MULTIHANCE

Nchi: Indonesia

Lugha: Kiindonesia

Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Viambatanisho vya kazi:

GADOBENATE DIMEGLUMINE

Inapatikana kutoka:

DIPA PHARMALAB INTERSAINS - Indonesia

INN (Jina la Kimataifa):

GADOBENATE DIMEGLUMINE

Kipimo:

0.529 G

Dawa fomu:

CAIRAN INJEKSI

Vitengo katika mfuko:

DUS, 1 VIAL @ 10 ML

Viwandani na:

PATHEON ITALIA S.P.A - Italy

Idhini ya tarehe:

2019-06-19

Tabia za bidhaa

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