For a full list of excipients, see section 6.1.
Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray
contrast medium. Omnipaque in the concentration of 140 mg I/ml is
isotonic with blood and tissue fluid.
The osmolality and viscosity values of Omnipaque are as follows:

Concentration
140 mg I/ml
240 mg I/ml
300 mg I/ml
350 mg I/ml

Osmolality *
mOsm/kg H2O
37°C
290
510
640
780

Viscosity (mPa·s)*
20°C
37°C
2.3
1.5
5.6
3.3
11.6
6.1
23.3
10.6

PHARMACEUTICAL FORM

4.1 Indications
This medicinal product is for diagnostic use only.
X-ray contrast medium for use in adults and children for urography,
phlebography, i.v. DSA, CT, arteriography, cardioangiography and i.a.
DSA. Myelography. For use in body cavities: Arthrography, ERP/ERCP,
herniography, hysterosalpingography, sialography and use in the G-I tract.

4.2 Posology and method of administration
The dosage depends on the type of investigation and the technique used.
Usually the same iodine concentration and volume is used as for other
iodinated X-ray contrast media in current use.
Adequate hydration should be assured before and after administration as
for other contrast media.
For intravenous, intra-arterial and intrathecal use, and use in body
cavities.
The following dosages may serve as a guide:
Guidelines for intravenous use
Urography
Adults
Children < 7 kg
Children > 7 kg
Phlebography (leg)
Digital subtraction
angiography
Adults

For elderly patients, patients with hepatic and/or renal impairments, the
usual/proposed doses for adults can be used.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Manifest thyrotoxicosis.

4.4 Special warnings and precautions for use.
Special precautions for use of non-ionic monomeric contrast media in
general:
Hypersensitivity: A positive history of allergy, asthma, or untoward
reactions to iodinated contrast media indicates a need for special caution.
Any application of contrast media should, therefore, be preceded by a
detailed medical history, in patients with allergic diathesis and in patients
with known hypersensitivity reactions a very strict indication is required.
Premedication with corticosteroids or histamine H1 and H2 antagonists
might be considered in patients at risk for intolerance, they may, however,
not prevent anaphylactic shock, they may actually mask initial symptoms.
In patients with bronchial asthma especially the risk for bronchospasm is
increased.
The risk of serious reactions in connection with use of Omnipaque is
regarded as minor. However, iodinated contrast media may provoke
serious, life-threatening, fatal anaphylactic/anaphylactoid reactions or
other manifestations of hypersensitivity.
Independent of quantity and route of administration, symptoms such as
angio-oedema, conjunctivitis, coughing, pruritus, rhinitis, sneezing and
urticaria may be indicative of a serious anaphylactoid reaction requiring
treatment.
A course of action should therefore be planned in advance, with necessary
drugs and equipment, medical experience and skilled personnel available
for immediate treatment, should a serious reaction occur. In imminent
state of shock, administration of the contrast medium must be terminated
immediately and - if necessary - specific intravenous treatment must be
initiated. It is advisable always to use an indwelling cannula or catheter for
quick intravenous access throughout the entire X-ray procedure.
Patients using ß-blockers may present with atypical symptoms of
anaphylaxis which may be interpreted as vagal reaction.
Usually, hypersensitivity reactions become manifest as minor respiratory
or cutaneous symptoms, such as mild difficulties of breathing, skin
reddening (erythema), urticaria, pruritus or facial oedema. Severe
reactions such as angio-oedema, subglottis oedema, bronchial spasm and

