PROHANCE INJECTION

Active substance: GADOTERIDOL

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Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Prodotto:

PROHANCE FLACONI (UK)

Dimensioni:
Color i n°:

Traduzione braille:

Materiale:

SPECIFICA
RIFERIMENTO:

Codice Bracco:

Istruzione

148 X 600 mm

Fustella

Black

Pantone Green 347

1

Codice Bracco superato:

CL63E01

2154ZD

Pantone Rosso 185

Eurolaser

Pantone Rosso 185

Vers. e N. Id:

000000

Vers. e N. Id superato:

GB F1/3009643

000000

2154ZD

Pantone Rosso 185

CODICE LAETUS

Pantone Rosso 185

Pantone Rosso 185

Vernice

2401

Modifica rispetto la versione precedente:

ADDITION OF BIPSO AS BATCH RELEASE SITE

Quality Assurance
Packaging Development, Italy

Data Emissione

CROMinFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

Via G. Tartini, 2 - 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Data Obsolescenza

Archiviare almeno fino a:

03 MAR 2014
FCL63E01-PIL-PRO-FLACONI
Versione Bracco: 01
Versione interna: 01

Status

I colori su questa prova sono approssimativi,
questa è 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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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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ProHance
(Gadoteridol)

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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.

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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

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1. What ProHance is and what it is used for

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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.

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

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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.

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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.

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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.

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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.

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Other medicines and ProHance
There are no reports of reactions between ProHance and other medicines.

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

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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.

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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.

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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.

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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.

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3. How you are given ProHance

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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.

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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.

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The recommended dose for adults for MRI of the whole body is 0.2 ml/kg.

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Dosage in special patient groups

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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.

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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.

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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.

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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.

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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:

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Prior to administration of ProHance, it is recommended that all patients are
screened for renal dysfunction by obtaining laboratory tests.

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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.

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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.

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Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Prodotto:

PROHANCE FLACONI (UK)

Dimensioni:
Color i n°:

Traduzione braille:

Materiale:

SPECIFICA
RIFERIMENTO:

Codice Bracco:

Istruzione

148 X 600 mm

Fustella

Black

Pantone Green 347

1

Codice Bracco superato:

CL63E01

2154ZD

Pantone Rosso 185

Eurolaser

Pantone Rosso 185

Vers. e N. Id:

000000

Vers. e N. Id superato:

GB F1/3009643

000000

2154ZD

Pantone Rosso 185

CODICE LAETUS

Pantone Rosso 185

Pantone Rosso 185

Vernice

2401

Modifica rispetto la versione precedente:

ADDITION OF BIPSO AS BATCH RELEASE SITE

Quality Assurance
Packaging Development, Italy

Data Emissione

CROMinFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

Via G. Tartini, 2 - 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Data Obsolescenza

Archiviare almeno fino a:

03 MAR 2014
FCL63E01-PIL-PRO-FLACONI
Versione Bracco: 01
Versione interna: 01

Status

I colori su questa prova sono approssimativi,
questa è una stampa a 600 dpi ottenuta con colori
a base acqua CMYK. Definizione e colori non
riflettono il risultato finale della produzione stampata.

RETRO - Font size heading c.19 - Font size subheading c.10
Font size main text c.9 - Font size line-spacing 11
0
1

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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Most of the side effects that have been reported with ProHance have been mild
and were not prolonged, and spontaneously resolved without residual effects.

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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

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The following side effects have been reported

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Common: (more than 1 out of 100 persons and less than 1 out of 10 persons)
• Feeling sick (nausea)

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Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons)
• Severe allergic reactions( anaphylactic reactions)
• 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
• Fatigue
• Increased heart beat

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Rare: (more than 1 out 10,000 persons and less than1 out of 1,000 persons)
• 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

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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

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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.

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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.

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5. How to store ProHance
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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.

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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.

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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.

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6. Contents of the pack and other information
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What ProHance contains
The active substance is gadoteridol
The other ingredients are:
- Calteridol Calcium
- Tromethamine
- Hydrochloric Acid
- Sodium Hydroxide
- Water

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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.

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Marketing Authorisation Holder and manufacturers
Bracco International B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, The
Netherlands

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Manufacturers
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany
and
FAMAR ITALIA S.P.A., Via Zambeletti 25, 20021 Baranzate (MI), Italy

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This leaflet was last revised in
March 2014

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

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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.

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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.

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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.

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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.

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CL63E01-GB F1/3009643

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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