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Clariscan

Clariscan

Manufacturer:

GE Healthcare (Oslo Plant)

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Gadoteric acid
Indications/Uses
Contrast media used for lesions of the brain, spine, & surrounding tissues, & whole body MRI in adults & childn 0-18 yr, & lesions or stenoses of the non-coronary arteries (MR angiography) in adults.
Dosage/Direction for Use
Administer IV at infusion rate of 3-5 mL/min (up to 120 mL/min may be used for angiography). MRI of brain & spine Adult 0.1 mmol/kg ie, 0.2 mL/kg. Additional 0.2 mmol/kg (ie, 0.4 mL/kg) may improve tumor characterisation in brain tumors. Whole body MRI (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breast, & musculoskeletal system) Adult 0.1 mmol/kg ie, 0.2 mL/kg. Angiography Adult 0.1 mmol/kg ie, 0.2 mL/kg. A 2nd consecutive inj of 0.1 mmol/kg (ie, 0.2 mL/kg) may be justified in exceptional circumstances eg, failure to gain satisfactory images of an extensive vascular territory. If use of 2 consecutive doses are anticipated prior to commencing angiography, 0.05 mmol/kg (ie, 0.1 mL/kg) for each dose may be of benefit. Encephalic, spinal & whole body MRI Childn 0-18 yr Recommended & max dose: 0.1 mmol/kg. Do not use >1 dose during a scan. Neonate up to 4 wk & infant up to 1 yr Dose should not exceed 0.1 mmol/kg. Do not use >1 dose during a scan. Do not repeat unless interval between inj is at least 7 days. Mild-moderate renal (GFR ≥30 mL/min/1.73 m2) & hepatic impairment Adult dose. Severe renal impairment (GFR <30 mL/min/1.73 m2) & patient in perioperative liver transplantation period Dose should not exceed 0.1 mmol/kg. Do not use >1 dose during a scan. Do not repeat unless interval between inj is at least 7 days.
Contraindications
Special Precautions
Discontinue use immediately if hypersensitivity reactions occur. Aggravated hypersensitivity reactions in patients on β-blockers, & particularly in presence of bronchial asthma. For diagnostic use only. Should be used only when diagnostic information is essential & not available w/ unenhanced MRI. Strictly by IV inj only. Not to be used intrathecally & not to be administered by subarachnoid (or epidural) inj. May aggravate symptoms of existing asthma. Extravasation local intolerance reactions may be observed. Patients w/ severe CV disease. Take usual precaution for MRI exam eg, exclude patients w/ pacemakers, vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporeal metallic foreign bodies particularly in the eye. Closely monitor patients w/ low threshold for seizures. Refrain from eating for 2 hr prior to investigation. Reports of nephrogenic systemic fibrosis in patients w/ acute or chronic severe renal impairment (GFR <30 mL/min/1.73 m2), undergoing liver transplantation, & in the perioperative liver transplantation period. Nausea may incidentally occur which may affect ability of ambulant patients to drive & use machines. Not to be used during pregnancy. Lactation. Not recommended for whole body MRI in childn <6 mth; angiography in childn <18 yr. Use in neonates up to 4 wk & infants up to 1 yr only after careful consideration. Screen elderly ≥65 yr for renal dysfunction.
Adverse Reactions
Inj site reactions, nausea & headache.
Drug Interactions
Concomitant use w/ β-blockers, vasoactive substances, ACE inhibitors, angiotensin receptor antagonists as they induce decreased efficacy of CV compensation mechanisms of BP changes. May increase incidence of hypersensitivity reactions w/ β-blockers.
MIMS Class
Radiographic & Diagnostic Agents
ATC Classification
V08CA02 - gadoteric acid ; Belongs to the class of paramagnetic agents used as magnetic resonance imaging contrast media.
Presentation/Packing
Form
Clariscan soln for inj 0.5 mmol/mL
Packing/Price
10 mL x 10 × 1's;20 mL x 10 × 1's
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