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ULTRAVIST 150

Active substance(s): IOPROMIDE

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Packaging Technology Berlin sgqwx
page 1
Bayer Pharma AG
client: 0021
material-no.: 85021990
PZ: 2663O-3
code-no.:
name: LF-INS-Ultravist 150 BT
country: GB/-/BPH
colors: Black
version: 23.03.2016/05
approval:
dimension: 353 x 770 mm

85021990

Package leaflet: Information for the patient.

Ultravist® 150
Ultravist® 240
Ultravist® 300
Ultravist® 370
Iopromide
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 staff.
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
Ultravist
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 iodine-containing 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
arteriosclerosis)

diabetes mellitus
damaged lungs (pulmonary emphysema)
poor general health
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-mediumrelated 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
getting 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 biguanides (metformin) because
you may be at increased risk of developing lactic
acidosis (too much acid in the blood).
Ask the X-ray department staff if you are not sure.
R
R
R
R

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 include:
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 200ml.
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.
However, as with similar contrast media, severe and
life-threatening reactions including life-threatening
skin rashes (Stevens-Johnson syndrome), as well as
deaths, have been reported.





Ultravist® 150
SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Ultravist® 150

2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
1ml contains 312mg of iopromide (equivalent to
150mg 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 intraarterial digital
subtraction angiography and for checking the
function of a dialysis shunt.
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.
Adults:
R Intraarterial DSA
Intraarterial digital subtraction angiography
requires smaller volumes and lower iodine
concentrations than with conventional
angiography.
For high-contrast demonstration of the arteries
of the head, neck and extremities, several
injections of 10-40ml Ultravist 150 - depending
on the size of the vessels - are usually given
directly or via a catheter.
Larger volumes of contrast medium (about
200ml) may be necessary in some cases to
demonstrate the vessels of the lower extremity,
e.g. if both legs are to be examined.
R Dialysis shunt
Ultravist 150 is suitable for checking the function
of a dialysis shunt. About 10ml of contrast
medium are required for this.
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).
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 media-induced 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
disorders.
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 beta-agonists (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 allergylike reactions, patients with a previous moderate or
severe acute reaction, asthma or allergy requiring
medical treatment, premedication with a
corticosteroid regimen may be considered.
In order to minimise risk if a severe reaction should
occur, patients:
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
consideration.
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 hyperuricaemia, as well as to newborns,
infants, 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 procedures.
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 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 ’sodiumfree’.
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 measurements of
kidney function, the need for an interruption in the
metformin administration should be considered.
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
Pregnancy
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.
Breast-feeding
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 literature.
The most frequently observed adverse drug
reactions ( ≥ 4%) in patients receiving Ultravist
are headache, nausea and vasodilatation.
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

85021990_05.indd 1

23.03.2016 13:01:57

Packaging Technology Berlin sgqwx
page 2
Bayer Pharma AG
client: 0021
material-no.: 85021990
PZ: 2663O-3
code-no.:
name: LF-INS-Ultravist 150 BT
country: GB/-/BPH
colors: Black
version: 23.03.2016/05
approval:
dimension: 353 x 770 mm

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 attention.
Apart from the symptoms listed above, these are the
other side effects of Ultravist, starting with the more
common ones:
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.
Uncommon
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

Rare
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 hearing
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Ultravist
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 after EXP. The expiry date refers
to the last day of that month.
Protect from light and X-rays. Do not store above
30°C.

6. Contents of the pack and other
information
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 injections.
What Ultravist looks like and contents of the pack
Ultravist is a solution for injection.
Ultravist 150 is available in packs of ten 50ml vials.
Ultravist 240 is available in packs of ten 50ml
bottles.
Ultravist 300 is available in packs of ten 20ml vials,
packs of ten 50ml, or 75ml bottles and in single
100ml and 200ml bottles.
Ultravist 370 is available in packs of ten 50ml, or
75ml 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
UK
Manufacturer: Bayer Pharma AG
Berlin
Germany
This leaflet was last revised in March 2016.
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000
(UK only)
Please be ready to give the following
information:
Product name

Reference number

Ultravist 150
Ultravist 240
Ultravist 300
Ultravist 370

00010/0564
00010/0565
00010/0566
00010/0567

This is a service provided by the Royal
National Institute of the Blind.




