OMNIPAQUE INJECTION 300 MG I/ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

1200202

1200202

Scientific Leaflet

GE Healthcare	Omnipaque™
	IOHEXOL

1 NAME OF THE MEDICINAL PRODUCT

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 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient	Strength	Content per ml
Iohexol (INN)	140 mg I/ml	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 section 6.1.

Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray contrast medium. Omnipaque in the concentration of 140 mg I/ml is isotonic with blood and tissue fluid.

The osmolality and viscosity values of Omnipaque are as follows:

Concentration	Osmolality * mOsm/kg H 2 O 37°C	Viscosity (mPa^s) 20°C	37°C
140 mg I/ml	290	2.3	1.5
240 mg I/ml	510	5.6	3.3
300 mg I/ml	640	11.6	6.1
350 mg I/ml	780	23.3	10.6

in aqueous solution of iohexol

3 PHARMACEUTICAL FORM

Solution for injection.

4 CLINICAL PARTICULARS

• 4.1 Indications

This medicinal product is for diagnostic use only.

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

• 4.2 Posology and method of administration

The dosage depends on the type of investigation and the technique used. Usually the same iodine concentration and volume is used as for other iodinated X-ray contrast media in current use.

Adequate hydration should be assured before and after administration as for other contrast media.

For intravenous, intra-arterial and intrathecal use, and use in body cavities.

The following dosages may serve as a guide:

Guidelines for intravenous use

Indication	Concentration	Volume Comments
Urography
Adults	300 mg I/ml or 350 mg I/ml	40–80 ml 40–80 ml
Children < 7 kg	240 mg I/ml or 300 mg I/ml	4 ml/kg b.w. 3 ml/kg b.w.
Children > 7 kg	240 mg I/ml or 300 mg I/ml	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 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.
Children	140 mg I/ml	dependent upon age, weight and pathology
CT enhancement
Adults	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

Guidelines for intra-arterial use

Indication	Concentration	Volume Comments
Arteriographies Arch aortography	300 mg I/ml	30–40 ml/inj.
Selective cerebral	300 mg I/ml	5–10 ml/inj.
Aortography	350 mg I/ml	40–60 ml/inj.
Femoral	300 mg I/ml or 350 mg I/ml	30–50 ml/inj.
Various	300 mg I/ml	depending on type of examination
Cardioangiography
Adults
Left ventricle and aortic 350 mg I/ml root inj.		30–60 ml/inj.
Selective coronary arteriography	350 mg I/ml	4–8 ml/inj.
Children	300 mg I/ml or 350 mg I/ml	depending on age, weight and pathology (max 8 ml/kg b.w.)
Digital subtraction angiography Adults	140 mg I/ml or 240 mg I/ml or 300 mg I/ml	4 – 10 ml/inj. 1 – 15 ml/inj. 1 – 15 ml/inj.
Children	140 mg I/ml	Dependent upon

age, weight and pathology

Guidelines for intrathecal use
Indication	Concentration	Volume	Comments

Lumbar and thoracic myelography (lumbar injection)	240 mg I/ml	8 – 12 ml
Cervical myelography (lumbar injection)	240 mg I/ml or 300 mg I/ml	10–12 ml 7 – 10 ml
Cervical myelography (lateral cervical injection)	240 mg I/ml or 300 mg I/ml	6 – 10 ml 6 – 8 ml
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	Concentration	Volume	Comments
Arthrography	240 mg I/ml or 300 mg I/ml or 350 mg I/ml	5 – 20 ml 5 – 15 ml 5 – 10 ml
ERP/ERCP	240 mg I/ml	20 – 50 ml
Herniography	240 mg I/ml	50 ml
Hysterosalpin­gography	240 mg I/ml or 300 mg I/ml	15 – 50 ml 15 – 25 ml
Sialography	240 mg I/ml or 300 mg I/ml	0.5 – 2 ml 0.5 – 2 ml
Gastrointestinal studies	350 mg I/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 H 1 and H 2 antagonists might be considered in patients at risk for intolerance, they may, however, not prevent anaphylactic shock, they may actually mask initial symptoms. In patients with bronchial asthma especially the risk for bronchospasm is increased.

The risk of serious reactions in connection with use of Omnipaque is regarded as minor. However, iodinated contrast media may provoke serious, life-threatening, fatal anaphylactic/a­naphylactoid reactions or other manifestations of hypersensitivity.

