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MULTIHANCE 529 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): GADOBENATE DIMEGLUMINE

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

Impianto di proprietà della:

MULTIHANCE SIRINGHE (UK-EIRE)

Prodotto:

SPECIFICA
RIFERIMENTO:
Dimensioni:

Codice Bracco:

Codice Bracco superato:

Codice Terzista:

Codice Terzista superato:

Istruzione

CI00SL06

CI00SL05

508112 CTF 0306

38CB22

Fustella

220 X 400 mm

Color i n°:

Black

Traduzione braille:

Materiale:

Pantone Green 347

Eurolaser

2154ZD

Pantone Rosso 185

Pantone Rosso 185

2154ZD

Pantone Rosso 185

CODICE LAETUS

Pantone Rosso 185

Pantone Rosso 185

Vernice

128

1
Modifica rispetto la versione precedente:

SAFETY VARIATION AND ADDITION OF KIT PRESENTATIONS

Quality Assurance
Packaging Development, Italy

CROM
inFOTO 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

Data Emissione

Data Obsolescenza

22 OTT 2015
FCI00SL06-PIL-MULTI-PFS
Versione interna: 05

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

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

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MultiHance 529 mg/ml
solution
for injection in
pre-filled syringe

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Pregnancy and breast-feeding
Ask your doctor for advice before being given this
medicine.

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Pregnancy
You must tell your doctor if you think you are or might
become pregnant or are planning to have a baby as
MultiHance 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 MultiHance.

Gadobenate dimeglumine

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Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
- If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.

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Driving and using machines
There is no information about the effects of MultiHance 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 to use MultiHance

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MultiHance is injected into a vein, usually in your arm just
before the MRI scan. The amount in millilitre you will be
injected depends on how much you weigh in kilogram of
body weight.

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What is in this leaflet:
1. What MultiHance is and what it is used for
2. What you need to know before you use MultiHance
3. How to use MultiHance
4. Possible side effects
5. How to store MultiHance
6. Contents of the pack and other information

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The recommended dose is:
MRI of the liver: 0.1 ml per kilogram of body weight
MRI of brain/spine: 0.2 ml per kilogram of body weight
MRI of the breast: 0.2 ml per kilogram of body weight

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1. What MultiHance is and what it is used for

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The medical staff supervising your scan will administer your
injection of MultiHance. They should ensure that the needle
is correctly positioned: tell them if you feel pain or a burning
sensation at the site of the injection while it is being
administered.
You should remain in the hospital environment for one hour
after the time of the injection.

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MultiHance is a special dye (or contrast agent) which
contains the rare earth metal gadolinium and improves
images of the liver, brain/spine and breast during
magnetic resonance imaging (MRI) scans. It helps your
doctor to identify any abnormalities of your liver,
brain/spine and breast.
This medicine is for diagnostic use only.

Dosage in special patient groups

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4. Possible side effects

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Do not use MultiHance

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If you have any further questions on the use of this
medicine, ask your doctor.

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MultiHance 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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2. What you need to know before you use
MultiHance

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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MultiHance is approved for use in children above two
years of age for imaging of the brain and spine.

Impaired renal function
The use of MultiHance 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
MultiHance during a scan and you should not receive a
second scan for at least 7 days.

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-

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Tell your doctor if you are taking or have recently taken
any other medicines.

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-

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

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Rare:
(More than 1 out
10,000 persons and
less than 1 out of 1,000 persons)
-

Your doctor may decide to take a blood test to check how
well your kidneys are working before making the decision
to use MultiHance, especially if you are 65 years of age or
older.

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-

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Uncommon:
(More than 1 out
1,000 persons and
less than 1 out of 100 persons)
-

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Talk to your doctor before using MultiHance if:
• you suffer from a heart problem or have raised blood
pressure
• you have a history of epilepsy or brain lesions
• you have a cardiac pacemaker, or you are aware of the
presence in your body of any other metallic objects such
as clips, screws or plates as these might interfere with the
magnet of the MRI scanner
• if you are allergic ( hypersensitive ) to benzyl alcohol,
because small quantities of benzyl alcohol (a derivative
of alcohol) can be released in the MultiHance solution
during storage
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver
transplant.

