GADOVIST 1.0 MMOLML SOLUTION FOR INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

GADOBUTROL

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

GADOBUTROL

Units in package:

10 ml; 30 ml; 10 ml; 15 ml; 20 ml; 15ml1Units mL; 5 ml Units mL; 10 mL; 20 mL

Manufactured by:

BAYER AG

Summary of Product characteristics

Reference : Gadovist 1.0 mmol/ml solution for injection / CCDS / Version 19/ 13 May 2014 ,+ SG Gadovist PI CCDS19 09 Mar 2016
Gadovist ® 1.0 mmol/ml
Solution for injection 1. NAME OF THE MEDICINAL PRODUCT
Gadovist 1.0 mmol/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1.0 mmol gadobutrol (equivalent to 604.72 mg gadobutrol ).
For full list of excipients, see section �List of excipients�.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless to pale yellow solution.
4. CLINICAL PARTICULARS
4.1 Indication (s)
This medicinal product is for diagnostic use only.
Gadovist is indicated in adults, and children of all ages (including term neonates) for
• Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) .
Gadovist is particularly suitable for cases where the exclusion or demonstration of additional pathology may influence the
choice of therapy or patient management for detection of very small lesions and for visualization of tumours that do not
readily take up contrast media.
Gadovist is also suited for perfusion studies for the diagnosis of stroke, detection of focal cerebral ischaemia and tumour
perfusion.
• Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesion to classify
these lesions as benign or malignant.
• Contrast enhancement in Magnetic Resonance Angiography (CE -MRA).
Gadovist can also be used for MR Imaging of pathologies of the whole body.
It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathologi cal
tissue.
4.2 Dosage and method of administration
4.2.1 Method of administration
This medicinal product is for intravenous administration only.
For additional instructions see section ‘Instructions for use/handling’.
Contrast -enhanced MRI can commence immediately afterwards (shortly after the injection depending on the pulse
sequences used and the protocol for the examination). Optimal signal enhancement is