Independent of quantity and route of administration, symptoms such as angio-oedema, conjunctivitis, coughing, pruritus, rhinitis, sneezing and urticaria may be indicative of a serious anaphylactoid reaction requiring treatment.

A course of action should therefore be planned in advance, with necessary drugs and equipment, medical experience and skilled personnel available for immediate treatment, should a serious reaction occur. In imminent state of shock, administration of the contrast medium must be terminated immediately and – if necessary – specific intravenous treatment must be initiated. It is advisable always to use an indwelling cannula or catheter for quick intravenous access throughout the entire X-ray procedure.

Patients using beta-adrenergic blocking agents, particularly asthmatic patients, may have a lower threshold for bronchospasm and are less responsive to treatment with beta agonists and adrenaline, which may necessitate the use of higher doses. These patients may also present with atypical symptoms of anaphylaxis which may be misinterpreted as vagal reaction.

Usually, hypersensitivity reactions become manifest as minor respiratory or cutaneous symptoms, such as mild difficulties of breathing, skin reddening (erythema), urticaria, pruritus or facial oedema. Severe reactions such as angio-oedema, subglottis oedema, bronchial spasm and shock are rare. These reactions usually occur within one hour following application of the contrast medium. In rare cases, hypersensitivity may occur delayed (after hours or days), but these cases are rarely life threatening, and mainly affect the skin.

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.

Encephalopathy has been reported with the use of iohexol (see section 4.8). Contrast encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma and cerebral oedema. Symptoms usually occur within minutes to hours after administration of iohexol, and generally resolve within days.

Factors which increase blood-brain barrier permeability will ease the transfer of contrast media to brain tissue and may lead to possible CNS reactions for instance encephalopathy.

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, and in patients with cerebral oedema, acute demyelinisation or advanced cerebral atherosclerosis.

If contrast encephalopathy is suspected, appropriate medical management should be initiated and iohexol must not be readministered.

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 Waldenstrom’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 (<130pmol/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 (>130pmol/litre)/im­paired renal function: Metformin should be stopped and the contrast medium examination delayed for 48 hours. Metformin should only be restarted 48 hours later if renal function is not diminished (if serum creatinine is not increased) compared to pre-contrast values.

Emergency cases:

In emergency cases where renal function is impaired or unknown, the physician should evaluate the risk/benefit of the contrast medium examination, and the following precautions should be implemented: Metformin should be stopped. It is particularly important that the patient is fully hydrated prior to contrast medium administration and for 24 hours afterwards. Renal function (e.g. serum creatinine), serum lactic acid and blood pH should be monitored, as well as the patient with regard to signs of lactacidosis.

A pH <7.25 or a lactic acid level of >5 mmol/litre are indicative of lactic acidosis.

The patient should be observed for symptoms of lactic acidosis. These include vomiting, somnolence, nausea, epigastric pain, anorexia, hyperpnoea, lethargy, diarrhoea and thirst.

Hepatic reactions:

A potential risk of transient hepatic dysfunction exists. Particular care is required in patients with severe disturbance of both renal and hepatic function as they may have significantly delayed contrast medium clearance. Patients on haemodialysis may receive contrast media for radiological procedures. Correlation of the time of contrast media injection with the haemodialysis session is unnecessary.

Myasthenia gravis:

The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis.

Phaeochromocy­toma:

In patients with phaeochromocytoma undergoing interventional procedures, alpha blockers should be given as prophylaxis to avoid a hypertensive crisis.

Disturbed thyroid function:

Due to free iodide in the solutions and additional iodide released by deiodination, iodinated contrast media influence thyroid function. This may induce hyperthyroidism or even thyreotoxic crisis in predisposed patients

Patients with manifest but not yet diagnosed hyperthyroidism are at risk, patients with latent hyperthyroidism (e.g., nodular goitre) and patients with functional autonomy (often e.g. elderly patients, especially in regions with iodine deficiency) should therefore have their thyroid function assessed before examination if such conditions are suspected.

Before administering an iodinated contrast agent, make sure that the patient is not about to undergo thyroid scan or thyroid function tests or treatment with radioactive iodine, as administration of iodinated contrast agents, regardless of the route, interferes with hormone assays and iodine uptake by the thyroid gland or metastases from thyroid cancer until urinary iodine excretion returns to normal. See also section 4.5.

Following injection of an iodinated contrast agent, there is also a risk of induction of hypothyroidism.

Anxiety conditions:

A sedative may be administered in the case of marked anxiety.

Sickle cell disease:

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously and intra-arterially.

