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GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION PRE-FILLED SYRINGE/PLASTIC CARTRIDGE

Active substance(s): GADOBUTROL

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Transcript
What Gadovist contains

Gadovist 1.0 mmol/ml
solution for injection in prefilled syringe/cartridge
Gadobutrol
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, please ask your doctor or
the person giving you Gadovist (the radiologist) or the
hospital/MRI-centre personnel.
R If you get any side effects talk to your doctor or radiologist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Gadovist is and what it is used for
2. What you need to know before you are given Gadovist
3. How Gadovist will be given
4. Possible side effects
5. How to store Gadovist
6. Contents of the pack and other information

1. What Gadovist is and what it is used for
Gadovist is a contrast medium for magnetic resonance imaging
(MRI) used for diagnostics of the brain, spine and vessels.
Gadovist can also help the doctor find out the kind (benign or
malignant) of known or suspected abnormalities in the liver and
kidneys.
Gadovist can also be used for MRI of abnormalities of other body
regions.
It facilitates visualisation of abnormal structures or lesions and
helps in the differentiation between healthy and diseased tissue.
It is for use in adults and children of all ages (including term
newborn infants).
How Gadovist works
MRI is a form of medical diagnostic imaging that uses the
behaviour of water molecules in normal and abnormal tissues.
This is done by a complex system of magnets and radio waves.
Computers record the activity and translate that into images.
Gadovist is given as an injection into your vein. This medicine is
for diagnostic use only and will only be administered by
healthcare professionals experienced in the field of clinical MRI
practice.

2. What you need to know before you are given Gadovist
Do NOT use Gadovist if you
R are allergic to gadobutrol or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before you are given Gadovist if you
R suffer or have suffered from an allergy (e.g. hay fever, hives) or
asthma
R had a previous reaction to any contrast media
R have very poor kidney function
R suffer from brain conditions with seizures (fits) or from other
diseases of the nervous system
R have a heart pacemaker or if there are any implants or clips
containing iron in your body.
Your doctor will decide whether the intended examination is
possible or not.
R Allergy-like reactions leading to heart problems, breathing
difficulties or skin reactions may occur after use of Gadovist.
Severe reactions are possible. Most of these reactions occur
within half an hour after you are given Gadovist. Therefore you
will be observed after the examination. Delayed reactions have
been observed (after hours or days) (see section 4).
Kidneys/Liver
Tell your doctor if
R your kidneys do not work properly
R you have recently had, or soon expect to have, a liver
transplant.
Your doctor may decide to take a blood test to check how well
your kidneys are working before making the decision to use
Gadovist, especially if you are 65 years of age or older.
Neonates and infants
As kidney function is immature in babies up to 4 weeks of age
and infants up to 1 year of age, Gadovist will only be used in
these patients after careful consideration by the doctor.
Other medicines and Gadovist
Tell your doctor if you are taking or have recently taken or might
take any other medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
R Pregnancy
You must tell your doctor if you think you are, or might become,
pregnant as Gadovist should not be used during pregnancy
unless strictly necessary.
R Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Your doctor will discuss whether you should continue or
interrupt breast-feeding for a period of 24 hours after you receive
Gadovist.
Gadovist contains sodium
This medicinal product contains less than 23 mg sodium per dose
(based on the average amount given to a 70 kg person), i.e.
essentially ‘sodium-free’.

3. How Gadovist will be given
Gadovist is injected into your vein using a small needle by a
healthcare professional. Your MRI examination can start
immediately.
After the injection you will be observed for at least 30 minutes.
The usual dose
The actual dose that is right for you will depend on your body
weight and on the region being examined by MRI:
In adults a single injection of 0.1 millilitre Gadovist per kg body
weight is generally sufficient (this means for a person weighing
70 kg the dose would be 7 millilitre), however a further injection
of up to 0.2 millilitre per kg body weight within 30 minutes of the
first injection may be given. A total amount of 0.3 millilitre
Gadovist per kg body weight may be given.
Further information regarding the administration and handling
of Gadovist is given at the end of the leaflet.
Dosage in special patient groups
The use of Gadovist 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 Gadovist during a scan and you
should not receive a second injection for at least 7 days.
Neonates, infants, children and adolescents
In children of all ages (including term newborn infants) a single
dose of 0.1 millilitre Gadovist per kg body weight is
recommended for all examinations (see section 1).
As kidney function is immature in babies up to 4 weeks of age
and infants up to 1 year of age, Gadovist will only be used in
these patients after careful consideration by the doctor. Neonates
and infants should only receive one dose of Gadovist during a
scan and should not receive a second injection for at least 7 days.
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 receive more Gadovist than you should
Overdosing is unlikely. If it does happen, the doctor will treat any
symptoms and may use kidney dialysis to remove Gadovist from
your body.
There is no evidence to suggest that this will prevent the
development of Nephrogenic Systemic Fibrosis (NSF; see
section 4) and it should not be used as treatment for the
condition. In some cases your heart will be checked.
If you have any further questions on the use of this medicine, ask
your doctor or radiologist.

