This medicinal product is for diagnostic use only. Vistadot should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). Adult population Enhancement of the contrast in Magnetic Resonance Imaging. Encephalic and spinal MRI: Detection of brain tumours, tumours of the spine and the surrounding tissue, invertebral disc prolapse, infectious diseases. Whole Body MRI including imaging for renal, cardiac, uterine, ovarian, breast, abdominal and osteo-articular pathology. Angiography. - of lesions or stenoses of the non-coronary arteries (MR Angiography). Paediatric population (0-18 years) - Enhancement of contrast in Magnetic Resonance Imaging. - Encephalic and spinal MRI: Detection of brain tumours, tumours of the spine and the surrounding tissue, invertebral disc prolapse, infectious diseases. - Whole Body MRI including imaging for renal, cardiac, uterine, ovarian, breast, abdominal and osteo-articular pathology.

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. Adults including the elderly: Encephalic and Spinal MRI. In most cases the recommended dose is 0.1mmol.kg-1, i.e. 0.2ml.kg-1 which is sufficient to provide diagnostically adequate contrast. If a strong clinical suspicion of a lesion persists despite a normal MRI examination, a further injection of 0.2mmol.kg-1 , i.e. 0.4ml.kg-1 within 30 minutes, may improve tumour characterisation and facilitate therapeutic decision making. Whole body MRI and Angiography. The administration of 0.1mmol.kg-1, i.e. 0.2ml.kg-1 is recommended to provide diagnostically adequate contrast. Angiography: Infusion rate: 3-5 mL/min (higher infusion rates up to 120 mL/min, i.e. 2 mL/sec, may be used for angiographic procedures). In exceptional circumstances (e.g. failure to gain satisfactory images of an extensive vascular territory) administration of a second consecutive injection of 0.1mmol.kg-1 , i.e 0.2ml.kg–1 may be justified. However, if the use of 2 consecutive doses of Vistadot is anticipated prior to commencing angiography of certain regions (such as leg arteries or lungs), use of 0.05 mmol.kg-1 (i.e. 0.1ml.kg-1) for each dose may be of benefit, depending on the imaging equipment available. Special populations Impaired renal function The adult dose applies to patients with mild to moderate renal impairment (GFR = 30 ml/min/1.73m2). Vistadot should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If it is necessary to use Vistadot, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Vistadot injections should not be repeated unless the interval between injections is at least 7 days. Elderly (aged 65 years and above) No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4). Impaired hepatic function The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period. Paediatric population (0-18 years) MRI of brain and spine / whole-body MRI: the recommended and maximum dose of gadoteric acid is 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Vistadot should only be used in these patients after careful consideration, at a dose not exceeding 0.1 mmol/kg body weight. Because of the lack of information on repeated administration, Vistadot injections should not be repeated unless the interval between injections is at least 7 days. Angiography: Gadoteric acid is not recommended for angiography in children under 18 years of age due to insufficient data on its efficacy and safety in this indication. Method of administration The product is indicated for intravenous administration only. Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time. For single use only, any unused solution should be discarded. The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used. Paediatric population (0-18 years): Depending on the amount of Vistadot to be given to the child, it is preferable to use Vistadot vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume. In neonates and infants the required dose should be administered by hand.

Hypersensitivity to gadoteric acid, to meglumine, to any medicinal products containing gadolinium or to any of the excipients listed in section 6.1.

Do not use by intrathecal route. Take care to maintain strictly intravenous injection: extravasation may result in local intolerance reactions, requiring the usual local care. The usual precaution measures for MRI examination should be taken, such as exclusion of patients with pacemakers, ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporal metallic foreign bodies, particularly in the eye. Hypersensitivity • As with other gadolinium containing contrast media hypersensitivity reactions can occur, including life-threatening reactions (see section 4.8). Hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non allergic. They can be either immediate (less than 60 minutes), or delayed (up to 7 days). Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose of the product, and are often unpredictable. • There is always a risk of hypersensitivity regardless of the dose injected. • Patients who have already experienced a reaction during previous administration of a gadolinium-containing MRI contrast agent present an increased risk of experiencing another reaction on subsequent administration of the same product, or possibly other products, and are therefore considered to be at high risk. • The injection of gadoteric acid may aggravate symptoms of an existing asthma. In patients with asthma unbalanced by the treatment, the decision to use gadoteric acid must be made after careful evaluation of the risk/benefit ratio. • As known from the use of iodinated contrast media, hypersensitivity reactions can be aggravated in patients on beta-blockers, and particularly in the presence of bronchial asthma. These patients may be refractory to standard treatment of hypersensitivity reactions with beta-agonists. • Before any contrast medium is injected, the patient should be questioned for a history of allergy (e.g. seafood allergy, hay fever, hives), sensitivity to contrast media and bronchial asthma as the reported incidence of adverse reactions to contrast media is higher in patients with these conditions and premedication with antihistamines and/or glucocorticoids may be considered. • During the examination, supervision by a physician is necessary. If hypersensitivity reactions occur, administration of the contrast medium must be discontinued immediately and - if necessary - specific therapy instituted. A venous access should thus be kept during the entire examination. To permit immediate emergency countermeasures, appropriate drugs (e.g. epinephrine and antihistamines), an endotracheal tube and a respirator should be ready at hand. Impaired renal function Prior to administration of Vistadot, 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 < 30 ml/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 Vistadot, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after gadoteric acid administration may be useful at removing gadoteric acid 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 gadoteric acid may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Paediatric population Neonates and infants Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Vistadot should only be used in these patients after careful consideration. CNS disorders Like with other gadolinium containing contrast agents special precaution is necessary in patients with a low threshold for seizures. Precautionary measures should be taken, e.g. close monitoring. All equipment and drugs necessary to counter any convulsions which may occur must be made ready for use beforehand.

