Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Gadoxetic acid, disodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Gadoxetate disodium is a contrast medium for magnetic resonance imaging (MRI) of the liver. It is used to help detect and diagnose changes that may be found in the liver. Abnormal signs within the liver can be better evaluated as to number, size, and distribution. Gadoxetate disodium can also help the doctor determine the nature of any abnormalities, thereby increasing the confidence in the diagnosis. It is provided as a solution for intravenous injection. This medicine is for diagnostic use only. MRI is a form of medical diagnostic imaging that forms pictures after water molecules have been detected in normal and abnormal tissues. This is done using a complex system of magnets and radio waves. 2.
What you need to know before you take it
Gadoxetate disodium
Do not use Gadoxetate disodium
- if you are allergic to gadoxetate disodium or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor before you are given Gadoxetate disodium if you have:
- or have had asthma or an allergy such as hay fever, nettle rash
- had a previous reaction to contrast media
- reduced kidney function. The use of some gadolinium-containing contrast agents in patients with these conditions has been associated with a disease called Nephrogenic Systemic Fibrosis (NSF). NSF is a disease involving thickening of the skin and connective tissues. NSF may result in debilitating joint immobility, muscle weakness or impairment of the function of internal organs which may potentially be life threatening.
- a serious disease of the heart and blood vessels
- low potassium levels
- or someone in your family, has had problems with the electrical rhythm of the heart called long QT syndrome
- had heart rhythm changes after taking medicines
- a heart pacemaker or if there are any implants or clips containing iron in your body V032_0
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Allergy-like reactions may occur after use of Gadoxetate disodium with delayed reactions after hours or days. See section 4. Tell your doctor if:
- your kidneys do not work properly
- you have recently had, or soon expect to have, a liver transplant Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use Gadoxetate disodium, especially if you are 65 years of age or older. Accumulation in the body Gadoxetate disodium works because it contains a metal called gadolinium. Studies have shown that small amounts of gadolinium can remain in the body, including the brain. No side effects have been seen due to gadolinium remaining in the brain. Children and adolescents The safety and efficacy of Gadoxetate disodium have not been established in patients under 18 years as there is limited experience on its use. Further information is given at the end of the leaflet. Other medicines and Gadoxetate disodium Tell your doctor if you are taking, have recently taken or might take any other medicines. These include especially:
- betablockers, medicines to treat high blood pressure or other heart conditions
- medicines that change the rhythm or rate of your heartbeat such as amiodarone, sotalol
- rifampicin, medicine to treat tuberculosis or certain other infections Pregnancy and breast-feeding Pregnancy Gadoxetate disodium can cross the placenta. It is not known whether it affects the baby. You must tell your doctor if you think you are or might become pregnant, as Gadoxetate disodium should not be used during pregnancy unless strictly necessary. Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive Gadoxetate disodium. Driving and using machines Gadoxetate disodium has no influence on the ability to drive and use machines. Gadoxetate disodium contains sodium This medicine contains 82 mg sodium (main component of cooking/table salt) in each dose based on the amount given to a 70 kg person. This is equivalent to 4.1 % of the recommended maximum daily dietary intake of sodium for an adult. 3.
How to take it
Gadoxetate disodium
Gadoxetate disodium is injected via a small needle into a vein. Gadoxetate disodium will be administered immediately before your MRI examination. After the injection you will be observed for at least 30 minutes.
