Patient leaflet - Scanlux 300 mg I/ml solution for injection
1. What Scanlux is and what it is used for
Scanlux is a non-ionic iodinated X-ray contrast agent (opacifying).
Scanlux has been prescribed for an X-ray examination to visualise your blood vessels, heart, brain and other organs and urinary tract.
Scanlux is used in adults and children and adolescents aged 0 - 18 years.
This medicine is intended for diagnostic use only.
2. What you need to know before you are given Scanlux
You should not be given Scanlux
- if you are allergic to iopamidol or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from an overactive thyroid gland,
- if you suffer from tetany (involuntary contractions of the muscles).
Warnings and precautions
Talk to your doctor or nurse before Scanlux is administered.
If you suffer from epilepsy and are already being treated, treatment must not be interrupted for the administration of Scanlux.
Tell your doctor if you suffer from any of the following conditions. Your doctor may take any necessary additional precautions:
- previous hypersensitivity reaction to contrast media
- impaired kidney function, especially with concurrent liver damage
- diabetes mellitus (diabetes)
- severe heart diseases, especially cardiac insufficiency (reduced cardiac output)
- diseases of the bone marrow (multiple myeloma, paraproteinaemia)
- phaeochromocytoma (overproduction of a hormone that leads to severe high blood pressure)
- lung diseases (lung dysfunction, pulmonary hypertension, lung embolism)
- severe thyroid diseases
- allergies (e.g. asthma, skin rash, hives etc.)
- severe anxiety
- dehydration due to insufficient fluid intake or poor general condition
- sickle cell anaemia (a defect in red blood cells)
- diseases of the brain, especially acute stroke, acute brain bleed, brain tumours or metastases, diseases of the blood vessels in the brain, epilepsy
alcoholism
- drug addiction
- hypercalcaemia (increased calcium levels in the blood)
- myasthenia gravis (autoimmune disease with severe muscle weakness)
- children under 1 year of age and elderly people (over 65 years of age)
- if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Scanlux or other iodinated contrast media.
Take special care with Scanlux:
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell’s syndrome or TEN) and acute generalised exanthematous pustulosis (AGEP), have been reported in association with the use of Scanlux.
Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Patients must be adequately hydrated before and after the examination. If you have a fluid or electrolyte imbalance (detectable via a blood test), this will be corrected before the contrast medium is administered. Particular attention should be paid to this in infants, small children, elderly patients and patients with bone marrow disease, diabetes, kidney or liver disease, polyuria (if you have to urinate frequently), oliguria (if you can only urinate rarely), gout, patients with severe systemic diseases, heart disease or patients in poor general condition.
Anxiety, agitation or pain can increase possible reactions to the contrast medium. In this case, your doctor can give you a sedative.
If you suffer from allergies or have already had an allergic reaction to a contrast medium in the past, your doctor may give you an antihistamine as a preventive measure to avoid a severe allergic reaction. As such reactions cannot be predicted, it is not advisable to administer test doses.
Thyroid disorders may be observed after administration of iopamidol. Particular caution should be exercised in newborns, including those whose mother received iopamidol during pregnancy, and premature babies. Doctors may check the child's thyroid function.
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 symptoms related to this condition described in section 4.
Other medicines and Scanlux
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
- Metformin (a treatment for diabetes)
- Neuroleptics/sedatives (tranquillisers/antipsychotics), analgesics (painkillers), and antiemetics (treatments that prevent nausea and vomiting)
- Beta-blockers (medication for the treatment of high blood pressure)
- Vasopressors such as papaverine (used to treat impotence (erectile dysfunction))
- Interleukin-2, a substance that actives the immune system
Influence on laboratory tests
Scanlux may affect the results of laboratory tests such as thyroid function test, and laboratory values of bilirubin (bile pigment), protein or other substances, if these tests are performed on the same day after you have received Scanlux. Tell your doctor or the laboratory staff if you have received Scanlux.
Thyroid function tests may still be inaccurate 2 - 6 weeks after you have received Scanlux.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Scanlux should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the unborn child.
Small amounts of iodinated contrast media pass into breast milk. However, it is not necessary to stop breast-feeding.
Driving and using machines
There is no known effect of Scanlux on the ability to drive or operate machines.
Scanlux contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How Scanlux is administered
Your doctor will determine the dose of Scanlux depending on your age and weight and the type of examination you are having. Scanlux is given to you as an injection during the X-ray examination.
As a rule, Scanlux is administered once or several times as part of an examination. It is possible that individual examinations may be repeated.
You should lie down during the injection.
Method of administration
For intravenous and intra-arterial administration.
If you are given more Scanlux than you should
Your doctor will take the necessary measures.