shock are rare. These reactions usually occur within one hour following
application of the contrast medium. In rare cases, hypersensitivity
may occur delayed (after hours or days), but these cases are rarely life
threatening, and mainly affect the skin.
Coagulopathy
Catheter angiography with contrast media carries a risk to induce
thromboembolic events. In vitro, non-ionic contrast media have a weaker
coagulation inhibiting effect than ionic contrast media.
During catheterization it should be considered that besides the contrast
medium numerous other factors may also influence the development of
thromboembolic events.
These are: duration of the examination, number of injections, type
of catheter and syringe material, existing underlying diseases and
concomitant medication. When performing vascular catheterization
procedures one should pay meticulous attention to the angiographic
technique and flush the catheter frequently (e.g.: with heparinized saline)
so as to minimize the risk of procedure-related thrombosis and embolism.
The examination shall be kept as short as possible. Care should be taken in
patients with homocystinuria. (Risk for thromboembolism).
Hydration:
Adequate hydration should be assured before and after contrast media
administration. If necessary, the patient should be hydrated intravenously
until excretion of the contrast medium is complete. This applies especially
to patients with dys- and paraproteinaemias like multiple myeloma,
diabetes mellitus, renal dysfunction, hyperuricaemia, as well as to infants,
small children, elderly patients and patients in bad general condition. In
patients at risk the water and electrolyte metabolism must be controlled
and symptoms of a dropping serum calcium level must be taken care of.
Due to the risk of dehydration induced by diuretics, at first, water and
electrolyte rehydration is necessary to limit the risk of acute renal failure.
Cardio-circulatory reactions:
Care should also be taken in patients with serious cardiac disease /
cardio-circulatory disease and pulmonary hypertension as they may
develop haemodynamic changes or arrhythmias.
This is especially applicable following intracoronary, left and right
ventricular application of contrast media (see also section 4.8).
Patients with cardiac insufficiency, severe coronary heart disease, instable
angina pectoris, valvular diseases, previous myocardial infarction,
coronary bypass and pulmonary hypertension are especially predisposed
for cardiac reactions.
In elderly patients and patients with pre-existing cardiac diseases
reactions with ischemic changes in the ECG and arrhythmia occur more
frequently.
In patients with cardiac insufficiency intravasal injection of contrast media
can induce pulmonary oedema.
CNS disturbances:
Patients with acute cerebral pathology, tumours or a history of epilepsy
are predisposed for seizures and merit particular care. Also alcoholics
and drug addicts have an increased risk for seizures and neurological
reactions.
Caution is advised in intravascular application to patients with acute
cerebral infarction or acute intracranial bleeding as well as in patients
with diseases causing disturbance of the blood-brain barrier, in patients
with cerebral oedema, acute demyelinisation or advanced cerebral
atherosclerosis.
Neurological symptoms caused by metastases, degenerative or
inflammatory processes can be aggravated by application of contrast
media. Intra-arterial injection of contrast media may induce vasospasm
with resulting cerebral ischaemic phenomena.
Patients with symptomatic cerebrovascular diseases, previous stroke or
frequent transitory ischemic attacks are at increased risk for contrast
medium-induced neurological complications following intra-arterial
injection.
A few patients have experienced a temporary hearing loss or even
deafness after myelography, which is believed to be due to a drop in spinal
fluid pressure by the lumbar puncture per se.
Renal reactions:
Use of iodinated contrast media may cause contrast induced nephropathy,
impairment of renal function or acute renal failure. To prevent these
conditions following contrast media administration, special care should
be exercised in patients with preexisting renal impairment and diabetes
mellitus as they are at risk.
Other predisposing factors are preceding renal failure following
application of contrast media, a history of renal disease, age over
60 years, dehydration, advanced arteriosclerosis, decompensated cardiac
insufficiency, high doses of contrast media and multiple injections, direct
application of contrast media to the renal artery, exposition to further
nephrotoxins, severe and chronic hypertension, hyperuricaeia,,
paraproteinemias (myelomatosis and Waldenström’s macroglobulinemia,
plasmocytoma) or dysproteinemias.
Preventive measures include:
- Identification of high risk patients
- Ensuring adequate hydration. If necessary by maintaining an i.v. infusion
from before the procedure until the contrast medium has been cleared
by the kidneys.
- Avoiding additional strain on the kidneys in the form of nephrotoxic
drugs, oral cholecystographic agents, arterial clamping, renal arterial
angioplasty, or major surgery, until the contrast medium has been
cleared.
- Dose reduction to a minimum.
- Postponing a repeat contrast medium examination until renal function
returns to pre-examination levels.
Patients on haemodialysis may receive contrast media for radiological
procedures. Correlation of the time of contrast media injection with the
haemodialysis session is unnecessary.
Diabetic patients receiving metformin.
There is a risk of the development of lactic acidosis when iodinated
contrast agents are administered to diabetic patients treated with
metformin, particularly in those with impaired renal function. To reduce
the risk of lactic acidosis, the serum creatinine level should be measured
in diabetic patients treated with metformin prior to intravascular
administration of iodinated contrast media and the following precautions
undertaken in the following circumstances:
Normal serum creatinine (<130μmol/litre)/normal renal function:
Administration of metformin should be stopped at the time of
administration of contrast medium and should not be resumed for

