OPTIMARK INJECTION PHARMACY BULK PACK 0.5 mmol/ml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

GADOVERSETAMIDE

Beschikbaar vanaf:

TRANSMEDIC PTE LTD

ATC-code:

V08CA06

Dosering:

0.5 mmol/ml

farmaceutische vorm:

INJECTION

Toedieningsweg:

INTRAVENOUS

Prescription-type:

Prescription Only

Geproduceerd door:

Mallinckrodt Inc

Autorisatie datum:

2003-04-28

Bijsluiter

P
HARMACOKINETICS
The pharmacokinetics of intravenously administered gadoversetamide in
normal 
subjects conforms to a two-compartment open-model with mean
distribution 
and elimination half-lives (reported as mean ± SD) of about 13.3 ±
6.8 and 
103.6 ± 19.5 minutes.
D
ISTRIBUTION
Gadoversetamide does not undergo protein binding in
vitro. In pregnant and 
lactating rats which received 
153
Gd-labeled gadoversetamide, radioactivity was 
detected in the placenta, fetus, and maternal milk
(_see_ PRECAUTIONS, P
REGNANCY

C
ATEGORY
 C and N
URSING
  M
OTHERS
). The volume of distribution at steady state of 
gadoversetamide in normal subjects is 162 ± 25 mL/kg, roughly
equivalent to that 
of extracellular water (_see_ PRECAUTIONS, P
REGNANCY
 C
ATEGORY
 C).
M
ETABOLISM
Biotransformation or decomposition of gadoversetamide was not
detected.
E
LIMINATION
Gadoversetamide (0.1 mmol/kg) is eliminated primarily in the urine
with 
95.5 ± 17.4% (mean ± SD) of the administered dose eliminated by 24
hours. Animal 
data demonstrated that insignificant levels of radioactive [
153
Gd] MP-1177/10 
are eliminated via the feces. In experimentally induced anephria in
the rat, 
hepatobiliary excretion did not significantly compensate for the
absence of urinary 
elimination. The renal and plasma clearance rates of gadoversetamide
in normal 
subjects are essentially identical (69 ± 15.4 and 72 ± 16.3
mL/hr/kg, respectively) 
indicating that the drug is essentially cleared through the kidneys
via glomerular 
filtration. Within the studied dose range (0.1 to 0.7 mmol/kg), the
kinetics of 
gadoversetamide appear to be linear (_see_  PRECAUTIONS).
S
PECIAL
 P
OPULATIONS
Renal Insufficiency: A single intravenous dose of 0.1 mmol/kg
of OptiMARK™ 
Injection was administered to 28 (17 men and 11 women) patients with
impaired 
renal function (mean serum creatinine of 2.4 mg/dL). Sixteen patients
had 
concurrent central nervous system or liver pathology. Renal impairment
was 
shown to delay