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The recommended dose is 0.1 ml Gadoxetate disodium per kg body weight. Dosage in special patient groups The use of Gadoxetate disodium is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant. However if use is required you should only receive one dose of Gadoxetate disodium during a scan and you should not receive a second injection for at least 7 days. Elderly It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working. If you receive more Gadoxetate disodium than you should Overdosing is unlikely. If it does happen, the doctor will treat any symptoms that follow. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate. If you get any side effects, talk to your doctor. As with other contrast media, in rare cases allergy-like reactions may occur. Delayed reactions hours to days after the administration of Gadoxetate disodium may occur. The most serious side effect in patients receiving Gadoxetate disodium is anaphylactoid shock (a severe allergy-like reaction). Inform your doctor immediately if you experience any of the following signs or have difficulty in breathing:
- low blood pressure
- swelling in the tongue, throat, or face
- runny nose, sneezing, cough
- red, watery and itchy eyes
- stomach pain
- nettle rash
- reduced feeling or sensitivity in the skin, itching, pale skin The following further side effects may occur: Common: may affect up to 1 in 10 people
- headache
- nausea Uncommon: may affect up to 1 in 100 people
- dizziness
- numbness and tingling
- problems with sense of taste or smell
- flushing
- high blood pressure
- breathing difficulties
- vomiting
- dry mouth
- skin rash V032_0
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–
severe itching, affecting the whole body or the eye back pain, chest pain injection site reactions, such as
- burning, coldness, irritation, pain feeling hot chills tiredness feeling abnormal
Rare: may affect up to 1 in 1000 people
- incapability to sit or stand still
- uncontrollable shaking
- feeling of increased heart rate
- irregular heartbeat (signs of heart block)
- discomfort of the mouth
- increased production of saliva
- red skin rash with pimples or spots
- increased sweating
- feeling of discomfort, generally feeling unwell Not known: frequency cannot be estimated from the available data
- fast heartbeat
- restlessness Changed laboratory values may occur shortly after you have been given Gadoxetate disodium. Inform your healthcare professional if you have recently been administered Gadoxetate disodium if giving blood or urine samples. There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents. 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 5.
How to store it
Gadoxetate disodium
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 syringe and outer carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. This medicine should be used immediately after opening.
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It should be visually inspected before use. This medicine should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container. 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. 6.
Contents of the pack and other information
What Gadoxetate disodium contains –
The active substance is gadoxetate disodium. Each ml of solution for injection contains 0.25 mmol gadoxetate disodium (equivalent to 181.43 mg gadoxetate disodium) The other ingredients are caloxetate trisodium, trometamol, sodium hydroxide and hydrochloric acid (both for pH adjustment), water for injections.
1 pre-filled syringe with 5.0 ml contains 907 mg gadoxetate disodium. 1 pre-filled syringe with 7.5 ml contains 1361 mg gadoxetate disodium [glass syringe only], 1 pre-filled syringe with 10.0 ml contains 1814 mg gadoxetate disodium. What Gadoxetate disodium looks like and contents of the pack Gadoxetate disodium is a clear, colourless to pale yellow solution free from visible particles. The contents of the packs are 1, 5 or 10 pre-filled syringes with 5.0 ml solution for injection (in 10-ml glass/plastic prefilled syringes) 7.5 ml solution for injection (in 10-ml glass prefilled syringes) [glass syringe only] 10.0 ml solution for injection (in 10-ml glass/plastic prefilled syringes) Not all pack sizes may be marketed. Marketing Authorisation Holder Bayer plc 400 South Oak Way Reading RG2 6AD Manufacturer Bayer AG Müllerstrasse 178 13353 Berlin, Germany This leaflet was last revised in April 2026. —————————————————————————————————————————-The following information is intended for healthcare professionals only:
- Renal impairment Prior to administration of Gadoxetate disodium, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
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There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadoliniumcontaining contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min /1.73 m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with Gadoxetate disodium, it should be avoided
- in patients with severe renal impairment
- in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI. If use of Gadoxetate disodium cannot be avoided, the dose should not exceed 0.025 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadoxetate disodium injections should not be repeated unless the interval between injections is at least 7 days. As the renal clearance of gadoxetate may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Haemodialysis shortly after Gadoxetate disodium administration may be useful at removing Gadoxetate disodium from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
- Pregnancy and breast-feeding Gadoxetate disodium should not be used during pregnancy unless the clinical condition of the woman requires use of gadoxetate. Continuing or discontinuing breast feeding for a period of 24 hours after administration of Gadoxetate disodium, should be at the discretion of the doctor and lactating mother.
