ELUCIREM

This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing gadolinium enhanced MRI. 05 mmol/kg BW) to provide diagnostically adequate contrast for all indications. The dose should be calculated based on the patient’s BW and should not exceed the recommended dose per kilogram of BW detailed in this section.

Table 1 below indicates the volume to be administered according to BW. 0 Elderly No dose adjustment is necessary. 2). Renal impairment No dose adjustment is necessary for patients with any level of renal impairment. 4). 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. Hepatic impairment No dose adjustment is considered necessary for patients with hepatic impairment.

Caution is recommended, especially in the case of perioperative liver transplantation period (see above “renal impairment”). 05 mmol/kg BW) for all indications. More than one dose should not be used during a scan. The safety and efficacy of Elucirem in children less than 2 years has not yet been established.

No data are available. Method of administration The medicinal product is for intravenous use only. 9%), solution for injection via manual injection or power injector. Intravenous administration of contrast agent should, if possible, be done with the patient lying down.

4). 6. Paediatric population In children, Elucirem in vials with a single use syringe of a volume adapted to the amount to be injected should be used in order to have better precision of the injected volume. Image acquisition Contrast-enhanced MRI can start after the injection depending on the pulse sequences used and the protocol for the examination.

Optimal signal enhancement is generally observed during arterial phase and within a period of about 15 minutes after injection. Longitudinal relaxation times (T1)-weighted sequences are particularly suitable for contrast-enhanced examinations.

Summary of the safety profile The most frequent adverse reactions were injection site pain, headache, nausea, injection site coldness, fatigue and diarrhoea. 3 mmol/kg BW). The adverse reactions are listed 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 < 1/1 000), very rare (< 1/10 000).

Table 2:

Adverse reactions reported following gadopiclenol administration Frequency System Organ Class Common Uncommon Immune system disorders - Hypersensitivity* Nervous System Disorders Headache Dysgeusia Gastrointestinal Disorders - Diarrhoea, Nausea, Abdominal pain, Vomiting General Disorders and Administration Site Conditions Injection site reaction** Fatigue, Feeling hot * Including immediate (dermatitis allergic, erythema, dyspnoea, dysphonia, throat tightness, throat irritation, paraesthesia oral and flushing) and delayed (periorbital oedema, swelling, rash and pruritus) reactions.

** Injection site reaction includes the following terms: injection site pain, injection site oedema, injection site coldness, injection site warmth, injection site haematoma and injection site erythema. Description of selected adverse reactions Hypersensitivity Immediate reactions include one or more effects, which appear simultaneously or sequentially, which are most often cutaneous, respiratory and/or vascular reactions.

Each sign may be a warning sign of a starting shock and go very rarely to death. 4). Paediatric population (2 years and older) A total of 80 paediatric patients aged 2 years and older were included in the clinical trial. As compared to adults, the safety profile of gadopiclenol in this population did not show any specific safety concern.

5%). Twelve TEAEs were reported in the CNS cohort and 2 in the Body cohort. 25%) from the CNS cohort was considered related to gadopiclenol. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Gadopiclenol must not be used intrathecally. g. coma, encephalopathy, seizures), have been reported with intrathecal use of gadolinium-based contrast agents. The usual precautions for MRI examination should be applied, 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.

MRI images produced with this medicinal product should only be analysed and interpreted by the healthcare professionals trained in interpretation of gadolinium enhanced MRI. There are no or limited clinical data investigating the performance of gadopiclenol for CNS imaging in patients with inflammatory, infectious, autoimmune or demyelinating disorders (such as multiple sclerosis), patients with acute or chronic infarct, or patients with intramedullary spine lesions.

There are also no or limited clinical data investigating the performance of gadopiclenol for body imaging in patients with inflammatory, infectious and autoimmune conditions, including acute/chronic pancreatitis, inflammatory bowel disease, inflammatory diseases of head and neck region and endometriosis.

Potential for hypersensitivity or anaphylactic reactions - As with other gadolinium-containing contrast agents, hypersensitivity reactions can occur, including life-threatening. 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 hypersensitivity reactions occur, administration of the contrast agent must be discontinued immediately and – if necessary – a specific therapy must be instituted.

1.