48 hours and only be restarted if renal function/serum creatinine remains
in the normal range.
Abnormal serum creatinine (>130μmol/litre)/impaired renal function:
Metformin should be stopped and the contrast medium examination
delayed for 48 hours. Metformin should only be restarted 48 hours later
if renal function is not diminished (if serum creatinine is not increased)
compared to pre-contrast values.
Emergency cases:
In emergency cases where renal function is impaired or unknown, the
physician should evaluate the risk/benefit of the contrast medium
examination, and the following precautions should be implemented:
Metformin should be stopped. It is particularly important that the patient
is fully hydrated prior to contrast medium administration and for 24 hours
afterwards. Renal function (e.g. serum creatinine), serum lactic acid and
blood pH should be monitored, as well as the patient with regard to signs
of lactacidosis.
A pH <7.25 or a lactic acid level of >5 mmol/litre are indicative of lactic
acidosis. The patient should be observed for symptoms of lactic acidosis.
These include vomiting, somnolence, nausea, epigastric pain, anorexia,
hyperpnoea, lethargy, diarrhoea and thirst.
Hepatic reactions:
A potential risk of transient hepatic dysfunction exists. Particular care is
required in patients with severe disturbance of both renal and hepatic
function as they may have significantly delayed contrast medium
clearance. Patients on haemodialysis may receive contrast media for
radiological procedures. Correlation of the time of contrast media injection
with the haemodialysis session is unnecessary.
Myasthenia gravis:
The administration of iodinated contrast media may aggravate the
symptoms of myasthenia gravis.
Phaeochromocytoma:
In patients with phaeochromocytoma undergoing interventional
procedures, alpha blockers should be given as prophylaxis to avoid a
hypertensive crisis.
Disturbed thyroid function:
Due to free iodide in the solutions and additional iodide released by
deiodination, iodinated contrast media influence thyroid function. This may
induce hyperthyroidism or even thyreotoxic crisis in predisposed patients
Patients with manifest but not yet diagnosed hyperthyroidism are at risk,
patients with latent hyperthyroidism (e.g., nodular goitre) and patients with
functional autonomy (often e.g. elderly patients, especially in regions with
iodine deficiency) should therefore have their thyroid function assessed
before examination if such conditions are suspected.
Before administering an iodinated contrast agent, make sure that the
patient is not about to undergo thyroid scan or thyroid function tests or
treatment with radioactive iodine, as administration of iodinated contrast
agents, regardless of the route, interferes with hormone assays and iodine
uptake by the thyroid gland or metastases from thyroid cancer until
urinary iodine excretion returns to normal. See also section 4.5.
Following injection of an iodinated contrast agent, there is also a risk of
induction of hypothyroidism.
Anxiety conditions:
A sedative may be administered in the case of marked anxiety.
Sickle cell disease:
Contrast media may promote sickling in individuals who are homozygous
for sickle cell disease when injected intravenously and intra-arterially.
Further risk factors:
Among patients with autoimmune diseases cases of serious vasculitis or
Stevens-Johnson-like syndromes have been observed.
Severe vascular and neurological diseases, especially in elderly patients
are risk factors for reactions to contrast media.
Extravasation:
Extravasation of contrast media may on rare occasions give rise to local
pain, and oedema and erythema,, which usually recedes without sequelae.
However, inflammation and even tissue necrosis have been seen. Elevating
and cooling the affected site is recommended as routine measures.
Surgical decompression may be necessary in cases of compartment
syndrome.
Observation-time
Patients must be kept under close observation for 30 minutes following the
last injection as the majority of severe reactions occur at this time.
Intrathecal use
Following myelography the patient should rest with the head and thorax
elevated by 20° for one hour. Thereafter he/she may ambulate carefully
but bending down must be avoided. The head and thorax should be kept
elevated for the first 6 hours if remaining in bed. Patients suspected of
having a low seizure threshold should be observed during this period.
Outpatients should not be completely alone for the first 24 hours.
Cerebral arteriography:
In patients with advanced arteriosclerosis, severe hypertension, cardiac
decompensation, old age, and previous cerebral thrombosis or embolism
and migraine, cardiovascular reactions such as bradycardia and increases
or decreases in blood pressure may occur more often.
Arteriography:
In relation to procedure used, injury of the artery, vein, aorta and adjacent
organs, pleurocentesis, retroperitoneal bleeding, spinal cord injury and
symptoms of paraplegia may occur.
Paediatric population:
Transient hypothyroidism has been reported in premature infants,
neonates and in other children after administration of iodinated contrast
media. Premature infants are particularly sensitive to the effect of iodine.
It is advisable to monitor thyroid function. Thyroid function should be
checked in neonates during the first week of life, following administration
of iodinated contrast agents to the mother during pregnancy. Repeat
testing of thyroid function is recommended at 2 to 6 weeks of age,
particularly in low birth weight newborn or premature newborn.
Especially in infants and small children, adequate hydration should be
assured before and after contrast media administration. Nephrotoxic
medication should be suspended. The age dependent reduced glomerular
filtration rate in infants can also result in delayed excretion of contrast
agents.
Young infants (age < 1 year) and especially neonates are susceptible to
electrolyte disturbance and haemodynamic alterations.

