Consumer medicine information

Iomeron

Iomeprol

BRAND INFORMATION

Brand name

Iomeron

Active ingredient

Iomeprol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Iomeron.

What is in this leaflet

This leaflet answers some common questions about Iomeron®.

It does not contain all the available information. It does not take the place of talking to your radiologist (the specialist doctor who does X-rays), doctor or pharmacist.

All preparations of this type have risks and benefits. Your radiologist and/or your doctor have weighed the risks of your receiving Iomeron® against the benefits they expect it will have for you.

If you have any concerns about being given this preparation, ask your radiologist, doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Iomeron® is used for

Iomeron® (iomeprol) is an iodine-containing dye, called a “contrast medium”.

Iomeron® is injected into blood vessels or body cavities to make blood vessels and other parts of the body visible to X-rays.

Iomeron® is used for the radiological visualisation of the vascular, renal and other physiological systems.

Injection of Iomeron® into the spinal cord allows the nerve within the spine to be seen in the X-ray. The resulting X-ray photographs may help your doctor to diagnose your illness or problem.

This medicine belongs to a group of medicines called contrast agents.

In children, Iomeron® is injected only into the blood vessels. Ask your radiologist or doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

Before you are given Iomeron®

When you must not be given it

You must not be given Iomeron® if you have an allergy to:

  • any medicine containing iomeprol
  • any of the ingredients listed at the end of this leaflet.
  • any other similar medicines

Some of the symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing;
  • swelling of the face, lips, tongue or other parts of the body;
  • rash, itching or hives on the skin.

You must not be given Iomeron®:

  • if you suffer from multiple myeloma or Waldenstroem's paraproteinaemia (a disorder of the immuno-globulins -cells involved in the body’s natural ability to fight disease)
  • if you suffer from kidney disease or a combination of severe liver and kidney disease.
  • if you underwent a myelography procedure during the last 48hours

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you have any questions not answered in this leaflet please ask the medical staff supervising your scan.

Before you are given it

Tell your radiologist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your radiologist or doctor if you have or have had any of the following medical conditions:

  • asthma.
  • allergy such as hay fever or food allergy
  • an overactive thyroid gland or goitre (neck swelling of the thyroid gland).
  • diabetes and being treated with metformin (Diabex, Diaformin or Glucophage). You must not take this medication for 48 hours before, and 48 hours after your X-ray to avoid harming your kidneys. Also, on making the appointment for the X-ray, remember to tell your radiologist that you are taking metformin but that you will not be taking it for at least 48 hours before, or 48 hours after the X-ray. Tell your radiologist again when you arrive for your X-ray appointment. If you are unsure about this or what to do, discuss it with your doctor.
  • phaeochromocytoma (a tumour which raises blood pressure).
  • heart disease or problems with your heart, especially if you are elderly
  • increased blood pressure
  • any disorder or injuries affecting your brain or nervous system, for example, stroke, bleeding inside the skull or brain, accumulation of fluid on the brain, multiple sclerosis, brain tumours or tumours (or cancer) spreading to the brain, epilepsy, transient ischaemic attacks (mild strokes).
  • alcoholism (there is an increased risk of seizure (fit))
  • addiction to, or dependence on drugs or medicines (there is an increased risk of seizure (fit)).
  • inflammation of the female sex organs. This is only relevant if you are undergoing a uterine x-ray.
  • myasthenia gravis
  • sickle-cell disease

Iomeron may affect the way the thyroid gland works for several weeks after being given it. If you are going to have an iodine test for thyroid disease, tell your doctor or the laboratory staff if you have received Iomeron recently.

Tell your doctor if you are pregnant or intend to become pregnant. It is not known if Iomeron® harms the developing baby. X-rays can be harmful to unborn babies. Iomeron® should therefore not be used in pregnancy unless there are compelling reasons. Your doctor and/or radiologist can discuss with you the risks and benefits involved.

If you received contrast media whilst pregnant your baby may be given a test for hypothyroidism in the period shortly after birth.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if IOMERON® passes into human breast milk. Because many substances do pass into human breast milk, stop breastfeeding your baby before you have an injection of IOMERON®, feed the baby with formula milk and do not start breastfeeding again until you have checked with your doctor that it is safe to do so.

If you have not told your doctor/radiologist about any of the above, tell him/her before you are given Iomeron®.

