MAGNEVIST INJECTION 469 mg/ml
4.1 Indication(s)
This medicinal product is for diagnostic use only.
Cranial and spinal magnetic resonance imaging (MRI)
In particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e. g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin.
Additionally in spinal MRI: Differentiation of intra and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread.
Whole body MRI
Including the facial skull, the neck region, the thoracic and abdominal space, the female breast, the pelvis and the active and passive locomotive apparatus.
In particular, Magnevist permits diagnostic information:
For the demonstration or exclusion of tumours, inflammations and vascular lesions;
For determination of the spread and demarcation of these lesions;
For the differentiation of the internal structure of lesions;
For assessment of the circulatory situation of normal and pathologically changed tissues;
For the differentiation of tumour and scar tissue after therapy;
For the recognition of recurrent prolapse of a disk after surgery;
For the semi-quantitative evaluation of the renal function combined with anatomical organ diagnosis.
4.3 Contraindications
Use of Magnevist is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and in patients in the perioperative liver transplantation period.
4.2 Dosage and method of administration
4.2.1 Method of administration
This medicinal product is for intravenous administration only.
The safety rules customary for magnetic resonance imaging must be observed, e.g. exclusion of cardiac pacemakers, ferromagnetic implants.
As with other contrast enhanced diagnostic procedures, post-procedure observation of the patient is recommended.
For additional instructions see section ‘Instructions for use/handling’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
4.2.2 Dosage regimen
Adults
Cranial and spinal MRI
In general, the administration of 0.2 ml Magnevist per kg body weight (equivalent to 0.1 mmol gadopentetate dimeglumine per kg body weight) is sufficient for good enhancement and to answer the clinical question.
If a strong clinical suspicion of a lesion persists despite a normal contrast-enhanced MRI, a further injection of 0.2 or, in adults, of even 0.4 ml Magnevist per kg body weight within 30 minutes with immediately following MRI may increase the diagnostic yield of the examination.
For the exclusion of metastases or recurrent tumours in adults the injection of 0.6 ml Magnevist per kg body weight often leads to higher diagnostic confidence.
Maximum single dose: 0.6 ml Magnevist per kg body weight.
Whole body MRI
In general, the administration of 0.2 ml Magnevist per kg body weight is sufficient for good enhancement and to answer the clinical question.
In special cases, e. g. in lesions with poor vascularization and/or a small extracellular space, the administration of 0.4 ml Magnevist per kg body weight may be necessary for an adequate contrast effect especially on use of relatively slightly T¡-weighted scanning sequences.
In cases of exclusion of a lesion or tumour recurrences in adults, the injection of 0.6 ml Magnevist per kg body weight may lead to a higher diagnostic confidence.
Maximum single dose: 0.6ml Magnevist per kg body weight.
4.2.3 Additional information on special populations
4.2.3.1 Pediatric population
Cranial and spinal MRI
Children: 0.2ml Magnevist per kg body weight.
Due to immature renal function in infants up to 1 year of age, Magnevist should only be used in these patients after careful consideration at a dose not exceeding 0.2 ml/kg body weight. More than one dose should not be used during a scan. Because gadopentetate is renally excreted, a sufficient period of time for elimination of the contrast agent from the body should be ensured prior to any re-administration in patients with renal impairment.
If a strong clinical suspicion of a lesion persists despite a normal scan in patients over 1 year of age, a further injection of 0.2ml Magnevist /kg body weight within 30 minutes may increase the diagnostic yield.
In children below two years of age, the required dose should be administered manually and not in combination with an auto-injector to avoid injury.
Whole body MRI
Children over 2 years of age: 0.2 ml Magnevist per kg body weight.
Maximum single dose: 0.4ml Magnevist per kg body weight.
Experience in children under the age of 2 years is limited. However, this limited experience has shown that 0.2ml Magnevist/kg body weight may be used in this particular age group. Due to immature renal function in infants up to 1 year of age, Magnevist should only be used in these patients after careful consideration at a dose not exceeding 0.2ml/kg body weight. More than one dose should not be used during a scan. Because gadopentetate is renally excreted, a sufficient period of time for elimination of the contrast agent from the body should be ensured prior to any re-administration in patients with renal impairment.
In children below two years of age, the required dose should be administered manually and not in combination with an auto-injector to avoid injury.
4.2.3.2 Elderly population (aged 65 years and above)
No dosage adjustment is considered necessary in elderly (aged 65 years and above). Caution should be exercised in elderly patients (see also section ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
4.2.3.3 Patient with hepatic impairment
Since gadopentetate is exclusively eliminated in an unchanged form via the kidneys, no dosage adjustment is considered necessary in patients with moderate hepatic impairment. Data on patients with severe hepatic impairment are not available (see also section ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
4.2.3.4 Patient with renal impairment
Magnevist is contraindicated in patients with severe renal impairment (GFR <30 ml/min/ 1.73 m2) and in patients in the perioperative liver transplantation period (see section 4.3). Magnevist should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30–59 ml/ min/ 1.73m2) at a dose not exceeding 0.2 ml/kg body weight. More than one dose should not be used during a scan. Because gadopentetate is renally excreted, a sufficient period of time for elimination of the contrast agent from the body should be ensured prior to any re-administration in patients with renal impairment (see “Special Warnings and Precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
