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Hepatobiliary contrast agent for MRI
¹
MINIMUM PRODUCT INFORMATION
PRIMOVIST
®
[disodium gadoxetate 0.25 mmol/mL]
INDICATIONS:
Enhancement of magnetic resonance imaging (MRI) of focal liver lesions in adults.
CONTRAINDICATIONS: k
nown hypersensitivity to disodium gadoxetate or any of the
excipients.
PRECAUTIONS:
Impaired renal function and liver transplant patients (see boxed warnings); impaired hepatic function; anaphylactoid/hypersensitivity or other idiosyncratic
reactions (higher risk in the case of previous reaction to contrast media, history of bronchial asthma, history of allergic disorders); intramuscular administration; severe cardiovascular
disease; risk factors for arrhythmias; not recommended in children below 18 years of age; pregnancy (Category B3).
INTERACTIONS WITH OTHER MEDICINES:
rifampicin; interference
with diagnostic tests (serum iron).
ADVERSE EFFECTS:
common: headache; nausea. Please refer to PI for a complete list.
BOXED WARNINGS:
NEPHROGENIC SYSTEMIC FIBROSIS:
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with: acute or chronic severe renal insufficiency (glomerular filtration rate <30
mL/min/1.73m
2
; or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
DOSAGE AND ADMINISTRATION:
0.1 mL/kg body weight given as an intravenous injection at a flow rate of about 2 mL/sec.
DATE OF PREPARATION:
May 2012.
Please review the full Product Information before administering. Approved PI available at
http://www.bayerresources.com.au/resources/uploads/PI/file9412.pdfor upon request from
Bayer Australia Ltd. ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073. ® Registered trademark of the Bayer Group, Germany. L.AU.MKT.DI.03.2016.0073 March 2016
Reference: 1
. Australian approved product information: 3 September 2015.
2.
Grazioli L, Bondioni MP et at. Hepatocellular Adenoma and Focal Nodular Hyperplasia: Value of Gadoxetic Acid
- enhanced MR Imaging in Differential Diagnosis. Radiology: Vol 262: Number 2 – February 2012.
Primovist® – enhanced MRI facilitates the
differentiation of Focal Nodular Hyperplasia
(FNH) from Hepatocellular Adenoma (HCA)
2