Elucirem

Patient Information Leaflet

Elucirem 0.5 mmol/mL injection solution

gadopiclenol
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, radiologist, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, radiologist, or pharmacist. See section 4.

Contents of this leaflet

1. What Elucirem is and what it is used for
2. What you need to know before receiving Elucirem
3. How Elucirem will be administered to you
4. Possible side effects
5. How to store Elucirem
6. Contents of the pack and other information

1. What Elucirem is and what it is used for

Elucirem is a contrast agent that enhances the contrast of images obtained during magnetic resonance imaging (MRI) scans. Elucirem contains the active substance gadopiclenol.
It improves the visualisation and delineation of abnormal structures or lesions in certain parts of the body and helps to distinguish between healthy and diseased tissue.
It is used in adults and children from birth.
It is administered by intravenous injection. This medicinal product is intended for diagnostic use only and may be administered only by healthcare professionals experienced in the clinical practice of magnetic resonance imaging.

2. What you need to know before receiving Elucirem

Elucirem must not be administered

• if the patient is allergic to gadopiclenol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, radiologist or pharmacist before you are given Elucirem:

• if you have previously had a reaction to any contrast agent,
• if you suffer from asthma,
• if you have a history of allergies (such as hay fever, hives),
• if you have kidney problems,
• if you have had seizures (fits) or are being treated for epilepsy,
• if you suffer from a disease affecting the heart or blood vessels.

In all these cases, the doctor will decide whether the planned examination can proceed. If Elucirem is administered, the doctor or radiologist will take the necessary precautions and the administration of Elucirem will be closely monitored.
Your doctor or radiologist may decide to perform a blood test to check kidney function before deciding to use Elucirem, especially if you are aged 65 years or older.
Children
Since kidney function is immature in newborns up to 4 weeks of age and in infants up to 1 year of age, Elucirem will only be used in these patients after careful evaluation by the doctor.
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, you must inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart conditions and high blood pressure, such as beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists.
Pregnancy and breastfeeding
Pregnancy
Gadopiclenol may cross the placenta. It is not known whether it has effects on the unborn child.
Inform your doctor or radiologist if you suspect you are pregnant or if there is a possibility you could become pregnant, since Elucirem should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Inform your doctor or radiologist if you are breastfeeding or are planning to breastfeed.
Your doctor will advise whether you should continue or interrupt breastfeeding for a period of 24 hours after receiving Elucirem.
Driving and using machines
Elucirem does not affect or has negligible influence on the ability to drive or operate machinery.
However, if you feel unwell after the examination, do not drive or use machinery.
Elucirem contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 15 mL vial, i.e. it is essentially "sodium-free".

3. How Elucirem will be administered to you

Elucirem will be injected into a vein by a specially trained healthcare professional, using a small needle.
It may be administered manually or by means of an automatic injector.
Your doctor or radiologist will determine the dose to be given and will monitor the injection.
The usual dose of 0.1 mL/kg body weight is the same for both adults and children.
In children, the doctor or radiologist will use Elucirem in vials with a single-use syringe to ensure greater accuracy in the injected volume.
After the injection, you will be monitored for at least 30 minutes, as most adverse reactions (such as allergic reactions) may occur during this period. However, in rare cases, reactions may occur hours or even days later.

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 necessary, the patient must receive only one dose of Elucirem during the examination and must not receive a second injection within at least 7 days.

Use in children
Since kidney function is immature in neonates up to 4 weeks of age and in infants up to 1 year of age, Elucirem will be used in these patients only after careful medical evaluation. Children must receive only one dose of Elucirem during an examination and must not receive a second injection within at least 7 days.

Use in elderly patients
Dose adjustment is not necessary in patients aged 65 years or older, but a blood test may be performed to assess kidney function.

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. In the event this occurs, Elucirem can be removed from the body by haemodialysis (blood cleansing).

For any further questions regarding the use of this medicine, please consult your doctor, radiologist, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After receiving Elucirem, you will be monitored. Most side effects occur within minutes. There is a low risk of an allergic reaction to Elucirem.
These reactions may occur immediately or up to seven days after the injection. Such reactions can be severe and lead to shock (a type of allergic reaction that may be life-threatening).
Inform your doctor, radiologist or healthcare professional immediately if you experience any of the
following side effects, as they could be early signs of shock:

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

The possible side effects observed during clinical studies with Elucirem are listed below, classified according to their likelihood:

*"Injection site reaction" includes: pain, swelling, feeling of cold, feeling of warmth,
bruising, or redness.
**"Allergic reaction" may include: skin inflammation, skin redness, breathing
difficulty, voice impairment, throat tightness, throat irritation, abnormal sensation
in the mouth, transient facial flushing (early reactions), and eye swelling, 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; however, during clinical studies, no cases of NSF were reported with Elucirem.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your
doctor or pharmacist. You may also report adverse reactions through the national reporting
system detailed in Annex V. By reporting adverse reactions, you can help provide
further information on the safety of this medicine.

