Elucirem™ 0.5 mmol/mL, solution for injection. Composition: 1 mL of solution contains 485.1 mg gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and to 78.6 mg of gadolinium). Indications (*): This medicinal product is for diagnostic use only. Gadopiclenol is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax including breast, abdomen including liver and kidneys, pelvis including prostate, and musculo-skeletal system). Gadopiclenol should be used only when diagnostic information is essential and not available with unenhanced MRI. Posology and method of administration: The recommended dose of gadopiclenol is 0.1 mL/kg body weight (BW) (equivalent to 0.05 mmol/kg BW) to provide diagnostically adequate contrast for all indications. The product is for intravenous use only. The recommended dose is administered intravenously as a bolus injection at approximatively 2 mL/sec followed by a flush of sodium chloride 9 mg/ml (0.9%), solution for injection, via a manual injection or using power injector. Intravenous administration of contrast agent should, if possible, be done with the patient lying down. Since experience shows that most undesirable effects occur within minutes after administration, the patient should be kept under observation during and following administration for at least half an hour. Elderly: No dosage adjustment is necessary. Caution should be exercised in elderly patients. Renal impairment: No dosage adjustment is necessary for patients with any level of renal impairment. Gadopiclenol should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73 m2) 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. If it is necessary to use gadopiclenol, the dose should not exceed 0.1 mL/kg BW (equivalent to 0.05 mmol/kg BW). More than one dose should not be used during a scan. Because of the lack of information on repeated administration, gadopiclenol injections should not be repeated unless the interval between injections is at least 7 days. Paediatric population (2 years and older): The recommended and maximum dose of gadopiclenol is 0.1 mL/kg BW (equivalent to 0.05 mmol/kg BW) for all indications. More than one dose should not be used during a scan. The safety and efficacy of gadopiclenol in children less than 2 years has not yet been established. No data are available. Contraindications: Hypersensitivity to gadopiclenol or to any of the excipients. Special warnings and precautions for use: Gadopiclenol must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use of gadolinium-based contrast agents. 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. Potential for hypersensitivity or anaphylactic reactions: As with other gadolinium-containing contrast agents, hypersensitivity reactions can occur, including life-threatening reactions. Hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non-allergic. They can occur either immediately (less than 60 minutes) after injection 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. During the examination, supervision by a physician is necessary. If a hypersensitivity reaction occurs, the administration of the contrast agent must be discontinued immediately and – if necessary – a specific therapy must be 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. The risk of hypersensitivity reaction may be higher in patients with a history of previous reaction to a gadolinium-containing contrast agent, bronchial asthma or allergy. Renal impairment and nephrogenic systemic fibrosis (NSF): Prior to administration of gadopiclenol, 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 gadopiclenol, it should only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful benefit/risk assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after gadopiclenol administration may be useful at removing it 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 gadopiclenol may be impaired in the elderly, it is particularly important to screen elderly patients for renal dysfunction. Caution should be exercised in patients with renal impairment. Seizures: As with other gadolinium-containing contrast agents, special caution is necessary in patients with a lowered threshold for seizures. All equipment and drugs necessary to counter convulsions occurring during the MRI examination must be made ready for use beforehand. Extravasation: Caution during administration is necessary to avoid any extravasation. In case of extravasation, the injection must be stopped immediately. In case of local reactions, evaluation and treatment should be carried out as necessary. Interactions with other medicinal products and other forms of interaction: No interaction studies have been performed. Beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists decrease the efficacy of the mechanisms of cardiovascular compensation for blood pressure disorders. The physician must obtain information before injection of gadopiclenol about the concomitant intake of those medicinal products. Fertility, pregnancy and lactation: Data on the use of gadolinium-based contrast agents including gadopiclenol 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 showed little placental transfer and do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Gadopiclenol should not be used during pregnancy unless the clinical condition of the woman requires use of gadopiclenol. There is no data from the use of gadopiclenol in breast-feeding women. Gadolinium-containing contrast agents are excreted into breast milk in very small amounts. 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 gadopiclenol, should be at the discretion of the doctor and lactating mother. Animal studies do not indicate impairment of fertility. Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Undesirable effects: The most frequent adverse reactions were injection site pain, headache, and nausea. Common (≥ 1/100 to < 1/10): headache, injection site reaction, injection site pain. Uncommon (≥ 1/1000 to < 1/100): hypersensitivity, dermatitis allergic, periorbital oedema, dysgeusia, paraesthesia oral, flushing, dyspnoea, dysphonia, throat tightness, throat irritation, diarrhoea, nausea, abdominal pain, vomiting, erythema, rash, pruritus, fatigue, feeling hot, swelling, injection site coldness, injection site oedema, injection site warmth, injection site haematoma, injection site erythema. Overdose: The maximum daily single dose tested in humans was 0.6 mL/kg BW (equivalent to 0.3 mmol/kg BW), which corresponds to 6 times the recommended dose. No signs of intoxication from an overdose have so far been reported. Gadopiclenol can be removed by haemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of NSF. Pharmacological properties: Pharmacotherapeutic group: paramagnetic contrast media, ATC code: V08CA12. Presentation (*): 3, 7,5, 10, 15, 30, 50 & 100 mL solution for injection in vial (glass) and 7,5, 10, 15 mL in a prefilled syringe (polypropylene). Marketing authorisation holder (*): Guerbet – 15 rue des Vanesses - 93420 Villepinte - France. Information:  Tel: 33 (0) 1 45 91 50 00. Revision: February 2025.

For current and complete prescribing information refer to the Summary of Product Characteristics and/or contact your local Guerbet organization.

(*) Indications, presentations, and marketing authorization holder may differ from country to country.

Reporting of suspected adverse reactions is important as it helps to continuously assess the benefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to your health authorities or to our local Guerbet representative.