PROHANCE 279.3 mg/ml INJECTABLE SOLUTION

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.

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/

--------------------------------------------------------------------------------------------------------------------

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).