- Paediatric population An observational study was performed in 52 paediatric patients aged over 2 months and less than 18 years. Patients were referred for Gadoxetate disodium enhanced liver MRI to evaluate suspected or known focal liver lesions. Additional diagnostic information was obtained when combined unenhanced and enhanced liver MRI were compared with unenhanced MRI alone. Serious adverse events were reported, however none were assessed by the investigator to be related to Gadoxetate disodium. Due to the retrospective nature and small sample size of this study, no definitive conclusion can be made regarding efficacy and safety in this population.
- Before injection Gadoxetate disodium is a clear, colourless to pale yellow solution free from visible particles. The contrast medium should be inspected visually before use. Contrast media should not be used in case of severe discolouration, the occurrence of particulate matter or a defective container.
- Administration Gadoxetate disodium is to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection the intravenous cannula / line should be flushed using physiological saline solution (9 mg/ml).
- Patient should be observed for at least 30 minutes after the injection.
- Gadoxetate disodium must not be mixed with other medicinal products.
- Intramuscular injection must be strictly avoided.
- Handling Gadoxetate disodium is ready to use. The pre-filled syringe should be prepared for the injection immediately before the examination. The tip cap should be removed from the pre-filled syringe immediately before use. Any solution not used in one examination is to be discarded in accordance with local requirements.
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The peel-off tracking label on the syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Glass syringe only:
1. Open the package
2. Screw the plunger on the syringe
3. Break the protective cover
4. Remove the protective cover
5. Remove the rubber stopper
6. Remove the air in the syringe
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Plastic syringe only:
Hand injection
Injection with a power injector
1. Take out the syringe and plunger rod
1. Take out the syringe
2. Turn the plunger rod clockwise into the syringe
2. Open the cap with a twist
3. Open the cap with a twist
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3. Connect the tip of the syringe to the tubing system by turning it clockwise. Proceed according to the instructions for the device
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4. Remove the air in the syringe
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Frequently asked questions about Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe
How do I take Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe?
Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe comes as injection containing 0.25mmol. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe?
The active substance in Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe is gadoxetic acid, disodium.
Are there equivalent medicines to Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe?
Medicines with the same active substance, strength and form include: Primovist 0.25 mmol/ml, solution for injection, prefilled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: gadoxetic acid, disodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Gadoxetate disodium is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).
Gadoxetate disodium should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when delayed phase imaging is required.
This medicinal product is for diagnostic use by intravenous administration only.
4.2. Posology and method of administration
Method of administration
Gadoxetate disodium is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection of the contrast medium the intravenous cannula/ line should be flushed using sterile 9 mg/ml (0.9 %) saline solution.
For detailed imaging information refer to section 5.1.
For additional instructions see section 6.6.
Posology
The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.
The recommended dose of gadoxetate disodium is:
Adults
0.1 ml per kg body weight gadoxetate disodium.
Repeated use
No clinical information is available about repeated use of gadoxetate disodium.
Additional information on special populations
Impaired renal function
Use of gadoxetate disodium should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If use of gadoxetate disodium cannot be avoided, the dose should not exceed 0.025 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, gadoxetate disodium injections should not be repeated unless the interval between injections is at least 7 days.
Patients with hepatic impairment
No dosage adjustment is necessary.
Paediatric population
The safety and efficacy of gadoxetate disodium have not been established in patients under 18 years old. Currently available data are described in section 5.1.
Elderly population (aged 65 years and above)
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
The usual safety precautions for MRI must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants.
Diagnostic procedures that involve the use of contrast agents should be carried out under the direction of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
After the injection, the patient should be kept under observation for at least 30 minutes, since experience with contrast media shows that the majority of undesirable effects occur within this time.
