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DOTAGRAF 0.5 MMOL/ML SOLUTION FOR INJECTION

Active substance(s): GADOTERIC ACID / GADOTERIC ACID / GADOTERIC ACID

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Package leaflet: Information for the user

Dotagraf 0.5 mmol/ml
Solution for injection
Gadoteric acid
Read all of this leaflet carefully before you start using 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, ask your doctor or radiologist.
R If you get any side effects, talk to your doctor, radiologist or
pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Dotagraf is and what it is used for
2. What you need to know before Dotagraf is used
3. How Dotagraf is used
4. Possible side effects
5. How to store Dotagraf
6. Contents of the pack and other information

1. WHAT DOTAGRAF IS AND WHAT IT IS USED FOR
Dotagraf is a diagnostic agent. It belongs to the group of contrast agents
used for magnetic resonance imaging (MRI).
Dotagraf is used to enhance the contrast of the images obtained during
MRI examination techniques. This contrast enhancement improves the
visualisation and delineation of:
R MRI of the CNS including defects (lesions) in brain, spinal cord and
adjacent tissue;
R Whole body MRI including defects (lesions) in liver, kidneys, pancreas,
pelvis, lungs, heart, breast and musculoskeletal system;
R MR angiography including defects (lesions) and narrowing (stenosis)
in arteries, except in coronary arteries.
This medicine is for diagnostic use only.

2. WHAT YOU NEED TO KNOW BEFORE DOTAGRAF IS USED
The information in this section should be read carefully.
The information given should be taken into consideration by you and
your doctor or radiologist before you are given Dotagraf.
You should NOT be given Dotagraf
R if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in section 6).
R if you are allergic to medicines containing gadolinium (like other
contrast agents used for magnetic resonance imaging).
Warnings and precautions
Inform your doctor or radiologist if the following applies to you:
R you have previously reacted to a contrast agent during an
examination
R you have asthma
R you have a history of allergy (such as seafood allergy, urticaria, hay
fever)
R you are being treated with a beta-blocker (medicine for heart and
blood pressure disorders, such as metoprolol)
R your kidneys do not work properly
R you have recently had, or soon expect to have, a liver transplant
R you have a disease affecting your heart or your blood vessels
R you have had convulsions or you are being treated for epilepsy.
In all these cases, your doctor or radiologist will assess the benefit-to-risk
ratio and decide whether you should be given Dotagraf. If you are given
Dotagraf, your doctor or radiologist will take the precautions necessary
and the administration of Dotagraf will be carefully monitored.
Your doctor or radiologist may decide to take a blood test to check how
well your kidneys are working before making the decision to use
Dotagraf, 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, Dotagraf will only be used in these patients
after careful consideration by the doctor.
Remove all metallic objects you may wear before the examination.
Inform your doctor or radiologist if you have:
R a pacemaker
R a vascular clip
R an infusion pump
R a nerve stimulator

1.3.2

The following information is intended for medical or healthcare
professionals only:
Posology
R Brain and spinal MRI: In neurological examinations, the dose can vary
from 0.1 to 0.3 mmol/kg BW, corresponding to 0.2 to 0.6 ml/kg BW.
After administration of 0.1 mmol/kg BW to patients with brain
tumours, the additional dose of 0.2 mmol/kg BW may improve tumour
characterisation and facilitate therapeutic decision- making.
R MRI of other organs and Angiography: The recommended dose for
intravenous injection is 0.1 mmol/kg (i.e. 0.2 ml/kg) to provide
diagnostically adequate contrast.
R Angiography: In exceptional circumstances (e.g. failure to gain
satisfactory images of an extensive vascular territory) administration
of a second consecutive injection of 0.1 mmol/kg BW, equivalent to
0.2 ml/kg BW may be justified. However, if the use of 2 consecutive
doses of Dotagraf is anticipated prior to commencing angiography,
use of 0.05 mmol/kg BW, equivalent to 0.1ml/kg BW for each dose
may be of benefit, depending on the imaging equipment available.
R Children: The 0.1 mmol/kg BW dose applies to all indications except
angiography due to insufficient data on efficacy and safety in this
indication.
Due to immature renal function in neonates up to 4 weeks of age and
infants up to 1 year of age, Dotagraf 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, Dotagraf injections should not be repeated unless the
interval between injections is at least 7 days.
In neonates and infants the required dose should be administered by
hand.
R Patients with renal impairment: The adult dose applies to patients
with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73m2).
See also below “Impaired renal function”.
R Patients with hepatic impairment: The adult dose applies to these
patients. Caution is recommended, especially in the case of
perioperative liver transplantation period.
Method of administration
Dotagraf is indicated for intravenous administration only. Dotagraf must
not be administered by subarachnoid (or epidural) injection.
Infusion rate: 3-5 ml/min (for angiographic procedures, higher infusion
rates up to 120 ml/min, i.e. 2 ml/sec, may be used for angiographic
procedures)
Optimal imaging: within 45 minutes after injection
Optimal image sequence: T1-weighted
Intravascular administration of contrast media should, if possible, be
done with the patient lying down. After the administration, the patient
should be kept under observation for at least half an hour, since
experience shows that the majority of undesirable effects occur within
this time.