5. How to store 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 prefilled syringe and on the outer cardboard box after "Exp.". The expiry date refers to the last day of that month.
This medicine is a clear solution, colourless to pale yellow.
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 in-use stability has been demonstrated for 24 hours up to 25 °C. From a microbiological point of view, the medicine should be used immediately after opening.
For prefilled syringes: do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Elucirem contains

• 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 components are tetraxetan, trometamol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. See section 2 “Elucirem contains sodium”.

Description of the appearance of Elucirem and contents of the pack
It is a clear, colourless to pale yellow solution.
It is available in packs containing:

• 1 vial containing 3, 7.5, 10, 15, 30, 50 or 100 mL of injectable solution.
• 25 vials containing 7.5, 10 or 15 mL of injectable solution.
• 1 or 10 (10 x 1) pre-filled syringes containing 7.5, 10 or 15 mL of injectable solution.
• 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with a manual injection administration kit (one extension set and one catheter).
• 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with an administration kit for the Optistar Elite injector (one extension set, one catheter and one empty 60 mL plastic syringe).
• 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with an administration kit for the Medrad Spectris Solaris EP injector (one extension set, 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)
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
sa Guerbet nv Guerbet
Tél/Tel: +32 2 726 21 10 Tel: +33 1 45 91 50 00
България Luxembourg/Luxemburg
Guerbet sa Guerbet nv
Teл.: +33 1 45 91 50 00 Tél/Tel: +32 2 726 21 10
Česká republika Magyarország
Diagnostic Pharmaceuticals a.s. Astromedic Kft
Tel: +420 241 431 122 Tel.: +36-30-9444921
Danmark Malta
Vingmed A/S Guerbet
Tlf.: +45 45 82 33 66 Tel: +33 1 45 91 50 00
Deutschland Nederland
Guerbet GmbH Guerbet Nederland B.V.
Tel: +49 6196 76 20 Tel: +31 183 633 688
Eesti Norge
Guerbet Guerbet
Tel: +33 1 45 91 50 00 Tlf: +33 1 45 91 50 00
Ελλάδα Österreich
Syn Innovation Lab A.E. Guerbet Ges.m.b.H.
Τηλ.: +30 216 9390105/177 Tel: +43 1 710 62 06
España Polska
Laboratorios Farmacéuticos Guerbet S.A. Guerbet Poland Sp. z o.o
Tel: +34 915 04 50 00 Tel.: +48 22 668 41 10
France Portugal
Guerbet France Martins & Fernandes S.A
Tél: +33 1 45 91 50 00 Tel: +351 21 75 73 215
Hrvatska România
Pharmacol d.o.o. ThreePharm SRL
Tel: +385 1 4852 947 Tel: +4 0265 268 670
Ireland Slovenija
Guerbet Pharmacol d.o.o.
Tel: +33 1 45 91 50 00 Tel: +385 1 4852 947
Ísland Slovenská republika
Guerbet Guerbet
Tel: +33 1 45 91 50 00 Tel: +33 1 45 91 50 00
Italia Suomi/Finland
Guerbet S.p.A Grex Medical Oy
Tel: +39 297 168 200 +358 50 3600 082
Κύπρος Sverige
Guerbet Vingmed AB
Τηλ: +33 1 45 91 50 00 Tel: +46 8 583 593 00
Latvija
Guerbet
Tel: +33 1 45 91 50 00
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:

For details on the methods of use of the product, please refer to section 6.6 Special precautions for disposal and handling of the Summary of Product Characteristics of this product.
ANNEX IV
CONCLUSIONS OF THE EUROPEAN MEDICINES AGENCY REGARDING THE REQUEST FOR
ONE-YEAR MARKETING PROTECTION
Conclusions of the European Medicines Agency on:

• one-year marketing protection
  In consideration of the provisions set out in Article 14(11) of Regulation 726/2004/EC, the Committee for Medicinal Products for Human Use (CHMP) has reviewed the data submitted by the marketing authorization holder and considers that the new therapeutic indication provides a significant clinical benefit compared to currently available therapies, as further described in the European Public Assessment Report (EPAR).