150 mg I/ml, 240 mg I/ml, 300 mg I/ml, 370 mg I/ml solution for injection/infusion
iopromide
What Ultravist is and what it is used for
Ultravist is a contrast-enhancing agent that contains iodine (in the form of the active substance iopromide). It is used in X-ray examinations and computed tomography of various parts of the body such as kidneys, blood vessels, and joints. Contrast-enhancing agents make the areas of the body being examined clearer on the X-ray images. Ultravist works by iodine blocking the X-rays.
The drug is provided as a solution that is given into the blood by trained X-ray personnel. This medicine is only intended for diagnostics, i.e. as an aid in determining the disease, and not in connection with treatment.
What you need to know before receiving Ultravist
Do not use Ultravist
– if you are allergic to the active substance(s) or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or radiologist before receiving Ultravist if you are allergic or suspect you are allergic to iopromide, iodine or iodinated contrast media, or any of the other ingredients of this medicine (listed in section 6), or if you have ever developed a severe skin rash or peeling of the skin, blistering and/or mouth ulcers after using Ultravist.
Take special care with Ultravist:
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of Ultravist. Seek medical attention immediately if you notice any of the signs described in section 4.
Central and peripheral nervous system
During or shortly after the imaging examination, you may get a short-term brain disease called encephalopathy. Tell your doctor immediately if you notice any of the signs and symptoms of this condition described in section 4.
Ultravist is not recommended for use during X-ray examination of the spinal canal, brain cavity, or cerebrospinal fluid (spinal fluid).
Tell the doctor or radiologist if you:
- have previously reacted to any contrast medium
- recently received Ultravist
- have reduced kidney function
- have epilepsy, have had seizures, or any other disease that affects the brain or spine
- have diabetes
- have weakened lungs ( pulmonary emphysema )
- have a bad general condition
- have an overactive thyroid gland ( hyperthyroidism ) or enlarged thyroid gland ( goiter ) have had thyroid disease, including hypothyroidism (underactive thyroid gland ). It happens that blood tests show signs of hypothyroidism or transient reduction of thyroid function after injection of iodinated contrast agents
- being investigated for thyroid disease as Ultravist can affect the result
- have a serious metabolic disorder called homocystinuria
- have cancer of the bone marrow (multiple myeloma ) or abnormal levels of paraprotein in the blood (paraproteinemia)
- have a tumor in the adrenal medulla ( pheochromocytoma ), as the risk of a serious form of high blood pressure may then be increased. You may need preventive medicine before the examination.
- have asthma, allergies, or are prone to hypersensitivity reactions (e.g. if you have hay fever, asthma, or eczema ). In such cases, the doctor may consider giving you cortisone (used to treat inflammation ) before treatment.
- have serious heart or blood circulation problems. If a serious hypersensitivity reaction were to occur, patients with cardiovascular disease are at greater risk of serious side effects, which in the worst case can be fatal
- are using blood pressure-lowering drugs called beta blockers, as these can reduce the effect of drugs (so-called beta agonists) that can be used to treat certain hypersensitivity reactions
- have a chronic muscle disease (myasthenia gravis)
- suffer from diseases linked to the immune system, so-called autoimmune diseases, as severe inflammation of blood vessels and skin diseases have been reported for these patients
- have problems with alcohol or drugs as this can increase the risk of convulsions.
Ultravist should not be given if you are dehydrated. You must take in enough fluids before the examination (see “Acute kidney injury”). This is especially important if you have cancer of the bone marrow (multiple myeloma ), diabetes, increased urine output ( polyuria ), decreased urine output ( oliguria ), high levels of uric acid in the blood (hyperuricemia), if you are elderly, newborn, infant or child.
Tell the doctor if you have problems with your kidneys. The doctor will ensure that you get enough fluids before the examination. It is not recommended to give intravenous fluids (fluids in the veins) if you have kidney problems. If you have severe kidney problems and concomitant heart disease, giving intravenous fluids (fluid in the veins) can be dangerous.
Acute kidney injury
If you receive Ultravist as an intravascular injection ( contrast fluid in the veins) there is a risk of developing kidney damage after the injection ( acute nose injury (AKI). This can lead to your kidneys not working properly for a short time, some patients experience reduced kidney function.
This is especially important if you have any of the following conditions:
- impaired kidney function
- diabetes
- bone marrow cancer (multiple myeloma )
- abnormal levels of paraprotein in the blood (paraproteinaemia)
- dehydrated or
- if you have received large or repeated doses of Ultravist.
You may experience allergy-like delayed reactions after using Ultravist. Serious reactions are possible (see section 4. Possible side effects ) and reactions may be irregular and unpredictable. Most of these reactions usually occur within 30 minutes of receiving Ultravist. Therefore, you will be kept under observation for a while after injection one. However, delayed reactions (after hours to days) may occur.
If you are worried, talk to your doctor or radiologist before receiving Ultravist. Pronounced states of tension, anxiety, and pain may increase the risk of side effects or enhance contrast agent-related reactions (see section 4. Possible side effects ).