85018140_01.indd 1

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The most serious side effects (which have been fatal or lifethreatening in some cases) are:
R heart stops beating (cardiac arrest) and severe allergy-like
(anaphylactoid) reactions (including stop of breathing and
shock).
In addition for the following side effects life-threatening or
fatal outcomes have been observed in some cases:
R shortness of breath (dyspnoea), loss of consciousness, severe
allergy-like reaction, severe decrease of blood pressure may
lead to collapse, stop of breathing, fluid in the lungs, swelling
of mouth and throat and low blood pressure.
In rare cases:
R allergy-like reactions (hypersensitivity and anaphylaxis) may
occur, including severe reactions (shock) that may need
immediate medical intervention.
If you notice:
R swelling of the face, lips, tongue or throat
R coughing and sneezing
R difficulty breathing
R itching
R runny nose
R hives (nettle-type rash)
tell the MRI department staff immediately. These may be the
first signs that a severe reaction is happening. Your investigation
may need to be stopped and you may need further treatment.
Delayed allergy-like reactions, hours to several days after you
have received Gadovist, have been observed in rare cases. If this
should happen to you, tell your doctor or radiologist
immediately.
The most frequently observed side effects (may affect 5 or
more in 1,000 people) are:
R headache, feeling sick (nausea) and dizziness.
Most of the side effects are mild to moderate.
Possible side effects which have been observed in clinical trials
before the approval of Gadovist are listed below by how likely
they are.
Common (may affect up to 1 in 10 people)
R headache
R feeling sick (nausea)
Uncommon (may affect up to 1 in 100 people)
R allergy-like reaction, e.g.
P low blood pressure
P hives
P swelling of the face
P swelling (oedema) of the eyelid
P flushing
The frequency of the following allergy-like reactions is not
known:
P severe allergy-like reaction (anaphylactoid shock)
P severe decrease of blood pressure may lead to collapse
(shock)
P breathing stops
P fluid in the lungs
P breathing difficulties (bronchospasm)
P blueness of the lips
P swelling of the mouth and throat
P swelling of the throat
P increased blood pressure
P chest pain
P swelling of the face, throat, mouth, lips and/or tongue
(angioedema)
P conjunctivitis
P increased sweating
P cough
P sneezing
P burning sensation
P pale skin (pallor)
R dizziness, disturbed sense of taste, numbness and tingling
R shortness of breath (dyspnoea)
R vomiting
R redness of the skin (erythema)
R itching (pruritus including generalised pruritus)
R rash (including generalised rash, small flat red spots [macular
rash], small, raised, circumscribed lesions [papular rash] and
itchy rash [pruritic rash])
R various kinds of injection site reactions (e.g. leakage into the
surrounding tissue, burning, coldness, warmth, reddening,
rash, pain or bruising)
R feeling hot
Rare (may affect up to 1 in 1,000 people)
R fainting
R convulsion
R disturbed sense of smell
R rapid heart beat
R palpitations
R dry mouth
R generally feeling unwell (malaise)
R feeling cold
Additional side effects which have been reported after the
approval of Gadovist with unknown frequency (frequency
cannot be estimated from the available data):
R Heart stops beating (cardiac arrest)
R There have been reports of nephrogenic systemic fibrosis - NSF
(which causes hardening of the skin and may affect also soft
tissue and internal organs).
Variations in blood tests of the kidney function (e.g. increase of
serum creatinine) have been observed after administration of
Gadovist.
Reporting of side effects
If you get any side effects talk to your doctor or radiologist. This
includes any side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Gadovist
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label and the carton after EXP. The expiry date refers to the
last day of that month. This medicinal product does not require
any special storage conditions.
Chemical, physical and microbiological in-use stability has been
demonstrated for 24 hours at 20-25 °C. From a microbiological
point of view, the product should be used immediately after
opening.
This medicinal product is a clear, colourless to pale yellow
solution. Do not use this medicine if you notice severe
discolouration or the presence of particulate matter or if the
container appears defective.
Medicines should not be disposed of via wastewater or household
waste. The healthcare professional will dispose of this medicine
when no longer required. These measures will help to protect the
environment.