No

Pregnancy There are no data from the use of gadoteric acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Vistadot should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteric acid. 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 Vistadot, should be at the discretion of the doctor and lactating mother. Fertility There are no clinical data available with regard to effects on fertility.

No studies on the effects on the ability to drive and use machines have been performed. Ambulant patients while driving vehicles or operating machinery should take into account that nausea may incidentally occur.

Side effects in association with the use of gadoteric acid are usually mild to moderate in intensity and transient in nature. Injection site reactions, nausea and headache are the most frequently observed reactions. During clinical trials, nausea, headache, injection site reactions, feeling cold, hypotension, somnolence, dizziness, feeling hot, burning sensation, rash, asthenia, dysgeusia and hypertension were the most frequent, uncommonly observed (=1/1000 to <1/100) related adverse events. Since post-marketing, the most commonly reported adverse reactions following administration of gadoteric acid are nausea, vomiting, pruritus and hypersensitivity reactions. In hypersensitivity reactions, the reactions most frequently observed are skin reactions, which can be localized, extended or generalized. These reactions occur most often immediately (during the injection or within one hour after the start of injection) or sometimes delayed (one hour to several days after injection), presenting as skin reactions in this case. Immediate reactions include one or more effects, which appear simultaneously or sequentially, which are most often cutaneous, respiratory, gastrointestinal, articular and/or cardiovascular reactions. Each sign may be a warning sign of a starting shock and go very rarely to death. Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with gadoteric acid, most of which were in patients co-administered other gadolinium- containing contrast agents (see section 4.4). The adverse reactions are listed in the table below by SOC (System Organ Class) and by frequency with the following guidelines: very common (>1/10), common (=1/100 to <1/10), uncommon (=1/1000 to <1/100), rare (=1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). The data presented are from clinical trials involving 2822 patients when available, or from a pool of observational studies involving 185,500 patients. Organ Class System Frequency: adverse reaction Immune system disorders Uncommon: hypersensitivity Very rare: anaphylactic reaction, anaphylactoid reaction Psychiatric disorders Rare: anxiety Very rare: agitation Nervous system disorders Uncommon: headache, dysgeusia, dizziness, somnolence, paraesthesia (including burning sensation) Rare: presyncope Very rare: coma, convulsion, syncope, tremor, parosmia Eye disorders Rare: eyelid oedema Very rare: conjunctivitis, ocular hyperaemia, vision blurred, lacrimation increased Cardiac disorders Rare: palpitations Very rare: tachycardia, cardiac arrest, arrhythmia, bradycardia Vascular disorders Uncommon: hypotension, hypertension Very rare: pallor, vasodilatation Respiratory, thoracic and mediastinal disorders Rare: sneezing Very rare: cough, dyspnoea, nasal congestion, respiratory arrest, bronchospasm, laryngospasm, pharyngeal oedema, dry throat, pulmonary oedema Gastrointestinal disorders Uncommon: nausea, abdominal pain Rare: vomiting, diarrhoea, salivary hypersecretion Skin and subcutaneous tissue disorders Uncommon: rash Rare : urticaria, pruritus, hyperhidrosis Very rare: erythema, angioedema, eczema Not known : nephrogenic systemic fibrosis Musculoskeletal and connective tissue disorders Very rare: muscle cramps, muscular weakness, back pain General disorders and administration site conditions Uncommon: feeling hot, feeling cold, asthenia, injection site reactions (extravasation, pain, discomfort, oedema, inflammation, coldness) Rare: chest pain, chills Very rare: malaise, chest discomfort, pyrexia, face oedema, injection site necrosis (in case of extravasation), phlebitis superficial Investigations Very rare: decreased oxygen saturation The following adverse reactions were reported with other intravenous contrast agents for MRI: Organ Class System Adverse reaction Blood and lymphatic system disorders Haemolysis Psychiatric disorders Confusion Eye disorders Blindness transient, eye pain Ear and labyrinth disorders Tinnitus, ear pain Respiratory, thoracic and mediastinal disorders Asthma Gastrointestinal disorders Dry mouth Skin and subcutaneous tissue disorders Dermatitis bullous Renal and urinary disorders Urinary incontinence, renal tubular necrosis, renal failure acute Investigations Electrocardiogram PR prolongation, blood iron increased, blood bilirubin increased, serum ferritin increased, liver function test abnormal Paediatric population Safety of paediatric patients was considered in clinical trials and postmarketing studies. As compared to adults, the safety profile of Gadoteric acid did not show any specificity in children. Most of reactions are gastrointestinal symptoms or signs of hypersensitivity. 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 at: www.mhra.gov.uk/yellowcard.

