Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Disodium gadoxetate
Bayer Australia Ltd
Medicine Registered
PRIMOVIST ® CMI 1 PRIMOVIST ® (PREE·MOE·VIST) _disodium gadoxetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Primovist. It does not contain all available information. It does not take the place of talking to your doctor. All diagnostic agents have risks and benefits. Your doctor has weighed the risks of you using Primovist against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS DIAGNOSTIC AGENT, ASK YOUR DOCTOR OR RADIOLOGIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PRIMOVIST IS USED FOR Primovist is used to help detect and diagnose changes that may be found in the liver. Abnormal signs within the liver can be better evaluated. Primovist can also help the doctor determine the nature of any abnormalities, thereby increasing the confidence one can have in the diagnosis. The diagnosis can be made quicker, earlier, and with greater accuracy than without using Primovist. Primovist is used together with an imaging technique called magnetic resonance imaging (MRI). MRI is a form of medical diagnostic imaging that distinguishes between normal and abnormal tissues without using x-rays. Primovist is a magnetic liquid that alters the way in which tissues appear, showing abnormalities that may not be visible using MRI alone. Primovist is available only at MRI units for use in conjunction with MRI. Primovist is for diagnostic use only. ASK YOUR DOCTOR/RADIOLOGIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN PRIMOVIST _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN PRIM Preberite celoten dokument
1204 Primovist PI 1 PRODUCT INFORMATION PRIMOVIST ® NAME OF THE MEDICINE Primovist 0.25 mmol/mL, solution for injection is an injectable contrast media agent for use in Magnetic Resonance Imaging (MRI) and contains disodium gadoxetate (Gd-EOB-DTPA). The chemical name for disodium gadoxetate is (4S)-4-(4-ethoxybenzyl)-3,6,9-triazaundecanedioic acid, gadolinium-complex, disodium salt and has the following chemical structure: O N N N O O O O O O Gd 3+ 2 Na + O O O O Molecular Formula: C 23 H 28 N 3 O 11. Gd.2Na Molecular Weight: 725.7 CAS No.: 135326-22-6 PHYSICO-CHEMICAL PROPERTIES The physico-chemical properties of Primovist are listed below: Osmolality at 37°C (mOsm/kg H 2 O) 688 Density at 37 o C (g/mL) 1.0881 Viscosity at 37°C (mPa·s) 1.19 pH 6.8-8.0 DESCRIPTION Primovist is presented as a solution for injection. Each 1 mL of the MRI contrast agent Primovist contains 0.25 mmol disodium gadoxetate (equivalent to 181.43 mg disodium gadoxetate as the active ingredient). The excipients are: trisodium caloxetate trometamol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. Each mL contains 0.511 mmol (equivalent to 11.755 mg) of sodium. (See Precautions) . Primovist contains no antimicrobial preservative. 1204 Primovist PI 2 PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Primovist is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadoxetate, an ionic complex consisting of gadolinium (III) and the ethoxybenzyl-diethylenetriamine- pentaacetic acid which contains the lipophilic ethoxybenzyl moiety(Gd-EOB- DTPA). When T 1 -weighted scanning sequences are used in proton magnetic resonance imaging, the gado Preberite celoten dokument