Further risk factors:

Among patients with autoimmune diseases cases of serious vasculitis or Stevens-Johnson-like syndromes have been observed.

Severe vascular and neurological diseases, especially in elderly patients are risk factors for reactions to contrast media.

Extravasation:

Extravasation of contrast media may on rare occasions give rise to local pain, and oedema and erythema,, which usually recedes without sequelae. However, inflammation and even tissue necrosis have been seen. Elevating and cooling the affected site is recommended as routine measures. Surgical decompression may be necessary in cases of compartment syndrome.

Observation-time

Patients must be kept under close observation for 30 minutes following the last injection as the majority of severe reactions occur at this time.

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.

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.

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1200202

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

GE Healthcare	Omnipaque™	©
	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

1. What Omnipaque is and what it is used for

2. What you need to know before you use Omnipaque

3. How to use Omnipaque

4. Possible side effects

5. How to store Omnipaque

6. 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 useomnipaquedo not use omnipaque

• If you suffer from severe thyroid problems
• If you are allergic (hypersensitive) to iohexol or any of the other ingredients of Omnipaque (listed in Section 6).

Warnings and precautions

Check with your doctor before having Omnipaque:

• If you have ever had an allergic reaction after a medicine similar to Omnipaque, called a ‘contrast medium’.
• If you have any thyroid problems.
• If you have ever had any allergies.
• If you have asthma.
• If you have diabetes.
• If you have any brain disease or tumours.
• If you have or have had severe heart disease (involving heart or blood vessels) including high blood pressure, blood clots, stroke and irregular heartbeats (arrhythmia).
• If you have kidney problems or both liver and kidney problems.
• If you have an illness called ‘myasthenia gravis’ (a condition causing severe muscle weakness).
• If you have a ‘phaeochromocytoma’ (constant or attacks of high blood pressure due to a rare tumour of your adrenal gland).
• If you have “homocystinuria” (a condition with increased excretion of the amino acid cysteine in urine)
• If you have any problems with your blood or bone marrow.
• If you have ever been dependent on alcohol or drugs.
• If you have epilepsy.
• If you are having a thyroid function test in the next weeks.

During or shortly after the imaging procedure you may experience a short-term brain disorder called encephalopathy. Tell your doctor straight away if you notice any of the signs and symptoms related to this condition described in Section 4.

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.

Beta-blockers may increase your risk of experiencing breathing difficulties and may interfere with the treatment of severe allergic reactions, which is a risk of Omnipaque.

Fertility, Pregnancy and breast-feeding

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

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

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.

3. how to use omnipaque

Omnipaque will always be given to you by a specially trained and qualified person.

• Omnipaque will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe use.

Your doctor will decide the dose that is best for you.

The usual dose is:

• One single injection or you may be asked to swallow it.

After you have been given Omnipaque

You will be asked:

• to drink plenty of fluids afterwards (to help flush the medicine from your body), and
• to stay in or around the area where you had your scan or X-ray for around 30 minutes, and
• to stay in the clinic or hospital for one hour.

If you have any side effects during this time, tell your doctor straight away (see Section 4 ‘Possible Side Effects’).

The advice above applies to all patients who have had Omnipaque. If you are not sure about any of the above ask your doctor.

Omnipaque may be given in lots of different ways, a description of the ways it is usually given can be found below:

Injection into an artery or vein

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

Injection into your spine

Omnipaque will be injected into the space around the spinal cord to see your spinal canal. If you have been given Omnipaque into your spine afterwards you will be asked to follow the advice below:

• to rest with your head and body upright for one hour, or six hours if you stay in bed, and
• to walk carefully and try not to bend down for six hours, and
• not to be completely alone for the first 24 hours after having Omnipaque, if you are an outpatient and have ever had fits.

The advice above applies only if you have had Omnipaque injected in to your spine .

If you are not sure about any of the above ask your doctor.

Use in your body cavities or joints

Body cavities may be the joints, uterus and ovarian tubes. How and where Omnipaque is given will vary.

Use by mouth

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

4. possible side effects

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

Allergic reactions

If you have an allergic reaction when you are in hospital or a clinic having Omnipaque, tell the doctor straight away. The signs may include:

• wheeziness, difficulty in breathing or tightness or pain in your chest
• skin rash, lumps, itchy spots, blisters on skin and in mouth, red/itchy eyes, cough, running nose, sneezing or other allergic symptoms
• swelling of your face
• dizziness or feeling faint (caused by low blood pressure)
• severe skin reactions including potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Omnipaque, you must not be re-started on Omnipaque at any time.

