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Ultravist® 150
Ultravist® 240
Ultravist® 300
Ultravist® 370
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, ask the doctor giving
you Ultravist (the radiologist) or the X-ray department
R If you get any side effects, talk to your doctor or the
X-ray department staff / radiologist. This includes any
possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Ultravist is and what it is used for
2. What you need to know before you are given
3. How you will be given Ultravist
4. Possible side effects
5. How to store Ultravist
6. Contents of the pack and other information

1. What Ultravist is and what it is
used for
Ultravist is an injectable contrast medium (a dye) which
contains iodine. It is used to clearly show on X-rays the area
of your body that your doctor wants to investigate.
X-rays, like radio waves, can pass through objects and can
be focused to make a picture. When you have an X-ray, the
beam of rays goes through your body where it is absorbed
to differing degrees by different tissues such as bones,
muscles and organs. When the rays come out on the other
side they make a pattern of light and shade on a picture.
Ultravist helps to make this pattern clearer. The picture is
then examined by a specialist who will make a diagnosis.
This medicine is for diagnostic use only.

2. What you need to know before you
are given Ultravist
Do not use Ultravist
R if you have a condition caused by too much thyroid
hormone (uncontrolled thyrotoxicosis).
Warning and precautions
Talk to your doctor or the X-ray department staff/radiologist
before receiving Ultravist
Tell your doctor or the X-ray department staff if you are, or
suspect you are, allergic to Iopromide, iodine or iodinecontaining contrast media or any of the other ingredients of
this medicine (listed in section 6).
Tell your doctor or the X-ray department staff if you have
any of the following:
R reduced liver or kidney function
R epilepsy, a history of seizures, or any other condition
affecting the brain

R reduced urine production (oliguria) or passing large
volumes of urine (polyuria)
R gout (high level of uric acid in the blood)
R a disease of blood vessels in the brain (cerebral
R diabetes mellitus
R damaged lungs (pulmonary emphysema)
R poor general health
R an overactive thyroid gland (hyperthyroidism) or a
swollen neck due to an enlarged thyroid gland (benign
nodular goitre)
R multiple myeloma (cancer of the plasma cells in bone
marrow) / paraproteinaemia (excessive amounts of a
paraprotein in the blood)
R had repetitive and/or large doses of iodinated contrast
media like Ultravist
R a history of allergy or a tendency to develop
hypersensitivity reactions (for example if you have hay
fever, asthma or eczema). Your doctor might give you a
corticosteroid (a medicine used to treat inflammation)
prior to your examination
R heart or blood circulation problems, because in the rare
event that you have an allergic reaction, it is more likely
to be serious or fatal
R previously had a reaction to any contrast media.
R chronic disorder of the muscles (myasthenia gravis)
Allergy-like reactions may occur after the use of Ultravist.
Severe reactions are possible (see ‘Possible side effects’).
Most of these reactions occur within 30 minutes after
administration. Therefore, you will be observed for at least
30 minutes after the injection. However, delayed reactions
(after hours to days) may occur.
If you have a phaeochromocytoma (tumour of the adrenal
gland) you may be at an increased risk of getting a
hypertensive crisis (severe form of high blood pressure).
Ultravist may affect the results of an iodine test for
thyroid disease. Always tell your doctor or the laboratory
staff that you have been given Ultravist recently.
Before you are given Ultravist, tell your doctor or the
radiologist if you are feeling anxious – pronounced states of
excitement, anxiety and pain may increase the risk of side
effects or intensify contrast-medium-related reactions (see
‘Possible side effects’).
Other medicines and Ultravist
Tell the radiologist or X-ray department staff if you are
taking, have recently taken or might take any other
medicines. This is particularly important for:
R beta-blockers (medicines used to treat high blood
pressure), as beta-agonists (which may be used to treat
any side effects caused by Ultravist) may not be effective
R if you have been treated with a drug called interleukin,
because there is a higher chance of developing delayed
reactions (e.g. fever flu-like symptoms, joint pain and
pruritus (itching))
R if you have kidney disease due to diabetes (diabetic
nephropathy) and are taking a type of medicine called