1183344 GBR
1183344

PACKAGE LEAFLET: INFORMATION FOR
THE PATIENT

IOHEXOL

(medicines used to treat high blood pressure) or have recently been treated
with interleukin-2 or interferons (medicines used to treat immune system
diseases), neuroleptics or tricyclic antidepressants (medicines used to treat
mental disorders like i.e. depression). This is because some medicines can
affect the way Omnipaque works.

Fertility, Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or think you may be pregnant.
Your doctor will only use this product if it is considered that the benefit
outweighs the risk for both the mother and the baby. If Omnipaque has been
given to the mother during pregnancy, the thyroid function of the newborn
should be tested during the first week after birth. It is recommended that the
testing is repeated again between 2 and 6 weeks of age in premature and low
birth weight newborns.
Breast-feeding may be continued normally after an examination with
Omnipaque.

Iohexol
Read all of this leaflet carefully before you start using Omnipaque
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.
• If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. See section 4

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Omnipaque is and what it is used for
What you need to know before you use Omnipaque
How to use Omnipaque
Possible side effects
How to store Omnipaque
Contents of the pack and other information

1. WHAT OMNIPAQUE IS AND WHAT IT IS USED
FOR

This medicine is for diagnostic use only. It is used only to help identify an
illness.
Omnipaque is a ‘contrast medium’. It is given before an X-ray to make the
picture that your doctor takes clearer.
• Once injected, it can help your doctor tell apart normal or abnormal
appearance and shape of some organs in your body.
• It can be used for X-rays of your urinary system, spine or blood vessels,
including blood vessels of your heart.
• Some other people are given this medicine before or during a scan of their
head or body using ‘computed tomography’ (also called a CAT scan). This
type of scan uses X-rays.
• It can also be used to look at your salivary glands, stomach and intestine,
or for looking in body cavities, such as in your joints or womb and ovarian
tubes.
Your doctor will explain which part of your body will be scanned.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
OMNIPAQUE
Do not use Omnipaque
• If you suffer from severe thyroid problems
• If you are allergic (hypersensitive) to iohexol or any of the other ingredients
of Omnipaque (listed in Section 6).

Warnings and precautions
Check with your doctor before having Omnipaque:
• If you have ever had an allergic reaction after a medicine similar to
Omnipaque, called a ‘contrast medium’.
• If you have any thyroid problems.
• If you have ever had any allergies.
• If you have asthma.
• If you have diabetes.
• If you have any brain disease or tumours.
• If you have or have had severe heart disease (involving heart or blood
vessels) including high blood pressure, blood clots, stroke and irregular
heartbeats (arrhythmia).
• If you have kidney problems or both liver and kidney problems.
• If you have an illness called ‘myasthenia gravis’ (a condition causing severe
muscle weakness).
• If you have a ‘phaeochromocytoma’ (constant or attacks of high blood
pressure due to a rare tumour of your adrenal gland).
• If you have “homocystinuria” (a condition with increased excretion of the
amino acid cysteine in urine)
• If you have any problems with your blood or bone marrow.
• If you have ever been dependent on alcohol or drugs.
• If you have epilepsy.
• If you are having a thyroid function test in the next weeks.
If you are not sure if any of the above apply to you, talk to your doctor before
having Omnipaque. Make sure to drink plenty of fluid before and after receiving
Omnipaque. This applies especially to patients with multiple myeloma (white
blood cells disease), diabetes, kidney problems, patients in bad general
condition, children and elderly patients.
Omnipaque contains sodium. This medicinal product contains less than
1 mmol sodium (23 mg) per ml, i.e. essentially “sodium free”.

