OMNIPAQUE INJECTION 240MG I/ML SOLUTION FOR INJECTION

Active substance: IOHEXOL

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1170089

SCIENTIFIC LEAFLET

IOHEXOL

Name of the medicinal product
OMNIPAQUE™ 140 mg I/ml, 240 mg I/ml, 300 mg I/ml,
350 mg I/ml

Qualitative and quantitative composition
Active ingredient
Strength
Content per. ml
Iohexol (INN)
140 mg I/mll
302 mg equiv. 140 mg I
Iohexol (INN)
240 mg I/ml
518 mg equiv. 240 mg I
Iohexol (INN)
300 mg I/ml
647 mg equiv. 300 mg I
Iohexol (INN)
350 mg I/ml
755 mg equiv. 350 mg I
For a full list of excipients, see Pharmaceutical particulars
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:
Osmolality*
mOsm/kg H2O
Viscosity (mPa·s)
Concentration
37°C
20°C
37°C
140 mg I/ml
0.29
2.3
1.5
240 mg I/ml
0.51
5.6
3.3
300 mg I/ml
0.64
11.6
6.1
350 mg I/ml
0.78
23.3
10.6
* in aqueous solutions of iohexol

Pharmaceutical form
Solution for injection.

Clinical particulars
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.
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
Concentration

300 mg I/ml
or 350 mg I/ml
children < 7 kg
240 mg I/ml
or 300 mg I/ml
children > 7 kg
240 mg I/ml
or 300 mg I/ml
Phlebography (leg) 240 mg I/ml
or 300 mg I/ml
Digital subtraction angiography
adults:
140 mg I/ml

children:
CT-enhancement
adults:

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

Volume

Comments

40 - 80 ml
40 - 80 ml
4 ml/kg b.w.
3 ml/kg b.w.
3 ml/kg b.w.
2 ml/kg b.w.
20 - 100 ml/leg
up to 3 ml per kg
body weight
20 - 60 ml/inj.
20 - 60 ml/inj.
dependent upon age,
weight and pathology
100 - 400 ml
100 - 250 ml
100 - 200 ml
100 - 150 ml

Document: 1170089 GBR Version: 0

Guidelines for Intra-arterial use
Indication
Arteriographies
arch aortography
selective cerebral
aortography
femoral
various

Concentration

Volume

300 mg I/ml
300 mg I/ml
350 mg I/ml
300 mg I/ml
or 350 mg I/ml
300 mg I/ml

Guidelines for Intrathecal use
Indication
Concentration Volume
Comments
Lumbar and thoracic
myelography
240 mg I/ml
8 - 12 ml
(lumbar injection)
Cervical myelography 240 mg I/ml
10-12 ml
(lumbar injection)
or 300 mg I/ml 7 - 10 ml
Cervical myelography 240 mg I/ml
6 - 10 ml
(lateral cervical
or 300 mg I/ml 6 - 8 ml
injection)
CT cisternography
(lumbar injection)
240 mg I/ml
4 - 12 ml
To minimize possible adverse reactions a total dose of 3 g iodine
should not be exceeded.

Guidelines for Body cavities
Indication
Arthrography

Concentration Volume

240 mg I/ml
or 300 mg I/ml
or 350 mg I/ml
ERP/ERCP
240 mg I/ml
Herniography
240 mg I/ml
Hysterosalpingography
240 mg I/ml
or 300 mg I/ml
Sialography
240 mg I/ml
or 300 mg I/ml
Gastrointestinal studies
350 mg I/ml

Comments

5 - 20 ml
5 - 15 ml
5 - 10 ml
20 - 50 ml
50 ml
15 - 50 ml
15 - 25 ml
0.5 - 2 ml
0.5 - 2 ml
10 - 20 ml

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

Contraindications

Posology and method of administration

Indication
Urography
adults:

Cardioangiography
adults:
left ventricle and aortic
root inj.
350 mg I/ml
30 - 60 ml/inj.
selective coronary
arteriography
350 mg I/ml
4 - 8 ml/inj.
children:
300 mg I/ml
depending on age, weight
or 350 mg I/ml and pathology
(max 8 ml/kg b.w.)
Digital subtraction
angiography
adults:
140 mg I/ml
4 - 10 ml/inj.
or 240 mg I/ml 1 - 15 ml/inj.
or 300 mg I/ml 1 - 15 ml/inj.
children:
140 mg I/ml
Dependent upon age,
weight and pathology