Taking other medicines

Tell your radiologist, doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Iomeron® may interfere with each other. These include:

  • Neuroleptics - (medicines used for the treatment of some mental disorders - sometimes also called major tranquillisers). Check with your doctor or pharmacist if you are not sure whether you are taking a neuroleptic.
  • Antidepressants - (medicines used for the treatment of depression). Check with your doctor or pharmacist if you are not sure whether you are taking an antidepressant.
  • Anticonvulsants - Any medicine used for the treatment of epilepsy or fits. Check with your doctor or pharmacist if you are not sure whether you are taking an anticonvulsant.
  • Certain medicines used to treat diabetes such as metformin. Check with your doctor or pharmacist if you are not sure whether you are taking metformin.
  • Nephrotoxic drugs - medicines which can have a side effect of damaging the kidney in certain doses and under certain conditions.
    Check with your doctor or pharmacist if you are not sure whether you are taking a nephrotoxic drug.
  • Corticosteroids (a class of steroid hormones) may promote and affect the signs and symptoms of arachnoiditis (inflammation of arachnoid). Check with your doctor or pharmacist if you are not sure whether you are taking a corticosteroid.

These medicines may interact or affect the way Iomeron® works. Your doctor may ask you not to take certain medicines for 48 hours before receiving an injection of IOMERON®.

Your radiologist, doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Iomeron® is given

Follow all directions given to you by your radiologist, doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor for help.

Iomeron® is used to make blood vessels and other parts of the body visible to x-rays, so that x-ray photographs can be taken.

How much to take:

The strength and amount of Iomeron® you will be given depends upon the parts of your body which are being examined and your body weight. Your radiologist/doctor will inject the correct amount of Iomeron® into a blood vessel or body cavity, before taking the x-ray photographs. You will probably be observed for at least 30 minutes after the x-ray.

How to take it:

Iomeron® will be injected into a blood vessel or any other parts of the body by your radiologist/doctor.

You should have plenty to drink and can eat normally on the day of your x-ray up to two hours before receiving an injection of Iomeron®.

What if you are given too much (overdose)?

The radiologist/doctor giving you Iomeron® will be experienced in its use, so it is unlikely that you will be given an overdose.

You will be given Iomeron® by injection in a hospital environment so it is extremely unlikely you will be given too much.

However, if you experience any side effects after being given Iomeron® tell your radiologist or doctor immediately. Your radiologist or doctor will know how to treat you.

Immediately telephone the Poison Information Centre on 13 11 26 in Australia or 0800 764 766 in New Zealand for any advice if you think you or anyone else may have taken too much Iomeron. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Iomeron®

Things you must do:

Your radiologist or doctor will advise you what to do before, during and after your procedure.

Things you must not do:

Do not drive a vehicle or operate machinery for at least 24 hours after receiving the injection of Iomeron® as delayed reactions to iodine-containing dyes may occur within this period. Your radiologist will make appropriate records during your treatment and will note any unexpected effects you may experience.

Side effects

Tell the radiologist/doctor immediately if you are not feeling well after receiving an injection of Iomeron®, during the x-ray procedure and afterwards.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your radiologist or doctor to answer any questions you may have.

Tell your radiologist or doctor if you notice any of the following and they worry you:

  • flushing
  • heat sensation
  • headache
  • nausea
  • disturbance of taste sensation
  • pain at the site where Iomeron® is injected;

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor or radiologist as soon as possible if you notice any of the following:

  • abdominal pain
  • vomiting
  • chest pain
  • back pain
  • chills
  • fatigue
  • fever
  • headache
  • swelling
  • generally feeling unwell
  • pain, bleeding and swelling at the site of injection
  • changes in heart rate or heart beat (fast, slow or irregular)
  • ECG change
  • high or low blood pressure
  • heart attack
  • palpitation
  • shock
  • fainting
  • confusion
  • dizziness
  • dry mouth
  • mood swings
  • paralysis
  • muscle stiffness
  • low muscle strength
  • increased salivation
  • nervousness
  • numbness or weakness of arms and legs
  • sensation of tingling, prickling or numbness of the skin
  • drowsiness
  • excessive hairiness
  • itching
  • rash
  • skin discolouration
  • sweating
  • inflammation of the lip
  • diarrhoea
  • difficulty in swallowing
  • burping
  • swollen, red, sore tongue
  • abnormal vision
  • swollen runny eyes
  • eye pain
  • unusual weakness
  • difficulty in breathing
  • asthma
  • coughing
  • sore throat and discomfort when swallowing
  • runny or blocked nose
  • feeling of tension or fullness in the nose and behind the ears (sinusitis)
  • swelling of the throat
  • urinary incontinence

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

Tell your doctor or radiologist if you notice any of the following and they worry you:

  • life threatening allergic reaction
  • heart failure
  • collapse due to very low blood pressure
  • CNS disturbances such as tremor, muscular spasms, loss of consciousness, loss of ability to comprehend language, loss of smell, taste, convulsive seizures and coma
  • Passing less urine than is normal
  • Protein in urine
  • Faecal incontinence

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your radiologist, doctor or pharmacist if you notice anything that is making you feel unwell.

