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VUEWAY 0.5 mmol/mL Injectable Solution

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About the medicine

How to use VUEWAY 0.5 mmol/mL Injectable Solution

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Vueway 0.5 mmol/ml Solution for Injection

gadopiclenol

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Doctor consultation

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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 or radiologist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

Vueway is a contrast medium 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 differentiate between healthy and diseased tissue.

It is used in adults and children (from 2 years of age).

It is administered by injection into a vein. This medicine is for diagnostic use only and will only be administered by healthcare professionals with experience in the clinical practice of magnetic resonance imaging.

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

Vueway must not be given

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, radiologist or pharmacist before you are given Vueway:

  • 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, hives),
  • if your kidneys do not work properly,
  • if you have had seizures or are being treated for epilepsy,
  • if you have any heart or blood vessel disease,

In all these cases, your doctor will decide whether the planned examination is possible or not. If you are given Vueway, 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 your kidney function before deciding to use Vueway, especially if you are 65 years of age or older.

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, tell your doctor, radiologist or pharmacist if you are receiving or have recently received medicines to treat heart or blood pressure conditions such as beta-blockers, vasoactive substances, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists.

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding

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

Your doctor will assess whether you should continue breast-feeding or interrupt it for up to 24 hours after receiving Vueway.

Driving and using machines

Vueway has a negligible influence on the ability to drive and use machines. However, if you feel unwell after the examination, you should not drive or use machines.

Vueway contains sodium

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

3. How Vueway will be given to you

A healthcare professional will inject Vueway into your vein with a small needle. Vueway can be injected manually or with an automatic injector.

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

The usual dose of 0.1 ml/kg body weight is the same in adults and children from 2 years of age.

In children, your doctor or radiologist will use Vueway in vials with a single-use syringe to have greater precision of the injected volume.

After the injection, you will remain under supervision for at least 30 minutes. This is the time when most unwanted 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 Vueway is not recommended 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, it is not necessary to adjust the dose, but you may have a blood test to check your kidney function.

If you receive more Vueway than you should

It is very unlikely that you will receive an overdose of Vueway, as it will be administered by a qualified healthcare professional. If this happens, Vueway can be removed from the body by haemodialysis (blood cleaning).

If you have any other questions about 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 Vueway, you will remain under observation. Most side effects occur within minutes. There is a small risk of having an allergic reaction to Vueway. 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).

Tell 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 runny nose

The following side effects have been observed during clinical trials with Vueway and are listed according to their frequency:

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 heat

Vomiting (feeling sick)

*The injection site reaction can be pain, swelling, feeling of cold or heat, bruising and redness.

**Allergic reactions can 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 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, but no cases of NSF have been reported with Vueway during clinical trials.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vueway

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 or on the carton after "EXP" or "CAD". The expiry date refers to the last day of that month.

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

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 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. See section 2 "Vueway contains sodium".

Appearance and pack of Vueway

It is a clear, colourless to pale yellow solution for injection.

It is available in packs that include:

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

78224

Germany

Date of last revision of this leaflet December 2024

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 for healthcare professionals only:

For more details on how to use the medicine, see section 6.6 Special precautions for disposal and other handling of the Summary of Product Characteristics of this medicine.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

  • Preventive consultations and check-up planning.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
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  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Frequently Asked Questions

Is a prescription required for VUEWAY 0.5 mmol/mL Injectable Solution?
VUEWAY 0.5 mmol/mL Injectable Solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in VUEWAY 0.5 mmol/mL Injectable Solution?
The active ingredient in VUEWAY 0.5 mmol/mL Injectable Solution is gadopiclenol. This information helps identify medicines with the same composition but different brand names.
Who manufactures VUEWAY 0.5 mmol/mL Injectable Solution?
VUEWAY 0.5 mmol/mL Injectable Solution is manufactured by Bracco Imaging S.P.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of VUEWAY 0.5 mmol/mL Injectable Solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether VUEWAY 0.5 mmol/mL Injectable Solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to VUEWAY 0.5 mmol/mL Injectable Solution?
Other medicines with the same active substance (gadopiclenol) include ELUCIREM 0.5 mmol/mL Injectable Solution, ELUCIREM 0.5 mmol/mL Injectable Solution, CLARISCAN 0.5 mmol/mL Injectable Solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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