Comments

30 - 40 ml/inj.
5 - 10 ml/inj.
40 - 60 ml/inj.
30 - 50 ml/inj.
depending on type of
examination

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

Special warnings and precautions for use.
Special precautions for use of non-ionic monomeric contrast
media in general:
A positive history of allergy, asthma, or untoward reactions to
iodinated contrast media indicates a need for special caution.
Premedication with corticosteroids or histamine H1 and H2
antagonists might be considered in these cases.
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. A course of action should therefore be planned
in advance, with necessary drugs and equipment available
for immediate treatment, should a serious reaction occur. It is
advisable always to use an indwelling cannula or catheter for
quick intravenous access throughout the entire X-ray procedure.
Patients using β-blockers may present with atypical symptoms of
anaphylaxis which may be interpreted as vagal reaction.
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.
Adequate hydration should be assured before and after contrast
media administration. This applies especially to patients with
multiple myeloma, diabetes mellitus, renal dysfunction, as well as
to infants, small children and elderly patients.
Care should also be taken in patients with serious cardiac
disease and pulmonary hypertension as they may develop
haemodynamic changes or arrhythmias.
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. 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.
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. Patients with paraproteinemias (myelomatosis and
Waldenström’s macroglobulinemia) are also at risk.

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.
- Postponing a repeat contrast medium examination until renal
function returns to pre-examination levels.
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. 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.
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.
The administration of iodinated contrast media may aggravate
the symptoms of myasthenia gravis. In patients with
phaeochromocytoma undergoing interventional procedures,
alpha blockers should be given as prophylaxis to avoid a
hypertensive crisis. Special care should be exercised in patients
with hyperthyroidism. Patients with multinodular goiter may
be at risk of developing hyperthyroidism following injection of
iodinated contrast media.
Extravasation of contrast media may on rare occasions give
rise to local pain, and oedema, 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 15 minutes
following the last injection as the majority of severe reactions
occur at this time. The patient should remain in the hospital
environment (but not necessarily the radiology department)
for one hour after the last injection, and should return to the
radiology department if any symptoms develop.
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.
Paediatric population
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.

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
Special warnings and precautions for use).

Patients treated with interleukin-2 less than two weeks previously
have been associated with an increased risk for delayed
reactions (flu-like symptoms or skin reactions).
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.

1170089 GBR

1170089

PACKAGE LEAFLET: INFORMATION FOR
THE PATIENT

3. HOW TO USE OMNIPAQUE
IOHEXOL

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.
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.

Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been
performed. There is no known effect on the ability to drive or
operate machines. However, because of the risk of reactions,
driving or operating machinery 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 Special warnings
and precautions for use). However, individual judgement must be
performed if persistent post myelography symptoms.

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.
Serious reactions as well as fatalities are only seen on very rare
occasions. Undesirable effects associated with Omnipaque are
usually mild to moderate and transient in nature.
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, 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.
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
General disorders and administration site conditions:
Common:
Feeling hot
Rare:
Pyrexia
Very rare:
Shivering (chills)
Injury, poisoning and procedural complications:
Not known:
Iodism

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.
Children and adolescents
Make sure to drink plenty of fluid before and after receiving
Omnipaque. This applies especially to infants and small children.

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:
Omnipaque 140 mg I/ml solution for injection
Omnipaque 240 mg I/ml solution for injection
Omnipaque 300 mg I/ml solution for injection
Omnipaque 350 mg I/ml solution for injection

Iohexol

Read all of this leaflet carefully before you start using
Omnipaque:
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Omnipaque is and what it is used for
Before you use Omnipaque
How to use Omnipaque
Possible side effects
How to store Omnipaque
Further 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.

• 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 15 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

2. 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).

Take special care with Omnipaque
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 severe heart disease.
• 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 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.

Taking other medicines
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.
This is because some medicines can affect the way Omnipaque
works.

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. Breast-feeding may be
continued normally after an examination with Omnipaque.

Driving and using machines
Do not drive or use tools or machines after your last injection of

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, 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 StevensJohnson 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.
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.