Impaired renal function
Prior to administration of gadoxetate disodium, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min/1.73 m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with gadoxetate disodium, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Haemodialysis shortly after gadoxetate disodium administration may be useful at removing gadoxetate disodium from the body.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Elderly
As the renal clearance of gadoxetate may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Patients with cardiovascular disease
Caution should be exercised when gadoxetate disodium is administered to patients with severe cardiovascular problems because only limited data are available so far.
Gadoxetate disodium should not be used in patients with uncorrected hypokalemia.
Gadoxetate disodium should be used with special care in patients
- with known congenital long QT syndrome or a family history of congenital long QT syndrome
- with known previous arrhythmias when on drugs that prolong cardiac repolarisation
- who are currently taking a drug that is known to prolong cardiac repolarisation e.g. a class III antiarrhythmic, (e.g. amiodarone, sotalol).
Gadoxetate disodium may cause transient QT-prolongation in individual patients. (see section 5.3).
Hypersensitivity
Allergy-like reactions, including shock, are known to be rare events after administration of gadolinium-based MRI contrast media. Most of these reactions occur within half an hour after administration of contrast media. However, as with other contrast media of this class, delayed reactions may occur after hours to days in rare cases. Medication for the treatment of hypersensitivity reactions as well as preparedness for institution of emergency measures are necessary.
The risk of hypersensitivity reactions is higher in case of:
- previous reaction to contrast media
- history of bronchial asthma
- history of allergic disorders.
In patients with an allergic disposition (especially with a history of the above mentioned conditions) the decision to use gadoxetate disodium must be made after particularly careful evaluation of the risk-benefit ratio.
Hypersensitivity reactions can be more intense in patients on beta-blockers, particularly in the presence of bronchial asthma. It should be considered that patients on beta-blockers may be refractory to standard treatment of hypersensitivity reactions with beta-agonists.
If hypersensitivity reactions occur, injection of the contrast medium must be discontinued immediately.
Local intolerance
Intramuscular administration may cause local intolerance reactions including focal necrosis and must therefore be strictly avoided (see section 5.3).
Accumulation in the body
After administration of gadoxetate disodium gadolinium can be retained in the brain and in other tissues of the body (bones, liver, kidneys, skin) and can cause dose-dependent increases in T1-weighted signal intensity in the brain, particularly in the dentate nucleus, globus pallidus, and thalamus. Clinical consequences are unknown. The possible diagnostic advantages of using gadoxetate disodium in patients who will require repeated scans should be weighed against the potential for deposition of gadolinium in the brain and other tissues.
Excipients
This medicinal product contains 11.7 mg sodium per ml, equivalent to 0.585% of the WHO recommended maximum daily intake of 2 g sodium for an adult, (4.1% (82 mg) based on the amount given to a 70 kg person). The dosage is 0.1 ml/kg body weight.
4.5. Interaction with other medicinal products and other forms of interaction
As transport of gadoxetate to the liver may be mediated by OATP transporters it cannot be excluded that potent OATP inhibitors could cause drug interactions reducing the hepatic contrast effect. However, no clinical data have been presented to support that theory.
An interaction study in healthy subjects demonstrated that the co-administration of erythromycin did not influence efficacy and pharmacokinetics of gadoxetate disodium. No further clinical interaction studies with other medicinal products have been performed.
Interference from elevated bilirubin or ferritin levels in patients
Elevated levels of bilirubin or ferritin can reduce the hepatic contrast effect of gadoxetate disodium (see section 5.1).
Interference with diagnostic tests
Serum iron determination using complexometric methods (e.g. Ferrocine complexation method) may result in false values for up to 24 hours after the examination with gadoxetate disodium because of the free complexing agent contained in the contrast medium solution.
4.6. Pregnancy, lactation and fertility
Pregnancy
Data on gadolinium-based contrast agents in pregnant women is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the foetus. Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3). Gadoxetate disodium should not be used during pregnancy unless the clinical condition of the woman requires use of gadoxetate.