The active substance is gadobutrol.
1 ml of solution for injection contains 604.72 mg gadobutrol
(equivalent to 1.0 mmol gadobutrol containing 157.25 mg
gadolinium).
1 prefilled syringe with 5.0 ml contains 3023.6 mg gadobutrol,
1 prefilled syringe with 7.5 ml contains 4535.4 mg gadobutrol,
1 prefilled syringe with 10 ml contains 6047.2 mg gadobutrol,
1 prefilled syringe with 15 ml contains 9070.8 mg gadobutrol,
1 prefilled syringe with 20 ml contains 12094.4 mg gadobutrol.
1 cartridge with 15 ml contains 9070.8 mg gadobutrol,
1 cartridge with 20 ml contains 12094.4 mg gadobutrol,
1 cartridge with 30 ml contains 18141.6 mg gadobutrol
The other ingredients are calcobutrol sodium (see end of
section 2), trometamol, hydrochloric acid 1N and water for
injections.
What Gadovist looks like and contents of the pack
Gadovist is a clear, colourless to pale yellow solution for injection.
The contents of the packs are:
R 1 or 5 prefilled syringes with 5, 7.5, 10 ml solution for injection
(in 10-ml glass prefilled syringe)
R 1 or 5 prefilled syringes with 15 ml solution for injection (in
17-ml glass prefilled syringes)
R 1 or 5 prefilled syringes with 20 ml solution for injection
(in 20-ml glass prefilled syringe)
R 1 or 5 cartridges with 15, 20, 30 ml solution for injection (in
65-ml cartridge).
Hospital pack:
R 5 prefilled syringes with 5, 7.5, 10, 15, 20 ml solution for
injection
R 5 prefilled cartridges with 15, 20, 30 ml solution for injection
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer
Bayer Pharma AG
Müllerstrasse 178
13353 Berlin
Germany
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Germany

Gadovist 1,0 mmol/ml Injektionslösung
in Fertigspritzen/Patronen
Gadovist

Belgium, Denmark,
Finland, Greece, Italy,
Luxembourg,
Norway, Portugal,
Sweden
Croatia
Gadovist 1,0 mmol/ml otopina za
injekciju u napunjenoj štrcaljki/ulošku
France
GADOVIST 1,0 mmol/mL, solution
injectable en seringue préremplie
Ireland
Gadovist 1.0 mmol/ml solution for
injection in prefilled syringe
Gadovist 1.0 mmol/ml solution for
injection in prefilled cartridge
Netherlands
Gadovist 1,0 mmol/ml, oplossing voor
injectie in voorgevulde spuit/ patroon
Spain
Gadovist 1 mmol/ml solución inyectable
en jeringa precargada / cartucho
precargado
United Kingdom
Gadovist 1.0 mmol/ml solution for
injection pre-filled syringe / cartridge
This leaflet was last revised in September 2015
The following information is intended for healthcare
professionals only:
R Renal impairment
Prior to administration of Gadovist, 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/1.73 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 Gadovist, 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 Gadovist, 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,
Gadovist injections should not be repeated unless the interval
between injections is at least 7 days.
As the renal clearance of Gadovist may be impaired in the elderly,
it is particularly important to screen patients aged 65 years and
older for renal dysfunction.
Haemodialysis shortly after Gadovist administration may be
useful at removing Gadovist 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.
R Pregnancy and breast-feeding
Gadovist should not be used during pregnancy unless the clinical
condition of the woman requires use of Gadovist.
Continuing or discontinuing of breast-feeding for a period of
24 hours after administration of Gadovist, should be at the
discretion of the doctor and lactating mother.
R Hypersensitivity reactions
As with other intravenous contrast agents, Gadovist can be
associated with anaphylactoid/hypersensitivity or other
idiosyncratic reactions, characterized by cardiovascular,
respiratory or cutaneous manifestations, and ranging to severe
reactions including shock. In general, patients with
cardiovascular disease are more susceptible to serious or even
fatal outcomes of severe hypersensitivity reactions.
The risk of hypersensitivity reactions may be higher in case of:
P previous reaction to contrast media
P history of bronchial asthma
P history of allergic disorders
In patients with an allergic disposition the decision to use
Gadovist must be made after particularly careful evaluation of
the risk-benefit ratio.
Most of these reactions occur within half an hour of
administration. Therefore, post-procedure observation of the
patient is recommended.
Medication for the treatment of hypersensitivity reactions as well
as preparedness for institution of emergency measures are
necessary.
Delayed reactions (after hours up to several days) have been
rarely observed.
R Seizure disorders
Like with other gadolinium containing contrast agents special
precaution is necessary in patients with a low threshold for
seizures.
R Overdose
In case of inadvertent overdosage, cardiovascular monitoring
(including ECG) and control of renal function are recommended
as a measure of precaution.
In case of overdose in patients with renal insufficiency, Gadovist
can be removed by haemodialysis. After 3 haemodialysis sessions
approx. 98 % of the agent are removed from the body. However,
there is no evidence that haemodialysis is suitable for prevention
of nephrogenic systemic fibrosis (NSF).