Some people may experience other side effects after an injection of Iomeron®.

Some of these side effects can only be found when your radiologist or doctor does tests from time to time to check your progress.

Your radiologist/doctor may give you other medicines before you receive an injection of Iomeron® to prevent these side effects from occurring.

STORAGE of Iomeron®

Storage

You will not normally be required to store Iomeron®. It will usually be kept by your radiologist or in the radiology or pharmacy department of the hospital where you are having the x-ray.

Your radiologist should store this product below 25°C and protect it from light. It is advisable to store the product out of reach of ionising radiation.

Product description

What it looks like

Iomeron® is a sterile solution, which is supplied in vials with rubber stoppers. It is available in the following different strengths and sizes:

Ingredients

Iomeron® 300
Each mL of Iomeron® 300 contains:
612.4 mg iomeprol.

It also contains:

  • 1 mg trometamol
  • 0.24 mg hydrochloric acid
  • water for injections to make 1 mL.

Iomeron® 350
Each mL of Iomeron® 350 contains:
714.4 mg iomeprol

It also contains:

  • 1 mg trometamol
  • 0.24 mg hydrochloric acid
  • water for injections to make 1 mL.

Distributor/Supplier

Sponsor:

Bracco Pty Ltd
14 Allambie Avenue, East Lindfield
NSW 2070
[email protected]

Australian distributor:

Regional Healthcare Group
Medi-Consumables Pty Ltd
(ACN 001 394 323)
3-11 Primrose Avenue
ROSEBERY NSW 2018

New Zealand distributor

Regional Health Limited
PO Box 101-140
North Shore Mall Centre
Auckland
New Zealand

This leaflet was prepared in June 2020.

Iomeron® 300 is available in the following pack sizes:

50 mL vial - AUST R 63955

100 mL vial - AUST R 63957

Iomeron® 350 is available in the following pack sizes:

50 mL vial - AUST R 63960

100 mL vial - AUST R 63961

200 mL vial - AUST R 63963

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Iomeron

Active ingredient

Iomeprol

Schedule

S4

 

Notes

Distributed by Regional Health Care Products Group Medi-Consumables Pty. Ltd.

1 Name of Medicine

Iomeprol.

2 Qualitative and Quantitative Composition

Iomeron 300 - Each mL contains iomeprol 612.4 mg.
Iomeron 350 - Each mL contains iomeprol 714.4 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, solution. Clear solution, practically free from visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Iomeron is indicated for use for the radiological visualisation of the vascular, renal and other physiological systems in adults and children. See Section 4.2 Dose and Method of Administration for a listing of specific indications for each Iomeron concentration.

4.2 Dose and Method of Administration

In relation to the procedure.

Coagulation, flushing of catheters.

Non-ionic contrast media have less anticoagulant activity in vitro than ionic media.
Medical personnel performing vascular catheterisation procedures should be aware of this and pay meticulous attention to the angiographic technique and catheter flushing so as to minimise the risk of procedure related thrombosis and embolism.

Observation of the patient.

Intravascular administration of contrast media should, if possible, be done with the patient lying down. The patient should be kept under observation for at least 30 minutes after the administration.
Following intrathecal use, the patient should rest with the head and chest elevated for one hour and be kept well hydrated.
Thereafter, he/she may ambulate carefully but bending down must be avoided. If remaining in bed, the head and chest should be kept elevated for a few hours. Patients suspected of having a low seizure threshold should be observed during this period.

Pretesting.

Sensitivity test doses are not recommended since severe or fatal reactions to contrast media are not predictable from a patient's history or a sensitivity test.
When examining the subarachnoidal space the total amount of administered contrast substance should be kept as low as possible within the recommended dose interval.

Instructions for use.

See Table 1.

4.3 Contraindications

Hypersensitivity to iomeprol or other components in the formulations.
Spinal puncture should not be performed in the presence of significant local or systemic infection where bacteraemia is likely.
Immediate repeat myelography is contraindicated and a repeat dose interval of at least 48 hours is recommended.

Severe renal impairment.

