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PROHANCE 279.3 mg/ml INJECTABLE SOLUTION

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About the medicine

How to use PROHANCE 279.3 mg/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 User

ProHance 279.3 mg/ml Solution for Injection

Gadoteridol

Read all of this leaflet carefully before you start using 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 or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is ProHance and what is it used for

This medicinal product is for diagnostic use only.

ProHance belongs to a group of medicines called paramagnetic contrast media.

  • ProHance is used as a contrast medium in Magnetic Resonance Imaging (MRI) to improve visualization (compared to MRI without contrast) of the brain, spinal cord, and surrounding tissues when there are lesions with abnormal vascularization or that determine an alteration of the blood-brain barrier.
  • ProHance may also be used in MRI of the whole body, including pathologies in the head, neck, liver, chest, musculoskeletal system, and soft tissues.
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2. What you need to know before you use ProHance

ProHance should only be administered in hospitals or clinics where there are facilities and medical personnel trained to treat allergic reactions.

Do not use ProHance

  • if you are allergic (hypersensitive) to gadoteridol or any of the other ingredients of this medicinal product (listed in section 6).
  • if you are allergic to another contrast medium containing gadolinium.

Warnings and precautions

Consult your doctor before starting to use ProHance if:

  • you have a history of allergy
  • you have a history of epilepsy or brain injuries
  • your kidneys do not work properly
  • you have recently undergone, or are about to undergo, a liver transplant

Your doctor may decide to perform a blood test to check the proper functioning of your kidneys before deciding on the use of ProHance, especially if you are 65 years old or older.

The administration of ProHance has been associated in some cases with transient, clinically irrelevant changes in serum iron concentration (within the normal range in most cases).

Neonates and Infants

Since renal function is immature in newborns up to 4 weeks and infants up to 1 year of age, ProHance should only be used in these patients after careful evaluation by the doctor.

Using ProHance with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No medicinal interactions with gadoteridol are known. During clinical trials with ProHance, no clinically significant changes or laboratory abnormalities were observed.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

Gadoteridol crosses the placenta. It is not known whether it can affect the fetus. You should inform your doctor if you are pregnant or think you may be pregnant, as ProHance should not be used during pregnancy unless strictly necessary.

Breastfeeding:

Tell your doctor if you are breastfeeding or about to start. Your doctor will assess whether you should continue breastfeeding or interrupt it 24 hours after administration of ProHance.

Driving and using machines

There is no information on the effects of ProHance on driving or using tools or machines. Ask your doctor if you can drive and if it is safe to use any tool or machine.

ProHance contains sodium hydroxide

This medicinal product contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use ProHance

Follow exactly the administration instructions of ProHance indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

ProHance is a contrast agent used for a diagnostic test, which must be performed in the presence of qualified personnel or preferably under the supervision of a doctor who will indicate the instructions to follow at all times.

ProHance should not be mixed with any other medicinal product.

ProHance will be administered intravenously.

The recommended dose of ProHance in adults for a complete examination of most brain and spinal pathologies is 0.1 mmol/Kg (0.2 ml/Kg). However, doses of 0.3 mmol/Kg have been shown to be effective in patients suspected of having cerebral metastases or other poorly enhanced cerebral lesions.

The recommended dose for MRI of the whole body is 0.1 mmol/Kg.

If the radiologist considers it convenient to administer an additional injection of ProHance to expand and improve the study, a complementary dose of 0.1 mmol/Kg can be administered approximately 30 minutes after the first injection. If repeat examinations are to be performed, at least 6 hours should elapse for ProHance to be eliminated.

Use in special populations

The use of ProHance is not recommended in patients with severe kidney problems or in patients who have recently undergone, or are about to undergo, a liver transplant. However, if use is required, during an examination, only one dose of ProHance should be administered, and a second injection should not be administered until at least 7 days have passed.

Use in children from term neonates

The recommended dose of ProHance for cerebral and spinal pathologies is 0.1 mmol/Kg (0.2 ml/Kg).

The safety and efficacy of doses greater than 0.1 mmol/Kg and sequential or repeated administrations have not been established.

In children under 18 years of age, use for MRI of the whole body is not recommended.

Neonates and Infants

Since renal function is immature in newborns up to 4 weeks and infants up to 1 year of age, ProHance should only be administered to these patients after careful evaluation by the doctor and at a dose not exceeding 0.1 mmol/Kg body weight. During an examination, only one dose of ProHance should be administered to neonates and infants, and a second injection should not be administered until at least 7 days have passed.

Elderly patients

If you are 65 years old or older, it is not necessary to adjust the dose, but a blood test may be performed to check the proper functioning of your kidneys.

If you use more ProHance than you should

No cases of overdose have been reported to date; therefore, the signs and symptoms of ProHance intoxication are not known. In clinical trials, where doses of up to 0.3 mmol/Kg have been administered, no clinically significant alterations have been observed. In case of overdose, the patient should be subject to clinical observation and symptomatic treatment.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone (91) 562 04 20, indicating the medicinal product and the quantity administered.

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4. Possible side effects

Like all medicines, ProHance can cause side effects, although not everybody gets them.

When using ProHance in the MRI unit, the same safety rules and procedures as usual will be taken into account.