15.09.2015 08:13:54

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
material-no.: 85018140
PZ: 2589C-3
code-no.: 97
name: LF-INS-Gadovist 1,0 PFS
country: GB/-/BPH
colors: Black
version: 15.09.2015/01
approval:
dimension: 297 x 594 mm

6. Contents of the pack and other information

Package leaflet: Information for the patient

HAND INJECTION

1. Open the package

2. Screw the plunger on the
syringe

3. Break the protective cover

4. Remove the protective cover

5. Remove the rubber stopper

6. Remove the air in the syringe

Cartridges
Administration of contrast media should be performed by
qualified personnel with the appropriate procedures and
equipment.
Sterile technique must be used in all injections involving contrast
media.
The contrast medium must be administered by means of a
MEDRAD Spectris® type injector.
Instructions of the device manufacturer must be followed.
Any solution not used in one examination is to be discarded in
accordance with local requirements.
Shelf life after first opening of the container
Any solution for injection not used in one examination must be
discarded. Chemical, physical and microbiological in-use stability
has been demonstrated for 24 hours at 20-25 °C. From a
microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user.
The peel-off tracking label on the syringes/cartridges 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.
Posology
R Adults
CNS indications
The recommended dose for adults is 0.1 mmol per kilogram body
weight (mmol/kg BW). This is equivalent to 0.1 ml/kg BW of the
1.0 M solution.
If a strong clinical suspicion of a lesion persists despite an
unremarkable MRI or when more accurate information might
influence therapy of the patient, a further injection of up to
0.2 ml/kg BW within 30 minutes of the first injection may be
performed.
Whole Body MRI (except MRA)
In general, the administration of 0.1 ml Gadovist per kg body
weight is sufficient to answer the clinical question.

CE-MRA
Imaging of 1 field of view (FOV): 7.5 ml for body weight below
75 kg; 10 ml for body weight of 75 kg and higher (corresponding
to 0.1-0.15 mmol/kg BW).
Imaging of > 1 field of view (FOV): 15 ml for body weight below
75 kg; 20 ml for body weight of 75 kg and higher (corresponding
to 0.2-0.3 mmol/kg BW).
R Paediatric population
For children of all ages (including term neonates) the
recommended dose is 0.1 mmol gadobutrol per kg body weight
(equivalent to 0.1 ml Gadovist per kg body weight) for all
indications (see section 1).
Due to immature renal function in neonates up to 4 weeks of age
and infants up to 1 year of age, Gadovist 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. Because of the lack of information on
repeated administration, Gadovist injections should not be
repeated unless the interval between injections is at least 7 days.
Imaging
The dose required is administered intravenously as a bolus
injection. Contrast-enhanced MRI can commence immediately
afterwards (shortly after the injection depending on the pulse
sequences used and the protocol for the examination).
Optimal signal enhancement is observed during arterial first pass
for CE-MRA and within a period of about 15 minutes after
injection of Gadovist for CNS indications (time depending on type
of lesion/tissue).
T1 -weighted scanning sequences are particularly suitable for
contrast-enhanced examinations.
Further information regarding the use of Gadovist is given in
section 3 of the leaflet.

85018140

Gadovist
1.0 mmol/ml
85018140

85018140_01.indd 2

15.09.2015 08:14:15

Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
material-no.: 85018140
PZ: 2589C-3
code-no.: 97
name: LF-INS-Gadovist 1,0 PFS
country: GB/-/BPH
colors: Black
version: 15.09.2015/01
approval:
dimension: 297 x 594 mm

R Before injection
This product is intended for single use only.
This medicinal product is a clear, colourless to pale yellow
solution. It should be visually inspected before use.
Gadovist should not be used in case of severe discoloration, the
occurrence of particulate matter or a defective container.
R Instructions for use
Prefilled syringes
The prefilled syringe must be taken from the pack and prepared
for the injection immediately before the administration.
The tip cap should be removed from the prefilled syringe
immediately before use.
Glass syringe only:

