Elucirem 0.5 mmol/mL solution for injection – patient leaflet, side effects, dosage

1. What Elucirem is and what it is used for

Elucirem is a contrast agent which enhances the contrast of the images obtained during magnetic resonance imaging (MRI) examinations. Elucirem contains the active substance gadopiclenol. It improves the visualisation and delineation of abnormal structures or lesions of certain parts of the body and helps in the differentiation between healthy and diseased tissue. It is used in adults and children from birth.

It is given as an injection into your vein. This medicine is for diagnostic use only and will only be administered by healthcare professionals experienced in the field of clinical MRI practice.

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

Elucirem must not be given to you

• if you are allergic to gadopiclenol or 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 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 had seizures (fits) or are being treated for epilepsy,
• if you have a disease affecting your heart or your blood vessels.

In all these cases, your doctor will decide whether the intended examination is possible or not. If you are given Elucirem, your doctor or radiologist will take the necessary precautions and the administration of it will be carefully monitored.

Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before making the decision to use Elucirem, especially if you are 65 years of age or older. Children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration 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, please inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blocking agents, vasoactive substances, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists. Pregnancy and breast-feeding

Pregnancy

Gadopiclenol can cross the placenta. It is not known whether it affects the baby. Tell your doctor or radiologist if you think you are, or might become pregnant as Elucirem should not be used during pregnancy unless strictly necessary.

Breast-feeding

Tell your doctor or radiologist if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue or interrupt breast-feeding for a period of 24 hours after you receive Elucirem.

Driving and using machines

Elucirem has no effect on the ability to drive. 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 sodium (23 mg) per 15 mL vial, that is to say essentially ‘sodium-free’.

3. How Elucirem will be given to you

Elucirem will be injected into your vein using a small needle by a specialised healthcare professional. It can be administered by hand or by an automatic injector.

Your doctor or radiologist will determine the dose you will receive and supervise the injection. The usual dose of 0.1 mL/kg body weight is the same in adults and children. In children, your doctor or radiologist will use Elucirem in vials with a single use syringe to be able to have a better precision of the injected volume.

After the injection, you will be kept under supervision for at least 30 minutes. This is the time where most undesired 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 it is required you should only receive one dose of Elucirem during a scan and you should not receive a second injection for at least 7 days.

Use in children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration by the doctor. Children should only receive one dose of Elucirem during a scan and should not receive a second injection for at least 7 days.

Use in elderly

It is not necessary to adjust your dose if you are 65 years of age or older, but you may have a blood test to check how well your kidneys are working.

If you receive more Elucirem than you should

It is highly unlikely that you will receive an overdose of Elucirem, as it will be given to you by a trained healthcare professional. If it does happen, Elucirem can be removed from the body by haemodialysis (blood cleaning).

If you have any further questions on 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 be kept under observation. Most side effects occur within minutes. There is a small risk that you may have an allergic reaction to it. These effects can occur immediately and up to seven days after the injection. Such reactions can be severe and result in shock (case of allergic reaction that could put your life in danger).

Tell your doctor, radiologist or health professional immediately if you get any of the following side effects as it may be the first signs of a shock:

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

Possible side effects which have been observed during clinical trials with Elucirem are listed below by how likely they are:

Frequency Possible side effects

Common (may affect up to

1 in 10 people)

Injection site reaction*

Headache

Uncommon (may affect up

to 1 in 100 people)

Allergic reaction**

Diarrhoea

Nausea (feeling sick)

Fatigue (tiredness)

Abdominal pain

Unusual taste in the mouth

Feeling of warmth

Vomiting (being sick)

* Injection site reaction includes: pain, swelling, cold feeling, warm feeling, bruising or redness. ** Allergic reaction may include: inflammation of the skin, reddening of the skin, breathing difficulties, voice impairment, throat tightness, throat irritation, abnormal sensation in the mouth, transient reddening of the face (early reactions) and puffy eyes, swelling, rash and itching (late reactions).

There have been reports of nephrogenic systemic fibrosis (NSF) (which causes hardening of the skin and may affect also soft tissue and internal organs) with other contrast agent containing gadolinium however no NSF case has been reported with Elucirem during the clinical trials. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more 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 vial label and the carton box after “EXP”. The expiry date refers to the last day of that month.

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

Do not use this medicine if the solution is not clear or if it contains visible particles. This medicine does not require any special storage conditions.

Chemical, physical and microbiological in-use stability has been demonstrated for 24 hours at up to 25 °C. From a microbiological point of view, the product should be used immediately after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Elucirem contains

• The active substance is gadopiclenol. Each mL of solution contains 485.1 mg gadopiclenol

  (equivalent to 0.5 mmol of gadopiclenol and to 78.6 mg of gadolinium). - The other ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment, if needed), sodium hydroxide (for pH adjustment, if needed) and water for injections. See section 2 “Elucirem contains sodium”.