Children and adolescents
Make sure to drink plenty of fluid before and after receiving Omnipaque.
This applies especially to infants and small children. Drugs that can damage
the kidneys should not be taken at the same time as Omnipaque. If Omnipaque
has been given to the mother during pregnancy, the thyroid function of the
newborn should be tested during the first week after birth. It is recommended
that the testing is repeated again between 2 and 6 weeks of age in premature
and low birth weight newborns.
Omnipaque may be removed from an infant’s body more slowly than an adult.
Young infants ( less than 1 year of age) and especially newly born are
susceptible to changes in certain laboratory tests (in balance in salts and
minerals) and circulatory changes in blood circulation (blood flow to the heart).

Taking other medicines and Omnipaque
Please tell your doctor if you are diabetic and are taking any medicine
containing metformin, or have recently taken any other medicines, including
medicines obtained without a prescription or if you are using beta-blockers,
vasoactive substances, ACE- enzyme inhibitors or angiotensin antagonists

Do not drive or use tools or machines after your last injection of
Omnipaque for:
• 24 hours, if it has been given into your spine, or
• one hour in all other cases.
This is because you may feel dizzy or have other signs of a reaction afterwards.

3. HOW TO USE OMNIPAQUE

Omnipaque will always be given to you by a specially trained and qualified
person.
• Omnipaque will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe use.
Your doctor will decide the dose that is best for you.

The usual dose is:
• One single injection or you may be asked to swallow it.

After you have been given Omnipaque
You will be asked:
• to drink plenty of fluids afterwards (to help flush the medicine from your
body), and
• to stay in or around the area where you had your scan or X-ray for around
30 minutes, and
• to stay in the clinic or hospital for one hour.
If you have any side effects during this time, tell your doctor straight away
(see Section 4 ‘Possible Side Effects’).
The advice above applies to all patients who have had Omnipaque. If you are
not sure about any of the above ask your doctor.
Omnipaque may be given in lots of different ways, a description of the ways it
is usually given can be found below:

Injection into an artery or vein
Omnipaque will most commonly be injected into an arm vein or leg vein.
Sometimes it will be given through a thin plastic tube (catheter), inserted into
an artery usually in your arm or groin.

Injection into your spine
Omnipaque will be injected into the space around the spinal cord to see your
spinal canal. If you have been given Omnipaque into your spine afterwards you
will be asked to follow the advice below:
• to rest with your head and body upright for one hour, or six hours if you stay
in bed, and
• to walk carefully and try not to bend down for six hours, and
• not to be completely alone for the first 24 hours after having Omnipaque,
if you are an outpatient and have ever had fits.
The advice above applies only if you have had Omnipaque injected in to your
spine. If you are not sure about any of the above ask your doctor.

Use in your body cavities or joints
Body cavities may be the joints, uterus and ovarian tubes. How and where
Omnipaque is given will vary.

Use by mouth
For examination of the gullet, stomach or small bowel, Omnipaque is normally
given by mouth. Omnipaque may be diluted with water for these examinations.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omnipaque can cause side effects, although not everybody
gets them.