Breast-feeding
Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3). At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of gadoxetate disodium, should be at the discretion of the doctor and lactating mother.
Fertility
Animal studies did not indicate impairment of fertility.
4.7. Effects on ability to drive and use machines
Gadoxetate disodium has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The overall safety profile of gadoxetate disodium is based on data from more than 1,900 patients in clinical trials, and from post-marketing surveillance.
The most frequently observed adverse drug reactions (≥ 0.5 %) in patients receiving gadoxetate disodium are nausea, headache, feeling hot, blood pressure increased, back pain and dizziness.
The most serious adverse drug reaction in patients receiving gadoxetate disodium is anaphylactoid shock.
Delayed allergoid reactions (hours later up to several days) have been rarely observed.
Most of the undesirable effects were transient and of mild to moderate intensity.
Tabulated list of adverse reactions
The adverse drug reactions observed with gadoxetate disodium are represented in the table below. They are classified according to System Organ Class (MedDRA version 12.1). The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Adverse drug reactions from clinical trials are classified according to their frequencies. Frequency groupings are defined according to the following convention: common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000. The adverse drug reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under 'not known'.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1: Adverse drug reactions reported in clinical trials or during post-marketing surveillance in patients treated with gadoxetate disodium
System Organ Class (MedDra)
Common
Uncommon
Rare
Not known
Immune system disorders
Hypersensitivity / anaphylactoid reaction (e.g. shock*, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough, pallor)
Nervous system disorders
Headache
Vertigo
Dizziness
Dysgeusia
Paresthesia
Parosmia
Tremor
Akathisia
Restlessness
Cardiac disorders
Bundle branch block
Palpitation
Tachycardia
Vascular disorders
Blood pressure increased
Flushing
Respiratory, thoracic and mediastinal disorders
Respiratory disorders (Dyspnea*, Respiratory distress)
Gastrointestinal disorders
Nausea
Vomiting
Dry mouth
Oral discomfort
Salivary hypersecretion
Skin and subcutaneous tissue disorders
Rash
Pruritus**
Maculopapular rash
Hyperhidrosis
Musculoskeletal and connective tissue disorders
Back pain
General disorders and administration site conditions
Chest pain
Injection site reactions (various kinds)***
Feeling hot
Chills
Fatigue
Feeling abnormal
Discomfort
Malaise
* Life-threatening and/or fatal cases have been reported. These reports originated from post-marketing experience.
**Pruritus (generalized pruritus, eye pruritus)
***Injection site reactions (various kinds) comprise the following terms: Injection site extravasation, injection site burning, injection site coldness, injection site irritation, injection site pain
Description of selected adverse reactions
Laboratory changes such as elevated serum iron, elevated bilirubin, increases in liver transaminases, decrease of hemoglobin, elevation of amylase, leucocyturia, hyperglycemia, elevated urine albumin, hyponatremia, elevated inorganic phosphate, decrease of serum protein, leucocytosis, hypokalemia, elevated LDH were reported in clinical trials. ECGs were regularly monitored during clinical studies and transient QT prolongation was observed in some patients without any associated adverse clinical events.
Cases of nephrogenic systemic fibrosis (NSF) have been reported with other gadolinium-containing contrast agents (see section 4.4).
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 the Yellow Card Scheme, www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No cases of overdose have been reported and no symptoms could be characterised.
Single doses of gadoxetate disodium as high as 0.4 ml/kg (0.1mmol/kg) body weight were tolerated well.
In a limited number of patients, a dose of 2.0 ml/kg (0.5 mmol/kg) body weight was tested in clinical trials, more frequent occurrences of adverse events but no new undesirable effects were found in these patients.
In the event of excessive inadvertent overdose, the patient should be carefully observed including cardiac monitoring. In this case induction of QT prolongations is possible (see section 5.3).
Gadoxetate disodium can be removed by hemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
💬 Ask about this leaflet
Ask anything about Gadoxetate disodium 0.25 mmol/ml, solution for injection, pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.