Iomeron should not be used in patients with severe impairment of renal function, as the kinetics and safety of Iomeron have not been established in this group of patients. Iomeron is also contraindicated in patients with a combination of severe hepatic and renal impairment which can delay contrast media excretion, therefore predisposing to untoward reactions.

Multiple myeloma, Waldenstroem's paraproteinaemia.

The use of the product is generally contraindicated. It is necessary to consider that the presence of myelomatosis or paraproteinaemias is a factor predisposing to renal impairment following intravascular contrast media administration. Adequate hydration is recommended.

4.4 Special Warnings and Precautions for Use

Special warnings - common to all types of administration.

In consideration of possible serious side effects, the use of iodine containing contrast media should be limited to cases for which there is a precise need for the examination. The need should be evaluated on the basis of the clinical status of the patient, in particular in relation to pathologies of the cardiovascular, urinary or hepatobiliary systems. The risks of the specific radiographic contrast procedure itself should be carefully evaluated in each patient. Contrast media designed for angiocardiographic procedures should be used in hospitals or clinics equipped and staffed for intensive care in emergencies.
For other more common diagnostic procedures calling for the use of iodinised contrast media, in the institutions, where such procedures are to take place, resuscitation equipment and therapeutic measures should be immediately available.

General.

Adverse reactions to iodinated contrast media are more common in patients with a history of allergy, including hay fever, hives and food allergy.
Hypersensitivity or a previous history of a reaction to iodinated contrast media also increase the risk of recurrence of a severe reaction. Hence, before administering Iomeron, the patient should be questioned about his/her allergic history to determine his/her allergic disposition or history of hypersensitivity. A history of allergy, including asthma, while implying a greater than usual risk, is not, however, an absolute contraindication to the use of Iomeron.
Patients should be well hydrated prior to and following administration of any contrast media including Iomeron. The procedure of preparatory dehydration is dangerous and may lead to acute renal failure in patients with advanced renal disease, diabetics and other susceptible non-diabetic patients, particularly the elderly with pre-existing renal disease. The osmotic diuretic effect of contrast media appears to increase dehydration in these patients. High risk patients should therefore be identified and well hydrated before administration of Iomeron, preferably by maintaining i.v. infusion before and during the procedures and until the contrast medium has been cleared by the kidneys.

Special precaution.

High concentrations of Iomeron by intra-arterial route in critical circulations (i.e. coronary and cerebral) may, due to their higher viscosity, induce or aggravate ischaemia in these circulations.

Management of severe allergic or cardiovascular reactions.

Severe allergic or cardiovascular reactions, including fatalities, have occurred following administration of water soluble iodinated contrast media. Prior to administration of Iomeron, therefore, a planned course of action, including having appropriate and adequate facilities and personnel available, must be in place and be capable of immediate implementation, in case a serious reaction occurs.

Use with caution in the following circumstances.

Paediatric use.

Young infants (age < 1 year), especially neonates, are particularly susceptible to electrolyte imbalances and haemodynamic alterations. Care should be taken regarding the dosage to be used, the details of the procedure, and the patient's status. Safety and efficacy of Iomeron for use in myelography in children have not been adequately demonstrated.
Thyroid function in infants exposed to iodinated contrast media (ICM) should be evaluated and monitored. Decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased level of thyroid stimulating hormone (TSH) were reported after exposure to ICM in infants, especially preterm infants, which remained for up to a few weeks or more than a month. Thyroid function in infants exposed to ICM should therefore be evaluated and monitored until thyroid function is normalised. Some patients were treated for hypothyroidism.

Use in the elderly.

The elderly are at special risk of reactions due to high dosage of contrast media. Myocardial ischaemia, major arrhythmias and extrasystoles are more likely to occur in these patients. The frequently encountered combination of neurological disturbances and severe vascular pathologies constitutes a serious complication.
The probability of acute renal insufficiency is higher in these subjects.

History of hypersensitivity, allergic disposition.

It is generally agreed that adverse reactions to iodinated contrast media are more common in patients having a history of allergy, including hay fever, hives and food allergy. Hypersensitivity or a previous history of a reaction to iodinated contrast media also increases the risk of recurrence of a severe reaction with non-ionic media.

Asthmatic patients.

The risk of bronchospasm inducing reactions in asthmatic patients is higher after contrast media administration.

Hyperthyroidism, nodular goitre.

The release of free inorganic iodine from iodinated molecules, especially from lipid soluble and water soluble ionic compounds, may affect thyroid function. These effects appear to be more evident in patients with hyperthyroidism or goitre. Iodine containing contrast media should not be administered to patients with known hyperthyroidism.

