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OMNIPAQUE INJECTION 240MG I/ML SOLUTION FOR INJECTION

Active substance(s): IOHEXOL / IOHEXOL

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1190443

Arteriographies
Arch aortography
Selective cerebral
Aortography
Femoral

Scientific Leaflet

Various

IOHEXOL

1

NAME OF THE MEDICINAL PRODUCT

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

30-40 ml/inj.
5-10 ml/inj.
40-60 ml/inj.
30-50 ml/inj.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

Strength

Content per ml

Iohexol (INN)
Iohexol (INN)
Iohexol (INN)
Iohexol (INN)

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

302 mg
518 mg
647 mg
755 mg

equiv. 140 mg I
equiv. 240 mg I
equiv. 300 mg I
equiv. 350 mg I

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

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

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

Digital subtraction
angiography
Adults
Children

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

Comments

depending on type
of examination

30-60 ml/inj.
4-8 ml/inj.
depending on
age, weight and
pathology
(max 8 ml/kg b.w.)
4 - 10 ml/inj.
1 - 15 ml/inj.
1 - 15 ml/inj.
Dependent upon
age, weight and
pathology

Guidelines for intrathecal use
Indication

Concentration

Volume

Lumbar and thoracic
myelography
(lumbar injection)
Cervical myelography
(lumbar injection)
Cervical myelography
(lateral cervical
injection)
CT cisternography
(lumbar injection)

240 mg I/ml

8 - 12 ml

240 mg I/ml
or 300 mg I/ml
240 mg I/ml
or 300 mg I/ml

10-12 ml
7 - 10 ml
6 - 10 ml
6 - 8 ml

240 mg I/ml

Comments

4 - 12 ml

* in aqueous solution of iohexol

To minimize possible adverse reactions a total dose of 3 g iodine should not be
exceeded.
Guidelines for body cavities

3

Indication

PHARMACEUTICAL FORM

Solution for injection.

4

CLINICAL PARTICULARS

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
Indication

Concentration

Volume

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

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.

Phlebography (leg)

240 mg I/ml
or 300 mg I/ml

20-100 ml/leg

Digital subtraction
angiography
Adults

140 mg I/ml

140 mg I/ml

Up to 3 ml per kg
body weight
20 - 60 ml/inj.
20 - 60 ml/inj.
dependent upon
age, weight and
pathology

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

100-400 ml
100-250 ml
100-200 ml
100-150 ml

Urography
Adults
Children < 7 kg
Children > 7 kg

Children
CT enhancement
Adults

Concentration

Arthrography

4.1 Indications

Document: 1190443 GBR Version: 2 Draft: 1

Volume

Cardioangiography
Adults
Left ventricle and aortic 350 mg I/ml
root inj.
Selective coronary
350 mg I/ml
arteriography
Children
300 mg I/ml
or 350 mg I/ml

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

2

Concentration

300 mg I/ml
or 350 mg I/ml

Comments

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

Volume

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
10-20ml

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 angiooedema, 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 angiooedema, 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 StevensJohnson-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.

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.

Fertility, Pregnancy and breast-feeding

1190443 GBR
1190443

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT

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.

Driving and using machines
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.

IOHEXOL
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 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

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.

• 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).

4. POSSIBLE SIDE EFFECTS

Warnings and precautions

Allergic reactions

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 (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.

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

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)
• increased/abnormal sweating, cold feeling, dizziness/fainting
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

Turn over

M

Indication



Guidelines for intra-arterial use

1190443 GBR

Common: affects 1 to 10 users in 100
• short-term changes in breathing rate, respiratory problems
Uncommon: affects 1 to 10 users in 1,000
• pain and discomfort
Rare: affects 1 to 10 users in 10,000
• diarrhoea
• irregular heartbeats, including fast heart rate
• Impairment of kidney function/acute kidney failure (kidneys not working)
• cough, stopped breathing, fever, general discomfort
• dizziness, feeling weak, muscle weakness
• intolerance to bright lights
• feeling abnormally tired
• skin rash and itching, reddening of the skin
• reduced eyesight
Very rare: affects less than 1 user in 10,000
• seizures (fits), clouding consciousness, stroke, disturbance of senses
(like touch), trembling
• flushing
• difficulty breathing
• myocardial infarction
Not known: frequency cannot be estimated from the available data
• severe skin reactions including severe rash, blistering and peeling of skin
• feeling confused, feeling disorientated, feeling agitated, restless or anxious
• 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 heart failure, spasms of the heart arteries and
cyanosis (blue to purple colour of skin because of decreased oxygen)
• tightness in chest or troubled breathing, including swellings of the lungs, spasms in
airways
• 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
• coma
• retrograde amnesia (loss of memories), disorientation, oedema/swelling of the brain
• iodism (excessive amounts of iodine in the body) resulting in swelling and tenderness
(pain) of your salivary glands
• short-term brain disorders (encephalopathy) including short term memory loss, coma
and stupor ("sleepy state")
• thrombocytopenia (a condition where the platelet count is low causing the blood not
to clot as well as it does normally)

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
• feeling agitated
• 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”).

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
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: 1190443 GBR Version: 2 Draft: 1

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.

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.