Allergic reactions
If you have an allergic reaction when you are in hospital or a clinic having
Omnipaque, tell the doctor straight away. The signs may include:
• wheeziness, difficulty in breathing or tightness or pain in your chest
• skin rash, lumps, itchy spots, blisters on skin and in mouth, red/itchy eyes,
cough, running nose, sneezing or other allergic symptoms
• swelling of your face
• dizziness or feeling faint (caused by low blood pressure)
• severe skin reactions including potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially
as reddish target-like spots or circular patches often with central blisters
on the trunk. Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivitis (red and swollen eyes). These potentially
life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin. If you
have developed Stevens-Johnson syndrome or toxic epidermal necrolysis
with the use of Omnipaque, you must not be re-started on Omnipaque at
any time.
The above side effects may happen several hours or days after Omnipaque is
given. If any of these side effects happen after you leave the hospital or clinic,
go straight to the casualty department of your nearest hospital.
A short term decrease in formation of urine due to decreased kidney function is
common after Omnipaque is given. This may lead to damage to the kidney.
Other side effects that you may have are listed below; these depend on how or
why Omnipaque was given to you. Ask your doctor if you are not sure how you
were given Omipaque.

Short-term underactive thyroid gland (transient hypothyroidism) has been
reported in premature infants, neonates and in other children after receiving
Omnipaque. Premature infants are particularly sensitive to the effect of iodine.
Thyroid function should be checked in neonates during the first week of life,
following administration of iodinated contrast agents to the mother during
pregnancy. Repeat testing of thyroid function is recommended at 2 to 6 weeks
of age, particularly in low birth weight newborn or premature newborn.
If you get any side effects, talk to your doctor. 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 OMNIPAQUE

• Keep out of the sight and reach of children.
• Do not use Omnipaque after the expiry date which is stated on the label EXP.
• Store in the outer carton in order to protect from light

(such as uterus and ovarian tubes, gall bladder and pancreas or hernia)
Very common: affects more than 1 user in 10
• pain around your stomach area
Common: affects 1 to 10 users in 100
• inflammation of the pancreas (an organ behind the stomach) causing
stomach pain that is worsened with eating.
• abnormal amount of a substance produced by the pancreatic gland
detected by lab investigation
Not known: frequency cannot be estimated from the available data
• pain

Very common: affects more than 1 user in 10
• pain where it was injected
Not known: frequency cannot be estimated from the available data
• inflammation of the joint

After being given it by mouth
Document: 1183344 GBR Version: 0

Very rare: affects less than 1 user in 10,000
• momentary change in sense of taste
• high or low blood pressure, shivering (chills)
• diarrhoea, pain around your stomach area
Not known: frequency cannot be estimated from the available data
• allergic reaction, including severe allergic reaction leading to shock and
collapse, see ‘Allergic reactions’ above for other signs
• swelling and tenderness (pain) of your salivary glands

Very common: affects more than 1 user in 10
• diarrhoea
Common: affects 1 to 10 users in 100
• feeling sick (nausea), vomiting
Uncommon: affects 1 to 10 users in 1,000
• pain around your stomach area
If any of the side effects gets serious, or if you notice any side effects not listed,
please tell your doctor.

This leaflet was last revised in
July 2016
Omnipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General Electric Company.

4.5 Interaction with other medicinal products and other forms of
interaction
Use of iodinated contrast media may result in a transient impairment of
renal function and this may precipitate lactic acidosis in diabetics who are
taking metformin (see section 4.4).
Patients treated with interleukin-2 and interferons less than two weeks
previously have been associated with an increased risk for delayed
reactions (erythema, flu-like symptoms or skin reactions).
The concomitant use of certain neuroleptics or tricyclic antidepressants
can reduce the seizure threshold and thus increase the risk of contrast
medium-induced seizures.
Treatment with ß-blockers may lower the threshold for hypersensitivity
reactions, as well as necessitating higher doses of ß-agonists when
treating hypersensitivity reactions.
Beta-blockers, vasoactive substances, angiotensin-converting enzyme
inhibitors, angiotensin receptor antagonists may reduce efficacy of
cardiovascular compensation mechanisms of blood pressure changes.
All iodinated contrast media may interfere with tests on thyroid function,
thus the iodine binding capacity of the thyroid may be reduced for up to
several weeks.
High concentrations of contrast media in serum and urine can interfere
with laboratory tests for bilirubin, proteins or inorganic substances
(e.g. iron, copper, calcium and phosphate). These substances should
therefore not be assayed on the day of examination.