General
(applies to all uses of Omnipaque)
Common: affects 1 to 10 users in 100
• feeling hot
Uncommon: affects 1 to 10 users in 1,000
• feeling sick (nausea)

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1170089 GBR



Rare: affects 1 to 10 users in 10,000
• allergic (hypersensitivity) reactions
• slow heart rate
• headache, vomiting, fever
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

After an injection into an artery or vein
Uncommon: affects 1 to 10 users in 1,000
• pain and discomfort
Rare: affects 1 to 10 users in 10,000
• diarrhoea
• irregular heartbeats
• kidney problems
• cough, fever, general discomfort
• dizziness
Very rare: affects less than 1 user in 10,000
• seizures (fits), clouding consciousness, disturbance of senses
(like touch), trembling
• flushing
• difficulty breathing, including severe breathing difficulty due to
fluids in your lungs
• short-term brain disorders (encephalopathy) including
short term memory loss, coma and stupor (“sleepy state”),
myocardial infarction
Not known: frequency cannot be estimated from the available data
• severe skin reactions
• feeling confused, feeling disorientated
• overactive thyroid gland (an excess of thyroid hormones in
the blood causing a variety of symptoms, as e.g. rapid heart
beat, sweating, anxiety), short-term underactive thyroid gland
(an abnormality of the thyroid function which later reverts to
normal. Normally, no symptoms are seen).
• difficulty moving around for awhile
• speech disorders including aphasia (unable to speak),
dysarthria (difficulties with pronouncing words)
• short-term blindness (hours to a few days), short-term
hearing loss
• chest pain, heart problems, including arrest of the heart
• tightness in chest or troubled breathing, worsening of an
inflammation of the pancreas (an organ behind the stomach)
causing stomach pain that is worsened with eating.
• pain and swelling of your vein, blood clots (thrombosis)
• joint pain, injection site reaction, back pain
• asthma attack
• psoriasis flare-up

After an injection into your spine
Very common: affects more than 1 user in 10
• headache (may be severe and lasting)
Common: affects 1 to 10 users in 100
• feeling sick (nausea), vomiting
Uncommon: affects 1 to 10 users in 1,000
• inflammation of the membranes that surround the brain and
spinal cord
Rare: affects 1 to 10 users in 10,000
• seizures (fits), dizziness, diarrhoea
• pain in arms or legs, neck pain
Not known: frequency cannot be estimated from the available data
• abnormal electric activity of the brain in an examination called
electroencephalography
• intolerance of bright light, neck stiffness
• difficulty moving around for awhile, feeling confused
• disturbance of senses (like touch), short-term blindness (hours
to a few days), short-term hearing loss
• tingling sensations, muscle contractions (spasms), injection site
reaction
• Short term brain disorders (encephalopathy) including short
term memory loss, coma and stupor (“sleepy state”).

Additional side effects in children and adolescents:
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.

5. HOW TO STORE OMNIPAQUE
• Keep out of the reach and sight 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

6. FURTHER INFORMATION
What Omnipaque contains
• The active substance is iohexol.
Omnipaque 140 mg l/ml contains 302 mg iohexol per ml
(equivalent to 140 mg iodine per ml).
Omnipaque 240 mg l/ml contains 518 mg iohexol per ml
(equivalent to 240 mg iodine per ml).
Omnipaque 300 mg l/ml contains 647 mg iohexol per ml
(equivalent to 300 mg iodine per ml).
Omnipaque 350 mg l/ml contains 755 mg iohexol per ml
(equivalent to 350 mg iodine per ml).
• The other ingredients are small amounts of trometamol, sodium
calcium edetate, hydrochloric acid (for pH adjustment), and
water.

What Omnipaque looks like and contents of the pack
Omnipaque is a solution for injection. The product is a clear,
colourless to pale yellow, aqueous solution.
Omnipaque is supplied as:
140 mg I/ml
10 bottles of 50 ml
6 bottles of 200 ml
10 polypropylene bottles of 50 ml
10 polypropylene bottles of 100 ml
10 polypropylene bottles of 200 ml
240 mg I/ml

300 mg I/ml

350 mg I/ml

After use in body cavities
(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

After injection into your joints

Document: 1170089 GBR Version: 0

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
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.

10 vials of 10 ml
6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
6 bottles of 200 ml
10 polypropylene bottles of 50 ml
10 polypropylene bottles of 100 ml
10 polypropylene bottles of 200 ml
10 vials of 10 ml
6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
10 bottles of 75 ml
6 bottles of 100 ml
10 polypropylene bottles of 50 ml
10 polypropylene bottles of 75 ml
10 polypropylene bottles of 100 ml
10 polypropylene bottles of 150 ml
10 polypropylene bottles of 175 ml
10 polypropylene bottles of 200 ml
6 vials of 20 ml
25 vials of 20 ml
10 bottles of 40 ml
10 bottles of 50 ml
10 bottles of 75 ml
10 bottles of 100 ml
6 bottles of 200 ml
10 polypropylene bottles of 50 ml
10 polypropylene bottles of 75 ml
10 polypropylene bottles of 100 ml
10 polypropylene bottles of 150 ml
10 polypropylene bottles of 175 ml
10 polypropylene bottles of 200 ml

Not all pack sizes may be marketed.