Use in renal impairment.

Pre-existing renal impairment may predispose to acute renal dysfunction following intra-arterial or intravenous contrast media administration. Preventive measures include: identification of high risk patients; ensuring adequate hydration before contrast media administration, preferably by maintaining i.v. infusion before and during the procedures and until the contrast media has been cleared by the kidneys; avoiding whenever possible the administration of nephrotoxic drugs or major surgery or procedure such as renal angioplasty until the contrast media has been cleared; postponing a new contrast agent examination until renal function returns to pre-examination levels.

Diabetes mellitus.

The presence of renal damage in diabetic patients is one of the factors predisposing to renal impairment following intravascular contrast media administration. This may precipitate lactic acidosis in patients who are taking biguanides. As a precaution, biguanides should be stopped 48 hours prior to the contrast media examination and reinstated only after control of renal function has been regained.

Phaeochromocytoma.

These patients may develop severe (rarely uncontrollable) hypertensive crises following intravascular contrast media usage during radiological procedures. Premedication with alpha-receptor blockers is recommended because of the risk of blood pressure crises.

Sickle cell disease.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease. Adequate hydration is recommended.

Myasthenia gravis.

The administration of iodinated contrast media may aggravate myasthenia signs and symptoms.

Severe cardiovascular disease.

There is an increased risk to severe reactions in individuals with severe cardiac disease and particularly in those with heart failure and coronary artery disease. The intravascular contrast media injection may precipitate pulmonary oedema in patients with manifest or incipient heart failure, whereas contrast media administration, in pulmonary hypertension and heart valvular diseases, may lead to pronounced haemodynamic changes. Ischaemic ECG changes and major arrhythmias are more common in elderly patients and in those with pre-existing cardiac disease - their frequency and severity appear to be related to the severity of cardiac impairment. Severe and chronic hypertension may increase the risk of renal damage following intravascular contrast media administration and the risks associated with the catheterisation procedure.

CNS disorders.

Particular care should be paid to the intravascular and intrathecal administration of contrast media in patients with acute cerebral infarction, acute intracranial haemorrhage, and conditions involving blood-brain-barrier (BBB) damage, brain oedema and acute demyelination. Intrathecal administration of contrast media should be undertaken with caution in patients with a likelihood of reduced seizure threshold, since there is no barrier to contrast media in the CSF penetrating the brain. The presence of intracranial tumours or metastases and a history of epilepsy may increase the probability of the occurrence of convulsive seizures. Neurological symptoms due to degenerative, inflammatory or neoplastic cerebrovascular pathologies may be exacerbated by intravascular contrast media administration. Vasospasm and consequent cerebral ischaemic phenomena may be caused by intravascular injections of contrast media. Patients with symptomatic cerebrovascular diseases, recent stroke or frequent transient ischaemic attack have an increased risk of transient neurological complications.

Alcoholism.

Acute and chronic alcoholism have been proven both experimentally and clinically to increase BBB permeability. This facilitates the passage of iodinated agents into the cerebral tissue, possibly leading to CNS disorders. Caution must be exercised in the intravascular and intrathecal administration of contrast media in alcoholics because of the possibility of a reduced seizure threshold.

Drug addiction.

Caution must be exercised in drug addicts because of the possibility of a reduced seizure threshold.

Check the following before use.

Hydration.

Any severe disorders of water and electrolyte balance should be corrected. Adequate hydration must be ensured before examination, especially in patients with multiple myeloma, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as in babies, small children and elderly patients.

Dietary suggestion.

Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination. Adequate fluid intake must be ensured. However, for two hours prior to the procedure the patient should refrain from eating.

History of hypersensitivity.

In patients with an allergic disposition, known hypersensitivity to iodinated contrast media and a history of asthma, premedication with antihistamines and/or corticoids may be considered in order to prevent possible anaphylactoid reactions.

Anxiety.

Pronounced states of excitement, anxiety and pain can be the cause of side effects or intensify contrast related reactions. These patients may be given a sedative.

Effects of laboratory tests.

Thyroid function tests.

Following administration of iodinated contrast media, the capacity of the thyroid tissue to take up radioisotopes for the diagnosis of thyroid disorders is reduced for up to two weeks, or even longer in individual cases. These findings have not been associated with clinical manifestations. Thyroid function tests not depending on iodine estimations, e.g. T3 resin uptake and total or free thyroxine (T4) assays are not affected.

Laboratory tests.

