Vueway

Patient Information Leaflet

Vueway 0.5 mmol/mL injectable solution

gadopiclenol
This medicinal product is subject to additional monitoring. This will allow for 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 because it contains important information for you.

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

Contents of this leaflet

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

1. What Vueway is and what it is used for

Vueway is a contrast agent that enhances the contrast of images obtained during magnetic resonance imaging (MRI) examinations.
Vueway 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 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 must be administered only by healthcare professionals experienced in the clinical practice of magnetic resonance imaging.

2. What you need to know before being given Vueway

Vueway 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 Vueway:

• if you have previously had a reaction to any contrast agent,
• if you have 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 have a disease affecting the heart or blood vessels.

In all these cases, the doctor will decide whether the planned examination can be carried out or not. If
Vueway is administered, the doctor or radiologist will take the necessary precautions and the administration
of Vueway will be closely monitored.
The doctor or radiologist may decide to perform a blood test to check kidney function before deciding to use
Vueway, especially if the patient is 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, Vueway
will be used in these patients only after careful evaluation by the doctor.
Other medicines and Vueway
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), or 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 may become pregnant, as
Vueway must not be used during pregnancy unless strictly necessary.
Breastfeeding
Inform your doctor or radiologist if you are breastfeeding or are about to start breastfeeding.
Your doctor will advise whether you should continue or temporarily interrupt breastfeeding for a period of
24 hours after administration of Vueway.
Driving and using machines
Vueway does not affect or has a negligible effect on the ability to drive and use machines.
However, if you feel unwell after the examination, do not drive or operate machinery.
Vueway 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 Vueway will be administered to you

Vueway will be injected into a vein by a qualified healthcare professional using a small needle.
It can be administered manually or by means of an automatic injector.
The doctor or radiologist will determine the dose to be administered and will monitor the injection.
The usual dose of 0.1 mL/kg body weight is the same for adults and children.
In children, the doctor or radiologist will use Vueway vials with a single-use syringe to ensure greater accuracy in the injected volume.
After the injection, you will remain under observation 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 Vueway is not recommended in patients with severe kidney problems. However, if its use is necessary, the patient should receive only one dose of Vueway during the examination and should not be given a second injection within at least 7 days.

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

Use in elderly patients
Dose adjustment is not required for patients aged 65 years or older, but they may undergo a blood test to assess kidney function.

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. In the event this occurs, Vueway 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 administration of Vueway, you will be monitored. Most side effects occur within minutes. There is a low risk of an allergic reaction to Vueway. These reactions may occur immediately or up to seven days after injection. Such reactions can be severe and may lead to shock (a type of allergic reaction that can 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 Vueway are listed below, grouped according to their frequency:

*"Injection site reaction" includes: pain, swelling, cold sensation, warm sensation,
bruising, or redness.
**"Allergic reaction" may include: skin inflammation, skin redness, difficulty
breathing, voice changes, throat tightness, throat irritation, abnormal mouth sensations, transient facial flushing (early reactions), and eye swelling, generalised 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 Vueway.
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 more information on the safety of this medicine.

5. How to store Vueway

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or prefilled syringe label and on the outer carton 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 Vueway 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 “Vueway contains sodium”.

Description of the appearance of Vueway and package contents
It is a clear, colourless to pale yellow solution.
It is available in pack sizes 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 60 mL empty 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 115 mL empty plastic syringe).

Not all pack sizes may be marketed.
Marketing Authorisation 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)
Germany
Bracco Imaging S.p.A.
Bioindustry Park, Via Ribes 5
10010 Colleretto Giacosa (TO)
Italy
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:

For details on the instructions for 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 RELATING TO THE APPLICATION FOR COMMERCIAL PROTECTION
WITH ANNUAL VALIDITY SUBMITTED BY THE
EUROPEAN MEDICINES AGENCY
Conclusions submitted by the European Medicines Agency on:

• one-year commercial protection
  Taking into account the provisions set out in Article 14(11) of Regulation 726/2004/EC, the Committee for Human Medicinal Products (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).