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
convention:
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'.

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

Common

Immune system
disorders

Uncommon

Rare

Not known

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,
angioedema)

Endocrine disorders

Thyrotoxic crisis, Thyroid
disorder

Psychiatric disorders
Nervous system
Dizziness,
disorders
Headache,
Dysgeusia

Eye disorders
Ear and labyrinth
disorders
Cardiac disorders

Vascular disorders

Coma*,
Cerebral ischaemia /
Infarction*,
Stroke*,
Brain oedemaa*,
Convulsion*,
Transient cortical
blindnessa,
Loss of
consciousness,
Agitation,
Amnesia,
Tremor,
Speech disorders,
Paresis / paralysis

Blurred /
disturbed vision
Hearing disorders
Chest pain /
discomfort

Arrhythmia*

Hypertension,
Vasodilatation

Hypotension*

Respiratory, thoracic
and mediastinal
disorders
Gastrointestinal
Vomiting,
disorders
Nausea
Skin and
subcutaneous tissue
disorders
Musculoskeletal,
connective tissue
and bone disorders
Renal and urinary
disorders
General disorders
and administration
site conditions

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

Pain, Injection
site reactions
(various kinds,
e.g. pain,
warmth§,
oedema§,
inflammation§
and soft tissue
injury§ in case
of
extravasation),
Feeling hot

Cardiac arrest*, Myocardial infarction*,
Myocardial
Cardiac failure*, Bradycardia*,
Tachycardia, Cyanosis*
ischaemia*
Palpitations,
Shock*, Thromboembolic
eventsa, Vasospasma
Pulmonary oedema*,
Respiratory insufficiency*,
Aspiration*
Dysphagia, Salivary gland
enlargement, Diarrhoea
Bullous conditions (e.g.
Stevens-Johnson’s or Lyell
syndrome), Rash, Erythema,
Hyperhydrosis
Compartment syndrome in
case of extravasationa

Dyspnoea*

Abdominal pain

Renal impairmenta
Acute renal failurea
Malaise, Chills, Pallor

Oedema

Investigations
*
a
§

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:
www.mhra.gov.uk/yellowcard.
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
Non-ionic contrast media have little pharmacological
activity. The sole desired action of Ultravist 150 is the
absorption of x-rays. This action is ensured through
3 atoms of the relatively heavy element, iodine, in
one iopromide molecule.
Ultravist 150 has been developed for intraarterial
digital subtraction angiography. The high sensitivity

85021990_05.indd 2

Body temperature
fluctuations

of this examination method allows the injection of a
lower contrast medium volume in a lower
concentration than the intravenous technique.
Ultravist 150 is well tolerated. 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
(mg/ml)
Osmolality
(osm/kg H2O) at
37 °C
Viscosity (mPa·s)
at 20 °C
at 37 °C
Density (g/ml)
at 20 °C
at 37 °C

150

240

300

370

0.33

0.48

0.59

0.77

2.3
1.5

4.9
2.8

8.9
4.7

22.0
10.0

1.164
1.158

1.263
1.255

1.328
1.322

1.409
1.399

volume at steady state is about 16 L corresponding
to the volume of the extracellular space.
Protein binding is negligible (about 1 %). There is no
indication that iopromide crossed the intact bloodbrain barrier. A small amount crossed the placental
barrier in animal studies (<0.3% of the dose was
found in rabbit foetuses).
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
Colourless glass infusion vials of 50ml.
Packs of 10 x 50ml are available.
6.6 Special precautions for disposal and other
handling
Contrast media should be visually inspected prior to
use and must 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 the 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
PL 00010/0564

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
distribution into the extracellular space and
subsequent elimination. The total distribution

9. DATE OF FIRST AUTHORISATION/
RENEWAL OF THE AUTHORISATION
01 May 2008

10. DATE OF REVISION OF THE TEXT
To be updated once the variation is approved

85021990

23.03.2016 13:02:23

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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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