Product Information for the User

ProHance 279.3 mg/ml Injectable Solution

Gadoteridol

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

1. What isProHanceand how it is used

2. What you need to know before starting to useProHance

3. How to useProHance

4. Possible adverse effects

5. Storage ofProHance

6. Contents of the package and additional information

This medication is solely for diagnostic use.

ProHance belongs to a group of medications known asParamagnetic Contrast Agents.

• ProHanceis used as a contrast agent in Magnetic Resonance Imaging to improve visualization (compared to Magnetic Resonance Imaging without contrast) of the brain, spinal cord, and surrounding tissues when there are lesions with abnormal vascularization or that determine a change in the blood-brain barrier.
• ProHancemay also be used in Magnetic Resonance Imaging throughout the body, including pathologies in the head, neck, liver, chest, musculoskeletal system, and soft tissues.

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

Do not use ProHance

• if you are allergic (hypersensitive) to gadoteridol or to any of the other components of this medication (listed in section 6).of this medication (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 function correctly.
• if 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 to use ProHance, especially if you are 65 years old or older.

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

Newborns and infants

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

Use of ProHance with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions with other medications have been reported for gadoteridol. During clinical trials conducted with ProHance, no clinically significant changes or abnormalities were observed in laboratory tests.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy:

Gadoteridol crosses the placenta. It is unknown whether it can affect the fetus. 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:

Inform 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 operating machinery

No information is available on the effects of ProHance on driving or using tools or machinery. Ask your doctor if you can drive and if it is safe to use any tools or machinery.

ProHance contains sodium hydroxide

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

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

ProHance should not be mixed with any other medication.

ProHance will be administered intravenously.

The recommended dose of ProHance in adultsfor complete exploration of most brain and spinal cord 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 poorly enhanced brain lesions.

The recommended dose for Whole Body Magnetic Resonance is 0.1 mmol/Kg.

If, in the opinion of the radiologist, it is considered convenient to administer an additional injection of ProHance to expand and improve the study, a supplementary dose of approximately 0.1 mmol/Kg can be administered about 30 minutes after the first injection. If repeat explorations are indicated, at least a period of 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 will soon undergo a liver transplant. However, if use is required, only a single dose of ProHance should be administered during an examination, and a second injection should not be administered until at least 7 days have elapsed.

Use in children from neonates to term

The recommended dose of ProHancefor brain and spinal cord 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.

The use is not recommended in children under 18 years for Whole Body Magnetic Resonance.

Newborns and infants

As in newborns up to 4 weeks and in infants up to 1 year of age, renal function is immature, ProHance should only be administered in these patients after careful evaluation by a doctor andat a dose not exceeding0.1 mmol/Kg of body weight. During an examination, only a single dose of ProHance should be administered to newborns and infants, and a second injection should not be administered until at least 7 days have elapsed.

Geriatric patients

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

If you use more ProHance than you should

No cases of overdose have been described to date; therefore, the signs and symptoms of ProHance intoxication are unknown. In clinical studies, where doses of up to 0.3 mmol/Kg have been administered, no clinical alterations have been observed due to the increased dose. Incase of overdose, the patient should be subjected to clinical observation and symptomatic treatment.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20, indicating the medication and the amount administered.

Like all medications, ProHance may cause side effects, although not everyone will experience them.

When using ProHance in the Magnetic Resonance Unit, the same usual safety standards and procedures will be taken into account.

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

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

• Unpleasant feeling (nausea)

Rarely (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
• Tendency to itch, 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 constriction, 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 in the ears
• Changes in heart rhythm
• Throat spasms, difficulty breathing, nasal secretion, cough, temporary absence of breathing, respiratory sounds
• Abdominal pain, tongue swelling, mouth itching, gum inflammation, diarrhea
• Face swelling
• Rigid muscles
• Chest pain, fever

Unknown frequency (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, dizziness, and excessive salivation)

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

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 they are side effects that do not appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Store the product at room temperature (between15°Cand30°C).

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

Do not freeze.Freezed vials must be discarded.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition ofProHance

• The active principle is gadoteridol.

Each vial contains:

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

• The other components are calcium chelate of calteridol, trometamine, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

ProHanceis an injectable solution with 279.3 mg/ml (500 milimolar) of gadoteridol.

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

The vial is a type I glass vial with:

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BRACCO INTERNATIONAL BV

3051 Strawinskylaan

1077 ZX Amsterdam

Netherlands

Responsible for manufacturing:

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 medication by contacting the local representative of the holder of the marketing authorization:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Last review date of this leaflet: June 2024

Other sources of information

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

The complete technical file of ProHance is supplied 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 medication.

Please, consult the technical file (the technical file must be included in the box).