Ultravist® 240
Ultravist® 300
Ultravist® 370
Summary of Product Characteristics
1. Name of the Medicinal Product
Ultravist® 240
Ultravist® 300
Ultravist® 370

2. Qualitative and quantitative
1ml of Ultravist 240 contains 499mg of iopromide
(equivalent to 240mg iodine)
1ml of Ultravist 300 contains 623mg of iopromide
(equivalent to 300mg iodine)
1ml of Ultravist 370 contains 769mg of iopromide
(equivalent to 370mg iodine)
Excipient with known effect
Sodium calcium edetate: Each ml contains 0.000534 mmol
(equivalent to 0.0123 mg) of sodium
For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Aqueous solution for injection.
Clear, colourless to pale yellow solution

4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
X-ray contrast medium for computerised tomography,
digital subtraction angiography, intravenous urography,
venography (phlebography), arteriography, arthrography,
hysterosalpingography and fistulography.
4.2 Posology and method of administration
R General information
Experience shows that contrast medium is tolerated better
if it is warmed to body temperature.
Intravenous urography
Adults: The minimum dose is 0.8ml/kg body weight Ultravist
370, (1ml/kg Ultravist 300 or 1.3ml/kg Ultravist 240). These
doses should provide adequate filling of the ureters. It may
be necessary to increase the dose in individual cases.
Children: The poor concentrating ability of the immature
nephron of infantile kidneys necessitates the use of
relatively high doses of contrast medium, i.e. for Ultravist
4.0 ml/kg body weight
3.0 ml/kg body weight
Small children:
1.5 ml/kg body weight
Computerised tomography
Cranial CT: The following dosages are recommended for
cranial CT:
Ultravist 240:
1.5–2.5ml/kg body weight
Ultravist 300:
1–2ml/kg body weight
Ultravist 370:
1–1.5ml/kg body weight
Whole-body CT: For whole-body computerised tomography,
the doses of contrast medium and the rates of
administration depend on the organs under investigation,
the diagnostic problem and, in particular, the different scan
and image-reconstruction times of the scanners in use.
Angiography: The dosage depends on the age, weight,
cardiac output and general condition of the patient, the
clinical problem, examination technique and the nature and
volume of the vascular region to be investigated.
The following dosages may serve as a guide:
Cerebral angiography
Aortic arch angiography
50–80 ml Ultravist 300/inj.
Selective angiography
6–15 ml Ultravist 300/inj.
Retrograde carotid angiography 30–40 ml Ultravist 300/inj.
Thoracic aortography:
50–80 ml Ultravist 300/inj.
Abdominal aortography:
40–60 ml Ultravist 300/inj.
Bifemoral arteriography:
40–60 ml Ultravist 300/inj.
Peripheral angiography:
Upper extremities:
8–12 ml Ultravist 300/inj.
50–60 ml Ultravist 240/inj.
15–30 ml Ultravist 300/inj.
Lower extremities:
20–30 ml Ultravist 300/inj.
50–80 ml Ultravist 240/inj.
30–60 ml Ultravist 300/inj.
40–60 ml Ultravist 370/inj.
Coronary angiography:
5–8 ml Ultravist 370/inj.
Digital subtraction angiography (DSA): I.V. injection of
30–60 ml Ultravist 300 or 370 as a bolus (flow-rate:
8–12 ml/second into the cubital vein; 10–20 ml/second into
the vena cava) is recommended for high-contrast
demonstrations of the great vessels, of the pulmonary
arteries and of the arteries of the neck, head, kidneys and
Intra-arterial digital subtraction angiography requires
smaller volumes and lower iodine concentrations than the
intravenous technique.
R Additional information on special populations
P Paediatric population
Young infants (age < 1 year) and especially newborns are
susceptible to electrolyte imbalance and haemodynamic
alterations. Care should be taken regarding the dose of
contrast medium to be given, the technical performance of
the radiological procedure and the patient status (see
section 5.2).