High concentrations of contrast media in serum and urine can interfere with laboratory test results of bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium, phosphate).

4.5 Interactions with Other Medicines and Other Forms of Interactions

No specific clinical studies on interactions with other drugs have been conducted with iomeprol. Nevertheless, in analogy to other iodinated contrast media, the following measures should be taken in respect of the drugs mentioned below.

Neuroleptics and phenothiazine derivative anti-depressants.

Treatment should be discontinued 48 hours before the examination because they reduce the seizure threshold. Treatment should not be resumed until 24 hours post-procedure.

Anti-convulsants.

Therapy must not be discontinued and should be administered in optimal dosage.

Oral cholecystographics.

Interactions of renally excreted contrast media with oral cholecystographics contrast media are unlikely to occur.

Nephrotoxic drugs.

Whenever possible, the administration of nephrotoxic drugs should be delayed until the contrast media has been cleared.

Biguanides.

Intravascular contrast media administration may precipitate lactic acidosis in diabetic patients with renal damage who are taking biguanides.
Biguanides should be stopped 48 hours prior to contrast media examination and reinstated only after control of renal function has been regained.

Corticosteroids.

Epidural and intrathecal corticosteroids should never be concurrently administered intrathecally when iodinated contrast media are used, because corticosteroids may promote and affect the signs and symptoms of arachnoiditis.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility was not impaired in rats with daily exposures (based on the dosage) up to more than twice that recommended in patients.
(Category B3)
There are no controlled studies in pregnant women to confirm the safety of iomeprol.
In animal studies, after pregnant rats were dosed with radio-labelled iomeprol i.v., maternal tissues, placentae and fetuses showed a comparable distribution of radioactivity.
Iomeprol was not teratogenic at doses of 2 or 4 g I/kg i.v., administered daily, in rabbits or rats, respectively, during pregnancy. However, there were slight increases in the frequency of skeletal anomalies in both rabbits and rats, although no statistically significant differences or dose related responses were observed.
Iomeprol should be used during pregnancy only if clearly needed. Infants born to women who received iodinated contrast media while pregnant should have testing for hypothyroidism in the neonatal period. Some patients were treated for hypothyroidism. Also see Paediatric use.
 There is no information on the excretion of iomeprol in the milk of animals. For testing perinatal and postnatal toxicity, rats were dosed with iomeprol at 0.6, 1.5 or 4 g I/kg i.v. daily during the final period of gestation and throughout lactation. Neonatal mortality was increased, and the survival index, viability index and mean bodyweight of the pups were lower at a dose of 4 g I/kg.
Since no data are available in respect of the adverse effects in nursing infants, use of iomeprol in lactation is not recommended. Also see "Paediatric use".

4.7 Effects on Ability to Drive and Use Machines

No data are available but, since delayed reactions can rarely occur after administration of iodinated contrast media, driving or operating machinery is not advisable for the first 24 hours following contrast medium examination.

4.8 Adverse Effects (Undesirable Effects)

The use of iodinated compounds may cause untoward effects which are generally of a mild to moderate nature, as well as more severe ones, with fatal anaphylactoid reactions. Symptoms are, however, usually mild, of short duration and self limiting. More severe neurological sequelae may be the result of complications of a pre-existing pathology. In myelography common adverse events are headache, nausea, vomiting and pain.
General or local sensation of heat is the most frequent complaint associated with administration of Iomeron.

Body as a whole.

Common. Pain at the injection site, headache.
Uncommon. Abdominal, back and chest pain, chills, fatigue, fever, headache, malaise, mucous disorder, oedema.
Rare. Fatal anaphylactoid reactions.

Cardiovascular.

Common. Flushing.
Uncommon. Angina pectoris, arrhythmia, bradycardia, ECG change, tachycardia, hypertension, hypotension, cardiac arrest, palpitation, peripheral vascular disorder, shock, syncope.
Rare. Cardiac failure, peripheral vasodilation with pronounced hypotension, hypertension, tachycardia or bradycardia, cyanosis, dyspnoea and circulatory collapse.

Central nervous system.

Common. Disturbance of taste sensation.
Uncommon. Confusion, dizziness, dry mouth, emotional lability, hemiplegia, hypertonia, hypotonia, increased salivation, nervousness, neuropathy, paraesthesia, somnolence.
Rare. The intravenous or intra-arterial injection of contrast agents may cause symptoms related to CNS disturbances: tremor, muscular spasms, mental confusion, loss of consciousness, disturbances of visual field, muscular palsies, aphasia, convulsive seizures, and coma.

