Patient leaflet - Prohance injection
1. What ProHance is and what it is used for
ProHance is a special dye (or contrast agent) which contains the rare earth metal gadolinium.
ProHance is used for magnetic resonance examinations to provide a better visualization of the brain, spine and surrounding tissues in case of lesions involving the blood brain barrier.
ProHance can also be used for whole body Magnetic Resonance Imaging (MRI) including the head, neck, liver, breast, skeleton, muscles and surrounding tissues. This medicine is for diagnostic use only.
2. What you need to know before you are given ProHance
ProHance should only be given to you in a hospital or clinic where there are equipment and medically trained staff able to deal with allergic reactions.
Do not use ProHance if you:
- Are allergic to gadoteridol or any of the other ingredients of this medicine (listed in section 6) or other contrast media that contain gadolinium
Warnings and precautions
- Talk to your doctor or pharmacist before being given ProHance if your kidneys do not work properly
- you have recently had, or soon expect to have, a liver transplant
- you have a history of epilepsy or brain lesions
Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use ProHance especially if you are 65 years of age or older.
Neonates and infants
As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, ProHance will only be used in these patients after careful consideration by the doctor.
Other medicines and ProHance
There are no reports of reactions between ProHance and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gadoteridol can cross the placenta. It is not known whether it affects the baby. You must tell your doctor if you think you are or might become pregnant as ProHance should not be used during pregnancy unless strictly necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive ProHance.
Driving and using machines
There is no information about the effects of ProHance on driving, or using tools or machines. Ask your doctor if you can drive and if it is safe for you to use any tools or machines.
ProHance contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially "sodium free".
3. How you are given ProHance
Dosage
ProHance is injected into a vein, usually in your arm just before the MRI scan. The amount in millilitres you will be injected with depends upon how much you weigh.
The recommended dose for adults for MRI of the brain and spine is 0.2 - 0.6 ml/kg; for children the usual dose is 0.2 ml/kg.
The recommended dose for adults for MRI of the whole body is 0.2 ml/kg.
Dosage in special patient groups
The use of ProHance is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant. However if use is required you should only receive one dose of ProHance during a scan and you should not receive a second injection for at least 7 days.
As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, ProHance will only be used in these patients after careful consideration by the doctor. Neonates and infants should only receive one dose of ProHance during a scan and should not receive a second injection for at least 7 days.
Use for whole body MRI is not recommended in children less than 18 years of age.
Elderly
It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
If you are given more ProHance than you should
As ProHance is given by a doctor or nurse you are unlikely to be given too much. However, if you think you have been given too much tell your doctor or nurse
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ProHance
(Gadoteridol)
The following information is intended for medical or healthcare professionals only:
Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it is necessary to use ProHance the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7days.
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, ProHance should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg (0.2 ml/kg) body weight. More than one dose should not be used during a scan.
PROHANCE FLACONI (UK) - COLLERETTO
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CLF1004 immediately. The hospital area or clinic where ProHance is given to you is well equipped to treat any effects of overdose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects that have been reported with ProHance have been mild and were not prolonged, and spontaneously resolved without residual effects.
If you experience any of the following side effects tell your doctor or nurse immediately. These are signs of an allergic reaction, which is serious and may require medical treatment:
- wheezing or difficulty breathing
- rash
- itching
- swelling of the face, lips, tongue or throat
The following side effects have been reported
Common: (more than 1 out of 100 persons and less than 1 out of 10 persons)
- Feeling sick (nausea)
Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons)
- Less severe allergic reactions( hypersensitivity)
- Headache
- Numbness
- Dizziness
- Strange taste in the mouth
- Increased tears
- Flushing
- Low blood pressure
- Dry mouth
- Vomiting
- Itching; skin rash, urge to itch
- Pain where the injection was given
- Injection site reaction (local pain, erythema or swelling; in some cases they are due to leakage of the medicine)
- Fatigue
- Increased heart beat
Rare: (more than 1 out 10,000 persons and less than1 out of 1,000 persons)
- Severe allergic reactions (anaphylactic reactions)
- Anxiety
- Confusion
- Abnormal coordination of movement
- Fits
- Ringing in the ears ( tinnitus)
- Changes in heart rhythm
- Throat spasm
- Shortness of breath
- Temporary absence of breath
- Runny nose
- Cough
- wheezing
- Abdominal pain
- Tongue swelling
- Itching in the mouth
- Inflammation of the gums
- Diarrhoea
- Face swelling
- Stiff muscles
- Chest pain
- Fever
Not known: (frequency cannot be estimated from the available data).
- Loss of consciousness
- Coma
- Faintness
- Cardiac arrest
- Respiratory arrest
- Fluid in the lungs
- Kidney failure
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) most of which were in patients who received ProHance together with other gadolinium-containing contrast agents.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ProHance
You will not be required to store the medicine yourself. Your doctor or hospital pharmacist will know how to store ProHance.
Keep this medicine out of the sight and reach of children.
ProHance should be stored at room temperature (15-30°C) and protected from light. It should not be frozen.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. The hospital pharmacist will dispose of any unused product or waste material. These measures will help to protect the environment.
6. Contents of the pack and other information
What ProHance contains
The active substance is gadoteridol
The other ingredients are:
- Calteridol Calcium
- Tromethamine
- Hydrochloric Acid
- Sodium Hydroxide
- Water
What ProHance looks like and contents of the pack
ProHance is an aqueous sterile solution (clear, colourless to slightly yellow colour) for intravenous injection.
ProHance is supplied in glass vials containing 5, 10, 15, or 20 ml of solution. Not all packs sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Bracco UK Ltd, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, United Kingdom
Manufacturers
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany Bracco Imaging S.p.A., Bioindustry Park, Via Ribes 5, 10010 Colleretto Giacosa (TO), Italy
This leaflet was last revised in May 2024
Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.
As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.
Continuing or discontinuing breastfeeding for a period of 24 hours after administration, of ProHance should be at the discretion of the doctor and lactating mother.
The peel-off tracking label on the vial should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record. (continuation of information intended for medical and healthcare professionals only)
PROHANCE FLACONI (UK) - COLLERETTO
Impianto di proprietà della:
Prodotto:
SPECIFICA
RIFERIMENTO:
Materiale:
Istruzione
Codice Bracco: Codice Bracco superato: Vers. e N. Id:
Vers. e N. Id superato:
Modifica rispetto la versione precedente:
Quality Assurance
Data Obsolescenza Archiviare almeno fino a:
Data Emissione Status
CLF1004 CLF1003 00000000 00000000
SAFETY UPDATE FOLLOWING PSUSA
Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy
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