Dotagraf is a contrast agent that contains gadoteric acid. It is for
diagnostic use only.
Dotagraf is used to enhance the contrast of the images obtained in
examinations with Magnetic Resonance Imaging (MRI). This contrast
enhancement improves the visualisation and delineation in:
Adult and paediatric population (0 - 18 years)
MRI of the Central Nervous System including defects (lesions) in
brain, spinal cord and adjacent tissue;
Whole body MRI including defects (lesions) in liver, kidneys,
pancreas, pelvis, lungs, heart, breast and musculoskeletal system.
Adult population
MR angiography including defects (lesions) and narrowing
(stenosis) in arteries, except in coronary arteries.

You should NOT be given Dotagraf
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in section 6).
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:
RRyou have previously reacted to a contrast agent during an
examination
you have asthma
you have a history of allergy (such as seafood allergy, urticaria,
hay fever)
you are being treated with a beta-blocker (medicine for heart and
blood pressure disorders, 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 your blood vessels
you have had convulsions or you are being treated for epilepsy.
In all these cases, your doctor or radiologist will assess the benefitto-
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:
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 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, have recently taken
or might take 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, vasoactive substances, angiotensin-converting
enzyme inhibitors, angiontensin II receptor antagonists.
Dotagraf with food and drink
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 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 or radiologist for advice
before taking this medicine.
Pregnancy
Dotagraf should not be used during pregnancy unless strictly
necessary.
Breast-feeding
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.

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 neonates and infants, 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.
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.

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:
swelling of the face, mouth or throat which may cause you
difficulties in swallowing or breathing
swelling of hands or feet
lightheadedness (low blood pressure)
breathing difficulties
whistling respiration
coughing
itching
runny nose
sneezing
eye irritation
hives
skin rash
Uncommon side effects (may affect up to 1 in 100 people)
hypersensitivity (allergic reaction)
headaches
unusual taste in the mouth
dizziness
somnolence (sleepiness)
sensation of tinglings, warmth/burning, cold and/or pain
low or high blood pressure
nausea (feeling sick)
stomach pain
rash
feeling hot, feeling cold
asthenia (loss of energy; weakness)
injection site discomfort, injection site reaction, injections site
coldness, injection site swelling, diffusion of the product outside
of blood vessels that can lead to inflammation (redness and local
pain)
Rare side effects (may affect up to 1 in 1,000 people)
anxiety, faintness (dizziness and feeling of imminent loss of
consciousness)
eyelid swelling
palpitations
sneezing
vomiting (being sick)
diarrhea
increased saliva secretion
hives, itching, sweating
chest pain, chills
Very rare side effects: (may affect up to 1 in 10,000 people)
anaphylactic or anaphylactic-like reactions (a serious, potentially
life-threatening allergic reaction)
agitation
coma, seizures, syncope (brief loss of consciousness), disorder of
smell (perception of often unpleasant odours), tremor
conjunctivitis, red eye, blurred vision, increased tear secretion
cardiac arrest, accelerated or slow heart beat, irregular heart beat,
vascular dilatation, pallor
respiratory arrest, pulmonary oedema, breathing difficulties,
wheezing, stuffy nose, cough, dry throat, throat constriction with
feeling of suffocation, respiratory spasms, throat swelling
eczema, redness of the skin, swelling of the lips and localized in
the mouth
muscle cramps, muscle weakness, back pain
malaise, chest discomfort, fever, swelling of the face, diffusion of
the product outside of blood vessels that can lead to tissue dying
off at the injection site, inflammation of a vein
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.
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. By reporting side effects you can help provide more
information on the safety of this medicine.
To report any side effect(s):
The National Pharmacovigilance Centre (NPC).
Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa

Keep this medicine out of the sight and reach of children.
Store below 30°C .
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.