Gadovis

Indications & Dose:

This medicinal product is for diagnostic use only.

Adults and children of all ages (including term neonates) for:

• Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI).

• Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these

lesions as benign or malignant.

• Contrast enhancement in magnetic resonance angiography (CE-MRA).

Gadovist can also be used for MR Imaging of pathologies of the whole body.

It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathological

tissue.

Used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).

4.2 Posology and method of administration Gadovist should only be administered by healthcare professionals experienced in the

field of clinical MRI practice

METHOD OF ADMINISTRATION

This medicinal product is for intravenous administration only.

The dose required is administered intravenously as a bolus injection. Contrast-enhanced MRI can commence immediately afterwards (shortly

after the injection depending on the pulse sequences used and the protocol for the examination).

Optimal signal enhancement is observed during arterial first pass for CE-MRA and within a period of about 15 minutes after injection of Drug for

CNS indications (time depending on type of lesion/tissue).

T1 -weighted scanning sequences are particularly suitable for contrast-enhanced examinations.

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  

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:CNSindications:The recommended dose for adults is 0.1 mmol per kilogram body weight (mmol/kg BW). This is equivalent to 0.1 ml/kg

BW of the 1.0 M solution. If a strong clinical suspicion of a lesion persists despite an unremarkable MRI or when more accurate information

might influence therapy of the patient, a further injection of up to 0.2 ml/kg BW within 30 minutes of the first injection may be performed.

Whole Body MRI (except MRA):In general, the administration of 0.1 ml Gadovist per kg body weight is sufficient to answer the clinical question.

CE-MRA:Imaging of 1 field of view (FOV): 7.5 ml for body weight below 75 kg; 10 ml for body weight of 75 kg and higher (corresponding to

0.1-0.15 mmol/kg BW). Imaging of >1 field of view (FOV): 15 ml for body weight below 75 kg; 20 ml for body weight of 75 kg and higher

(corresponding to 0.2-0.3 mmol/kg BW).

RENAL IMPAIRMENT

Drug 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 (see section 4.4). If it is necessary to use Gadovist, 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, Gadovist injections should not be repeated

unless the interval between injections is at least 7 days.

PAEDIATRIC POPULATION

For children of all ages (including term neonates) the recommended dose is 0.1 mmolgadobutrol per kg body weight (equivalent to 0.1 ml

Gadovist per kg body weight) for all indications   Neonates up to 4 weeks of age and infants up to 1 year of age

Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these

patients after careful consideration at a dose not exceeding 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, Gadovist 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  

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