What Elucirem looks like and contents of the pack

It is a clear, colourless to pale yellow sterile solution.

It is available in packs including:

• 1 vial containing 3, 7.5, 10, 15, 30, 50 or 100 mL of solution for injection.
• 25 vials containing 7.5, 10 or 15 mL of solution for injection.

All pack sizes may not be marketed.

Marketing Authorisation Holder

Guerbet

BP 57400

95943 Roissy CdG Cedex

France

Manufacturer

Guerbet

16 rue Jean Chaptal

93600 Aulnay-sous-Bois

France

This leaflet was last revised in January 2026.

The following information is intended for healthcare professionals only:

For details on how to use the product, please refer to the section 6.6 Special precautions for disposal and other handling of the Summary of Product Characteristics of this product.

Product:

Volume:

Print Process:

Barcode:

Project: Country:

Software:

Font(s):

Additionnal information:

File name:

Vendor: Guerbet Spec.:

Item Part: Rev.date:

Contact:

Exe:

Package: Size:

Markups:

Manufacturing site:

15 rue des Vanesses 93420 Villepinte, FRANCE

Elucirem AUL260017 XXXXXX 01/2026 Great Britain (GB)

3 - 15 mL Leaflet Vial All 140 x 832 mm

Offset CCL Marburg SP0141-V1

None Adobe InDesign

Notes: Folded size - 35 x 140 mm

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MOCKUP1 February 20, 2026

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CoE PACKAGING - VILLEPINTE

JOB INFORMATION

PACKAGING INFORMATION

Signature Graphic Designer:

1

2

Package leaflet: Information for the patient

Elucirem 0.5

mmol/mL solution for injection

gadopiclenol

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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, radiologist or pharmacist. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

1.

What Elucirem is and what it is used for

2.

What you need to know before you are given Elucirem

3.

How Elucirem will be given 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 which enhances the contrast of the images obtained during magnetic resonance imaging (MRI) examinations. Elucirem contains the active substance gadopiclenol.

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

It is used in adults and children from birth.

It is given as an injection into your vein. This medicine is for diagnostic use only and will only be administered by healthcare professionals experienced in the field of clinical MRI practice.

2.

What you need to know before you are given Elucirem

Elucirem must not be given to you

-

if you are allergic to gadopiclenol or 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 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 had seizures (fits) or are being treated for epilepsy,

-

if you have a disease affecting your heart or your blood vessels.

In all these cases, your doctor will decide whether the intended examination is possible or not. If you are given Elucirem, your doctor or radiologist will take the necessary precautions and the administration of it will be carefully monitored.

Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before making the decision to use Elucirem, especially if you are 65 years of age or older.

Children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration 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, please inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blocking agents, vasoactive substances, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists.

Pregnancy and breast-feeding

Pregnancy

Gadopiclenol can cross the placenta. It is not known whether it affects the baby. Tell your doctor or radiologist if you think you are, or might become pregnant as Elucirem should not be used during pregnancy unless strictly necessary.

Breast-feeding

Tell your doctor or radiologist if you are breast-feeding or about to start breast-feeding.

Your doctor will discuss whether you should continue or interrupt breast-feeding for a period of 24 hours after you receive Elucirem.

Driving and using machines

Elucirem has no effect on the ability to drive. 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 sodium (23 mg) per 15 mL vial, that is to say essentially ‘sodium-free’.

3.

How Elucirem will be given to you

Elucirem will be injected into your vein using a small needle by a specialised healthcare professional.

It can be administered by hand or by an automatic injector.

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

The usual dose of 0.1

mL/kg body weight is the same in adults and children.

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

After the injection, you will be kept under supervision for at least 30 minutes. This is the time where most undesired 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 it is required you should only receive one dose of Elucirem during a scan and you should not receive a second injection for at least 7 days.

Use in children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration by the doctor. Children should only receive one dose of Elucirem during a scan and should not receive a second injection for at least 7 days.

Use in elderly

It is not necessary to adjust your dose if you are 65 years of age or older, but you may have a blood test to check how well your kidneys are working.

If you receive more Elucirem than you should

It is highly unlikely that you will receive an overdose of Elucirem, as it will be given to you by a trained healthcare professional. If it does happen, Elucirem can be removed from the body by haemodialysis (blood cleaning).

If you have any further questions on 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 be kept under observation. Most side effects occur within minutes. There is a small risk that you may have an allergic reaction to it. These effects can occur immediately and up to seven days after the injection. Such reactions can be severe and result in shock (case of allergic reaction that could put your life in danger).

