Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GADOBENATE DIMEGLUMINE
DIPA PHARMALAB INTERSAINS - Indonesia
GADOBENATE DIMEGLUMINE
0.529 G
CAIRAN INJEKSI
DUS, 1 VIAL @ 10 ML
PATHEON ITALIA S.P.A - Italy
2019-06-19
Page 1 of 10 PRODUCT INFORMATION NAME OF THE DRUG: gadobenate dimeglumine DESCRIPTION MultiHance® is supplied as a sterile, non-pyrogenic, clear colourless to slightly yellow, aqueous solution at neutral pH (6.5-7.3) for intravenous injection. MultiHance® contains no preservatives. 1 mL of solution for injection contains: gadobenic acid 334 mg (0.5M) as the dimeglumine salt. [gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg]. _Chemical name _ Gadolinate(2-),(4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-5,8,11-triazatridecan-13- oato-(5-)-N5,N8,N11,O4,O5,O8,O11,O13]-dihydrogen compound with 1-deoxy-1-(methylamino)-D- glucitol (1:2). _Laboratory name _ B19036/7 Gd-BOPTA/dimeg The structural formula of gadobenate dimeglumine is: WARNING : NEPHROGENIC SYSTEMIC FIBROSIS AND GADOLINIUM RETENTION GADOLINIUM-BASED CONTRAST AGENTS (GBCAS) INCREASE THE RISK OF NSF AMONG PATIENTS WITH IMPAIRED ELIMINATION OF THE DRUGS. AVOID USE OF GBCAS IN THESE PATIENTS UNLESS THE DIAGNOSTIC INFORMATION IS ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRAST MRI OR OTHER MODALITIES. THE RISK FOR NSF APPEARS HIGHEST AMONG PATIENTS WITH: CHRONIC, SEVERE KIDNEY DISEASE (GFR <30 ML/MIN/1.73M 2 ), OR ACUTE KIDNEY INJURY. SCREEN PATIENTS FOR ACUTE KIDNEY INJURY AND OTHER CONDITIONS THAT MAY REDUCE RENAL FUNCTION. FOR PATIENTS AT RISK FOR CHRONICALLY REDUCED RENAL FUNCTION (E.G. AGE > 60 YEARS, HYPERTENSION OR DIABETES), ESTIMATE THE GLOMERULAR FILTRATION RATE (GFR) THROUGH LABORATORY TESTING. GADOLINIUM IS RETAINED FOR MONTHS OR YEARS IN SEVERAL ORGANS. THE HIGHEST CONCENTRATIONS (NANOMOLES PER GRAM OF TISSUE) HAVE BEEN IDENTIFIED IN THE BONE, FOLLOWED BY OTHER ORGANS (E.G. BRAIN, SKIN, KIDNEY, LIVER, AND SPLEEN). CONSEQUENCES OF GADOLINIUM RETENTION IN THE BRAIN HAVE NOT BEEN ESTABLISHED. PATHOLOGIC AND CLINICAL CONSEQUENCES OF GBCA ADMINISTRATION AND RETENTION IN SKIN AND OTHER ORGANS HAVE BEEN ESTABLISHED IN PATIENTS WITH IMPAIRED RENAL FUNCTION. WHILE CLINICAL CONSEQUENCES OF GADOLINIUM RETENT Baca dokumen lengkapnya