4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of Omnipaque for use in human pregnancy has not been
established. An evaluation of experimental animal studies does not
indicate direct or indirect harmful effects with respect to reproduction,
development of the embryo or foetus, the course of gestation and
peri- and postnatal development.
Since whenever possible, radiation exposure should be avoided during
pregnancy, the benefits of an X-ray examination, with or without contrast
media, should be carefully weighed against the possible risk. Omnipaque
should not be used in pregnancy unless the benefit outweighs the risk and
it is considered essential by the physician.
Apart from avoidance of exposition to radiation, the sensitivity of the foetal
thyroid gland to iodine should be taken into account when risk and benefit
are evaluated.
Thyroid function should be checked in all neonates during the first week
of life following administration of iodinated contrast agents to the mother
during pregnancy. Repeat testing of thyroid function is recommended at
2 to 6 weeks of age, particularly in low birth weight newborn or premature
newborn.
Breast-feeding
Contrast media are poorly excreted in human breast milk and minimal
amounts are absorbed by the intestine. Breast feeding may be continued
normally when iodinated contrast media are given to the mother.
The amount of iohexol in breast milk excreted in 24 hours after injection
was 0.5% of the weight adjusted dose in a trial. The amount of iohexol
ingested by the baby in the first 24 hours after injection corresponds to
only 0.2% of the paediatric dose.

4.7 Effects on ability to drive and use machines
It is not advisable to drive a car or use machines for one hour after
the last injection or for 24 hours following intrathecal procedure
(see section 4.4). However, individual judgement must be performed if
persistent post myelography symptoms.

4.8 Undesirable effects
General (applies to all uses of iodinated contrast media)
Below are listed possible general side effects in relation with radiographic
procedures, which include the use of non-ionic monomeric contrast media.
For side effects specific to mode of administration, please refer to these
specific sections.
Hypersensitivity reactions may occur irrespective of the dose and mode
of administration and mild symptoms may represent the first signs of
a serious anaphylactoid reaction/shock. Administration of the contrast
medium must be discontinued immediately and, if necessary, specific
therapy instituted via the vascular access.
An transient increase in S-creatinine is common after iodinated contrast
media, contrast induced nephropathy may occur.
Iodism or “iodide mumps” is a very rare complication of iodinated contrast
media resulting in swelling and tenderness of the salivary glands for up to
approximately 10 days after the examination.
The listed frequencies are based on internal clinical documentation and
published large scale studies, comprising more than 90,000 patients.
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to
<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known
(cannot be estimated from the available data)
Immune system disorders:
Rare: Hypersensitivity (including dyspnoea, rash, erythema, urticaria,
pruritus, skin reaction, conjunctivitis, coughing, rhinitis, sneezing,
vasculitis, angioneurotic oedema, laryngeal oedema, laryngospasm,
bronchospasm or non-cardiogenic pulmonary oedema). They may appear
either immediately after the injection or up to a few days later and may be
indicative of the beginning of a state of shock. Hypersensitivity related skin
reactions may appear up to a few days after the injection.
Not known: Anaphylactic /anaphylactoid reaction, anaphylactic/
anaphylactoid shock
Nervous system disorders:
Rare: Headache
Very rare: Dysgeusia (transient metallic taste)
Not known: Syncope vasovagal
Cardiac disorders:
Rare: Bradycardia
Vascular disorders:
Very rare: Hypertension, hypotension
Gastrointestinal disorders:
Uncommon: Nausea
Rare: Vomiting
Very rare: Diarrhoea, abdominal pain/discomfort
Not known: Salivary gland enlargement