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R a cochlear implant (implant in the inner ear)
R any suspected metallic foreign bodies, particularly in the eye.
This is important as these can result in serious problems, as magnetic
resonance imaging devices use very strong magnetic fields.
Other medicines and Dotagraf
Tell your doctor or radiologist if you are taking or have recently taken
any other medicines. In particular, please inform your doctor, radiologist
or pharmacist if you are taking or have recently taken medicines for
heart and blood pressure disorders such as beta-blocking agents (such as
metoprolol), vasoactive substances (such as doxazosin), angiotensinconverting enzyme inhibitors (such as ramipril), angiontensin II receptor
antagonists (such as valsartan).
Dotagraf with food, drink and alcohol
There are no known interactions between Dotagraf and food and drinks.
However, please check with your doctor, radiologist or pharmacist if it is
required not to eat or drink before the examination.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor or radiologist for advice before
taking this medicine.
Pregnancy
Dotagraf should not be used during pregnancy unless strictly necessary.
Breastfeeding
Your doctor or radiologist will discuss whether you should continue
breast-feeding or interrupt breast-feeding for a period of 24 hours after
you receive Dotagraf.
Driving and using machines
No data are available on the effects of Dotagraf on the ability to drive.
If you feel unwell after the examination, you should not drive or use
machines.

3. HOW DOTAGRAF IS USED
Dotagraf will be administered to you by intravenous injection.
During the examination, you will be under the supervision of a doctor or
radiologist. A needle will be left in your vein; this will allow the doctor or
radiologist to inject you with appropriate emergency drugs if necessary.
If you experience an allergic reaction, the administration of Dotagraf will
be stopped.
Dotagraf can be administered by hand or by the mean of an automatic
injector. In children, the product will only be administered by hand.
The procedure will be carried out in a hospital, clinic or private practice.
The attending staff know what precautions have to be taken for the
examination. They are also aware of the possible complications that can
occur.
Dosage
Your doctor or radiologist will determine the dose you will receive and
supervise the injection.
Dosage in special patient groups
The use of Dotagraf 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 Dotagraf during a scan and you should not receive a second
injection for at least 7 days.
Neonates, infants, children and adolescents
As kidney function is immature in babies up to 4 weeks of age and
infants up to 1 year of age, Dotagraf will only be used in these patients
after careful consideration by the doctor. Neonates and infants should
only receive one dose of Dotagraf during a scan and should not receive a
second injection for at least 7 days.
Use for angiography is not recommended in children less than 18 years
of age.
Use for whole body MRI is not recommended in children less than 6
months of age.
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 too much Dotagraf has been administered to you
It is highly unlikely that you will be given an overdose. You will be given
Dotagraf in a medical setting by a trained person. In the real case of
overdose, Dotagraf can be removed from the body by haemodialysis
(blood cleaning).
Additional information regarding the use and handling by the medical or
healthcare professional is given at the end of this leaflet.
If you have any further questions on the use of this medicine, ask your
doctor or radiologist.