85615696_02.indd 1

P Renal Impairment
Since iopromide is excreted almost exclusively in an
unchanged form via the kidneys, the elimination of
iopromide is prolonged in patients with renal impairment. In
order to reduce the risk of additional contrast mediainduced renal impairment in patients with pre-existing renal
impairment, the minimum possible dose should be used in
these patients (see also sections 4.4, 5.1 and 5.2).
P Patients with hepatic impairment
No dosage adjustment is necessary in patients with hepatic
impairment (see section 5.2).
P Elderly
When administered to elderly patients, the possibility of
reduced renal function (leading to reduced clearance) should
be considered (see section 5.2).
4.3 Contraindications
Uncontrolled thyrotoxicosis (see section 4.4).
4.4 Special warnings and precautions for use
R Hypersensitivity reactions
Ultravist can be associated with anaphylactoid/
hypersensitivity or other idiosyncratic reactions
characterised by cardiovascular, respiratory and cutaneous
manifestations. Allergy-like reactions ranging from mild to
severe reactions including shock are possible (see also
section 4.8). Most of these reactions occur within 30
minutes of administration. However, delayed reactions
(after hours to days) may occur.
The risk of hypersensitivity reactions is higher in the case of:
P previous reaction to contrast media
P history of bronchial asthma or other allergic
Particularly careful risk / benefit judgement is required in
patients with known hypersensitivity to Ultravist, or any
excipient of Ultravist, or with a previous hypersensitivity
reaction to any other iodinated contrast medium due to an
increased risk for hypersensitivity reactions (including
severe reactions). However, such reactions are irregular and
unpredictable in nature.
Patients who experience such reactions while taking beta
blockers may be resistant to treatment effects of betaagonists (see also section 4.5).
In the event of a severe hypersensitivity reaction, patients
with cardiovascular disease are more susceptible to serious
or even fatal outcomes.
Due to the possibility of severe hypersensitivity reactions
after administration, post-procedure observation of the
patient is recommended.
Preparedness for the institution of emergency measures is
necessary for all patients.
In patients with an increased risk of acute allergy-like
reactions, patients with a previous moderate or severe acute
reaction, asthma or allergy requiring medical treatment,
premedication with a corticosteroid regimen may be
In order to minimise risk if a severe reaction should occur,
P should lie down during Ultravist administration
P must be kept under close observation for 15 minutes
following the last injection as the majority of severe
reactions occur at this time
P should remain in the hospital environment (but not
necessarily the radiology department) for one hour
after the last injection, and should be advised to
return to the radiology department immediately if
any symptoms develop.
R Thyroid dysfunction
Particularly careful risk/benefit judgement is required in
patients with known or suspected hyperthyroidism or goitre,
as iodinated contrast media may induce hyperthyroidism
and thyrotoxic crisis in these patients. Testing of thyroid
function prior to Ultravist administration and/or preventive
thyrostatic medication may be considered in patients with
known or suspected hyperthyroidism.
In neonates, especially preterm infants, who have been
exposed to Ultravist either through the mother during
pregnancy or in the neonatal period, it is recommended to
monitor thyroid function, as exposure to excess iodine may
cause hypothyroidism, possibly requiring treatment.
R Cerebral arteriosclerosis, pulmonary emphysema or
poor general health
For patients with cerebral arteriosclerosis, pulmonary
emphysema or poor general health, the need for
examination with X-ray contrast media merits careful
R Renal impairment
Contrast media-induced nephrotoxicity, presenting as a
transient impairment of renal function, may occur after
intravascular administration of Ultravist.
Acute renal failure may occur in rare cases.
Risk factors include, for example:
P pre-existing renal insufficiency
P dehydration
P diabetes mellitus
P multiple myeloma / paraproteinaemia
P repetitive and / or large doses of Ultravist.
Adequate hydration must be ensured in all patients who
receive Ultravist administration.
Patients on dialysis, if without residual function, may
receive Ultravist for radiological procedures as iodinated
contrast media are cleared by the dialysis process.
R Hydration
Adequate hydration must be assured before and after
intravascular Ultravist administration in order to minimise
the risk of contrast-media-induced nephrotoxicity (see also
section 4.2, 'Renal impairment'). This applies especially to
patients with multiple myeloma, diabetes mellitus, polyuria,
oliguria or hyperuricemia as well as to newborns, infants,