The above side effects may happen several hours or days after Omnipaque is given. If any of these side effects happen after you leave the hospital or clinic, go straight to the casualty department of your nearest hospital.

A short term decrease in formation of urine due to decreased kidney function is common after Omnipaque is given. This may lead to damage to the kidney.

Other side effects that you may have are listed below; these depend on how or why Omnipaque was given to you. Ask your doctor if you are not sure how you were given Omipaque.

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

Turn over

SV-REG-049716, 1–3–2-hcpl-pil ompuk IA-PRAC recommendation­s, 3.0

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

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) which can cause confusion, hallucinations, difficulties with vision, loss of vision, seizures, loss of coordination, loss of movement in one side of the body, problems with speech, and loss of consciousness, 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

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

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

• 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, P.O.Box 4220 Nydalen,

NO-0401 Oslo, Norway.

Manufactured by:

GE Healthcare AS, Nycoveien 1, NO-0485 Oslo, Norway.

or

GE Healthcare Ireland Limited, IDA Business Park, Carrigtohill, Co. Cork, Ireland.

Local Representative:

GE Healthcare Limited

Pollards Wood

Nightingales Lane

Chalfont St Giles

Buckinghamshire HP8 4SP

This leaflet was last revised in

May 2021

Omnipaque is a trademark of GE Healthcare.

GE and the GE monogram are trademarks of General Electric Company.

Treatment with B-blockers may lower the threshold for hypersensitivity reactions, as well as necessitating higher doses of B-agonists when treating hypersensitivity reactions.

Beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists may reduce efficacy of cardiovascular compensation mechanisms of blood pressure changes.

All iodinated contrast media may interfere with tests on thyroid function, thus the iodine binding capacity of the thyroid may be reduced for up to several weeks.

High concentrations of contrast media in serum and urine can interfere with laboratory tests for bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium and phosphate). These substances should therefore not be assayed on the day of examination.

• 4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of Omnipaque for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.

Since whenever possible, radiation exposure should be avoided during pregnancy, the benefits of an X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. Omnipaque should not be used in pregnancy unless the benefit outweighs the risk and it is considered essential by the physician.

Apart from avoidance of exposition to radiation, the sensitivity of the foetal thyroid gland to iodine should be taken into account when risk and benefit are evaluated.

Thyroid function should be checked in all neonates during the first week of life following administration of iodinated contrast agents to the mother during pregnancy. Repeat testing of thyroid function is recommended at 2 to 6 weeks of age, particularly in low birth weight newborn or premature newborn.

Breast-feeding

Contrast media are poorly excreted in human breast milk and minimal amounts are absorbed by the intestine. Breast feeding may be continued normally when iodinated contrast media are given to the mother. The amount of iohexol in breast milk excreted in 24 hours after injection was 0.5% of the weight adjusted dose in a trial. The amount of iohexol ingested by the baby in the first 24 hours after injection corresponds to only 0.2% of the paediatric dose.

• 4.7 Effects on ability to drive and use machines

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

• 4.8 Undesirable effects

General (applies to all uses of iodinated contrast media)

Below are listed possible general side effects in relation with radiographic procedures, which include the use of non-ionic monomeric contrast media. For side effects specific to mode of administration, please refer to these specific sections. Hypersensitivity reactions may occur irrespective of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access.

An transient increase in S-creatinine is common after iodinated contrast media, contrast induced nephropathy may occur.

Iodism or “iodide mumps” is a very rare complication of iodinated contrast media resulting in swelling and tenderness of the salivary glands for up to approximately 10 days after the examination.

The listed frequencies are based on internal clinical documentation and published large scale studies, comprising more than 90,000 patients.

The frequencies of undesirable effects are defined as follows:

Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data)

Immune system disorders:

Rare: Hypersensitivity (including dyspnoea, rash, erythema, urticaria, pruritus, skin reaction, conjunctivitis, coughing, rhinitis, sneezing, vasculitis, angioneurotic oedema, laryngeal oedema, laryngospasm, bronchospasm or non-cardiogenic pulmonary oedema). They may appear either immediately after the injection or up to a few days later and may be indicative of the beginning of a state of shock. Hypersensitivity related skin reactions may appear up to a few days after the injection.