Note for healthcare professionals
Information on overdose can be found at the end of the package leaflet.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which can be serious and might require medical treatment.
Seek medical attention immediately if you notice any of the following symptoms:
- Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
The frequency of these side effects is not known.
The following side effects have been reported following injection of Scanlux in a blood vessel:
After injecting an iodinated contrast agent (such as Scanlux) into a blood vessel, most reactions occur within a few minutes, but sometimes reactions can still occur at a later time.
Common (may affect up to 1 in 10 people):
- Headache
- Feeling sick (nausea)
- Feeling hot
Uncommon: (may affect up to 1 in 100 people):
- Dizziness,
- Taste alteration
- Irregular heartbeat
- High or low blood pressure
- Redness of the skin
- Vomiting
- Diarrhoea
- Abdominal pain
- Dry mouth
- Itching, skin rash, possibly in combination with severe itching (hives) and wheal formation, reddening of the skin
- Increased sweating
- Back pain
- Kidney failure
- Chest pain, injection site pain
- Fever
- Feeling cold
- Increased creatinine level (value for measuring kidney function) in the blood, which can be detected in a test carried out by a doctor
Rare (may affect up to 1 in 1 000 people):
- Confusion,
- Abnormal sensation such as pins and needles, tingling, and itching with no recognisable cause (paraesthesia)
- Slow heart rate
- Water in the lungs
- Asthma (sudden shortness of breath due to narrowing of the airways and swelling of the mucous membrane in the airways)
- Breathing difficulties
- Muscle cramps
- Swelling at the site of injection
Not known (frequency cannot be estimated from the available data):
- Reduced blood platelet count (thrombocytopenia)
- Allergic reaction which can be severe and life-threatening (anaphylaxis)
- Coma, transient circulatory disorder in the brain with little or no permanent damage (TIA)
- Fainting, low level of consciousness, loss of consciousness, fits (convulsions)
- Inability to move one side of the body
- Brain disorder (encephalopathy) with symptoms including headache, difficulties with vision, loss of vision, confusion, seizures, loss of coordination, loss of movement in one side of the body, problems with speech, and loss of consciousness
- Temporary loss of vision, vision difficulties, conjunctivitis, abnormal sensitivity of the eyes to light
- Heart attack, heart not pumping blood as well as it should (heart failure), insufficient oxygen supply to the heart, increased heart rate
- Heart attack caused by an allergic reaction
- Failure of the blood circulation (circulatory collapse) or shock
- Breathing stopped, inability of the lungs to work properly, acute shortness of breath (acute respiratory distress syndrome), difficulty breathing or temporary suspension of breathing, shortness of breath
- Swelling of the throat, face, or salivary glands
- Increased salivation
- Severe disease of the skin (see on top of the section)
- Skin necrosis after product leakage out of the vessel
- Muscle pain with abnormal sensations (compartment syndrome)
- Pain in the bones, muscles, ligaments, tendons and/or nerves
- Weakness of the muscles
- Stiffness, pain, feeling generally unwell
- Redness, heat and pain at injection site
- Abnormal electrocardiogram
- An allergic skin reaction that may include round or oval patches of redness and swelling of the skin, blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is used again.
Additional side effects in children
Thyroid disorders have been reported in newborns born prematurely.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Scanlux
Do not store above 25 °C. Store in the original package in order to protect from light. Protect from X-rays.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after “Exp”. The expiry date refers to the last day of that month.
For single use only.
After first opening, the product should be used immediately
Do not use this medicine if you notice that the solution is cloudy or discolored.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Scanlux is disposed of by healthcare professionals.
6. Contents of the pack and other information
What Scanlux contains
The active substance is iopamidol.
1 ml Scanlux 300 contains:
Iopamidol 612 mg
Iodine concentration 300 mg/ml
1 ml Scanlux 370 contains:
Iopamidol 755 mg
Iodine concentration 370 mg/ml
- The other ingredients are trometamol, hydrochloric acid (for pH adjustment), sodium calcium edetate and water for injections.
What Scanlux looks like and contents of the pack
Scanlux is a clear, colourless to pale yellow solution (solution for injection) and available in the following pack sizes:
1, 10, 20 or 30 glass bottles each with 50 ml, 75 ml, 100 ml and 200 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Sanochemia Pharmazeutika GmbH
Landegger Straße 7
2491 Neufeld an der Leitha
Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Scanlux
Greece Scanlux
UK Scanlux
This leaflet was last revised in August 2026.
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The following information is intended for healthcare professionals only:
Use only clear and colourless to almost colourless solutions.
Dosages exceeding the specific dose recommendations are not recommended, as they might lead to life-threatening adverse effects.
In the event of an overdosage, the patient should be monitored and treated symptomatically.
Iopamidol can be dialysed.