Tell your doctor, radiologist or health professional immediately if you get any of the following side effects as it may be the first signs of a shock:

-

swelling of the face, lips, tongue or throat

-

lightheadedness (low blood pressure)

-

breathing difficulties

-

skin rash

-

coughing, sneezing or runny nose

Possible side effects which have been observed during clinical trials with Elucirem are listed below by how likely they are:

*

Injection site reaction includes: pain, swelling, cold feeling, warm feeling, bruising or redness.

**

Allergic reaction may include: inflammation of the skin, reddening of the skin, breathing difficulties, voice impairment, throat tightness, throat irritation, abnormal sensation in the mouth, transient reddening of the face (early reactions) and puffy eyes, swelling, rash and itching (late reactions).

There have been reports of nephrogenic systemic fibrosis (NSF) (which causes hardening of the skin and may affect also soft tissue and internal organs) with other contrast agent containing gadolinium however no NSF case has been reported with Elucirem during the clinical trials.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more 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 vial label and the carton box after "EXP". The expiry date refers to the last day of that month.

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

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

This medicine does not require any special storage conditions.

Chemical, physical and microbiological in-use stability has been demonstrated for 24 hours at up to 25 °C. From a microbiological point of view, the product should be used immediately after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Elucirem contains

-

The active substance is gadopiclenol. Each mL of solution contains 485.1 mg gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and to 78.6

mg of gadolinium).

-

The other ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment, if needed), sodium hydroxide

(for pH adjustment, if needed) and water for injections. See section 2 “Elucirem contains sodium”.

What Elucirem looks like and contents of the pack

It is a clear, colourless to pale yellow sterile solution.

It is available in packs including:

-

1 vial containing 3, 7.5, 10, 15, 30, 50 or 100 mL of solution for injection.

-

25 vials containing 7.5, 10 or 15 mL of solution for injection.

All pack sizes may not be marketed.

Marketing Authorisation Holder

Guerbet

BP 57400

95943 Roissy CdG Cedex

France

Manufacturer

Guerbet

16 rue Jean Chaptal

93600 Aulnay-sous-Bois

France

This leaflet was last revised in January 2026.

258557

The following information is intended for healthcare professionals only:

For details on how to use the product, please refer to the section 6.6 Special precautions for disposal and other handling of the Summary of Product Characteristics of this product.

Graphic Designer:

Product:

Volume:

Print Process:

Barcode:

Project: Country:

Software:

Font(s):

Additionnal information:

Signature Graphic Designer: File name:

Vendor: Guerbet Spec.:

Item Part: Rev.date:

Contact:

Exe: Package Size:

Markups:

Manufacturing site:

15 rue des Vanesses 93420 Villepinte, FRANCE

Elucirem

RAL250079

258557

Great Britain (GB)

3 - 50 mL

Leaflet vial

All

Packsize

342 x 560 mm

Offset

CCL Chicago

SP0173

None

Adobe InDesign

Myriad Pro Family > 9 pt

Notes: Folded size - 35 mm x 140 mm

JS2

MM2

february 11, 2026

Raleigh

CoE PACKAGING - VILLEPINTE

JOB INFORMATION

OPERATOR

PACKAGING INFORMATION

1

2

Package leaflet: Information for the patient

Elucirem 0.5

mmol/mL solution for injection

gadopiclenol

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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, radiologist or pharmacist. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

1.

What Elucirem is and what it is used for

2.

What you need to know before you are given Elucirem

3.

How Elucirem will be given 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 which enhances the contrast of the images obtained during magnetic resonance imaging (MRI) examinations. Elucirem contains the active substance gadopiclenol.

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

It is used in adults and children from birth.

It is given as an injection into your vein. This medicine is for diagnostic use only and will only be administered by healthcare professionals experienced in the field of clinical MRI practice.

2.

What you need to know before you are given Elucirem

Elucirem must not be given to you

-

if you are allergic to gadopiclenol or 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 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 had seizures (fits) or are being treated for epilepsy,

-

if you have a disease affecting your heart or your blood vessels.

In all these cases, your doctor will decide whether the intended examination is possible or not. If you are given Elucirem, your doctor or radiologist will take the necessary precautions and the administration of it will be carefully monitored.

Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before making the decision to use Elucirem, especially if you are 65 years of age or older.

Children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration 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, please inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blocking agents, vasoactive substances, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists.

Pregnancy and breast-feeding

Pregnancy

Gadopiclenol can cross the placenta. It is not known whether it affects the baby. Tell your doctor or radiologist if you think you are, or might become pregnant as Elucirem should not be used during pregnancy unless strictly necessary.

Breast-feeding

Tell your doctor or radiologist if you are breast-feeding or about to start breast-feeding.