Prepare a syringe with a needle. Remove the plastic disk. After cleaning
the stopper with a pad soaked in alcohol, puncture the stopper with the
needle. Withdraw the quantity of product required for the examination
and inject it intravenously.
For single use only, any unused solution should be discarded.
The solution for injection should be inspected visually prior to use. Only
clear solutions free of visible particles should be used.
Impaired renal function
Prior to administration of Dotagraf, it is recommended that all
patients are screened for renal dysfunction by obtaining laboratory
tests:
There have been reports of nephrogenic systemic fibrosis (NSF) associated
with use of some gadolinium- containing contrast agents in patients
with acute or chronic severe renal impairment (GFR < 30ml/min/1.73m2).
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 Dotagraf, 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
Dotagraf, 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, Dotagraf injections should not
be repeated unless the interval between injections is at least 7 days.
Haemodialysis shortly after Dotagraf administration may be useful at
removing Dotagraf 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.
Elderly
As the renal clearance of gadoteric acid may be impaired in the elderly, it
is particularly important to screen patients aged 65 years and older for
renal dysfunction.
Neonates and infants
See under Posology, Children
Pregnancy and lactation
Dotagraf should not be used during pregnancy unless the clinical
condition of the woman requires use of gadoteric acid.
Continuing or discontinuing breast feeding for a period of 24 hours after
administration of Dotagraf, should be at the discretion of the doctor and
lactating mother.
Instructions on handling
The peel-off tracking label on the vials should be stuck onto the patient
record to enable accurate recording of the gadolinium contrast agent
used. The dose used should also be recorded. If electronic patient records
are used, the name of the product, the batch number and the dose
should be entered into the patient record.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
After the administration, you will be kept under observation for at least
half an hour. Most side effects occur immediately or sometimes delayed.
Some effects can occur up to seven days after Dotagraf injection.
There is a small risk that you may have an allergic reaction to
Dotagraf. Such reactions can be severe and result in shock (case of
allergic reaction that could put your life in danger). The following
symptoms may be the first signs of a shock. Inform immediately your
doctor, radiologist or health professional if you feel any of them:
P swelling of the face, mouth or throat which may cause you
difficulties in swallowing or breathing
P swelling of hands or feet
P lightheadedness (hypotension)
P breathing difficulties
P whistling respiration
P coughing
P itching
P runny nose
P sneezing
P eye irritation
P hives
P skin rash
Very common side effects (may affect more than 1 in 10 people)
P headaches
P tingling sensation
Common side effects (may affect up to 1 in 10 people)
P sensation of warmth or cold and/or pain at the injection site
P nausea (feeling sick)
P vomiting (being sick)
P redness of the skin, itching and rash
Uncommon side effects (may affect up to 1 in 100 people)
P allergic reactions
Rare side effects (may affect up to 1 in 1,000 people)
P unusual taste in the mouth
P hives, increased perspiration
Very rare side effects (may affect up to 1 in 10,000 people)
P agitation, anxiety
P coma, seizures, syncope (brief loss of consciousness), faintness
(dizziness and feeling of imminent loss of consciousness), dizziness,
disorder of smell (perception of often unpleasant odours), tremor
P conjunctivitis, red eye, blurred vision, increased tear secretion, eye
swelling
P cardiac arrest, accelerated or slow heart beat, irregular heart beat,
palpitations, low or high blood pressure, vascular dilatation, pallor
P respiratory arrest, pulmonary oedema, breathing difficulties,
feeling of tight throat, wheezing, stuffy nose, sneezing, cough, dry
throat
P diarrhoea, stomach pain, increased saliva secretion
P eczema
P muscle contractures, muscle weakness, back pain
P malaise, chest pain, chest discomfort, fever, chills, swelling of the
face, fatigue, injection site discomfort, injection site reaction,
injection site swelling, diffusion of the product outside of blood
vessels that can lead to inflammation (redness and local pain) or
tissue dying off at the injection site, inflammation of a vein
P decrease in oxygen level in blood
There have been reports of nephrogenic systemic fibrosis (which causes
hardening of the skin and may affect also soft tissue and internal
organs), most of which were in patients who received Dotagraf together
with other gadolinium-containing contrast agents. If, during the weeks
following the MRI examination, you notice changes in the colour and/or
thickness of your skin in any part of your body, inform the radiologist
who performed the examination.
If you get any side effects, talk to your doctor or radiologist. This includes
any side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your radiologist, pharmacist, doctor or
nurse. This includes any possible 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 DOTAGRAF
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special precaution for
storage.
Chemical and physical in-use stability has been demonstrated 72 hours
at room temperature. 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 and
would normally not be longer that 24 hours at 2 to 8°C, unless opening
has taken place in controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the vial
and on the carton, after the abbreviation “Exp”. The expiry date refers to
the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dotagraf contains
R The active substance is gadoteric acid. One millilitre of solution for
injection contains 279.32 mg of gadoteric acid (as meglumine salt),
equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).
R The other ingredients are meglumine, DOTA and water for injection.
What Dotagraf looks like and contents of the pack
Dotagraf is a clear, colourless to yellow solution for intravenous
injection.
The Dotagraf pack contains one or ten vials with 10, 15 and 20 ml of
solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder United Kingdom
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
2491 Neufeld/Leitha, Austria
This leaflet was last revised in March 2017

1.3.2

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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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