Gadoscan is indicated as a contrast medium for cranial and spinal resonance imaging (MRI) and for general MRI of the body after intravenous administration. Gadoscan provides contrast enhancement and facilitates visualisation of abnormal structures or lesions in various parts of the body including the CNS.
Dosage & Administration
No special preparation of the patient is required. Gadoscan should be drawn into the syringe immediately before use.The vial is intended for one patient only. Contrast medium not used in one examination must be discarded.
When brain metastases are suspected, a dosage of 0.3 mmol/kg body weight (equivalent to 0.6 ml/ kg body weight) can be administered up to 100 kg. Above 100 kg body weight a total of 60 ml is usually sufficient. The dose of 0.3 mmol/kg body weight can be administered as a bolus intravenous injection. In patients with equivocal scans after administration of the 0.1 mmol/kg body weight injection, a second bolus injection of 0.2 mmol/kg body weight (equivalent to 0.4 ml/kg body weight) may be of additional diagnostic value when administered within 20 minutes of the first injection.
The accepted safety considerations and procedures that are required for magnetic resonance imaging are applicable when Gadoscan is used for contrast enhancement. Administration of contrast media should be performed by qualified personnel familiar with the procedure and an appropriate technique should be utilised. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular or other idiosyncratic reactions should always be considered, especially in those patients with known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders. A course of action should therefore be planned in advance; with necessary drugs and equipment available for immediate treatment should a serious reaction occur. Transitory changes in serum iron (within the normal range in the majority of cases) have been observed in some patients after administration of Gadoscan. The clinical significance of this, if any, is not known but all patients in whom this effect was observed remained asymptomatic. Gadoscan interferes with serum calcium measurements with some colorimetric (complexometric) methods commonly used in hospitals. It may also interfere with determinations of other electrolytes (e.g. iron). Thus it is recommended that such methods not be used for 12-24 hours after administration of Gadoscan. If such measurements are necessary, the use of other methods is recommended. Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. If Gadoscan is drawn into a disposable syringe it should be used immediately. If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Data on the safety of repeated injections are not available. If the physician determines sequential or repeat examinations are required, a suitable time interval between administrations should be observed to allow for clearance of the drug from the body. In some patients with severely impaired renal function (GFR < 10 ml/min), further small reductions in GFR and increases in serum creatinine have been observed after administration of Gadoscan. Since the clinical relevance of these findings is not fully known, care should be exercised before using Gadoscan in such patients.
The results of three in vitro and one in vivo short-term genotoxicity assays were negative. No long-term studies have been performed to evaluate the carcinogenic potential of Gadoscan. Gadoscan had no effect on the fertility and general reproductive performance in rats or in teratology studies in rats and rabbits at doses that did not cause maternal toxicity.
Use in Pregnancy
Pregnancy category B3. No effects of Gadoscan on reproductive performance were seen in rats at doses up to 1.0 mmol/kg. In rabbits, there is an increased incidence of litters with skeletal or visceral abnormalities at doses up to 0.5 and 1.0 mmol/kg. However, these effects are possibly attributable to maternal toxicity rather than a direct effect of the drug. There are no adequate and well-controlled studies of Gadoscan in pregnant women. Gadoscan should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use in Lactation
It is not known whether Gadoscan is excreted in human milk. Breast-feeding should be discontinued prior to administration and should not be recommenced until at least 24 hours after the administration of Gadoscan. Use in Children : The safety and effectiveness of Gadoscan have been established for whole body magnetic resonance imaging in children from 6 months of age.The safety and effectiveness in infants and neonates have been established in the evaluation of lesions within the brain and spine.
There is no experience with Gadoscan in children below 6 months of age with severe hepatic or renal disease, or with premature infants below 4 weeks, or those with a post-conceptional age of less than 30 weeks.
Use in elderly patients: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.