Patient Information Leaflet

Elucirem 0.5 mmol/ml injectable solution

Gadopiclenol

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you receive this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, radiologist or pharmacist.
• If you experience any adverse effects, consult your doctor or radiologist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Elucirem is and what it is used for
2. What you need to know before you receive Elucirem
3. How you will receive Elucirem
4. Possible side effects
5. Storage of Elucirem
6. Contents of the container and additional information

Elucirem is a contrast agent that improves the contrast of images obtained during magnetic resonance (MR) examinations. Elucirem contains the active ingredient gadopiclenol.

It improves 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 administered as an intravenous injection. This medication is for diagnostic use only and will only be administered by experienced healthcare professionals in clinical practice of magnetic resonance.

Elucirem should not be administered

if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, radiologist, or pharmacist before Elucirem is administered to you:

• 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, urticaria),
• if your kidneys do not function correctly,
• if you have had seizures or are being treated for epilepsy,
• if you have any heart or blood vessel disease,

Your doctor will decide if the planned examination is possible or not. If Elucirem is administered to you, 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 old or older.

Other medications and Elucirem

Inform your doctor, radiologist, or pharmacist if you are taking, have taken recently, or may need to take other medications.

Particularly, inform your doctor, radiologist, or pharmacist if you are receiving or have received recently medications to treat the heart or blood pressure such as beta-blockers, vasodilators, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II receptor antagonists.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Consult your doctor or radiologist if you are breastfeeding.

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

Driving and operating machines

Elucirem has no or insignificant effect on the ability to drive and use machines. However, if you feel unwell after the examination, do not drive or use machines.

Elucirem contains sodium

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

A qualified healthcare professional will inject Elucirem into a vein using a small needle. Elucirem can be injected manually or using 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 of body weight is the same for adults and children aged 2 years and older.

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

After the injection, you will be kept under supervision for at least 30 minutes. This is the time when unwanted reactions (such as allergic reactions) are more likely to occur. However, in rare cases, reactions may occur hours or days later.

Use in Patients with Severe Kidney Problems

Elucirem is not recommended for use in patients with severe kidney problems. However, if its use is required, only a single dose should be administered 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, there is no need to adjust the dose, but you may be required to have a blood test to check the proper functioning of your kidneys.

If You Receive More Elucirem Than You Should

It is highly unlikely that you will receive an overdose of Elucirem, as it will be administered by a qualified healthcare professional. If an overdose occurs, Elucirem can be removed from the body through hemodialysis (blood cleansing).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

After receiving Elucirem, you will be kept under observation. Most side effects occur within minutes. There is a small risk of experiencing 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).

Inform 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 nasal discharge

The possible side effects observed during clinical trials with Elucirem are listed below, grouped by their likelihood:

*The reaction at the injection site may be pain, swelling, sensation of cold or heat, hematoma, and redness.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national notification system included in thesAppendix V.

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

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

Do not use this medication after the expiration date that appears on the vial label or pre-filled syringe label and on the carton box after "EXP" or “CAD”. The expiration date refers to the last day of that month.

This medication is a transparent solution, between colorless and pale yellow.

Do not use this medication if the solution is not transparent or contains visible particles.

For vials: This medication does not require special storage conditions.

Chemical and physical stability has 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 through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Elucirem

• The active ingredient is gadopiclenol. Each ml of solution contains 485.1 mg of gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and to 78.6 mg of gadolinium).
• The other components are tetraxetan, trometamol, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH) and water for injection preparations. See section 2 “Elucirem contains sodium”.

Appearance of Elucirem and contents of the package

It is a transparent injectable solution, between colorless and pale yellow.

It is available in packages that include:

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

Only some package sizes may be commercially available.

Marketing Authorization 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

Last review date 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 solely for healthcare professionals:

For more details on how to use the medicine, consult section 6.6 Special precautions for disposal and other manipulations of the Product Information of this medicine.