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Package leaflet: information for the patient

biguanides (metformin) because you may be at increased
risk of getting lactic acidosis (too much acid in the blood).
Ask the X-ray department staff if you are not sure.
Ultravist with food and drink
If the procedure is to look at your abdomen, kidneys or
bladder you may be asked to avoid foods that cause
flatulence (wind) for two days beforehand. These foods
P peas, beans, lentils, salads, fruit
P brown or granary bread
P all kinds of uncooked vegetables.
If you have a disorder of your body water and body salts
balance this will be corrected before the examination.
Do not reduce the amount you normally drink before the
investigation, especially if you have any of the following:
R multiple myeloma (disease of the bone marrow)
R diabetes mellitus
R polyuria (production of large amounts of urine which is
pale in colour)
R oliguria (production of small amounts of urine)
R gout.
Also, do not reduce the fluid intake of babies, young
children, or in someone who is in a very poor general state
of health.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask the doctor or
X-ray department staff /radiologist for advice before
receiving this medicine.
Driving and using machines
There is no known effect on the ability to drive or operate
machines. However, you should not drive or operate
machinery for 30 minutes after the examination as you may
have a delayed reaction to Ultravist.
Important information about some of the ingredients
of Ultravist
Ultravist contains sodium
Ultravist contains less than 1 mmol (23 mg) sodium per
dose (based on the average amount given to a 70 kg person),
i.e. essentially ‘sodium-free’.

3. How you will be given Ultravist
The staff in the X-ray department will decide how much
Ultravist is needed for your particular investigation. They
will explain how everything works and what position you
should lie in on the X-ray table.
The dose of Ultravist varies depending on the investigation
and your weight. The dose range is normally between 1 and
Once you lie down the Ultravist will be injected into a blood
vessel or body cavity.
If you receive more Ultravist than you should
Overdosing is unlikely. If it does happen the radiologist will
treat any symptoms that follow.
If you have any further questions on the use of this
medicine, ask your doctor or the X-ray department staff/
radiologist for advice before receiving this medicine.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Side effects you may get after being given a contrast
medium like Ultravist are usually mild to moderate and do
not last long.