Children and young people
Ultravist can be given to children and adolescents.
Other medicines and Ultravist
Tell the radiologist or the staff in the radiology department if you are using, have recently used, or maybe using other medicines. This is especially important for:
- beta-blockers (medicines used to treat high blood pressure ), as these, can reduce the effect of beta-agonists that can be used to treat certain hypersensitivity reactions
- if you are being treated or have been treated with a medicine called an interleukin (which can be used for example in cancer), as it carries a greater risk of delayed reactions (eg flu-like symptoms, joint pain, and itching )
- if you have kidney disease caused by diabetes (diabetic nephropathy) and are taking medicines called biguanides (eg metformin ), this may increase the risk of you developing too much acid in your blood (lactic acidosis).
- If you are being investigated or treated for thyroid disease and have received radioactive isotopes, using Ultravist may inhibit the absorption of radioactive isotopes for several weeks after receiving Ultravist.
Ultravist with food and drink
Before the examination, you must take in enough fluids. The doctor will give you further information about this.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or the X-ray department staff before receiving this medicine.
Pregnancy
Your doctor prescribes Ultravist during pregnancy only after special consideration as experience in pregnant women is limited.
Breast-feeding
Safety in breastfed infants has not been studied. As only a small part of the contrast agent is excreted in breast milk, it is unlikely that breastfed children will be affected. The thyroid function of infants exposed to Ultravist during pregnancy or after birth should be followed up by your doctor.
Driving ability and use of machinery
It is unknown whether Ultravist affects the ability to drive or use machines. Delayed reactions may occur (see section 4. Possible side effects ) and in such cases may prevent you from driving safely and impair your ability to use tools and machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Ultravist contains sodium
Ultravist contains less than 23 mg (1 mmol) of sodium per dose (based on the average dose of one for a person weighing 70 kg) and is therefore practically sodium-free.
How Ultravist is used
The radiologist determines how much Ultravist is needed for your examination. The recommended dose of Ultravist you receive depends on how much you weigh, your age, and the examination to be performed.
Ultravist is injected into a blood vessel or body cavity and is body-tempered to reduce pain and discomfort and facilitate injection. If Ultravist is to be given into the blood, it is advantageous to receive it in the supine position if this is possible.
When examining the abdomen or the kidneys and ureters, better X-ray images can be obtained if the bowel has been emptied. To minimize the risk of side effects such as blood clots, the radiologist or the radiologist may flush the tubes that give you contrast medium with saline or Heparin (a medicine that prevents blood clots) if the radiologist determines that you may need this.
Use for children
The radiologist will be extra careful with the dose and the performance of the examination if Ultravist is given to infants (under 1 year of age) and especially newborns (under 1 month of age) because they are sensitive to changes in water and salt levels (electrolyte disturbances) and changes in blood circulation ( hemodynamic changes).
Older
Usually, the dose does not need to be adjusted for elderly patients beyond what is specified for all patients in terms of age, body weight, general condition, and the examination to be carried out.
Patients with impaired liver function
No change in dose is needed for patients with impaired liver function because only a very small part of the active substance iopromide in Ultravist is eliminated by this route.
Patients with impaired renal function
Since iopromide, the active substance in Ultravist, disappears almost exclusively in the unchanged form via the kidneys, the time is extended if you have reduced kidney function. The lowest possible dose will be given to minimize the risk of the contrast agent worsening kidney function (see also the section What you need to know before you receive Ultravist).
If you have received too much Ultravist
Overdose is unlikely. If it does happen to you, the radiologist will treat the symptoms and it is recommended that your kidney function be checked for at least three days. If you have accidentally received too large a dose in a blood vessel, signs of a changed fluid and salt balance, kidney failure, and complications in the lungs, heart, or blood vessels may appear. The doctor may decide to use dialysis to remove Ultravist from the body.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects that can occur when using Ultravist are usually mild to moderate and do not last long.
The most serious side effects (deaths and life-threatening cases have been reported) in patients receiving Ultravist are an allergy-like severe drop in blood pressure, respiratory arrest, difficulty breathing, swelling of the larynx/vocal cord, pharynx, tongue or pharynx, asthma, coma, cerebral infarction, stroke, swelling of the brain, convulsions, irregular heart rhythm, cardiac arrest, angina pectoris, heart attack, heart failure, slow pulse, bluish skin, lips or mucous membranes due to reduced oxygen supply, low blood pressure, severe drop in blood pressure, shortness of breath, pulmonary edema, inadequate breathing, and respiratory arrest.
Seek immediate medical attention if you notice any of the following signs and symptoms (the frequency of which is not known):
- Red target-like or round spots on the trunk, often with blisters in the center, scaly skin, or sores in the mouth, throat, nose, genitals, or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome, toxic epidermal necrolysis ).