Headache
Nausea
Local reactions where the injection
was given such as: pain, burning,
coldness or warmth feeling,
redness, itching or discomfort at
the injection site
Dizziness, reduced sensitivity to
touch/pain/or other stimuli,
tingling, changes in taste
Changes in blood pressure, and in
heart rate or rhythm, flushing
Vomiting, diarrhoea, abdominal pain
Itching, skin rash, urticaria (hives),
sweating
Pain in the chest, feeling hot, fever
Abnormal laboratory tests, such as:
- abnormal electrocardiogram (a
test that monitors changes in your
heart beat)
- changes in liver function tests
- abnormal blood and urine tests
Serious allergic reaction which
causes difficulties in breathing or
dizziness
Fainting, tremor, convulsion, strange
smell
Abnormal vision
Insufficient blood supply to the
heart, slow heart beats
Shortness of breath, wheezing,
tightness of the throat, swelling and
irritation inside the nose, cough
Dry mouth, excessive salivation

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Warnings and precautions

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Children
MultiHance should not be given to children under two
years of age.

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Possible side effects
Common:
(More than 1 out 100 persons and less than 1 out of
10 persons)

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Like all medicines, MultiHance can cause side effects,
although not everybody gets them.
Most of the side effects that have been reported with
MultiHance have been mild and were not prolonged, and
spontaneously resolved without residual effects. However,
severe and life-threatening reactions sometimes leading to
death have been reported.

• If you are allergic to gadobenate dimeglumine or any of
the other ingredients of this medicine (listed in section 6)
• If you have had any allergic reaction (hypersensitivity
reaction) in the past such as rash, itching, urticaria
(hives) or difficulty in breathing following injection of any
special dye or contrast agent for a MRI scan.
Tell your doctor if you think any of the points in this section
apply to you

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

Impianto di proprietà della:

MULTIHANCE SIRINGHE (UK-EIRE)

Prodotto:

SPECIFICA
RIFERIMENTO:
Dimensioni:

Codice Bracco:

Codice Bracco superato:

Codice Terzista:

Codice Terzista superato:

Istruzione

CI00SL06

CI00SL05

508112 CTF 0306

38CB22

Fustella

220 X 400 mm

Color i n°:

Black

Traduzione braille:

Materiale:

Pantone Green 347

Eurolaser

2154ZD

Pantone Rosso 185

Pantone Rosso 185

2154ZD

Pantone Rosso 185

CODICE LAETUS

Pantone Rosso 185

Pantone Rosso 185

Vernice

128

1
Modifica rispetto la versione precedente:

SAFETY VARIATION AND ADDITION OF KIT PRESENTATIONS

Quality Assurance
Packaging Development, Italy

CROM
inFOTO 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

Data Emissione

Data Obsolescenza

Archiviare almeno fino a:

22 OTT 2015
FCI00SL06-PIL-MULTI-PFS
Versione interna: 05

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

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.10 - Font size line-spacing 10

0

To use the syringe, the threaded tip of the plunger rod
clockwise should be screwed into the plunger and pushed
forward a few millimetres to break any friction between the
plunger and syringe barrel.

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Whilst holding syringe erect (with the nozzle cap upwards),
the nozzle cap should be removed aseptically from the tip of
the syringe and either a sterile, disposable needle or 5/6
tubing with a compatible luer lock should be attached using
a push-twist action.

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While still holding the syringe erect, the plunger should be
pushed forward until all the air is evacuated and the fluid
either appears at the tip of the needle or the tubing is
completely filled.

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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) in patients who received
MultiHance together with other gadolinium-containing
contrast agents.

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Method of administration
MultiHance should be used immediately after opening and
should not be diluted. Any unused product should be
discarded and not be used for other MRI examinations.

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The following information is intended for medical or
healthcare professionals only.

Swollen face
Pain in in muscles
Incontinence of stool
Feeling weak, chills, malaise
Change in laboratory tests
Serious allergic shock
Loss of consciousness
Eyes inflammation
Cardiac arrest, blue discolouration
of the skin and mucous membranes
Difficulties or suspension of breathing,
swelling of the throat, lack of
oxygen, difficulties in breathing or
wheezing, fluid in the lungs
(pulmonary oedema)
Swelling inside the mouth
Serious allergic reaction which
causes swelling of the face or
throat
Swelling at the site of injection
Inflammation of the veins due to
blood clots

1

Not known
(cannot be
estimated
from the
available data)

-

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The injection should be completed following the usual
aspiration procedure.