Marketing authorisation holder:
GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen,
NO-0401 Oslo, Norway.

Manufactured by:
GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen,
NO-0401 Oslo, Norway.
or
GE Healthcare Ireland, IDA Business Park, Carrigtohill, Co. Cork,
Ireland.

Local Representative:
GE Healthcare Limited
Little Chalfont
Buckinghamshire HP7 9NA

This leaflet was last approved in
xxxxxxxxxx 2013
Omnipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General Electric
Company.

Intravascular use (Intraarterial and Intravenous use):
Please first read the section labelled “General”. Below, only
undesirable events with frequency during intravascular use of
nonionic monomeric contrast media are described.
The nature of the undesirable effects specifically seen during
intraarterial use depends on the site of injection and dose
given. Selective arteriographies and other procedures in
which the contrast medium reaches a particular organ in high
concentrations may be accompanied by complications in that
particular organ.
Immune system disorders:
Not known:
Severe pustular or exfoliative or bullous skin
reactions
Endocrine disorders:
Not known:
Thyrotoxicosis, transient hypothyroidism
Psychiatric disorders:
Not known:
Confusion
Nervous system disorders:
Rare:
Dizziness
Very rare:
Seizures, disturbance in consciousness, transient
contrast-induced encephalopathy (including
transient memory loss, coma, stupor, retrograde
amnesia), sensory abnormalities (including
hypoaesthesia), paraesthesia, tremor.
Not known:
Transient motor dysfunction (including speech
disorder, aphasia, dysarthria), disorientation.
Eye disorders:
Not known:
Transient cortical blindness
Ear and labyrinth disorders:
Not known:
Transient hearing loss
Cardiac disorders:
Rare:
Arrhythmia (including bradycardia, tachycardia).
Very rare:
myocardial infarction
Not known:
Severe cardiac complications (including cardiac
arrest, cardio-respiratory arrest), spasm of
coronary arteries, chest pain
Vascular disorders:
Very rare:
Flushing
Not known:
Shock, arterial spasm, ischaemia,
thrombophlebitis and thrombosis
Respiratory, thoracic and mediastinal disorders:
Rare:
Cough
Very rare:
Dyspnoea, non-cardiogenic pulmonary oedema
Not known:
Severe respiratory symptoms and signs,
bronchospasm, laryngospasm, asthma attack
Gastrointestinal disorders
Rare:
Diarrhoea
Not known:
Aggravation of pancreatitis, acute pancreatitis
Skin and subcutaneous tissue disorders
Not known:
Bullous dermatitis, Stevens-Johnson syndrome,
erythema multiforme, toxic epidermal necrolysis,
acute generalised exanthematous pustulosis, drug
rash with eosinophilia and systemic symptoms,
psoriasis flare-up
Musculoskeletal and connective tissue disorders:
Not known:
Arthralgia
Renal and urinary system disorders:
Rare:
Impairment of renal function including acute renal
failure
General disorders and administration site conditions:
Common:
Feeling hot
Uncommon: Pain and discomfort
Rare:
Asthenic conditions (including malaise, fatigue).
Not known:
Administration site reactions, including
extravasation, back pain
Intrathecal use
Please first read the section labelled “General”. Below, only
undesirable events with frequency during intrathecal use of
nonionic monomer contrast media are described.
Undesirable effects following intrathecal use may be delayed
and present some hours or even days after the procedure. The
frequency is similar to lumbar puncture alone. Headache, nausea,
vomiting or dizziness may largely be attributed to pressure loss in
the sub-arachnoid space resulting from leakage at the puncture
site. Excessive removal of cerebrospinal fluid should be avoided in
order to minimise pressure loss.
Psychiatric disorders:
Not known:
Confusion
Nervous system disorders:
Very common: Headache (may be severe and prolonged)
Uncommon: Aseptic meningitis (including chemical meningitis).
Rare:
Seizures, dizziness
Not known:
Electroencephalogram abnormal, meningism,
transient contrast-induced encephalopathy
(including transient memory loss, coma, stupor,
retrograde amnesia), motor dysfunction
(including speech disorder, aphasia, dysarthria),
paraesthesia, hypoesthesia and sensory
disturbance
Eye disorders:
Not known:
Transient cortical blindness, photophobia
Ear and labyrinth disorders:
Not known:
Transient hearing loss
Gastrointestinal disorders:
Common:
Nausea, vomiting
Musculoskeletal and connective tissue disorders:
Rare:
Neck pain, back pain
Not known:
Muscle spasm