Gadoteric acid can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

Pharmacotherapeutic group: paramagnetic contrast media ATC code: V08 CA 02 (gadoteric acid). Gadoteric acid is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadoteric acid which is an ionic gadolinium complex composed out of Gadolinium oxide and 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid (DOTA), and present as meglumine salt.

Distribution After intravenous administration gadoteric acid is rapidly distributed in the extracellular space. The distribution volume was approx. 18 L which is approximately equal to the volume of extra-cellular fluid. Gadoteric acid does not bind to proteins like serum albumin. Elimination Gadoteric acid is eliminated rapidly (89% after 6 h, 95% after 24 h) in unchanged form through the kidneys by glomerular filtration. Excretion via the feces is negligible. The elimination half life amounts to about 1.6 hours in patients with a normal renal function. In renally impaired patients, the elimination half life was increased to approximately 5 hours for a creatinine clearance between 30 and 60 mL/min and approximately 14 hours for a creatinine clearance between 10 and 30 mL/min. In animal experiments it has been demonstrated that gadoteric acid can be removed by dialysis. In patients with normal renal function, the plasmatic half life is about 90 minutes. It is eliminated by glomerular filtration in unchanged form. Gadoteric acid is poorly excreted in the milk and cross slowly through the placenta barrier. Special characteristics in patients with restricted kidney function The plasmatic clearance is reduced in case of renal impairment.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction. The acute toxicity of gadoteric acid injected intravenously (2ml.min-1) was studied in mice (at doses between 16 and 26 ml/kg) and in rats (at a dose of 25ml/kg). The manifestations observed were convulsive signs and transient respiratory disorders. Deaths occurred in the two studies, from a dose of 18ml/kg upwards in mice. Necropsy revealed a hemorrhagic appearance in the lungs and sometimes in the kidney. In another specific study in mice a minor proconvulsive effect was observed after IV administration of a dose of 4ml/kg. The administration of gadoteric acid in rats and in dogs at daily doses up to 3ml/kg, i.e. 15 times the dose laid down in clinical conditions, and for 28 days cause no other effect than a reversible vacuolisation of the proximal tubular cells of the kidney. Gadoteric acid is non-toxic for gestating females, non embryo-toxic and non teratogenic for the foetus. No prior peri- and post-natal toxicity and fertility studies have been carried out. Gadoteric acid showed no cytotoxic or mutagenic action in the in vivo and in vitro tests used. Animal studies have shown negligible (less than 1 % of the administered dose) secretion of gadoteric acid in maternal milk.

Meglumine Water for injection

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

5 years Chemical and physical in-use stability after first opening has been demonstrated for 24 hours at 20-25°C. From microbiological point of view, the product should be used immediately. If not used immediately, 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 20-25°C unless opening has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

Cartons contain 1 or 10 type I glass vials of 5 ml, 10 ml, 15 ml and 20 ml sealed with a stopper of bromobutyl rubber, and covered with a flip-off cap of Aluminium and plastic. Cartons contain 1 or 10 type II glass vials of 60 ml and 100 ml sealed with a stopper of bromobutyl rubber, and covered with a flip-off cap of Aluminium and plastic. Not all pack sizes may be marketed.

The solution for injection should be inspected visually prior to use. Solutions with visible signs of deterioration (such as particles in the solution, fissures in the vial) must not be used. The peel-off tracking label on the vials 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. Any unused portions and waste material derived from disposal and items which come into contact with the product when administering this product with an automatic application system should be disposed of in accordance with local requirements.

Feb. 16, 2026

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