- Widespread skin rash, fever, enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
- A red, scaly, widespread skin rash with nodules under the skin and blisters along with fever after the imaging examination ( acute generalized exanthematous pustulosis ).
- Short-term brain disease ( encephalopathy ) which can cause memory loss, confusion, hallucinations, vision problems, vision loss, seizures, loss of coordination, paralysis on one side of the body, speech problems, and unconsciousness.
Tell the radiologist or radiology department staff immediately if you experience any of the signs described below as these may be the first signs that a serious reaction is about to develop. Your examination may need to be stopped and you may need different treatment.
- itching of the skin, rash, hives
- breathing difficulties, feelings of choking, and suffocation
- swelling of the face, lips, neck, or body
- itchy or watery eyes, tickling in the throat or nose, hoarseness, coughing or sneezing
- headache, dizziness, feeling faint
- feeling hot or cold, sweating
- paleness or redness of the skin
- chest pain, cramps, tremors
- nausea.
Delayed reactions may occur, after hours to days, after receiving Ultravist. If you develop a severe form of skin rash with redness, fever, blisters, sores, joint or muscle pain, or eye inflammation (Steven-Johnson syndrome), you should go to the hospital immediately.
Other possible side effects are listed below according to how common they are:
Common (may affect up to 1 in 10 users)
- dizziness, headache, altered sense of taste
- visual disturbances, blurred vision
- chest pain or discomfort
- high blood pressure or dilation of the blood vessels (which can cause low blood pressure )
- nausea, vomiting
- pain sensations, reactions at the injection site (such as pain, feeling of warmth, swelling, inflammation, and local skin reaction if the injection does not go straight into the blood vessel), and feeling of warmth.
Uncommon (may affect up to 1 in 100 users)
- hypersensitivity and allergic reactions, for example, sudden severe drop in blood pressure with skin rash and swelling (anaphylactic shock ), respiratory arrest, difficulty breathing, swelling of the throat, larynx, tongue or face, cramp in the throat or larynx, asthma, inflammation of the eye, watery eyes, sneezing, cough, swollen mucous membranes, inflammation of the nose, throat irritation, hoarseness, itching, hives, local swelling of the skin and mucous membranes
- fainting, confusion, restlessness, altered or reduced sensation, drowsiness
- changes in heart rhythm
- low blood pressure
- respiratory distress
- stomach pain
- swelling.
Rare (may affect up to 1 in 1,000 users)
- concern
- cardiac arrest, angina pectoris (pain or pressure in the chest due to local lack of blood in the heart muscle), or palpitations.
Not known frequency (occurs in an unknown number of users)
- altered thyroid function or a severe form of overactive thyroid (thyrotoxic crisis)
- coma reduced blood or oxygen supply to parts of the brain, stroke, swelling of the brain, temporary loss of vision, unconsciousness, agitation, memory loss, tremors, problems with speech, partial or complete loss of movement
- change in hearing
- heart attack, heart failure, slow or fast pulse, bluish skin, lips, or mucous membranes due to reduced oxygenation
- shock (severe drop in blood pressure), blood clots, vasospasm
- fluid in the lungs, difficulty breathing, choking, and suffocation
- difficulty swallowing, swelling of the salivary glands in and around the mouth, diarrhea
- serious skin diseases (eg Steven-Johnson syndrome or Lyell’s syndrome, characterized by red, bleeding, painful skin with blisters, which may also affect the lips, mouth, nose, and genitals), rash, flushing, abnormal sweating
- if the injection is to be given into a blood vessel but accidentally ends up outside the blood vessel and instead hits one or near a muscle, one may experience a feeling of pressure or pain in the muscle and this may lead to nerve damage and problems with blood flow
- problems with the kidneys, kidney failure
- malaise, chills, pale skin
- varied body temperature.
Delayed reactions may occur. If this happens to you, contact a doctor.
How to store Ultravist
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bottle/ampoule label, after ex. date/EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30°C.
Store in the original packaging. Light sensitive. Store away from X-ray radiation.
Do not use this medicine if it is discolored, contains particles, or if the bottle is broken in any way.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is iopromide
- Other ingredients (excipients) are sodium calcium edetate, trometamol, hydrochloric acid ( pH adjuster), water for injections
Appearance and package sizes of the medicine
Ultravist is a colorless to slightly yellow solution for injection.
Package sizes:
| Ultravist 150 mg: | 10×50 ml |
| Ultravist 240 mg: | 10×20 ml, 10×50 ml, 10×100 ml, 10×200 ml |
| Ultravist 300 mg: | 10×20 ml, 10×50 ml, 10×75 ml, 10×100 ml, 10×125 ml, 10×150 ml, 10×200 ml, 8×500 ml |
| Ultravist 370 mg: | 10×30 ml, 10×50 ml, 10×75 ml, 10×100 ml, 10×125 ml, 10×150 ml, 10×200 ml, 8×500 ml. |
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Bayer AG
13353 berlin
Germany
Berlind SA, Madrid
28806 Alcalá de Henares, Madrid
Spain