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GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION

Active substance(s): GADOBUTROL / GADOBUTROL / GADOBUTROL

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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.

Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Your doctor will discuss
whether you should continue or interrupt breastfeeding 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 ‘sodiumfree’.

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.

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 life-threatening 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 lifethreatening 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.

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Bayer AG
code-no.:
country: GB/-/BAG

dimension: 210 x 462 mm

Gadobutrol

PZ: 2698O-3

Gadovist 1.0 mmol/ml solution for injection

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 generalized pruritus)
R rash (including generalized 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

Packaging chnology
page 1
client: 0
material-no.: 85669745
name: LF-INS-Gadovist 1,0 VL
colors: Black
version: 15.02.2017/02

Package leaflet: Information for the patient

6. Contents of the pack and other
information
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 vial with 2 ml contains 1209.44 mg gadobutrol
1 vial with 7.5 ml contains 4535.4 mg gadobutrol,
1 vial with 15 ml contains 9070.8 mg gadobutrol,
1 vial with 30 ml contains 18141.6 mg gadobutrol.
1 bottle with 65 ml contains 39306.8 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 3 vials with 2 ml solution for injection
R 1 or 10 vials with 7.5, 15 or 30 ml solution for
injection
R 1 or 10 bottles with 65 ml solution for injection
(in 100-ml bottle)
Hospital pack:
R 3 vials with 2 ml solution for injection
R 10 vials with 7.5, 15 or 30 ml solution for
injection
R 10 bottles with 65 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 AG
Müllerstrasse 178
13353 Berlin
Germany
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria,
Germany
Belgium,
Denmark,
Finland,
Greece, Italy,
Luxembourg,
Norway,
Portugal,
Sweden
Croatia
France
Ireland
Netherlands
Spain
United
Kingdom

Gadovist 1,0 mmol/ml
Injektionslösung
Gadovist

Gadovist 1,0 mmol/ml otopina za
injekciju
GADOVIST 1,0 mmol/mL, solution
injectable
Gadovist 1.0 mmol/ml solution for
injection
Gadovist 1,0 mmol/ml, oplossing
voor injectie
Gadovist 1 mmol/ml solución
inyectable en vial
Gadovist 1.0 mmol/ml solution for
injection

This leaflet was last revised in March 2017

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dimension: 210 x 462 mm

Bayer AG
code-no.:
country: GB/-/BAG

R Instructions for use
Gadovist should not be drawn up into the syringe
from the vial until immediately before use.
The rubber stopper should never be pierced more
than once.
Contrast medium not used in one examination must
be discarded
If this medicinal product is intended to be used with
an automatic application system, its suitability for
the intended use has to be demonstrated by the
manufacturer of the medicinal device. Any
additional instructions from the respective
equipment manufacturer must also be strictly
adhered to.
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 vials/bottles
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.

PZ: 2698O-3

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).
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.

Packaging Technology
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client: 0 1
material-no.: 85669745
name: LF-INS-Gadovist 1,0 VL
colors: Black
version: 15.02.2017/02

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, colorless to pale
yellow solution. Do not use this medicine if you
notice severe discoloration 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.

Expand Transcript

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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