small children and elderly patients. Existing disturbances of
the balance of water and electrolytes must be corrected
before the administration of Ultravist.
R Cardiovascular disease
Patients with significant cardiac disease or severe coronary
artery disease are at an increased risk of developing
clinically relevant haemodynamic changes and arrhythmia.
The intravascular injection of Ultravist may precipitate
pulmonary oedema in patients with heart failure.
R CNS disorders
Patients with CNS disorders may be at increased risk of
having neurological complications in relationship to
Ultravist administration. Neurological complications are
more frequent in cerebral angiography and related
Caution should be exercised in situations in which there may
be reduced seizure threshold, such as a previous history of
seizures and the use of certain concomitant medication.
Factors which increase blood-brain barrier permeability
facilitate the passage of the contrast medium into cerebral
tissue, possibly leading to CNS reactions.
R Myasthenia gravis
The administration of Ultravist may aggravate the
symptoms of myasthenia gravis.
R Thromboembolic events
A property of non-ionic contrast media is the low
interference with normal physiological functions. As a
consequence of this, non-ionic contrast media have less
anticoagulant activity in vitro than ionic media. Numerous
factors in addition to the contrast medium, including length
of procedure, number of injections, catheter and syringe
material, underlying disease state, and concomitant
medication may contribute to the development of
thromboembolic events. Therefore, when performing
vascular catheterisation procedures, one should be aware of
this and pay meticulous attention to the angiographic
technique and flush the catheter frequently with
physiological saline (if possible with the addition of heparin)
and minimise the length of the procedure so as to minimise
the risk of procedure-related thrombosis and embolism.
R Phaeochromocytoma
Patients with phaeochromocytoma may be at increased risk
of developing a hypertensive crisis.
R Anxiety
Pronounced states of excitement, anxiety and pain may
increase the risk of side effects or intensify contrast
medium-related reactions. Care should be taken to minimise
the state of anxiety in such patients.
R Myelography
Ultravist should not be used in myelography.
R Pretesting
Sensitivity testing using a small test dose of contrast
medium is not recommended as it has no predictive value.
Furthermore, sensitivity testing itself has occasionally led to
serious and even fatal hypersensitivity reactions.
R Ultravist contains sodium
Ultravist contains less than 1 mmol (23 mg) sodium per
dose (based on the average amount given to a 70 kg person),
i.e. essentially 'sodium-free'.
4.5 Interaction with other medicinal products and other
forms of interaction
Biguanides (metformin): In patients with acute kidney failure
or severe chronic kidney disease biguanide elimination can be
reduced leading to accumulation and the development of
lactic acidosis. As the application of Ultravist can lead to
renal impairment or an aggravation of renal impairment,
patients treated with metformin may be at an increased risk
of developing lactic acidosis, especially those with prior renal
impairment (see section 4.4 - 'Renal impairment'). Based on
the measurements of kidney function, the need for an
interruption in the metformin administration should be
Interleukin-2: Previous treatment (up to several weeks) with
Interleukin-2 is associated with an increased risk of delayed
reactions to Ultravist.
Radioisotopes: Diagnosis and treatment of thyroid disorders
with thyrotropic radioisotopes may be impeded for up to
several weeks after administration of Ultravist due to
reduced radioisotope uptake.
4.6 Fertility, pregnancy and lactation
Adequate and well-controlled studies in pregnant women
have not been conducted. Animal studies do not indicate
harmful effects with respect to pregnancy, embryonic /
foetal development, parturition or postnatal development
following diagnostic application of iopromide in humans.
Safety of Ultravist for nursed infants has not been
investigated. Contrast media are poorly excreted in human
breast milk. Harm to the nursed infant is unlikely (see also
section 4.4, ‘thyroid dysfunction’)
4.7 Effects on ability to drive and use machines
There is no known effect on the ability to drive or operate
machines. However, because of the risk of reactions, driving
or operating machinery is not advisable for 30 minutes after
the last injection (see Section 4.4).
4.8 Undesirable effects
Summary of the safety profile
The overall safety profile of Ultravist is based on data
obtained in pre-marketing studies in more than 3900
patients and post-marketing studies in more than 74,000
patients, as well as data from spontaneous reporting and
The most frequently observed adverse drug reactions (≥ 4%)
in patients receiving Ultravist are headache, nausea and
The most serious adverse drug reactions in patients
receiving Ultravist are anaphylactoid shock, respiratory
arrest, bronchospasm, laryngeal oedema, pharyngeal
oedema, asthma, coma, cerebral infarction, stroke, brain
oedema, convulsion, arrhythmia, cardiac arrest, myocardial
ischemia, myocardial infarction, cardiac failure,
bradycardia, cyanosis, hypotension, shock, dyspnoea,
pulmonary oedema, respiratory insufficiency and aspiration.

Please turn over J

4/18/2017 3:26:09 PM

client: 0021
material-no.: 85615696
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name: LF-INS-Ultravist 240/300/370
country: GB/-/BAG
colors: Black
version: 18.04.2017/02
Restricted Document
dimension: 353 x 770 mm

