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MULTIHANCE 0.5M SOLUTION FOR INJECTION

Active substance(s): GADOBENATE DIMEGLUMINE

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24 NOV 2017

CROM
inFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

FCI00SN08-PIL-MULTI-FLACONI
Versione interna: 04

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

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

Impianto di proprietà della:

Patheon Italia S.p.A. viale G.B. Stucchi, 110 - 20900 Monza (MB) - Italy

Cliente:

BRACCO s.p.a.

Prodotto: MULTIHANCE (UK-EIRE)
SPECIFICA
RIFERIMENTO: SF 0005 IS+P
Dimensioni:

150 x700 mm

Color i n°:

Materiale:

Codice Patheon:

Codice Patheon superato:

Codice Bracco:

Codice Bracco superato:

Istruzione

000000

257587

CI00SN08

CI00SN07

Stesa

Black

Piegata

Pantone Green 347

Pantone Green 372

Pantone Blu 297

CODICE LAETUS

Passo di taglio a mm 00

Pre taglio

Bobina

Pantone Red 185

Tipo Vernice

01
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Quality Assurance
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PACKAGE LEAFLET: INFORMATION FOR THE USER

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MultiHance, 0.5 M solution for injection

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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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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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1. What MultiHance is and what it is used for
MultiHance is a special dye (or contrast agent) which contains the rare earth
metal gadolinium and improves images of the liver during MRI scans. It helps
your doctor to identify any abnormalities of your liver.
This medicine is for diagnostic use only.

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MultiHance is approved for use in children above two years of age.

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2. What you need to know before you use MultiHance
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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Accumulation in the body
MultiHance works because it contains a metal called gadolinium. Studies
have shown that small amounts of gadolinium can remain in the body,
including the brain. No side effects have been seen due to gadolinium
remaining in the brain.

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

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Warnings and precautions
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
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant.

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

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

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Pregnancy and breast-feeding
Ask your doctor for advice before taking any 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.

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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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Important information about some of the ingredients of MultiHance
Small quantities of benzyl alcohol (a derivative of alcohol) may be released
in the MultiHance solution during storage.
Please tell your doctor if you are allergic to benzyl alcohol.

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3. How to use MultiHance
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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The recommended dose is:
MRI of the liver: 0.1 ml per kilogram of body weight

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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.

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You should remain in the hospital environment for one hour after the time of
the injection.

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Dosage in special patient groups

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

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4. Possible side effects
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.

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Possible side effects
- 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

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

- 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

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

- 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

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

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24 NOV 2017

CROM
inFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

FCI00SN08-PIL-MULTI-FLACONI
Versione interna: 04

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

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

Impianto di proprietà della:

Patheon Italia S.p.A. viale G.B. Stucchi, 110 - 20900 Monza (MB) - Italy

Cliente:

BRACCO s.p.a.

Prodotto: MULTIHANCE (UK-EIRE)
SPECIFICA
RIFERIMENTO: SF 0005 IS+P
Dimensioni:

150 x700 mm

Color i n°:

Black

Materiale:

Codice Patheon:

Codice Patheon superato:

Codice Bracco:

Codice Bracco superato:

Istruzione

000000

257587

CI00SN08

CI00SN07

Stesa

Piegata

Pantone Green 347

Pantone Green 372

Pantone Blu 297

CODICE LAETUS

Passo di taglio a mm 00

Pre taglio

Bobina

Pantone Red 185

Tipo Vernice

01
Modifica rispetto la versione precedente:

Apri nota
digitale
se presente

REVISION FURTHER TO EMA REFERRAL

Quality Assurance
Packaging Development, Italy

Data Emissione

Data Obsolescenza

Archiviare almeno fino a:

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 11.4

0
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- Shortness of breath, wheezing, tightness of
the throat, swelling and irritation inside the
nose, cough
- Dry mouth, excessive salivation
- Swollen face
- Pain in in muscles
- Incontinence of stool
- Feeling weak, chills, malaise
- Change in laboratory tests

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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

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Not known
(cannot be estimated
from the available data)

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

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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

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By reporting side effects you can help provide more information on the
safety of this medicine.

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5. How to store MultiHance
• 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 once drawn up
into the syringe.
• 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.

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6. Contents of the pack and other information
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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What MultiHance looks like and contents of the pack
MultiHance is an aqueous sterile solution (clear, colourless to slightly yellow
colour) for intravenous injection.
MultiHance is supplied to hospitals in single dose glass vials containing 5 mL,
10 mL, 15 mL, or 20 mL of solution.
MultiHance is also supplied as kits including the administration devices (15 and
20 mL vial, syringe for magnetic resonance automatic injector ((65 mL syringe
(polyethelene terephthalate/polycarbonate), 115 mL syringe (polyethelene
terephthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/
silicone), 2 spikes (ABS)), 20 G secured catheter.

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Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

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Marketing Authorisation Holder
Bracco Imaging spa, via Egidio Folli 50, 20134 Milano (Italy)

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Manufacturers
Patheon Italia S.p.A., 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR) (Italy)
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen (Germany)
Bracco Imaging S.p.A., Bioindustry Park, Via Ribes, 5
10010 Colleretto Giacosa (TO) (Italy)

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This leaflet was last revised in November 2017

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

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

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Method of administration
MultiHance should be drawn up into the syringe immediately before use and
should not be diluted. Any unused product should be discarded and not be
used for other MRI examinations.

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

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The injection should be followed by a flush of sodium chloride 9 mg/ml (0.9%)
solution for injection.

Immediately following bolus injection.

Delayed imaging:

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

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Dynamic imaging:

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Liver

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Post-contrast imaging acquisition:

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Prior to administration of MultiHance, 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< 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.

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If use of MultiHance cannot be avoided, the dose should not exceed 0.05 mmol/kg
body weight.

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

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CI00SN08 - 000000

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The peel-off tracking label on the vials 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.

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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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