OPTIMARK INJECTION GLASS VIAL 0.5 mmol/ml

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

GADOVERSETAMIDE

Commercializzato da:

TRANSMEDIC PTE LTD

Codice ATC:

V08CA06

Dosaggio:

0.5 mmol/ml

Forma farmaceutica:

INJECTION

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Mallinckrodt Inc

Data dell'autorizzazione:

2003-04-26

Foglio illustrativo

DESCRIPTION
OptiMARK™  (gadoversetamide injection) is a formulation of a
nonionic 
gadolinium chelate of diethylenetriamine pentaacetic acid
bismethoxyethylamide 
(gadoversetamide), for use in magnetic resonance imaging (MRI).
OptiMARK™ 
Injection is to be administered by intravenous injection only.
OptiMARK™ Injection is provided as a sterile, nonpyrogenic, clear,
colorless to pale 
yellow, aqueous solution of gadoversetamide. No preservative is
added. Each mL 
of OptiMARK™ Injection contains 330.9 mg of gadoversetamide (0.5
millimole), 
28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium
chloride 
dihydrate (0.005 millimole), and water for injection. Sodium
hydroxide and/or 
hydrochloric acid may have been added for pH adjustment.
OptiMARK™ Injection is designated chemically as [8,
11-bis(carboxymethyl)-14-[2-
[(2-methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-
16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and
empirical 
formula of C
20
H
34
N
5
O
10
Gd. The structural formula of gadoversetamide in aqueous 
solution is:
OptiMARK™ Injection has a pH of 5.5 to 7.5 and pertinent
physiochemical data are 
provided below:
TABLE 1:      PHYSIOCHEMICAL DATA
Osmolality (mOsmol/kg water) @ 37°C
1110
Viscosity (cP)
@ 20°C
3.1
@ 37°C
2.0
Density (g/mL)
@ 25°C
1.160
OptiMARK™ Injection has an osmolality of approximately 3.9 times
that of plasma 
(285 mOsm/kg water) and is hypertonic under conditions of use.
CLINICAL PHARMACOLOGY
G
ENERAL
OptiMARK™ Injection contains gadoversetamide, a complex formed
between 
a chelating agent (versetamide) and a paramagnetic ion, gadolinium
(III). 
Gadoversetamide is a paramagnetic agent that develops a magnetic
moment 
when placed in a magnetic field. The relatively large magnetic moment
can 
enhance the relaxation rates of water protons in its
vicinity, leading to an increase 
in signal intensity (brightness) of tissues.
P
HARMACOKINETICS
The pharmacokinetics of intravenously