Dermatological.

Uncommon. Angioedema, hirsutism, pruritus, rash, skin discolouration, subcutaneous nodule, sweating, urticaria, widespread erythema.
Skin reactions may be present in the form of diversified rashes or diffuse pomphus formation, and sometimes itching. Pain, haemorrhage and oedema may arise at the site of injection. In the case of extravasation a tissue reaction may ensue, but this is rare.

Endocrine.

Uncommon. Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and paediatric patients, including infants. Some patients were treated for hypothyroidism.

Gastrointestinal.

Common. Nausea.
Uncommon. Cheilitis, diarrhoea, dysphagia, eructation, glossitis, vomiting.

Ophthalmological.

Uncommon. Abnormal vision, conjunctivitis, eye disorder, eye pain.

Muscular-skeletal.

Uncommon. Asthenia.

Respiratory system.

Uncommon. Apnoea, asthma, worsening of cough, dyspnoea, pharyngitis, rhinitis, sinusitis, upper respiratory infection, laryngeal oedema.

Urogenital.

Uncommon. Incontinence, urinary urgency.
Rare. A transient renal failure with oliguria, proteinuria and an increase of serum creatinine level may arise, particularly in patients with pre-existing impairment of renal function.

Post marketing data.

The following adverse effects have been reported in less than 3 out of 10,000 patients (rare < 0.03%).
Intravascular and intrathecal administration.

Body as a whole.

Shock, malaise, fatigue, hot flushes, facial flushing, cold sweat, local sensation of coldness, taste abnormality, thirst, injection site reaction.

Nervous.

Hyperkinesia, encephalopathy, paralysis, oculomotor nerve paralysis, paraesthesia, dysarthria, giddiness, dysphonia, faecal incontinence, cerebral oedema.

Cardiovascular.

Cardiac arrest, myocardial infarction, angina pectoris, extrasystoles, arrhythmia, ventricular or atrial fibrillation, tachycardia, palpitation, atrioventricular block, abnormal ECG, elevation of ST.

Respiratory.

Respiratory arrest, pulmonary oedema, adult respiratory distress syndrome (ARDS), bronchospasm, asthma, pharynx oedema, laryngeal stridor, rhinitis, coughing, hyperventilation, hypoxia, pharyngolaryngeal abnormal sensation.

Skin and appendages.

Angioedema, eczema, urticaria, wheals.

Vascular (extracardiac).

Cerebrovascular disorder, transient ischaemic attack.

Gastrointestinal disorders.

Acute pancreatitis, ileus, diarrhoea, abdominal pain, salivation, dysphagia.

Urogenital.

Urinary incontinence, increase in blood urea nitrogen (BUN).

Special senses.

Parosmia.

Vision.

Transient cortical loss of vision, vision disturbance, conjunctivitis, lacrimation, photopsia, photophobic sensation.

Musculo-skeletal.

Arthralgia, muscle stiffness.

Psychiatric.

Amnesia, anorexia, anxiety, somnolence.

Liver and biliary tract.

Liver function tests abnormalities.

Platelet, bleeding and clotting.

Thrombocytopenia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdose may lead to life threatening adverse effects mainly through effects on the pulmonary and cardiovascular system.
Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
Iomeprol does not bind to plasma or serum proteins and is therefore dialysable.
Contact the Poisons Information Centre on 13 11 26 for advice on management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Iomeron is a sterile aqueous contrast medium solution for intravascular and body cavities administration. The active ingredient of Iomeron formulations is iomeprol, a tri-iodinated, non-ionic contrast agent, and is indicated for use in X-ray examinations.

Animal studies.

Results from studies in rats, mice and dogs demonstrate that iomeprol has an acute intravenous or intra-arterial toxicity similar to that of the other non-ionic contrast media, as well as a good systemic tolerability after repeated intravenous administrations in rats and dogs. After intravenous administration in rats iomeprol is distributed between plasma and the extracellular space. It does not bind to plasma proteins. It is not metabolised and is eliminated almost exclusively through the kidneys. In the rat, 94% of the administered dose is found unchanged in the urine within the first 8 hours.

Clinical trials.

The efficacy and safety of Iomeron was studied in 31 controlled trials and over 60 uncontrolled trials for the indications listed below. In 22 controlled studies, safety was assessed for 24 hours after contrast administration, by physical examinations, monitoring of vital signs, patient monitoring of adverse events, ECG controls, and clinical laboratory investigations. Renal function was monitored to 72 hours after Iomeron administration in 3 studies which involved approximately 60 adults and 60 children, but was not assessed for periods longer than 72 hours in any study.
In myelography, the safety and efficacy of Iomeron following lumbar injection has been demonstrated. Other sites of injection have not been adequately assessed.

