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DOTAGITA 0.5 MMOL/ML SOLUTION FOR INJECTION

Active substance(s): DOTA / GADOLINIUM OXIDE / GADOTERIC ACID

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UK

3

Package leaflet:
Information for the user

Dotagita™ 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.
∙ Keep this leaflet. You may need to read it again.
∙ If you have any further questions, ask your doctor, pharmacist or nurse.
∙ This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
∙ If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dotagita is and what it is used for
2. What you need to know before you use Dotagita
3. How you will be given Dotagita
4. Possible side effects
5. How to store Dotagita
6. Contents of the pack and other information

1

What Dotagita is and what it is used for

Dotagita is a diagnostic agent used in adults and children. It belongs to the
group of contrast agents used for magnetic resonance imaging (MRI).
Dotagita is used to enhance the contrast of the images obtained during MRI
examinations. This contrast enhancement improves the examination of some
areas of the body.
This medicine is for diagnostic use only.

2

What you need to know before you use Dotagita

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 Dotagita.
You should not be given Dotagita:
∙ if you are allergic (hypersensitive) to gadoteric acid, to meglumine or to
any medicinal products containing gadolinium (like other contrast agents
used for MRI) or to any of the other ingredients contained in this medicine
mentioned in section 6.
Warnings and precautions
Talk to your doctor or radiologist if the following applies to you:
∙ you have previously reacted to a contrast agent during an examination
∙ you have asthma
∙ you have a history of allergies (such as seafood allergy, urticaria, hay
fever)
∙ you are taking a beta-blocker (a medicine used against high blood
pressure, heart problems and other conditions; such as metoprolol)
∙ your kidneys do not work properly
∙ you have recently had, or soon expect to have, a liver transplant
∙ you have a disease affecting your heart or blood vessels
∙ 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 Dotagita. If you are given
Dotagita, your doctor or radiologist will take the precautions necessary and
the administration of Dotagita 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 Dotagita,
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, Dotagita will only be used in these patients after
careful consideration by the doctor.
Remove all metallic objects that you wear before the examination.
Inform your doctor if you have:
∙ a pacemaker
∙ a vascular clip
∙ an infusion pump
∙ a nerve stimulator
∙ a cochlear implant (implant in the inner ear)
∙ any suspected metallic foreign bodies, particularly in the eye.
This is extremely important as these can result in serious problems, as
magnetic resonance imaging devices use very strong magnetic fields.
Other medicines and Dotagita
Tell your doctor, radiologist or pharmacist if you are taking, have recently
taken or might take any other medicines. In particular, please inform your
doctor or radiologist 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).
Dotagita with food and drink
There are no known interactions between Dotagita 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 and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor, radiologist or pharmacist for
advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are or might become pregnant as
Dotagita 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 breast-feeding or
interrupt breast-feeding for a period of 24 hours after you receive Dotagita.
Driving and using machines
No data are available on the effects of Dotagita on the ability to drive. If
you feel unwell after the examination, you should not drive or use machines.

How you will be given Dotagita

Dotagita will be given by an authorised healthcare professional directly into
a vein (intravenously).
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 medicines if necessary.
If you experience an allergic reaction, the administration of Dotagita will be
stopped.
Dotagita 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.
Dose
Your doctor or radiologist will determine the dose you will receive and
supervise the injection.
Dose in special patient groups
The use of Dotagita 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 Dotagita 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 in infants
up to 1 year of age, Dotagita will only be used in these patients after
careful consideration by the doctor. Children should only receive one dose
of Dotagita 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.
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 Dotagita has been administered to you
It is highly unlikely that you will be given an overdose. You will be given
Dotagita in a medical setting by a trained person. In the real case of
overdose, Dotagita 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.

