Patient leaflet - OMNIPAQUE INJECTION 240 MG I/ML SOLUTION FOR INJECTION
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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.
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.
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
Not known: frequency cannot be estimated from the available data
- allergic reaction, including severe allergic reaction leading to shock and collapse, see ‘Allergic reactions’ above for other signs
- swelling and tenderness (pain) of your salivary glands
Turn over
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) 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
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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, Nycoveien 1–2, P.O.Box 4220 Nydalen,
NO-0401 Oslo, Norway.
Manufactured by:
GE Healthcare AS, Nycoveien 1–2, P.O.Box 4220 Nydalen,
NO-0401 Oslo, Norway.
or
GE Healthcare Ireland Limited, IDA Business Park, Carrigtohill, Co. Cork, Ireland.
Local Representative:
GE Healthcare Limited
Little Chalfont
Buckinghamshire HP7 9NA
This leaflet was last revised in
May 2017
Omnipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General Electric Company.
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.
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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.
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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.
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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
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© 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).
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(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: .
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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.
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5 PHARMACOLOGICAL PROPERTIES
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5.1 Pharmacodynamic properties
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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.
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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 %).
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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.
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6 PHARMACEUTICAL PARTICULARS
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6.1 List of excipients
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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.
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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.
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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.
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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.
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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.
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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.
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7 MARKETING AUTHORISATION HOLDER
GE Healthcare AS
Nycoveien 1–2
P.O.Box 4220 Nydalen NO-0401 Oslo, Norway
Tel.: +47 23 18 50 50
Fax: +47 23 18 60 00
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8 MARKETING AUTHORISATION NUMBER(S)
PL 00637/0038, 0034, 0035, 0036
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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20 April 1983
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10 DATE OF REVISION OF THE TEXT