Reporting of side effects
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

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.
Contents of pack
Omnipaque is supplied as:
140 mg I/ml
10 glass bottles of 50 ml
6 glass bottles of 200 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
240 mg I/ml
10 vials of 10 ml
6 vials of 20 ml
25 vials of 20 ml
10 glass bottles of 50 ml
6 glass bottles of 200 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
300 mg I/ml
10 vials of 10 ml
6 vials of 20 ml
25 vials of 20 ml
10 glass bottles of 50 ml
10 glass bottles of 75 ml
6 glass bottles of 100 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 75 ml
10 polypropylene bottles of 75 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 150 ml
10 polypropylene bottles of 150 ml
1 polypropylene bottle of 175 ml
10 polypropylene bottles of 175 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
6 polypropylene bottles of 500 ml
350 mg I/ml
6 vials of 20 ml
25 vials of 20 ml
10 glass bottles of 40 ml
10 glass bottles of 50 ml
10 glass bottles of 75 ml
10 glass bottles of 100 ml
6 glass bottles of 200 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 75 ml
10 polypropylene bottles of 75 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 150 ml
10 polypropylene bottles of 150 ml
1 polypropylene bottle of 175 ml
10 polypropylene bottles of 175 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
6 polypropylene bottles of 500 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 Limited, IDA Business Park, Carrigtohill, Co. Cork, Ireland.

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

This leaflet was last revised in
May 2017
Omnipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General Electric Company.



After an injection into an artery or vein

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
General disorders and administration site conditions:
Common: Feeling hot
Uncommon: Hyperhidrosis, cold feeling, vasovagal reactions
Rare: Pyrexia
Very rare: Shivering (chills)
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.
Blood and lymphatic system disorders
Not known: Thrombocytopenia
Endocrine disorders:
Not known: Thyrotoxicosis, transient hypothyroidism
Psychiatric disorders:
Not known: Confusion, agitation, restlessness, anxiety
Nervous system disorders:
Rare: Dizziness, paresis, paralysis, photophobia, somnolence
Very rare: Seizures, disturbance in consciousness cerebrovascular accident,
sensory abnormalities (including hypoaesthesia), paraesthesia, tremor.
Not known: Transient motor dysfunction (including speech disorder, aphasia,
dysarthria), transient contrast induced encephalopathy (including transient
memory loss, coma, stupor, retrograde amnesia), disorientation, brain oedema.

Eye disorders:
Rare: Visual impairment 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), cardiac failure, spasm of coronary arteries, cyanosis,
chest pain
Vascular disorders:
Very rare: Flushing
Not known: Shock, arterial spasm, thrombophlebitis and venous thrombosis
Respiratory, thoracic and mediastinal disorders:
Common: Transient changes in respiratory rate, respiratory distress
Rare: Cough, respiratory arrest
Very rare: Dyspnoea
Not known: Severe respiratory symptoms and signs, pulmonary oedema, acute
respiratory distress syndrome, bronchospasm, laryngospasm, apnoea, aspiration,
asthma attack
Gastrointestinal disorders
Rare: Diarrhoea
Not known: Aggravation of pancreatitis, acute pancreatitis
Skin and subcutaneous tissue disorders
Rare: Rash, pruritus, urticariaNot 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, erythema, drug eruption, skin exfoliation.
Musculoskeletal and connective tissue disorders:
Not known: Arthralgia, muscular weakness, musculoskeletal spasm
Renal and urinary system disorders:
Rare: Impairment of renal function including acute renal failure
General disorders and administration site conditions:
Uncommon: Pain and discomfort
Rare: Asthenic conditions (including malaise, fatigue).
Not known: Administration site reactions, including extravasation, back pain
Injury, poisoning and procedural complications
Not known: Iodism
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, agitation
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, status epilepticus,
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):
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 contrastenhanced 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

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 50ml
6 bottles of 200ml

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

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

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

Polypropylene bottles:
140 mg I/ml

240 mg I/ml

300 mg I/ml

350 mg I/ml

10 bottles of 50 ml
1 bottle of 100ml
10 bottles of 100ml
1 bottle of 200ml
10 bottles of 200ml

10 bottles of 50 ml
1 bottle of 100ml
10 bottles of 100ml
1 bottle of 200ml
10 bottles of 200ml

10 bottles of 50ml
1 bottle of 75ml
10 bottles of 75ml
1 bottle of 100ml
10 bottles of 100ml
1 bottle of 150ml
10 bottles of 150ml
1 bottle of 175ml
10 bottles of 175ml
1 bottle of 200ml
10 bottles of 200ml
6 bottles of 500 ml

10 bottles of 50ml
1 bottle of 75ml
10 bottles of 75ml
1 bottle of 100ml
10 bottles of 100ml
1 bottle of 150ml
10 bottles of 150ml
1 bottle of 175ml
10 bottles of 175ml
1 bottle of 200ml
10 bottles of 200ml
6 bottles of 500 ml

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.

7

MARKETING AUTHORISATION HOLDER

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

8

MARKETING AUTHORISATION NUMBER(S)

PL 00637/0038, 0034, 0035, 0036

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.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION

5.2 Pharmacokinetic properties

June 2016

20 April 1983

10 DATE OF REVISION OF THE TEXT

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 %).

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.

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.

6.5 Nature and content of container
Glass bottles:
The product is filled in infusion 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, 200
and 500 ml are supplied with a plastic screw cap, which is provided with a tamper
proof ring

1190443 GBR

Expand Transcript

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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