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 Dotagita injection.
There is a small risk that you may have an allergic reaction to Dotagita.
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:
∙ swelling of the face, mouth or throat which may cause you difficulties in
swallowing or breathing
∙ swelling of hands or feet
∙ lightheadedness (hypotension)
∙ breathing difficulties
∙ whistling respiration
∙ coughing
∙ itching
∙ runny nose
∙ sneezing
∙ eye irritation
∙ hives
∙ skin rash
Altogether, the side effects which have been described for Dotagita are the
following:
Very common side effects (may affect more than 1 in 10 people):
headaches
∙ tingling sensation


Common side effects (may affect up to 1 in 10 people):
sensation of warmth or cold and/or pain at the injection site
∙ nausea (feeling sick)
∙ vomiting (being sick)
∙ redness of the skin, itching and rash



Uncommon side effects (may affect up to 1 in 100 people):
∙ allergic reactions
Rare side effects (may affect up to 1 in 1,000 people):
∙ unusual taste in the mouth
∙ hives, increased perspiration
Very rare side effects (may affect up to 1 in 10,000 people):
agitation, anxiety
∙ 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
∙ conjunctivitis, red eye, blurred vision, increased tear secretion, eye
swelling
∙ cardiac arrest, accelerated or slow heart beat, irregular heart beat,
palpitations, low or high blood pressure, vascular dilatation, pallor
∙ respiratory arrest, pulmonary oedema, breathing difficulties, feeling of
tight throat, wheezing, stuffy nose, sneezing, cough, dry throat
∙ diarrhoea, stomach pain, increased saliva secretion
∙ eczema
∙ muscle contractures, muscle weakness, back pain
∙ 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
∙ decrease in oxygen level in blood


Not known (frequency cannot be estimated from the available data):
nephrogenic systemic fibrosis



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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 Dotagita 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.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5

The following information is intended for healthcare professionals only:
Posology


Brain and spinal MRI:
In neurological examinations, the recommended dose is 0.1 mmol/kg
body weight, corresponding to 0.2 ml/kg body weight. In some cases,
after administration of 0.1 mmol/kg body weight to patients with brain
tumours, an additional dose of 0.2 mmol/kg body corresponding to
0.4 ml/kg body weight, may improve tumour characterisation and
facilitate therapeutic decision-making.



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.



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 body weight, equivalent to
0.2 ml/kg body weight may be justified. However, if the use of 2
consecutive doses of Dotagita is anticipated prior to commencing
angiography, use of 0.05 mmol/kg body weight, equivalent to 0.1ml/kg
body weight for each dose may be of benefit, depending on the imaging
equipment available.



Children: The 0.1 mmol/kg body weight 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 in
infants up to 1 year of age, Dotagita should only be used to this group of
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, Dotagita
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.



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”.



Patients with hepatic impairment: The adult dose applies to these patients.
Caution is recommended, especially in the case of perioperative liver
transplantation period.

How to store Dotagita

This medicinal product does not require any special storage conditions.
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 vial and
on the carton, after the abbreviation “Exp”. The expiry date refers to the last
day of that month.
Do not use this medicinal product, if you have found any visible signs of
damage (for example, particles in the solution of cracks in the glass vial).
Chemical and physical in-use stability has been demonstrated for 48 hours
at 21°C to 23°C.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and conditions are
the responsibility of the user and would normally not be longer than 24
hours at 2°C to 8°C, unless opening has taken place in controlled and
validated aseptic conditions.
Contents not used in a patient during one investigation must be discarded.
Each vial is for single patient use only.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other information

What Dotagita contains
The active substance is gadoteric acid. One ml solution for injection
contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to
0.5 mmol.





Method of administration
Dotagita is indicated for intravenous administration only.
Dotagita 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.



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.



Each vial is for single patient use only. Contents not used in a patient
during one investigation must be discarded.



The solution for injection should be inspected visually prior to use. Only
clear solutions free of visible particles should be used.

The other ingredients are meglumine and water for injection.

What Dotagita looks like and contents of the pack
Dotagita is a clear, colourless to pale yellow solution practically free from
visible particles, for intravenous injection. Each pack contains one or 10
single-dose vials with 10 ml (filled with 5 ml or 10 ml), and 20 ml (filled with
15 ml or 20 ml) or 60 ml of solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Agfa HealthCare Imaging Agents GmbH
Am Coloneum 4
50829 Cologne
Germany
This leaflet was last revised in 07/2015

Impaired renal function
Prior to administration of Dotagita, 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 Dotagita, 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 Dotagita,
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, Dotagita injections should not be repeated unless
the interval between injections is at least 7 days.
Haemodialysis shortly after Dotagita administration may be useful at
removing Dotagita 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.
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.

1354-2-05/15

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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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