Patient Information Leaflet

Vueway 0.5 mmol/ml injectable solution

Gadopiclenol

This medicine is subject to additional monitoring, which will speed up 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 are given this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 Vueway is and what it is used for
2. What you need to know before you are given Vueway
3. How you will be given Vueway
4. Possible side effects
5. Storage of Vueway
6. Contents of the pack and additional information

Vueway is a contrast agent that improves the contrast of images obtained during magnetic resonance (MR) examinations. Vueway contains the active principle 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 administered as a venous injection. This medication is only for diagnostic use and will only be administered by experienced healthcare professionals in clinical practice of magnetic resonance.

Vueway 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 Vueway 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 whether the planned examination is possible or not. If Vueway 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 Vueway, especially if you are 65 years old or older.

Other medications and Vueway

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

Gadopiclenol may cross the placenta. It is not known if it affects the baby.Consult your doctor or radiologist if you are pregnant or if you think you may be pregnant, as Vueway should not be used during pregnancy unless it is 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 Vueway.

Driving and operating machines

Vueway 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.

Vueway contains sodium

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

A qualified healthcare professional will inject Vueway into a vein using a small needle. Vueway 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 Vueway in vials with a single-use syringe to achieve greater precision in the volume injected.

After the injection, you will be 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

Vueway 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 administered until at least 7 days have passed.

Use in Elderly Patients

If you are 65 years of age or older, no dose adjustment is necessary, but a blood test may be performed to check the proper functioning of your kidneys.

If You Receive More Vueway Than You Should

It is highly unlikely that you will receive an overdose of Vueway, as it will be administered by a qualified healthcare professional. If an overdose occurs, Vueway 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 may cause side effects, although not everyone will experience them.

After administration of Vueway, you will remain under observation. Most side effects occur within minutes. There is a small risk of experiencing an allergic reaction to Vueway. These effects may occur immediately or up to seven days after injection. These reactions can be severe and cause shock (an allergic reaction that can put your life in danger).

Immediately inform your doctor, radiologist, or healthcare professional 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 Vueway are listed below, grouped by their probability:

*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).

Cases of systemic nephrogenic fibrosis (FNS) (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 FNS have been reported with Vueway during clinical trials.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on 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 if it 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 Vueway

Appearance of Vueway and contents of the package

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

It is available in packages that include:

Only some package sizes may be commercially available.

Marketing Authorization Holder

Bracco Imaging SPA

Via Egidio Folli, 50

20134 Milano

Italy

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 December 2024

Other sources of information

The 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 SmPC for this medicine.