Gadoscan287 mg/ml

CNS (Central Nervous System): Gadoscan 287 mg/ml is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial ... Read moreCNS (Central Nervous System): Gadoscan 287 mg/ml is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Gadoscan 287 mg/ml is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.

Contrast medium for diagnostic procedures

The paramagnetic properties of Gadoscan 287 mg/ml provides contrast enhancement during MRI. There were no clinically significant deviations from pre-injection values in haemodynamic and blood and urine laboratory parameters following intravenous injection of Gadoscan 287 mg/ml in healthy volunteers. However, a minor transient change in serum iron levels 8 to 48 hours after Gadoscan 287 mg/ml injection was observed.Gadoscan 287 mg/ml does not cross the intact blood-brain barrier. Administration of Gadoscan 287 mg/ml causes signal enhancement from areas where blood-brain barrier dysfunction has been induced by pathological processes, and may provide greater diagnostic yield than unenhanced MRI. Lack of enhancement need not indicate absence of pathology since some types of low grade malignancies or inactive MS-plaques fail to enhance; it can be used for differential diagnosis between different pathologies.

No special preparation of the patient is required. Gadoscan 287 mg/ml 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. CNS (Central Nervous System): Adults: The recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Pediatric Patients (2-16 years): The recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of Gadoscan 287 mg/ml is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg)

No special preparation of the patient is required. Gadoscan 287 mg/ml 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. CNS (Central Nervous System): Adults: The recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Pediatric Patients (2-16 years): The recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of Gadoscan 287 mg/ml is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of Gadoscan 287 mg/ml is 0.2 mL/kg (0.1 mmol/kg)

There are no known drug interactions and none well documented.

Chronic, severe kidney disease (glomerular filtration rate < 30 ml/ min/1.73 m2), or acute kidney injury prior hypersensitivity reaction, should not be used in patients known to have hypersensitivity to Gadoscan 287 mg/ml or its constituents.

Nephrogenic systemic fibrosis, Hypersensitivity reactions

Pregnancy category B3. No effects of Gadoscan 287 mg/ml 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 287 mg/ml in pregnant women. Gadoscan 287 mg/ml 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 287 mg/ml 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 287 mg/ml.

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities.The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function.

Clinical consequences of overdose have not been reported and acute symptoms of toxicity are unlikely in patients with a normal renal function. Treatment is symptomatic. There is no antidote for this contrast medium. In patients with delayed elimination due to renal insufficiency and in patients who have received excessive doses, the contrast medium can be eliminated by haemodialysis.

Store at temperatures not exceeding 25° C. Protect from light.

Use in Children: The safety and effectiveness of Gadoscan 287 mg/ml 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 287 mg/ml 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.

Contrast medium for diagnostic procedures

The paramagnetic properties of Gadoscan 287 mg/ml provides contrast enhancement during MRI. There were no clinically significant deviations from pre-injection values in haemodynamic and blood and urine laboratory parameters following intravenous injection of Gadoscan 287 mg/ml in healthy volunteers. However, a minor transient change in serum iron levels 8 to 48 hours after Gadoscan 287 mg/ml injection was observed.Gadoscan 287 mg/ml does not cross the intact blood-brain barrier. Administration of Gadoscan 287 mg/ml causes signal enhancement from areas where blood-brain barrier dysfunction has been induced by pathological processes, and may provide greater diagnostic yield than unenhanced MRI. Lack of enhancement need not indicate absence of pathology since some types of low grade malignancies or inactive MS-plaques fail to enhance; it can be used for differential diagnosis between different pathologies.

Pregnancy category B3. No effects of Gadoscan 287 mg/ml 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 287 mg/ml in pregnant women. Gadoscan 287 mg/ml 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 287 mg/ml 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 287 mg/ml.

Use in Children: The safety and effectiveness of Gadoscan 287 mg/ml 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 287 mg/ml 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.