Gadovist 1.0 mmol/ml
solution for injection in prefilled syringe/cartridge
Gadobutrol
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, please ask your doctor or
the person giving you Gadovist (the radiologist) or the
hospital/MRI-centre personnel.
R If you get any side effects talk to your doctor or radiologist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Gadovist is and what it is used for
2. What you need to know before you are given Gadovist
3. How Gadovist will be given
4. Possible side effects
5. How to store Gadovist
6. Contents of the pack and other information

1. What Gadovist is and what it is used for
Gadovist is a contrast medium for magnetic resonance imaging
(MRI) used for diagnostics of the brain, spine and vessels.
Gadovist can also help the doctor find out the kind (benign or
malignant) of known or suspected abnormalities in the liver and
kidneys.
Gadovist can also be used for MRI of abnormalities of other body
regions.
It facilitates visualisation of abnormal structures or lesions and
helps in the differentiation between healthy and diseased tissue.
It is for use in adults and children of all ages (including term
newborn infants).
How Gadovist works
MRI is a form of medical diagnostic imaging that uses the
behaviour of water molecules in normal and abnormal tissues.
This is done by a complex system of magnets and radio waves.
Computers record the activity and translate that into images.
Gadovist is given as an injection into your vein. This medicine is
for diagnostic use only and will only be administered by
healthcare professionals experienced in the field of clinical MRI
practice.

2. What you need to know before you are given Gadovist
Do NOT use Gadovist if you
R are allergic to gadobutrol or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before you are given Gadovist if you
R suffer or have suffered from an allergy (e.g. hay fever, hives) or
asthma
R had a previous reaction to any contrast media
R have very poor kidney function
R suffer from brain conditions with seizures (fits) or from other
diseases of the nervous system
R have a heart pacemaker or if there are any implants or clips
containing iron in your body.
Your doctor will decide whether the intended examination is
possible or not.
R Allergy-like reactions leading to heart problems, breathing
difficulties or skin reactions may occur after use of Gadovist.
Severe reactions are possible. Most of these reactions occur
within half an hour after you are given Gadovist. Therefore you
will be observed after the examination. Delayed reactions have
been observed (after hours or days) (see section 4).
Kidneys/Liver
Tell your doctor if
R your kidneys do not work properly
R you have recently had, or soon expect to have, a liver
transplant.
Your doctor may decide to take a blood test to check how well
your kidneys are working before making the decision to use
Gadovist, especially if you are 65 years of age or older.
Neonates and infants
As kidney function is immature in babies up to 4 weeks of age
and infants up to 1 year of age, Gadovist will only be used in
these patients after careful consideration by the doctor.
Other medicines and Gadovist
Tell your doctor if you are taking or have recently taken or might
take any other medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
R Pregnancy
You must tell your doctor if you think you are, or might become,
pregnant as Gadovist should not be used during pregnancy
unless strictly necessary.
R Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Your doctor will discuss whether you should continue or
interrupt breast-feeding for a period of 24 hours after you receive
Gadovist.
Gadovist contains sodium
This medicinal product contains less than 23 mg sodium per dose
(based on the average amount given to a 70 kg person), i.e.
essentially ‘sodium-free’.

3. How Gadovist will be given
Gadovist is injected into your vein using a small needle by a
healthcare professional. Your MRI examination can start
immediately.
After the injection you will be observed for at least 30 minutes.
The usual dose
The actual dose that is right for you will depend on your body
weight and on the region being examined by MRI:
In adults a single injection of 0.1 millilitre Gadovist per kg body
weight is generally sufficient (this means for a person weighing
70 kg the dose would be 7 millilitre), however a further injection
of up to 0.2 millilitre per kg body weight within 30 minutes of the
first injection may be given. A total amount of 0.3 millilitre
Gadovist per kg body weight may be given.
Further information regarding the administration and handling
of Gadovist is given at the end of the leaflet.
Dosage in special patient groups
The use of Gadovist 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 Gadovist during a scan and you
should not receive a second injection for at least 7 days.
Neonates, infants, children and adolescents
In children of all ages (including term newborn infants) a single
dose of 0.1 millilitre Gadovist per kg body weight is
recommended for all examinations (see section 1).
As kidney function is immature in babies up to 4 weeks of age
and infants up to 1 year of age, Gadovist will only be used in
these patients after careful consideration by the doctor. Neonates
and infants should only receive one dose of Gadovist during a
scan and should not receive a second injection for at least 7 days.
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 receive more Gadovist than you should
Overdosing is unlikely. If it does happen, the doctor will treat any
symptoms and may use kidney dialysis to remove Gadovist from
your body.
There is no evidence to suggest that this will prevent the
development of Nephrogenic Systemic Fibrosis (NSF; see
section 4) and it should not be used as treatment for the
condition. In some cases your heart will be checked.
If you have any further questions on the use of this medicine, ask
your doctor or radiologist.