Use in Body Cavities
Please first read the section labelled "General". Below, only undesirable
events with frequency during use of non-ionic monomeric contrast media in
body cavities are described.
Endoscopic Retrograde Cholangiopancreatography (ERCP):
Gastrointestinal disorders:
Common: Pancreatitis, blood amylase increased
Oral use:
Gastrointestinal disorders:
Very common: Diarrhoea
Common: Nausea, vomiting
Uncommon: Abdominal pain
Hysterosalpingography (HSG):
Gastrointestsinal disorders:
Very common: Lower abdominal pain
Arthrography:
Musculoskeletal and connective tissue disorders:
Not known: Arthritis
General disorders and administration site conditions:
Very common: Pain
Herniography:
General disorders and administration site conditions:
Not known: Post procedural pain
(c) Description of selected adverse reactions
Thrombo-embolic complications have been reported in connection
with contrast-enhanced angiography of coronary, cerebral, renal and
peripheral arteries. The contrast agent may have contributed to the
complications (see section 4.4).
Cardiac complications including acute myocardial infarction have been
reported during or after contrast-enhanced coronary angiography. Elderly
patients or patients with severe coronary artery disease, unstable angina
pectoris and left ventricular dysfunction had a higher risk (see section 4.4).
In very rare occasions the contrast medium may cross the blood-brain
barrier resulting in uptake of contrast medium in the cerebral cortex that
may cause neurological reactions. They may include convulsions, transient
motor or sensory disturbances, transient confusion, transient memory
loss, and encephalopathy (see section 4.4).
Anaphylactoid reaction and anaphylactoid shock may lead to profound
hypotension and related symptoms and signs like hypoxic encephalopathy,
renal and hepatic failure (see section 4.4).
In several cases, extravasation of contrast media has caused local pain
and oedema, which usually receded without sequelae. Inflammation, tissue
necrosis and compartment syndrome have occurred (see section 4.4).
(d) Paediatric patients:
Transient hypothyroidism has been reported in premature infants,
neonates and in other children after administration of iodinated contrast
media. Premature infants are particularly sensitive to the effect of iodine.
Transient hypothyroidism in a premature breast fed infant has been
reported. The nursing mother was repeatedly exposed to Omnipaque
(see section 4.4).
Especially in infants and small children, adequate hydration should be
assured before and after contrast media administration. Nephrotoxic
medication should be suspended. The age dependent reduced glomerular
filtration rate in infants can also result in delayed excretion of contrast
agents.
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.

4.9 Overdose
Preclinical data indicate a high safety margin for Omnipaque and no
fixed upper dose level has been established for routine intravascular use.
Symptomatic overdosing is unlikely in patients with normal renal function
unless the patient has received an excess of 2000 mg I/kg body-weight
over a limited period of time. The duration of the procedure is important
for the renal tolerability of high doses of contrast media (t½ ~ 2 hours).
Accidental overdosing is most likely following complex angiographic
procedures in children, particularly when multiple injections of contrast
medium with high-concentration are given.
In cases of overdose, any resulting water- or electrolyte imbalance must
be corrected. Renal function should be monitored for the next 3 days.
If needed, haemodialysis may be used for clearance of excessive contrast
medium. There is no specific antidote.

5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: X-ray contrast media, iodinated, ATC code:
V08AB02
For most of the haemodynamic, clinical-chemical and coagulation
parameters examined following intravenous injection of iohexol in healthy
volunteers, no significant deviation from preinjection values has been
found. The few changes observed in the laboratory parameters were minor
and considered to be of no clinical importance.

5.2 Pharmacokinetic properties
Close to 100 per cent of the intravenously injected iohexol is excreted
unchanged through the kidneys within 24 hours in patients with normal
renal function. The maximum urinary concentration of iohexol appears
within approximately 1 hour after injection. No metabolites have been
detected. The protein binding of Omnipaque is very low (less than 2 %).

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
The following excipients are included:
Trometamol
Sodium calcium edetate
Hydrochloric acid (pH adjustment)
Water for injections.
The pH of the product is 6.8 - 7.6.

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be
mixed with other medicinal products. A separate syringe should be used.

6.3 Shelf life
Glass bottles:
3 years
Polypropylene bottles:
3 years
The expiry date is indicated on the label.

6.4 Special precautions for storage
Omnipaque should be stored at or below 30°C protected from light.
Furthermore, the product in glass vials and bottles can be stored at 37°C
for up to 3 months prior to use.
The product in polypropylene bottles may be stored at 37°C for up to
1 month prior to use.

6.6 Special precautions for disposal and other handling
Like all parenteral products, Omnipaque should be inspected visually for
particulate matter, discolouration and the integrity of the container prior
to use. The product should be drawn into the syringe immediately before
use. Vials and bottles are intended for single use only, any unused portions
must be discarded. Omnipaque may be warmed to body temperature (37°C)
before administration. Any unused product or waste material should be
disposed of in accordance with local requirements.

5.3 Preclinical safety data
Iohexol has a very low acute intravenous toxicity in mice and rats. Animal
studies have shown that iohexol has a very low protein binding, and is well
tolerated by the kidneys.

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.