If you think you notice any side effects after receiving an
injection of MultiHance, immediately tell the medical staff
supervising your scan.

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To minimise the potential risks of soft tissue extravasation of
MultiHance, it is important to ensure that the i.v. needle or
cannula is correctly inserted into a vein.

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If you have any other questions not answered in this leaflet
please ask the medical staff supervising your scan.

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The product should be administered intravenously either as a
bolus or slow injection (10 mL/min.), see table for
post-contrast imaging acquisition.

Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly:
- for UK via the Yellow Card Scheme - Website:
www.mhra.gov.uk/yellowcard
- for Ireland via HPRA Pharmacovigilance - Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 - Fax: +353 1 6762517 Website: www.hpra.ie -e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

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The injection should be followed by a flush of sodium
chloride 9 mg/ml (0.9%) solution for injection.
Post-contrast imaging acquisition:

Liver

Delayed imaging:

between 40 and 120
minutes following the
injection, depending
on the individual
imaging needs.

5. How to store MultiHance

Brain
and Spine

up to 60 minutes after the administration.
¬

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day
of that month.
• Do not freeze.
• MultiHance should be administered to you immediately
after opening.
• Do not use MultiHance if you notice that the container
and closure have been damaged or the solution is
discoloured or particulate matter is present.
• Do not throw away any medicines via wastewater or
household waste. The hospital pharmacist will dispose
any unused product or waste material. These measures
will help to protect the environment.

Breast

A T1-weighted, gradient-echo sequence
with a time resolution of 2 minutes or less
should be acquired before contrast
injection and repeated several times over a
period of 5 to 8 min after a rapid intravenous
contrast bolus injection.

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Immediately following
bolus injection.

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Dynamic imaging:

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

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6. Contents of the pack and other information

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What MultiHance looks like and contents of the pack
MultiHance is an aqueous solution for injection in pre-filled
single dose syringe (clear, colourless to slightly yellow
colour).
MultiHance is supplied in pre-filled syringes containing
10 ml, 15 ml, or 20 ml of solution for injection.
MultiHance is also supplied in kits with administration devices:
- 15 and 20 mL pre-filled syringe, 20 mL syringe
(polypropylene), connector with 3-way stopcock
(polycarbonate), spike (ABS/polypropylene), 20 G secured
catheter
- 15 and 20 mL pre-filled syringe, syringe for magnetic
resonance automatic injector ((115 mL syringe
(polyethelene terephthalate/polycarbonate), connector
(PVC/polycarbonate/polypropylene/silicone), spike (ABS)),
20 G secured catheter.

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What MultiHance contains
- The active substance is gadobenic acid as gadobenate
dimeglumine
1 ml of solution for injection contains: gadobenic acid
334 mg (0.5 mmol) as gadobenate dimeglumine (529 mg).
- The other ingredient (excipient) is water for injection.

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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< 30ml/min /1.73 m2). 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 MultiHance, it should
therefore be avoided in patients with severe renal
impairment and in patients in the perioperative liver
transplantation period unless the diagnostic information is
essential and not available with non-contrast enhanced MRI.
If use of MultiHance cannot be avoided, the dose should not
exceed 0.1 mmol/kg body weight when used for MR of the
brain and spine or breast MRI, and should not exceed 0.05
mmol/kg body weight when used for MR of the liver. More
than one dose should not be used during a scan. Because of
the lack of information on repeated administration,
MultiHance injections should not be repeated unless the
interval between injections is at least 7 days.

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As the renal clearance of MultiHance may be impaired in
the elderly, it is particularly important to screen patients
aged 65 years and older for renal dysfunction.

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Not all pack sizes may be marketed.

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Haemodialysis shortly after MultiHance administration may
be useful at removing MultiHance 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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Marketing Authorisation Holder
Bracco Imaging spa
via Egidio Folli 50
20134 Milano (Italy)

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MultiHance should not be used during pregnancy unless the
clinical condition of the woman requires use of gadobenate
dimeglumine.

Marketing Authorisation Holder and Manufacturer

36

Continuing or discontinuing breast feeding for a period of 24
hours after administration of MultiHance, should be at the
discretion of the doctor and lactating mother.

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The peel-off tracking label on the syringes 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.

This leaflet was last revised in October 2015

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CI00SL06

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Manufacturer
Bracco Imaging spa
Via Ribes 5
Colleretto Giacosa (TO)
Ivrea (Italy)

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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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