85001825_02.indd 1

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The most serious side effects (which have been fatal or lifethreatening in some cases) are:
R heart stops beating (cardiac arrest) and severe allergy-like
(anaphylactoid) reactions (including stop of breathing and
shock).
In addition for the following side effects life-threatening or
fatal outcomes have been observed in some cases:
R shortness of breath (dyspnoea), loss of consciousness, severe
allergy-like reaction, severe decrease of blood pressure may
lead to collapse, stop of breathing, fluid in the lungs, swelling
of mouth and throat and low blood pressure.
In rare cases:
R allergy-like reactions (hypersensitivity and anaphylaxis) may
occur, including severe reactions (shock) that may need
immediate medical intervention.
If you notice:
R swelling of the face, lips, tongue or throat
R coughing and sneezing
R difficulty breathing
R itching
R runny nose
R hives (nettle-type rash)
tell the MRI department staff immediately. These may be the
first signs that a severe reaction is happening. Your investigation
may need to be stopped and you may need further treatment.
Delayed allergy-like reactions, hours to several days after you
have received Gadovist, have been observed in rare cases. If this
should happen to you, tell your doctor or radiologist
immediately.
The most frequently observed side effects (may affect 5 or
more in 1,000 people) are:
R headache, feeling sick (nausea) and dizziness.
Most of the side effects are mild to moderate.
Possible side effects which have been observed in clinical trials
before the approval of Gadovist are listed below by how likely
they are.
Common (may affect up to 1 in 10 people)
R headache
R feeling sick (nausea)
Uncommon (may affect up to 1 in 100 people)
R allergy-like reaction, e.g.
P low blood pressure
P hives
P swelling of the face
P swelling (oedema) of the eyelid
P flushing
The frequency of the following allergy-like reactions is not
known:
P severe allergy-like reaction (anaphylactoid shock)
P severe decrease of blood pressure may lead to collapse
(shock)
P breathing stops
P fluid in the lungs
P breathing difficulties (bronchospasm)
P blueness of the lips
P swelling of the mouth and throat
P swelling of the throat
P increased blood pressure
P chest pain
P swelling of the face, throat, mouth, lips and/or tongue
(angioedema)
P conjunctivitis
P increased sweating
P cough
P sneezing
P burning sensation
P pale skin (pallor)
R dizziness, disturbed sense of taste, numbness and tingling
R shortness of breath (dyspnoea)
R vomiting
R redness of the skin (erythema)
R itching (pruritus including generalised pruritus)
R rash (including generalised rash, small flat red spots [macular
rash], small, raised, circumscribed lesions [papular rash] and
itchy rash [pruritic rash])
R various kinds of injection site reactions (e.g. leakage into the
surrounding tissue, burning, coldness, warmth, reddening,
rash, pain or bruising)
R feeling hot
Rare (may affect up to 1 in 1,000 people)
R fainting
R convulsion
R disturbed sense of smell
R rapid heart beat
R palpitations
R dry mouth
R generally feeling unwell (malaise)
R feeling cold
Additional side effects which have been reported after the
approval of Gadovist with unknown frequency (frequency
cannot be estimated from the available data):
R Heart stops beating (cardiac arrest)
R There have been reports of nephrogenic systemic fibrosis - NSF
(which causes hardening of the skin and may affect also soft
tissue and internal organs).
Variations in blood tests of the kidney function (e.g. increase of
serum creatinine) have been observed after administration of
Gadovist.
Reporting of side effects
If you get any side effects talk to your doctor or radiologist. This
includes any side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Gadovist
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label and the carton after EXP. The expiry date refers to the
last day of that month. This medicinal product does not require
any special storage conditions.
Chemical, physical and microbiological in-use stability has been
demonstrated for 24 hours at 20-25 °C. From a microbiological
point of view, the product should be used immediately after
opening.
This medicinal product is a clear, colourless to pale yellow
solution. Do not use this medicine if you notice severe
discolouration or the presence of particulate matter or if the
container appears defective.
Medicines should not be disposed of via wastewater or household
waste. The healthcare professional will dispose of this medicine
when no longer required. These measures will help to protect the
environment.

