manually or with an automatic injector.

Your doctor or radiologist will determine the dose you should receive and supervise the injection.

The usual dose of 0.1 ml/kg body weight is the same in adults and children from 2 years of age.

In children, your doctor or radiologist will use Elucirem in vials with a single-use syringe to have greater precision of the injected volume.

After the injection, you will remain under supervision for at least 30 minutes. This is the time when most unwanted reactions (such as allergic reactions) may occur. However, in rare cases, reactions may occur after hours or days.

Use in patients with severe kidney problems

The use of Elucirem is not recommended in patients with severe kidney problems. However, if its use is required, it should only be administered as a single dose during the examination and a second injection should not be given until at least 7 days have passed.

Use in elderly patients

If you are 65 years of age or older, it is not necessary to adjust the dose, but a blood test may be performed to check the proper functioning of your kidneys.

If you receive more Elucirem than you should

It is very unlikely that you will receive an overdose of Elucirem, as it will be administered by a qualified healthcare professional. If this happens, Elucirem can be removed from the body by haemodialysis (blood cleaning).

If you have any other questions about the use of this medicine, ask your doctor, radiologist or pharmacist.

4. Possible side effects

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

After the administration of Elucirem, you will remain under observation. Most side effects occur within minutes. There is a small risk of having an allergic reaction to Elucirem. These effects can occur immediately or up to seven days after the injection. These reactions can be severe and cause shock (a life-threatening allergic reaction).

Tell your doctor, radiologist or healthcare professional immediately if you experience any of the following side effects, as they may be the first signs of shock:

• swelling of the face, lips, tongue or throat
• dizziness (low blood pressure)
• difficulty breathing
• skin rash
• cough, sneezing or runny nose

The possible side effects that have been observed during clinical trials with Elucirem are listed below according to their frequency:

*The injection site reaction can be pain, swelling, feeling of cold or heat, bruising and redness.

**Allergic reactions can be: skin inflammation, skin redness, difficulty breathing, voice alteration, throat tightness, throat irritation, abnormal sensation in the mouth, transient facial redness (early reactions) and swollen eyes, swelling, skin rash and itching (late reactions).

Cases of nephrogenic systemic fibrosis (NSF) (which causes skin hardening and may also affect soft tissues and internal organs) have been reported with other gadolinium-containing contrast agents, but no cases of NSF have been reported with Elucirem during clinical trials.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V.

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

5. Storage of Elucirem

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the vial or pre-filled syringe and on the carton after "EXP" or "CAD". The expiry date refers to the last day of that month.

This medicine is a clear, colourless to pale yellow solution.

Do not use this medicine if the solution is not clear or if it contains visible particles.

For vials: This medicine does not require any special storage conditions.

Chemical and physical stability have been demonstrated for 24 hours at a temperature of up to 25°C.

From a microbiological point of view, the product should be used immediately after opening.

For pre-filled syringes: Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elucirem

• The active substance is gadopiclenol. Each ml of solution contains 485.1 mg of gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and 78.6 mg of gadolinium).
• The other ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. See section 2 "Elucirem contains sodium".

Appearance of Elucirem and pack contents

It is a clear, colourless to pale yellow solution for injection.

It is available in packs that include:

• 1 vial with 3, 7.5, 10, 15, 30, 50 or 100 ml of solution for injection.
• 25 vials with 7.5, 10 or 15 ml of solution for injection.
• 1 or 10 (10 x 1) pre-filled syringes with 7.5, 10 or 15 ml of solution for injection.
• 1 pre-filled syringe with 7.5, 10 or 15 ml of solution for injection with administration kit for manual injection (one extension line and one catheter).
• 1 pre-filled syringe with 7.5, 10 or 15 ml of solution for injection with administration kit for Optistar Elite injector (one extension line, one catheter and one empty 60 ml plastic syringe).
• 1 pre-filled syringe with 7.5, 10 or 15 ml of solution for injection with administration kit for Medrad Spectris Solaris EP injector (one extension line, one catheter and one empty 115 ml plastic syringe).

Not all pack sizes may be marketed.

Marketing authorisation holder

Guerbet

15 rue des Vanesses

93420 Villepinte

France

Manufacturer

Guerbet

16 rue Jean Chaptal

93600 Aulnay-sous-Bois

France

BIPSO GmbH

Robert-Gerwig-Strasse 4

Singen (Hohentwiel)

78224

Germany

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

For more details on how to use the medicine, see section 6.6 Special precautions for disposal and other handling of the Summary of Product Characteristics of this medicine.