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GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION

Active substance: GADOBUTROL

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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 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’.

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

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.
Children and adolescents
R Use of Gadovist is not recommended in
children less than 2 years of age.
R In children aged 2 years and older and in
adolescents a single injection of 0.1 millilitre
Gadovist per kg body weight is recommended
for all examinations (see section 1).
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.

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, adolescents and children
aged two years and older.
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.
Children
This medicine must not be given to children under
the age of 2 years.
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.

3. How Gadovist will be given

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 Pharma AG
code-no.: 0
country: GB/-/BPH
approval:

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.

PZ: 2698O-3

Gadobutrol

page 1

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).
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 ReportingThe Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Packaging Technology Berlin ju
client: 0021
itemno.: 83917202
name: LF-OUTS-Gadovist 1,0 VL
colors: Black
version: 20.02.2014/02

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 infusion bottle)
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
Belgium,
Denmark,
Finland,
Greece, Italy,
Luxembourg,
Norway,
Portugal,
Sweden
France
Ireland
Netherlands
Spain
United
Kingdom

Gadovist 1,0 mmol/ml
Injektionslösung
Gadovist

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 January 2014

83917202

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2/20/2014 8:09:37 AM

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH
approval:

PZ: 2698O-3

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
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.
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 aged 2 years and older and for
adolescents the recommended dose is 0.1 mmol
Gadovist per kg body weight (equivalent to 0.1 ml
Gadovist per kg body weight) for all indications
(see section 1).
Gadovist is not recommended for use in children
below 2 years of age due to a lack of data on
safety and efficacy.
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.

page 2

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.

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).

Packaging Technology Berlin ju
client: 0021
itemno.: 83917202
name: LF-OUTS-Gadovist 1,0 VL
colors: Black
version: 20.02.2014/02

5. How to store Gadovist

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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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