Not known: Anaphylactic /anaphylactoid reaction, anaphylactic/a­naphylactoid shock

Nervous system disorders: Rare: Headache

Very rare: Dysgeusia (transient metallic taste) Not known: Syncope vasovagal

Cardiac disorders: Rare: Bradycardia

Vascular disorders:

Very rare: Hypertension, hypotension

Gastrointestinal disorders:

Uncommon: Nausea

Rare: Vomiting

Very rare: Diarrhoea, abdominal pain/discomfort

Not known: Salivary gland enlargement

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

• © Description of selected adverse reactions

Thrombo-embolic complications have been reported in connection with contrast-enhanced angiography of coronary, cerebral, renal and peripheral arteries. The contrast agent may have contributed to the complications (see section 4.4).

Cardiac complications including acute myocardial infarction have been reported during or after contrast-enhanced coronary angiography. Elderly patients or patients with severe coronary artery disease, unstable angina pectoris and left ventricular dysfunction had a higher risk (see section 4.4).

In very rare occasions the contrast medium may cross the blood-brain barrier resulting in uptake of contrast medium in the cerebral cortex that may cause neurological reactions. They may include convulsions, transient motor or sensory disturbances, transient confusion, transient memory loss, and encephalopathy (see section 4.4).

Anaphylactoid reaction and anaphylactoid shock may lead to profound hypotension and related symptoms and signs like hypoxic encephalopathy, renal and hepatic failure (see section 4.4).

In several cases, extravasation of contrast media has caused local pain and oedema, which usually receded without sequelae. Inflammation, tissue necrosis and compartment syndrome have occurred (see section 4.4).

• (d) Paediatric patients:

Transient hypothyroidism has been reported in premature infants, neonates and in other children after administration of iodinated contrast media. Premature infants are particularly sensitive to the effect of iodine. Transient hypothyroidism in a premature breast fed infant has been reported. The nursing mother was repeatedly exposed to Omnipaque (see section 4.4).

Especially in infants and small children, adequate hydration should be assured before and after contrast media administration. Nephrotoxic medication should be suspended. The age dependent reduced glomerular filtration rate in infants can also result in delayed excretion of contrast agents.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: .

• 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 (t % ~ 2 hours). Accidental overdosing is most likely following complex angiographic procedures in children, particularly when multiple injections of contrast medium with high-concentration are given.

In cases of overdose, any resulting water- or electrolyte imbalance must be corrected. Renal function should be monitored for the next 3 days. If needed, haemodialysis may be used for clearance of excessive contrast medium. There is no specific antidote.

• 5 PHARMACOLOGICAL PROPERTIES

  • 5.1 Pharmacody­namic properties

Pharmacothera­peutic group: X-ray contrast media, iodinated, ATC code: V08AB02

For most of the haemodynamic, clinical-chemical and coagulation parameters examined following intravenous injection of iohexol in healthy volunteers, no significant deviation from preinjection values has been found. The few changes observed in the laboratory parameters were minor and considered to be of no clinical importance.

• 5.2 Pharmacoki­netic properties

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

• 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

In-use shelf-life: Chemical and physical in-use stability for the iohexol solution in the 500 ml polypropylene bottles has been demonstrated for 24 hours at 25°C.

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 closed with rubber stoppers and sealed 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 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 (multi-dose)	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 (multi-dose)

Not all pack sizes may be marketed.

• 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.

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.

Glass vials/bottles and polypropylene bottles up to 200 ml

The product should be drawn into the syringe immediately before use. For single use only, any unused portions must be discarded.

Polypropylene bottles of 500 ml

Chemical and physical in-use stability for the iohexol solution in the 500 ml polypropylene bottles has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately after opening. If not used immediately after opening, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at temperatures below 25°C, unless opening has taken place under controlled and validated aseptic conditions.

• The 500 ml contrast medium bottles should only be used in connection with auto injectors/pumps approved for this volume.
• A single piercing procedure should be used.
• Remove the plastic screw cap by tearing off the pull ring.
• After cleaning the stopper with a pad soaked in sporicidal solution followed by a pad soaked in alcohol, puncture the stopper with the needle.
• The line running from the auto injector/pump to the patient must be exchanged after each patient.
• Any unused portions of the contrast medium remaining in the bottle and all connecting tubes must be discarded after 24 hours.
• Instructions from the manufacturer of the auto injector/pump must be followed.

• 7 MARKETING AUTHORISATION HOLDER

GE Healthcare AS 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

• 9 DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

20 April 1983

• 10 DATE OF REVISION OF THE TEXT