Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
This medicinal product is for diagnostic use only.
Gadovist is indicated in adults and children of all ages (including term neonates) for:
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.
Gadovist should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).
Gadovist should only be administered by healthcare professionals experienced in the field of clinical MRI practice.
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 Gadovist 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 (see section 4.4).
This product is intended for single use only.
This medicinal product should be visually inspected before use.
Gadovist should not be used in case of severe discolouration, the occurrence of particulate matter or a defective container.
The prefilled syringe must be taken from the pack and prepared for the injection immediately before the administration.
The tip cap should be removed from the prefilled syringe immediately before use.
Administration of contrast media should be performed by qualified personnel with the appropriate procedures and equipment.
Sterile technique must be used in all injections involving contrast media.
The contrast medium must be administered by means of a MEDRAD Spectris type injector.
Instructions of the device manufacturer must be followed.
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.
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.
In general, the administration of 0.1 ml Gadovist per kg body weight is sufficient to answer the clinical question.
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).
Gadovist 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 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.
For children of all ages (including term neonates) the recommended dose is 0.1 mmol gadobutrol per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) for all indications (see section 4.1).
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.
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).
The maximum daily single dose tested in humans is 1.5 mmol gadobutrol/kg body weight.
No signs of intoxication from an overdose have so far been reported during clinical use.
In case of inadvertent overdosage, cardiovascular monitoring (including ECG) and control of renal function is recommended as a measure of precaution.
In case of overdose in patients with renal insufficiency, Gadovist can be removed by haemodialysis. After 3 haemodialysis sessions approx. 98% of the agent are removed from the body. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Shelf life: 3 years (prefilled syringe), 3 years (cartridge)
Shelf life after first opening of the container: Any solution for injection not used in one examination must be discarded. Chemical, physical and microbiological in-use stability has been demonstrated for 24 hours at 20-25°C.
From a 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.
This medicinal product does not require any special storage conditions.
For storage conditions after first opening of the medicinal product, see section 6.3.
Glass syringes:
One 10-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 5 ml, 7.5 ml and 10 ml solution for injection.
One 17-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 15 ml solution for injection.
One 20-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 20 ml solution for injection.
Plastic syringes:
One 10-ml prefilled syringe (cyclo-olefin polymer) with a plunger stopper (siliconized bromobutyl) and a tip seal (thermoplastic elastomer) contains 5 ml, 7.5 ml, 10 ml solution for injection.
One 20-ml prefilled syringe (cyclo-olefin polymer) with a plunger stopper (siliconized bromobutyl) and a tip seal (thermoplastic elastomer) contains 15 ml, 20 ml solution for injection.
Cartridge:
One 65-ml cartridge (cyclo-olefine-polymer) with a plunger stopper (polyisoprene, type I, siliconised with silicone oil), a tip cap (chlorobutyl rubber), a hard core (polycarbonate), a safety cap (polypropylene) and a swivelnut (polycarbonate) contains 15, 20 or 30 ml solution for injection.
Pack sizes of:
1 and 5 prefilled syringes
1 and 5 cartridges
Hospital pack:
5 prefilled syringes with 5, 7.5, 10, 15, 20 ml solution for injection
5 prefilled cartridges with 15, 20, 30 ml solution for injection
Not all pack sizes may be marketed.
Any contrast medium solution not used in one examination must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The peel-off tracking label on the pre-filled syringes/cartridges 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.
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