What Gadovist contains
The active substance is gadobutrol.
1 ml of solution for injection contains 604.72 mg gadobutrol
(equivalent to 1.0 mmol gadobutrol containing 157.25 mg
gadolinium).
1 prefilled syringe with 5.0 ml contains 3023.6 mg gadobutrol,
1 prefilled syringe with 7.5 ml contains 4535.4 mg gadobutrol,
1 prefilled syringe with 10 ml contains 6047.2 mg gadobutrol,
1 prefilled syringe with 15 ml contains 9070.8 mg gadobutrol,
1 prefilled syringe with 20 ml contains 12094.4 mg gadobutrol.
1 cartridge with 15 ml contains 9070.8 mg gadobutrol,
1 cartridge with 20 ml contains 12094.4 mg gadobutrol,
1 cartridge with 30 ml contains 18141.6 mg gadobutrol
The other ingredients are calcobutrol sodium (see end of
section 2), trometamol, hydrochloric acid 1N and water for
injections.
What Gadovist looks like and contents of the pack
Gadovist is a clear, colourless to pale yellow solution for injection.
The contents of the packs are:
R 1 or 5 prefilled syringes with 5, 7.5, 10 ml solution for injection
(in 10-ml plastic prefilled syringe)
R 1 or 5 prefilled syringes with 15 ml solution for injection (in
20-ml plastic prefilled syringe)
R 1 or 5 prefilled syringes with 20 ml solution for injection (in
plastic prefilled syringe)
R 1 or 5 cartridges with 15, 20, 30 ml solution for injection (in
65-ml cartridge).
Hospital pack:
R 5 prefilled syringes with 5, 7.5, 10, 15, 20 ml solution for
injection
R 5 prefilled cartridges with 15, 20, 30 ml solution for injection
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer
Bayer Pharma AG
Müllerstrasse 178
13353 Berlin
Germany
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Germany

Gadovist 1,0 mmol/ml Injektionslösung
in Fertigspritzen/Patronen
Gadovist

Belgium, Denmark,
Finland, Greece, Italy,
Luxembourg,
Norway, Portugal,
Sweden
Croatia
Gadovist 1,0 mmol/ml otopina za
injekciju u napunjenoj štrcaljki/ulošku
France
GADOVIST 1,0 mmol/mL, solution
injectable en seringue préremplie
Ireland
Gadovist 1.0 mmol/ml solution for
injection in prefilled syringe
Gadovist 1.0 mmol/ml solution for
injection in prefilled cartridge
Netherlands
Gadovist 1,0 mmol/ml, oplossing voor
injectie in voorgevulde spuit/ patroon
Spain
Gadovist 1 mmol/ml solución inyectable
en jeringa precargada / cartucho
precargado
United Kingdom
Gadovist 1.0 mmol/ml solution for
injection pre-filled syringe / cartridge
This leaflet was last revised in September 2015
The following information is intended for healthcare
professionals only:
R Renal impairment
Prior to administration of Gadovist, 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/1.73 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 Gadovist, 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 Gadovist, 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,
Gadovist injections should not be repeated unless the interval
between injections is at least 7 days.
As the renal clearance of Gadovist may be impaired in the elderly,
it is particularly important to screen patients aged 65 years and
older for renal dysfunction.
Haemodialysis shortly after Gadovist administration may be
useful at removing Gadovist 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.
R Pregnancy and breast-feeding
Gadovist should not be used during pregnancy unless the clinical
condition of the woman requires use of Gadovist.
Continuing or discontinuing of breast-feeding for a period of
24 hours after administration of Gadovist, should be at the
discretion of the doctor and lactating mother.
R Hypersensitivity reactions
As with other intravenous contrast agents, Gadovist can be
associated with anaphylactoid/hypersensitivity or other
idiosyncratic reactions, characterized by cardiovascular,
respiratory or cutaneous manifestations, and ranging to severe
reactions including shock. In general, patients with
cardiovascular disease are more susceptible to serious or even
fatal outcomes of severe hypersensitivity reactions.
The risk of hypersensitivity reactions may be higher in case of:
P previous reaction to contrast media
P history of bronchial asthma
P history of allergic disorders
In patients with an allergic disposition the decision to use
Gadovist must be made after particularly careful evaluation of
the risk-benefit ratio.
Most of these reactions occur within half an hour of
administration. Therefore, post-procedure observation of the
patient is recommended.
Medication for the treatment of hypersensitivity reactions as well
as preparedness for institution of emergency measures are
necessary.
Delayed reactions (after hours up to several days) have been
rarely observed.
R Seizure disorders
Like with other gadolinium containing contrast agents special
precaution is necessary in patients with a low threshold for
seizures.
R Overdose
In case of inadvertent overdosage, cardiovascular monitoring
(including ECG) and control of renal function are recommended
as a measure of precaution.
In case of overdose in patients with renal insufficiency, Gadovist
can be removed by haemodialysis. After 3 haemodialysis sessions
approx. 98 % of the agent are removed from the body. However,
there is no evidence that haemodialysis is suitable for prevention
of nephrogenic systemic fibrosis (NSF).