However, as with similar contrast media, severe and lifethreatening reactions including life-threatening skin rashes
(Stevens-Johnson syndrome), as well as deaths, have been
If you notice:
R itching of the skin, rash, wheals on the skin (urticaria)
R difficulty breathing, gagging, feeling of suffocation
R swelling of the face, neck or body
R itchy or watery eyes, tickling in the throat or nose,
hoarseness, coughing or sneezing
R headache, dizziness, feeling faint
R feeling particularly hot or cold, sweating
R paleness or reddening of the skin
R chest pain, cramp, tremor
R feeling sick
Tell the radiologist or X-ray staff immediately as these
may be the first signs of allergic reaction or shock. Your
investigation will need to be stopped, and you may need
further treatment.
Delayed reactions can occur, hours to days, after you have
been given Ultravist. If you develop a severe form of a skin
rash with flushing, fever, blisters,or ulcers, pain in your
joints or muscles or inflammation of the eye (Stevens
Johnson syndrome) you should seek immediate medical
Apart from the symptoms listed above, these are the other
side effects of Ultravist, starting with the more common
may affect up to 1 in 10 people
R problems with your sense of taste
R problems with your eyesight
R chest discomfort
R high blood pressure (hypertension)
R widening of the blood vessels (feeling of warmth)
R being sick
R a sensation of pain
R injection site reaction: pain; warmth; swelling;
inflammation and local skin reaction if the injection
does not go directly into the blood vessel.
may affect up to 1 in 100 people
R allergic reaction including allergy-like shock; runny
nose; difficulty breathing; stopped breathing
(respiratory arrest); asthma; swelling of the throat,
tongue or face, membranes and tissues
R confusion
R restlessness
R numbness and tingling; abnormal skin sensation, such
as burning, prickling; changes in body temperature
R drowsiness
R changes to heart beat; low blood pressure
R shortness of breath
R abdominal pain

may affect up to 1 in 1000 people
R anxiety
R cardiac arrest (heart stops); pain or tightness in the
chest; fast, slow or irregular heart beats
Not known: frequency cannot be estimated from the
available data
R altered thyroid gland function or a severe form of
overactive thyroid (thyrotoxic crisis)
R unconsciousness; coma; fit (convulsion); weakness
causing loss of movement; paralysis; decreased blood
flow to parts of the brain; stroke
R swelling of the brain
R temporary total or partial loss of vision
R agitation; loss of memory; problems with speech or
R fast or slow heart beat; heart attack; heart failure; blue
lips; blue or pale skin; shock; blockage of a blood vessel
by a clot; spasm in blood vessels causing decreased
blood flow;
R partial or complete loss of movement
R fluid in the lungs; severe skin disease (e.g. red, blistered,
bleeding, painful skin, which may affect the lips, eyes,
mouth, nose and genitals too)
R aspiration (taking foreign material into the lungs)
R difficulty swallowing; swelling of the salivary glands in
and around the mouth;
R diarrhoea
R changes in body temperature
R if the injection does not go directly into the blood vessel,
pressure in a muscle leading to muscle and nerve
damage and problems with blood flow
R kidney problems, kidney failure
R feeling unwell
Delayed reactions can occur, if you are concerned you
should contact your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, radiologist or
MRI-centre staff. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.

Tabulated list of adverse reactions
The adverse drug reactions observed with Ultravist are
represented in the table below.
They are classified according to System Organ Class.
The most appropriate MedDRA term is used to
describe a certain reaction and its synonyms and
related conditions.
Adverse drug reactions from clinical trials are
classified according to their frequencies. Frequency

groupings are defined according to the following
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
The adverse drug reactions identified only during
post-marketing surveillance and for which a
frequency could not be estimated are listed under
'not known'.

5. How to store Ultravist
Keep out of the reach and sight of children.
Do not use Ultravist after the expiry date which is stated on
the label. The expiry date refers to the last day of that
Protect from light and X-rays. Do not store above 30°C.

Table 1: Adverse drug reactions (ADRs) reported in clinical trials or during post-marketing surveillance in patients treated
with Ultravist.
System organ class
Immune system


Hypersensitivity /
anaphylactoid reactions
(Anaphylactoid shock§*,
respiratory arrest§*,
bronchospasm*, laryngeal* /
pharyngeal* / face oedema,
tongue oedema§, laryngeal /
pharyngeal spasm§, asthma§*,
conjunctivitis§, lacrimation§,
sneezing, cough, mucosal
oedema, rhinitis§,
hoarseness§, throat
irritation§, urticaria, pruritus,


Vasovagal reactions,
Confusional state,
Restlessness, Paraesthesia /
hypoaesthesia, Somnolence

