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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

CI00SL07

CI00SL06

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

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ADDITIONAL INDICATION: WHOLE BODY

Quality Assurance
Packaging Development, Italy

Data Emissione

Data Obsolescenza

12 SET 2016
FCI00SL07-PIL-MULTI-PFS
Versione interna: 04

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
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Archiviare almeno fino a:

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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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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.

3. How to use MultiHance

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Gadobenate dimeglumine

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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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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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The recommended dose is:
MRI of brain/spine: 0.2 ml per kilogram of body weight
MRI of arteries: 0.2 ml per kilogram of body weight
MRI of the liver, the kidney, urinary tract or adrenal glands:
0.1 ml per kilogram of body weight
MRI of the breast, heart or other body areas: 0.2 ml per 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 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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Dosage in special patient groups

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

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1. What MultiHance is and what it is used for

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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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MultiHance is approved for use in children above two 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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2. What you need to know before you use MultiHance

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

4. Possible side effects

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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• 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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Do not use MultiHance

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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.

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Serious allergic shock
Loss of consciousness
Eyes inflammation
Cardiac arrest, blue discolouration
of the skin and mucous membranes

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-

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Not known
(cannot be
estimated from
from the
available data)

Tell your doctor if you are taking or have recently taken any
other medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before being given this medicine.

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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.

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

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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.

Rare:
- Serious allergic reaction which causes
(More than 1 out
causes difficulties in breathing or
10,000 persons and dizziness
less than 1 out of
- Fainting, tremor, convulsion, strange
1,000 persons)
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
- Swollen face
- Pain in in muscles
- Incontinence of stool
- Feeling weak, chills, malaise
- Change in laboratory tests

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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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.

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

Warnings and precautions

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

- 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

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

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Possible side effects

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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

CI00SL07

CI00SL06

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:

ADDITIONAL INDICATION: WHOLE BODY

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:

12 SET 2016
FCI00SL07-PIL-MULTI-PFS
Versione interna: 04

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
1

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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- 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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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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The injection should be completed following the usual
aspiration procedure.

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.

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:
- f o r U K v i a t h e Ye l l o w C a r d S c h e m e - We b s i t e :
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.

Post-contrast imaging acquisition:
Immediately following
bolus injection.

Liver

Delayed imaging:

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

Brain
and Spine

up to 60 minutes after the administration.

MRA

immediately after the administration, with scan
delay calculated on the basis of test bolus or
automatic bolus detection technique.
If an automatic contrast detection pulse
sequence is not used for bolus timing, then a
test bolus injection ≤2 mL of the agent should be
used to calculate the appropriate scan delay.

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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• 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.

Dynamic imaging:

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5. How to store MultiHance

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

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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.

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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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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.

6. Contents of the pack and other information

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Other
T1-weighted sequences to be acquired as
body areas either dynamic or static delayed 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.

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

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Marketing Authorisation Holder and Manufacturer

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Not all pack sizes may be marketed.

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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, MR-angiography breast MRI or whole body MRI and
should not exceed 0.05 mmol/kg body weight when used for MR
of the liver, kidneys, urinary tract or adrenal glands. More than one
dose should not be used during a scan except for MR cardiac
perfusion imaging where two separate doses of 0.05 mmol/kg
body weight can be administered in the course of a single
examination. 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.

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

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

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This leaflet was last revised in September 2016

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

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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.

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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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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CI00SL07

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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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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.

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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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