If you notice any of the following side effects, tell your doctor immediately, as you may need urgent medical treatment.

Frequent (more than 1 in 100 people and less than 1 in 10 people)

  • Feeling unwell (nausea)

Uncommon (more than 1 in 1,000 people and less than 1 in 100 people)

  • Headache, change in sensations, dizziness, alteration of taste
  • Increased tearing
  • Flush, low blood pressure
  • Dry mouth, vomiting
  • Itching, skin rash, itching
  • Pain at the injection site
  • Reaction at the injection site (appears over time due to extravasation of the contrast medium)
  • Increased heart rate
  • Fatigue

Rare (more than 1 in 10,000 people and less than 1 in 1,000 people)

  • Hypersensitivity reactions (frequently reported symptoms include throat tightness, throat irritation, difficulty breathing, chest discomfort, feeling of heat, difficulty swallowing, burning sensation, throat swelling, and low blood pressure).
  • Anxiety
  • Confusion, abnormal movement coordination, convulsions
  • Tinnitus
  • Changes in heart rhythm
  • Laryngospasm, difficulty breathing, nasal secretion, cough, temporary absence of breathing, breathing sounds
  • Abdominal pain, tongue swelling, itching in the mouth, gum inflammation, diarrhea
  • Facial swelling
  • Stiff muscles
  • Chest pain, fever

Frequency not known (cannot be estimated from the available data)

  • Loss of consciousness
  • Coma
  • Cardiac arrest
  • Respiratory arrest, fluid in the lungs
  • Kidney failure
  • Vasovagal reaction (symptoms that are frequently experienced include nausea, dizziness, and excessive sweating. In severe cases, symptoms can include pallor, excessive sweating, slow heart rate, and possible loss of consciousness. Additional symptoms may be fear or anxiety, restlessness, fainting, and excessive salivation)

Cases of nephrogenic systemic fibrosis (which causes skin hardening and can also affect soft tissues and internal organs) have been reported, most of which were in patients who received ProHance in combination with other gadolinium-based contrast agents.

Pediatric population

The safety profile of ProHance is similar in children and adults.

If you experience side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of ProHance

Keep this medicinal product out of the sight and reach of children.

Store the product at room temperature (between 15°C and 30°C).

Keep the vial in the outer packaging to protect it from light.

Do not freeze. Frozen vials should be discarded.

Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and other information

Composition of ProHance

  • The active substance is gadoteridol.

Each vial contains:

Gadoteridol D.C.I. ………………………………………... 279.3 mg/ml (500 millimolar)

  • The other ingredients are calteridol calcium, trometamine, hydrochloric acid, sodium hydroxide, and water for injections.

Appearance of the product and pack contents

ProHance is a solution for injection containing 279.3 mg/ml (500 millimolar) of gadoteridol.

Each pack contains a vial of 5, 10, 15, 20, 50, or 100 ml.

The vial is a type I glass vial with:

  • gray butyl rubber stopper and aluminum cap.
  • gray bromobutyl or chlorobutyl rubber stopper and aluminum cap.

Marketing authorization holder and manufacturer

Marketing authorization holder:

BRACCO INTERNATIONAL BV

3051 Strawinskylaan

1077 ZX Amsterdam

Netherlands

Manufacturer:

BIPSO GmbH

Robert-Gerwig-Str. 4

78224 Singen

Germany

BRACCO IMAGING S.p.A.

Bioindustry Park

Via Ribes, 5

10010 Colleretto Giacosa (TO)

Italy

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Date of the last revision of this leaflet: June 2024

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The complete technical data sheet of ProHance is provided as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please consult the technical data sheet (the technical data sheet should be included in the box).

Online doctors for PROHANCE 279.3 mg/ml INJECTABLE SOLUTION

Discuss questions about PROHANCE 279.3 mg/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

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: 

  • seasonal and perennial allergies
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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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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
  • cough, sore throat, nasal congestion, breathing discomfort
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
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  • management of chronic conditions in stable phases
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.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
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  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
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  • review and interpretation of lab tests, imaging reports, and medical documents;
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  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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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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  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
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  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
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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).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

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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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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  • Interpretation of lab tests and medical reports, therapy adjustment.
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  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Frequently Asked Questions

Is a prescription required for PROHANCE 279.3 mg/ml INJECTABLE SOLUTION?
PROHANCE 279.3 mg/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 PROHANCE 279.3 mg/ml INJECTABLE SOLUTION?
The active ingredient in PROHANCE 279.3 mg/ml INJECTABLE SOLUTION is gadoteridol. This information helps identify medicines with the same composition but different brand names.
Who manufactures PROHANCE 279.3 mg/ml INJECTABLE SOLUTION?
PROHANCE 279.3 mg/ml INJECTABLE SOLUTION is manufactured by Bracco International B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PROHANCE 279.3 mg/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 PROHANCE 279.3 mg/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 PROHANCE 279.3 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (gadoteridol) include PROHANCE 279.3 mg/ml INJECTABLE SOLUTION IN PRE-FILLED SYRINGE, CLARISCAN 0.5 mmol/mL Injectable Solution, CLARISCAN 0.5 mmol/mL Injectable Solution in Pre-filled Syringe. 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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