Endocrine disorders
Psychiatric disorders
Nervous system

Eye disorders
Ear and labyrinth
Cardiac disorders

Vascular disorders
Respiratory, thoracic
and mediastinal
Skin and
subcutaneous tissue

Not known

Thyrotoxic crisis, Thyroid
Cerebral ischaemia /
Brain oedemaa*,
Transient cortical
Loss of
Speech disorders,
Paresis / paralysis

Blurred /
disturbed vision
Hearing disorders
Chest pain /



Cardiac arrest*,


Vomiting, Nausea Abdominal pain

connective tissue and
bone disorders
Renal and urinary

Myocardial infarction*,
Cardiac failure*,
Bradycardia*, Tachycardia,
Shock*, Thromboembolic
eventsa, Vasospasma
Pulmonary oedema*,
Respiratory insufficiency*,
Dysphagia, Salivary gland
enlargement, Diarrhoea
Bullous conditions (e.g.
Stevens-Johnson’s or Lyell
syndrome), Rash,
Erythema, Hyperhydrosis
Compartment syndrome in
case of extravasationa
Renal impairmenta
Acute renal failurea
Malaise, Chills, Pallor

General disorders and Pain, Injection site Oedema
administration site
reactions (various
kinds, e.g. pain,
and soft tissue
injury§ in case of
Feeling hot

Body temperature

*life threatening and / or fatal cases have been reported
intravascular use only
identified only during post-marketing surveillance (frequency not known)


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
4.9 Overdose
Symptoms may include fluid and electrolyte imbalance,
renal failure, cardiovascular and pulmonary complications.
In case of inadvertent intravascular overdosage, it is
recommended that fluids, electrolytes and renal function are
monitored. Treatment of overdose should be directed
towards the support of vital functions.
Ultravist is dialysable (see section 5.2).

5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Water soluble, nephrotropic,
low-osmolar X-ray contrast media
ATC code: V08AB05
Ultravist (iopromide) is a non-ionic contrast medium for
intravascular radiological examinations and has only
minimal pharmacological activity within the body.

The rate of protein binding is low and iopromide is a weak
liberator of histamine. Cardiovascular and renal tolerance
are good.
Ultravist has low osmolality.
The physico-chemical characteristics of the Ultravist range
are listed below:
Iodine concentration
150 240
Osmolality (osm/kg H2O)
at 37 ºC
0.33 0.48
0.59 0.77
Viscosity (mPa·s)
at 20 ºC
at 37 ºC
Density (g/ml)
at 20 ºC
1.164 1.263
1.328 1.409
at 37 ºC
1.158 1.255
1.322 1.399
5.2 Pharmacokinetic properties
Iopromide behaves in the organism like other highly
hydrophilic biologically inert, renally excreted compounds
(e.g. mannitol or inulin).
Following intravenous administration, plasma
concentrations of iopromide decline rapidly due to

6. Contents of the pack and other
What Ultravist contains
The active substance is iopromide.
1ml Ultravist 150 contains 312mg of iopromide (equivalent
to 150mg iodine).
1ml Ultravist 240 contains 499mg of iopromide (equivalent
to 240mg iodine).
1ml Ultravist 300 contains 623mg of iopromide (equivalent
to 300mg iodine).
1ml Ultravist 370 contains 769mg of iopromide (equivalent
to 370mg iodine).
The other ingredients are sodium calcium edetate (E 385),
trometamol, hydrochloric acid (diluted, 10%) and water for
What Ultravist looks like and contents of the pack
Ultravist is a solution for injection.
Ultravist 150 is available in packs of ten 50ml bottles.
Ultravist 240 is available in packs of ten 50ml bottles.
Ultravist 300 is available in packs of ten 20ml vials, packs of
ten 50ml bottles and in single 100ml and 200ml bottles.
Ultravist 370 is available in packs of ten 50ml bottles and in
single 100ml and 200ml bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer plc
Bayer House, Strawberry Hill
Newbury, Berkshire, RG14 1JA
Bayer AG
Müllerstrasse 178
13353 Berlin
This leaflet was last revised in April 2017.