General disorders and administration site conditions:
Rare:
Pain in extremity
Not known:
Administration site conditions
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):
Gastrointestinal 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
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 Special
warnings and precautions for use).
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 Special warnings and
precautions for use).
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 Special warnings and precautions for use).
Anaphylactoid reaction and anaphylactoid shock may lead to
profound hypotension and related symptoms and signs like
hypoxic encephalopathy, renal and hepatic failure (see section
Special warnings and precautions for use). 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 Special warnings and precautions for use).
Paediatric patients
Transient hypothyroidism has been reported in premature
infants, neonates and in other children after administration
of iodinated contrast media. Transient hypothyroidism in a
premature breast fed infant has been reported. The nursing
mother was repeatedly exposed to Omnipaque (see section
Special warnings and precautions for use).

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 (t1/2 ~ 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.

Pharmaceutical particulars

Legal category

List of excipients

POM

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.

Date of first authorisation/renewal of the
authorisation

Incompatibilities

Omnipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General Electric
Company.

20 April 1983

Date of revision of the text
November 2013

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

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

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.

Nature and content of container
Glass bottles:
The product is filled in injection vials (10, 15 and 20 ml) and
infusion bottles (40, 50, 75, 100 and 200 ml). Both containers are
made of colourless highly resistant borosilicate glass (Ph. Eur.
Type I), closed with chlorobutyl rubber stoppers (Ph. Eur. Type I),
and sealed with combined “flip off seal/tear off seal - flat plast
disc”.
Polypropylene bottles:
The product is filled in polypropylene bottles. Bottles of 50, 75,
100, 150, 175 and 200 ml are closed with chlorobutyl rubber
stoppers (Ph. Eur. Type I) and supplied with a plastic screw cap,
which is provided with a tamper proof ring
The product is supplied as:
Glass vials/bottles:
140 mg I/ml

240 mg I/ml

300 mg I/ml

350 mg I/ml

10 bottles of 50 ml
6 bottles of 200 ml

10 vials of 10 ml
6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
6 bottles of 200 ml

10 vials of 10 ml
6 vials of 20 ml
25 vials of 20ml
10 bottles of 50 ml
10 bottles of 75 ml
6 bottles of 100 ml

6 vials of 20 ml
25 vials of 20 ml
10 vials of 40 ml
10 bottles of 50 ml
10 bottles of 75 ml
10 bottles of 100 ml
6 bottles of 200 ml

300 mg I/ml

350 mg I/ml

10 bottles of 50 ml
10 bottles of 75 ml
10 bottles of 100 ml
10 bottles of 150 ml
10 bottles of 175 ml
10 bottles of 200 ml

10 bottles of 50 ml
10 bottles of 75 ml
10 bottles of 100 ml
10 bottles of 150 ml
10 bottles of 175 ml
10 bottles of 200 ml

Polypropylene bottles:
140 mg I/ml

240 mg I/ml

10 bottles of 50 ml
10 bottles of 100 ml
10 bottles of 200 ml

10 bottles of 50 ml
10 bottles of 100 ml
10 bottles of 200 ml

Not all pack sizes may be marketed.

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.

Name or style and permanent address or
registered place of business of the holder of
the marketing authorisation
MARKETING AUTHORISATION HOLDER

Pharmacological properties

GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
NO-0401 Oslo, Norway

Pharmacodynamic properties

Local Representative:

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.

Manufacturer:

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%).

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.

GE Healthcare Limited
Little Chalfont
Buckinghamshire HP7 9NA
GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
NO-0401 OSLO, Norway
Tel.: +47 23 18 50 50
Fax: +47 23 18 60 00

or

GE Healthcare Ireland,
IDA Business Park
Carrigtohill
Co. Cork, Ireland
Tel.: +353 21 88 3366
Fax: +353 21 88 3325

Marketing authorisation numbers
Omnipaque 140 mg I/ml
Omnipaque 240 mg I/ml
Omnipaque 300 mg I/ml
Omnipaque 350 mg I/ml

PL 00637/0038
PL 00637/0034
PL 00637/0035
PL 00637/0036

1170089 GBR

Expand view ⇕

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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