Your doctor will discuss whether you should continue or interrupt breast-feeding for a period of 24 hours after you receive Elucirem.

Driving and using machines

Elucirem has no effect on the ability to drive. 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 sodium (23 mg) per 15 mL vial, that is to say essentially ‘sodium-free’.

3.

How Elucirem will be given to you

Elucirem will be injected into your vein using a small needle by a specialised healthcare professional.

It can be administered by hand or by an automatic injector.

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

The usual dose of 0.1

mL/kg body weight is the same in adults and children.

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

After the injection, you will be kept under supervision for at least 30 minutes. This is the time where most undesired 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 it is required you should only receive one dose of Elucirem during a scan and you should not receive a second injection for at least 7 days.

Use in children

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Elucirem will only be used in these patients after careful consideration by the doctor. Children should only receive one dose of Elucirem during a scan and should not receive a second injection for at least 7 days.

Use in elderly

It is not necessary to adjust your dose if you are 65 years of age or older, but you may have a blood test to check how well your kidneys are working.

If you receive more Elucirem than you should

It is highly unlikely that you will receive an overdose of Elucirem, as it will be given to you by a trained healthcare professional. If it does happen, Elucirem can be removed from the body by haemodialysis (blood cleaning).

If you have any further questions on 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 be kept under observation. Most side effects occur within minutes. There is a small risk that you may have an allergic reaction to it. These effects can occur immediately and up to seven days after the injection. Such reactions can be severe and result in shock (case of allergic reaction that could put your life in danger).

Tell your doctor, radiologist or health professional immediately if you get any of the following side effects as it may be the first signs of a shock:

-

swelling of the face, lips, tongue or throat

-

lightheadedness (low blood pressure)

-

breathing difficulties

-

skin rash

-

coughing, sneezing or runny nose

Possible side effects which have been observed during clinical trials with Elucirem are listed below by how likely they are:

*

Injection site reaction includes: pain, swelling, cold feeling, warm feeling, bruising or redness.

**

Allergic reaction may include: inflammation of the skin, reddening of the skin, breathing difficulties, voice impairment, throat tightness, throat irritation, abnormal sensation in the mouth, transient reddening of the face (early reactions) and puffy eyes, swelling, rash and itching (late reactions).

There have been reports of nephrogenic systemic fibrosis (NSF) (which causes hardening of the skin and may affect also soft tissue and internal organs) with other contrast agent containing gadolinium however no NSF case has been reported with Elucirem during the clinical trials.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more 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 vial label and the carton box after "EXP". The expiry date refers to the last day of that month.

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

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

This medicine does not require any special storage conditions.

Chemical, physical and microbiological in-use stability has been demonstrated for 24 hours at up to 25 °C. From a microbiological point of view, the product should be used immediately after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Elucirem contains

-

The active substance is gadopiclenol. Each mL of solution contains 485.1 mg gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and to 78.6

mg of gadolinium).

-

The other ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment, if needed), sodium hydroxide

(for pH adjustment, if needed) and water for injections. See section 2 “Elucirem contains sodium”.

What Elucirem looks like and contents of the pack

It is a clear, colourless to pale yellow sterile solution.

It is available in packs including:

-

1 vial containing 3, 7.5, 10, 15, 30, 50 or 100 mL of solution for injection.

-

25 vials containing 7.5, 10 or 15 mL of solution for injection.

All pack sizes may not be marketed.

Marketing Authorisation Holder

Guerbet

BP 57400

95943 Roissy CdG Cedex

France

Manufacturer

BIPSO GmbH

Robert-Gerwig-Strasse 4

Singen (Hohentwiel)

78224

Germany

This leaflet was last revised in January 2026.

XXXXXX

The following information is intended for healthcare professionals only:

For details on how to use the product, please refer to the section 6.6 Special precautions for disposal and other handling of the Summary of Product Characteristics of this product.

Graphic Designer:

Product:

Volume:

Print Process:

Barcode:

Project: Country:

Software:

Font(s):

Additionnal information:

Signature Graphic Designer: File name:

Vendor: Guerbet Spec.:

Item Part: Rev.date:

Contact:

Exe: Package Size:

Markups:

Manufacturing site:

15 rue des Vanesses 93420 Villepinte, FRANCE

Elucirem

RAL250079

XXXXXX

Great Britain (GB)

3 - 50 mL

Leaflet

All

Packsize

342 x 560 mm

Offset

CCL Chicago

SP0173

None

Adobe InDesign

Myriad Pro Family > 9 pt

Notes: Folded size - 35 mm x 140 mm

JS1

MM1

February 11, 2026

Raleigh

CoE PACKAGING - VILLEPINTE

JOB INFORMATION

OPERATOR

PACKAGING INFORMATION