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Ultravist 150
Ultravist 240
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Ultravist 370


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distribution into the extracellular space and subsequent
elimination. The total distribution volume at steady state is
about 16 L corresponding to the volume of the extracellular
Protein binding is negligible (about 1 %). There is no
indication that iopromide crossed the intact blood-brain
barrier. A small amount crossed the placental barrier in
animal studies (<0.3% of the dose was found in rabbit
Iopromide is not metabolised.
The terminal elimination half-life of iopromide is
approximately 2 hours, irrespective of the size of the dose.
In the dose range tested, the mean total clearance of
iopromide amounts to 106 ± 12ml/min and is similar to the
renal clearance of 102 ± 15ml/min. Thus, excretion of
iopromide is almost exclusively renal. Only about 2% of the
dose administered is excreted via the faecal route within
3 days.
Approximately 60% of the dose is excreted within 3 hours
after intravenous administration via urine. In the mean
≥ 93% of dose was recovered within 12 hours. Excretion is
essentially complete within 24 hours.
The pharmacokinetic parameters of iopromide in humans
change dose proportionally (e.g. Cmax, AUC) or are dose
independent (e.g. Vss, t1/2).
R Paediatric population:
There are no clinical pharmacokinetic data available for
iopromide in paediatric population.
R Patients with renal impairment:
In patients with impaired renal function, the plasma half-life
of iopromide is prolonged according to the reduced
glomerular filtration rate. The mean terminal half-life is 6.1
hours in mildly and moderately impaired patients and 11.6
hours in severely impaired patients not depending on dialysis.
Iopromide can be eliminated by haemodialysis.
Approximately 60% of the iopromide dose is removed during
3 hours of dialysis.
R Patients with hepatic impairment:
Elimination is not affected by impaired liver function.
5.3. Preclinical safety data
There are no pre-clinical safety data which could be of
relevance to the prescriber and which are not already
included in other relevant sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients
Sodium calcium edetate, trometamol, hydrochloric acid
(diluted 10%), water for injection.
6.2 Incompatibilities
Some radiologists give an antihistamine or a corticosteroid
prophylactically to patients with a history of allergy.
Because of possible precipitation, X-ray contrast media and
prophylactic agents must not be injected as mixed solutions.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 30°C. Protect from light and X-rays.
6.5 Nature and contents of container
Ultravist 240: Colourless glass infusion bottles of 50ml.
Packs of 10 x 50ml bottles.
Ultravist 300: Colourless glass infusion bottles of 50, 100
and 200ml. Colourless glass vials of 20ml. Packs of
10 x 20ml vials, 10 x 50 bottles and 1 x 100 or 200ml
Ultravist 370: Colourless glass infusion bottles of 50, 100
and 200ml. Packs of 10 x 50 bottles and 1 x 100 or 200ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Contrast media should be visually inspected prior to use and
not be used if discoloured, nor in the presence of particulate
matter (including crystals) or defective containers. As
Ultravist is a highly concentrated solution, crystallization
(milky-cloudy appearance and/or sediment at bottom, or
floating crystals) may occur very rarely.
The contrast medium solution should not be drawn up into
the syringe of the infusion bottle attached to the infusion
set until immediately before the examination.
Vials containing contrast medium are not intended for the
withdrawal of multiple doses. The rubber stopper should
never be pierced more than once.
Contrast medium solution not used in one examination
session must be discarded.

7. Marketing authorisation holder
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire RG14 1JA
United Kingdom

8. Marketing authorisation number
Ultravist 240: PL 00010/0565
Ultravist 300: PL 00010/0566
Ultravist 370: PL 00010/0567

9. Date of first authorisation/renewal
of the authorisation
Ultravist 240:
Date of first authorisation: 1 May 2008
Ultravist 300:
Date of first authorisation: 1 May 2008
Ultravist 370:
Date of first authorisation: 1 May 2008

10. Date of revision of the text
27 March 2017



85615696_02.indd 2

4/18/2017 3:26:20 PM

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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.