5.2 Pharmacokinetic Properties

The pharmacokinetic profile of intravascularly injected iomeprol was determined in 18 healthy volunteers who received the contrast medium intravenously at a concentration of 400 mg iodine/mL at three dose levels: 50 mL, 100 mL and 200 mL.
The plasma concentration curves, expressed as a function of time, showed the plasma kinetics are not dose dependent and are well described as a two compartment model with a rapid phase for drug distribution on and a slower phase for drug elimination. The mean half-lives of the distribution and elimination phases of iomeprol were 23 ± 14 minutes and 109 ± 20 minutes, respectively, with excretion in the urine of approximately 50% within the first 2 hours, 83% within 8 hours and 90% within 96 hours of administration.

Intrathecal administration.

After intrathecal administration, iomeprol is completely absorbed from the cerebrospinal fluid in about 3 to 6 hours. The half-life of elimination is between 8 to 11 hours and is independent from the dose. Plasma concentrations were quantifiable up to 24 hours in 93% of the patients.
It is rapidly excreted from the body through the kidney as unchanged iomeprol. The majority of urinary excretion occurs in the first 24 hours post-dose with smaller percentage excreted during the first 24-48 hour period.

Renal impairment.

Iomeprol is mainly eliminated by the kidney through glomerular filtration. The mean half-lives of elimination for subjects with mild renal impairment is of 3.67 hours; for those with moderate impairment 6.9 hours, and for those with severe impairment of 15.1 hours. In patients with mild and moderate renal impairment the cumulative urinary excretion of iomeprol between 4 and 8 hours, expressed as percentage of administered intravenous dose, is approximately 50% of the injected dose. In patients with severe renal impairment 50% of the injected dose was recovered in the urine between 16 and 84 hours after injection.
In renal impaired patients, the additional route of elimination is the biliary route. Mean cumulative 120 hour fecal excretion of the total iomeprol dose administered averages from 1.6% in normal subjects to 7.2% in severe renal impaired patients.

Haemodialysis.

After a single dialysis session, approximately 58% of the dose is recovered in the dialysate.

5.3 Preclinical Safety Data

Genotoxicity.

Iomeprol, with or without metabolic activation as appropriate, was not mutagenic in the Salmonella typhimurium reverse mutation assay and Schizosaccharomyces pombe assay. Iomeprol was not clastogenic in the rat micronucleus test in vivo or in the chromosomal aberration test with the Chinese hamster cells (with or without S-9) in vitro, and was not genotoxic in the Saccharomyces cerevisiae-gene conversion and DNA repair test.

Carcinogenicity.

There are no data on the carcinogenicity of iomeprol.

6 Pharmaceutical Particulars

6.1 List of Excipients

Trometamol 1 mg, hydrochloric acid (d=1.18) 0.24 mg and water for injections q.s. to 1 mL.

6.2 Incompatibilities

In order to avoid possible incompatibilities, contrast media must not be mixed with other drugs.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Iomeron is available in vials containing contrast media solution and are not intended for the withdrawal of multiple doses.
The rubber stopper should never be pierced more than once. The use of proper withdrawal cannulas for piercing the stopper and drawing up the contrast medium is recommended. The contrast medium should not be drawn into the syringe until immediately before use. Solutions not used in one examination session must be discarded.
Store below 25°C. Protect from light. Although the sensitivity of iomeprol to X-rays is low, it is advisabIe to store the product out of reach of ionising radiation.

6.5 Nature and Contents of Container

Iomeron is available in the following strengths and pack sizes:
Iomeron 300: 50 mL, 100 mL vials.
Iomeron 350: 50 mL, 100 mL, 200 mL vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Iomeprol injection contains N,N'-bis-(2,3-dihydroxypropyl)- 5-[(hydroxyacetyl)-methylamino]- 2,4, 6-triiodo- 1,3-benzene-dicarboxamide and has a molecular weight of 777.09. Iomeprol is a white crystalline powder, which is highly water soluble. Organically bound iodine: 49% of its molecular weight.
The iodine strength specific physicochemical characteristics of Iomeron for injection are as follows. See Table 2.
The pH of the solutions ranges from 6.5-7.2.

Chemical structure.


CAS number.

78649-41-9.

7 Medicine Schedule (Poisons Standard)

Not scheduled. Not considered by committee.

Summary Table of Changes