Prohance 279.3 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ProHance 279.3 mg/ml solution for injection

Gadoteridol

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ProHance is and what it is 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 agent in Magnetic Resonance Imaging (MRI) to improve the visualization (as compared to non-contrast MRI) of the brain, spinal cord, and surrounding tissues in the presence of lesions with abnormal vascularity or that disrupt the blood-brain barrier.
• ProHance may also be used in whole-body MRI, including pathologies of the head, neck, liver, chest, musculoskeletal system, and soft tissues.

2. What you need to know before using ProHance

ProHance should only be administered in hospitals or clinics where equipment and trained medical personnel are available to manage allergic reactions.

Do not use ProHance

• if you are allergic (hypersensitive) to gadoteridol or to any of the other components of this medicine (listed in section 6).
• if you are allergic to another contrast agent containing gadolinium.

Warnings and precautions

Talk to your doctor before using ProHance if:

• you have a history of allergies
• you have a history of epilepsy or brain injury
• your kidneys are not functioning properly
• you have recently had, or are about to have, a liver transplant

Your doctor may decide to perform a blood test to check your kidney function before deciding to use ProHance, especially if you are 65 years of age or older.

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 of age and infants up to 1 year of age, ProHance will only be used in these patients after careful medical evaluation.

Use of ProHance with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

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

Breastfeeding:

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

Driving and use of machines

There is no information on the effects of ProHance on the ability to drive or use tools or machines. Ask your doctor whether you can drive and whether it is safe to use any tools or machines.

ProHance contains sodium hydroxide

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use ProHance

Follow exactly the administration instructions for ProHance provided by your doctor. If in doubt, consult your doctor or pharmacist again.

ProHance is a contrast agent used during a diagnostic procedure, which must be performed in the presence of qualified personnel or preferably under the supervision of a physician who will guide you through the necessary steps at all times.

ProHance must not be mixed with any other medicinal product.

ProHance is administered intravenously.

The recommended dose of ProHance in adults for complete evaluation of most brain and spinal cord pathologies is 0.1 mmol/kg (0.2 ml/kg). However, doses of 0.3 mmol/kg have proven effective in patients suspected of having cerebral metastases or other poorly enhancing brain lesions.

The recommended dose for whole-body Magnetic Resonance Imaging (MRI) is 0.1 mmol/kg.

If, at the radiologist's discretion, an additional injection of ProHance is considered beneficial to extend and improve the examination, a supplementary dose of 0.1 mmol/kg may be administered approximately 30 minutes after the first injection. If repeat imaging is indicated, at least a 6-hour interval must elapse to allow for elimination of ProHance.

Use in special populations

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

Use in children from neonates to term

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 higher than 0.1 mmol/kg, as well as sequential or repeated administrations, have not been established.

Whole-body MRI with ProHance is not recommended in children under 18 years of age.

Neonates and infants

Since renal function is immature in newborns up to 4 weeks of age and in infants up to 1 year of age, ProHance should only be administered to these patients after careful medical evaluation and at a dose not exceeding 0.1 mmol/kg body weight. Only a single dose of ProHance should be administered during an examination in neonates and infants, and a second injection must not be given until at least 7 days have passed.

Elderly patients

If you are 65 years of age or older, dose adjustment is not required, but a blood test may be performed to check proper kidney function.

If you use more ProHance than you should

Cases of overdose have not been reported to date; therefore, signs or symptoms of ProHance intoxication are unknown. In clinical studies where doses up to 0.3 mmol/kg were administered, no clinically relevant adverse effects related to dose increases were observed. In the event of overdose, the patient should be placed under clinical observation and receive symptomatic treatment.

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

4. Possible adverse effects

Like all medicines, ProHance can cause adverse effects, although not everyone experiences them.

When ProHance is used in the Magnetic Resonance Imaging unit, standard safety rules and procedures will be followed.

If you notice any of the following adverse effects, inform your doctor immediately, as you may require 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, altered sensation, dizziness, taste disturbance
• Increased lacrimation
• Flushing, low blood pressure
• Dry mouth, vomiting
• Tendency to itch, skin rash, pruritus
• Pain at injection site
• Reaction at injection site (develops 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 warmth, difficulty swallowing, burning sensation, throat swelling, and low blood pressure)
• Anxiety
• Confusion, abnormal movement coordination, seizures
• Tinnitus
• Changes in heart rhythm
• Throat spasms, breathing difficulty, nasal discharge, cough, temporary cessation of breathing, respiratory sounds
• Abdominal pain, tongue swelling, mouth itching, gum inflammation, diarrhea
• Facial swelling
• Muscle stiffness
• Chest pain, fever

Frequency not known (cannot be estimated from available data)

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

Cases of nephrogenic systemic fibrosis (which causes skin thickening and may also affect soft tissues and internal organs) have been reported, most of which occurred in patients who were administered ProHance together with other gadolinium-based contrast agents.

Paediatric population

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ProHance

Keep this medicine 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 must be discarded.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

6. Contents of the package and other information

Composition of ProHance

• The active substance is gadoteridol.

Each vial contains:

Gadoteridol INN………………………………...........……279.3 mg/ml (500 millimolar)

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

Appearance of the product and contents of the container

ProHance is an injectable solution containing 279.3 mg/ml (500 millimolar) of gadoteridol.

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

The vial is made of type I glass with:

• grey butyl rubber stopper and aluminium cap.
• grey bromobutyl or chlorobutyl rubber stopper and aluminium cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BRACCO INTERNATIONAL BV

Argonstraat 3

6422 PH Heerlen

The 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Date of the most recent review of this leaflet: June 2024

Other sources of information

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

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for ProHance is provided as a separate document within the product packaging, to provide healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please consult the Summary of Product Characteristics (the Summary of Product Characteristics must be included in the package).