07.09.2015 15:46:09

Packaging Technology Berlin sgrfh
page 1
Bayer Pharma AG
client: 0021
material-no.: 85001825
PZ: 2589C-3
code-no.: 72
name: LF-INS-Gadovist 1,0 PFSP
country: GB/-/BPH
colors: Black
version: 07.09.2015/02
approval:
dimension: 297 x 594 mm

6. Contents of the pack and other information

Package leaflet: Information for the patient

HAND INJECTION

INJECTION WITH A POWER
INJECTOR

1. Open the package

1. Open the package

2. Take syringe and plunger rod 2. Take syringe out of the
out of the package
package

3. Turn clock-wise the plunger
rod into the syringe

3. Open the cap with a twist

4. Open the cap with a twist

4. Connect the tip of the syringe
to the tubing system clockwise and go on according to
the instructions of the device
manufacturer

5. Remove the air in the syringe

Packaging Technology Berlin sgrfh
page 2
Bayer Pharma AG
client: 0021
material-no.: 85001825
PZ: 2589C-3
code-no.: 72
name: LF-INS-Gadovist 1,0 PFSP
country: GB/-/BPH
colors: Black
version: 07.09.2015/02
approval:
dimension: 297 x 594 mm

R Before injection
This product is intended for single use only.
This medicinal product is a clear, colourless to pale yellow
solution. It should be visually inspected before use.
Gadovist should not be used in case of severe discoloration, the
occurrence of particulate matter or a defective container.
R Instructions for use
Prefilled syringes
The prefilled syringe must be taken from the pack and prepared
for the injection immediately before the administration.
The tip cap should be removed from the prefilled syringe
immediately before use.
Plastic syringe only:

Shelf life after first opening of the container
Any solution for injection not used in one examination must be
discarded. Chemical, physical and microbiological in-use stability
has been demonstrated for 24 hours at 20-25 °C. From a
microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user.
The peel-off tracking label on the syringes/cartridges 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.
Posology
R Adults
CNS indications
The recommended dose for adults is 0.1 mmol per kilogram body
weight (mmol/kg BW). This is equivalent to 0.1 ml/kg BW of the
1.0 M solution.
If a strong clinical suspicion of a lesion persists despite an
unremarkable MRI or when more accurate information might
influence therapy of the patient, a further injection of up to
0.2 ml/kg BW within 30 minutes of the first injection may be
performed.
Whole Body MRI (except MRA)
In general, the administration of 0.1 ml Gadovist per kg body
weight is sufficient to answer the clinical question.
CE-MRA
Imaging of 1 field of view (FOV): 7.5 ml for body weight below
75 kg; 10 ml for body weight of 75 kg and higher (corresponding
to 0.1-0.15 mmol/kg BW).
Imaging of > 1 field of view (FOV): 15 ml for body weight below
75 kg; 20 ml for body weight of 75 kg and higher (corresponding
to 0.2-0.3 mmol/kg BW).
R Paediatric population
For children of all ages (including term neonates) the
recommended dose is 0.1 mmol gadobutrol per kg body weight
(equivalent to 0.1 ml Gadovist per kg body weight) for all
indications (see section 1).
Due to immature renal function in neonates up to 4 weeks of age
and infants up to 1 year of age, Gadovist 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. Because of the lack of information on
repeated administration, Gadovist injections should not be
repeated unless the interval between injections is at least 7 days.
Imaging
The dose required is administered intravenously as a bolus
injection. Contrast-enhanced MRI can commence immediately
afterwards (shortly after the injection depending on the pulse
sequences used and the protocol for the examination).
Optimal signal enhancement is observed during arterial first pass
for CE-MRA and within a period of about 15 minutes after
injection of Gadovist for CNS indications (time depending on type
of lesion/tissue).
T1 -weighted scanning sequences are particularly suitable for
contrast-enhanced examinations.
Further information regarding the use of Gadovist is given in
section 3 of the leaflet.

Cartridges
Administration of contrast media should be performed by
qualified personnel with the appropriate procedures and
equipment.
Sterile technique must be used in all injections involving contrast
media.
The contrast medium must be administered by means of a
MEDRAD Spectris® type injector.
Instructions of the device manufacturer must be followed.
Any solution not used in one examination is to be discarded in
accordance with local requirements.

85001825

Gadovist
1.0 mmol/ml
85001825

85001825_02.indd 2

07.09.2015 15:46:21

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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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