Document: leaflet MAH BRAND_PL 14447-0002 change

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SS

BRACCO

Read all of this leaflet carefully before you are being given this medicine.

-    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.

In this leaflet:

1.    What ProHance is and what it is used for

2.    What you need to know before you are given ProHance

3.    How to use ProHance

4.    Possible side effects

5.    How to store ProHance

6.    Content of the pack and other information

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 ProHance should not be given to children under 6 months of age.

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.

Infants

As kidney function is immature in infants up to 1 year of age, ProHance will only be used in patients 6 to 12 months of age 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

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.

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 (2 years and above) 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 infants up to 1 year of age, ProHance will only be used in these patients after careful consideration by the doctor. Infants 6 to 12 months of age should only receive one dose of ProHance during a scan and should not receive a second injection for at least 7 days.

Use of ProHance is not recommended in children less than 6 months of age.

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 immediately. The hospital area or clinic where ProHance is given to you is well equipped to treat any effects of overdose.

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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 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 body weight. More than one dose should not be used during a scan.    (pi_ease t_{urn over})

CROM nFOTO s.n.c. GRAFICA - FOTOCOMPOSIZIONE Via G. Tartini, 2 - 20158 - MILANO Tel. 02.375787 • e-mail: crominfoto@tiscali.it	05 NOV 2014 FCI00QP04-PIL-PRO-SIRINGHE Versione Bracco: 02 Versione interna: 02			I colori su questa prova sono approssimativi, questa e una stampa a 600 dpi ottenuta con colori a base acqua CMYK. Definizione e colori non riflettono il risultato finale della produzione stampata.
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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 pre-filled syringes containing 10 ml, 15 ml, or 17 ml of solution.

Not all packs sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Bracco International B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, The Netherlands Manufacturers

BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany and

Bracco Imaging s.p.a., Bioindustry Park, Via Ribes 5, 10010 Colleretto Giacosa (TO), Italy This leaflet was last revised in

November 2014

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(continuation of information intended for medical and healthcare professionals only)

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 syringe 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.    CI00QP04 - GB F1/0000000

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