MultiHance Adverse Reactions

The following adverse events were seen during the clinical development of MultiHance. (See Table 3.)

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Laboratory findings were mostly seen in patients with evidence of pre-existing impairment of hepatic function or pre-existing metabolic disease.
The majority of these events were non-serious, transient and spontaneously resolved without residual effects. There was no evidence of any correlation with age, gender or dose administered.
As with other gadolinium-chelates, there were reports of anaphylactic/anaphylactoid/ hypersensitivity reactions. These reactions manifested with various degrees of severity up to anaphylactic shock and death, and involved one or more body system, mostly respiratory, cardiovascular, and/or mucocutaneous systems. In patients with history of convulsion, brain tumours or metastasis, or other cerebral disorders, convulsions have been reported after MultiHance administration (see Precautions). Injection site reactions due to extravasation of the contrast medium leading to local pain or burning sensations, swelling, blistering and, in rare cases when localised swelling is severe, necrosis have been reported.
Localised thrombophlebitis has also been rarely reported.
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with MultiHance in patients co-administered other gadolinium-containing contrast agents (see Precautions).
Paediatric population: (See Table 4.)

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The adverse reactions reported among paediatric patients treated with MultiHance during clinical trials and tabulated previously were non-serious. The adverse reactions identified during post-marketing surveillance indicate that MultiHance safety profile is similar in children and adults.
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 national reporting system.