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Active substance(s): IOHEXOL

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Omnipaque Injection 240mg I/ml solution for injection


Active ingredient


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

Viscosity (mPa⋅s)*

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






* in aqueous solution of iohexol


Solution for injection.




Therapeutic 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.


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

Children < 7 kg
Children > 7 kg
Phlebography (leg)
Digital subtraction



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
240 mg I/ml
or 300 mg I/ml
140 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.
20-100 ml/leg

300 mg I/ml
or 350 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

CT enhancement

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

Guidelines for intraarterial use

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


Arch aortography
Selective cerebral
Left ventricle and
aortic root inj.
Selective coronary



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.

350 mg I/ml

30-60 ml/inj.

350 mg I/ml


4-8 ml/inj.

depending on type of

Digital subtraction

300 mg I/ml
depending on age,
or 350 mg I/ml weight and pathology
(max 8 ml/kg b.w.)
4 - 10 ml/inj.
140 mg I/ml
or 240 mg I/ml 1 - 15 ml/inj.
or 300 mg I/ml 1 - 15 ml/inj.


140 mg I/ml

Dependent upon age,
weight and pathology

Guidelines for intrathecal use

Lumbar and
(lumbar injection)
(lumbar injection)
(lateral cervical
CT cisternography

240 mg I/ml

8 - 12 ml

10-12 ml
240 mg I/ml
or 300 mg I/ml 7 - 10 ml
6 - 10 ml
240 mg I/ml
or 300 mg I/ml 6 - 8 ml
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





5 - 20 ml
240 mg I/ml
or 300 mg I/ml 5 - 15 ml
or 350 mg I/ml 5 - 10 ml


240 mg I/ml 20 - 50 ml


240 mg I/ml


50 ml

240 mg I/ml 15 - 50 ml
or 300 mg I/ml 15 - 25 ml

240 mg I/ml 0.5 - 2 ml
or 300 mg I/ml 0.5 - 2 ml
350 mg I/ml


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


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 -blockers may present with atypical symptoms of anaphylaxis which
may be interpreted as vagal reaction.

dna stelluB :dettamroF



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
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
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.
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 4.4).
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
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.

Fertility, pregnancy and lactation
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.
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 4.4).
However, individual judgement must be performed if persistent post myelography


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
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
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
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

Musculoskeletal and connective tissue disorders:
Not known: Arthritis
General disorders and administration site conditions:
Very common: Pain
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 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).
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 4.4).
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 theYellow Card Scheme


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 highconcentration 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.




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


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 %).


Pre-clinical 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.




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


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


Glass vials and bottles:
Polypropylene bottles: 100 and 200 ml

3 years
3 years

The expiry date is indicated on the label.


Special Precautions for Storage
Omnipaque should be stored at or below 302C protected from light.
Furthermore, the product in glass vials and bottles can be stored at 37ºC for up
to 3 months prior to use.
The product in polypropylene bottles: 100 and 200 ml volumes may be stored
at 37ºC for up to 1 month prior to use.


Nature and contents 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 and
200 ml are supplied with a plastic screw cap, which is provided with a tamper proof
The product is supplied as:
Glass vials/bottles:
140 mg I/ml
10 bottles of 50ml
6 bottles of 200ml

240 mg I/ml

300 mg I/ml

350 mg I/ml

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


300 mg I/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

350 mg I/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

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.


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


PL 00637/0034

15 October 1998



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Source: Medicines and Healthcare Products Regulatory Agency

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