HEXABRIX 200 SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

IOXAGLATE SODIUM; IOXAGLATE MEGLUMINE

Fáanlegur frá:

GUERBET

ATC númer:

V08AB03

INN (Alþjóðlegt nafn):

IOXAGLIC ACID

Skammtar:

123MG; 246MG

Lyfjaform:

SOLUTION

Samsetning:

IOXAGLATE SODIUM 123MG; IOXAGLATE MEGLUMINE 246MG

Stjórnsýsluleið:

INTRAVASCULAR

Einingar í pakka:

20/50/100/150/200ML

Gerð lyfseðils:

Ethical

Lækningarsvæði:

ROENTGENOGRAPHY

Vörulýsing:

Active ingredient group (AIG) number: 0216261002; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2015-07-08

Vara einkenni

PRODUCT MONOGRAPH
PROPRIETARY NAME:
Hexabrix® 200
PROPER NAME:
Ioxaglate Meglumine 24.6% and Ioxaglate
Sodium 12.3%
PROPRIETARY NAME:
Hexabrix® 320
PROPER NAME:
Ioxaglate Meglumine 39.3% and Ioxaglate
Sodium 19.6%
PHARMACOLOGY CLASSIFICATION:
Ionic,
low
osmolality,
water
soluble
radiopaque contrast medium for intravascular
use.
GUERBET
BP 57400
95943 Roissy CdG Cedex
FRANCE
Control No. 162948
Revised:
April 4, 2013
1
PRODUCT MONOGRAPH
NAME OF DRUG
HEXABRIX® 200
(Ioxaglate Meglumine 24.6% and Ioxaglate Sodium 12.3%)
HEXABRIX® 320
(Ioxaglate Meglumine 39.3% and Ioxaglate Sodium 19.6%)
Therapeutic or Pharmacological Classification
Ionic, Low Osmolality, Water Soluble, Radiopaque Contrast Medium
for Intravascular Use
2
ACTIONS AND CLINICAL PHARMACOLOGY
Following intravascular injection, Hexabrix is rapidly transported
through the circulatory
system to the kidneys and is excreted unchanged in the urine. The
pharmacokinetics of
intravascularly administered radiopaque contrast media are usually
best described by a two
compartment model with a rapid alpha phase for drug distribution and a
slower beta phase for
drug elimination. In patients with normal renal function, the alpha
and beta half lives of
Hexabrix 320 were 12 and 92 minutes, respectively.
Following the intravenous administration of 50 mL of Hexabrix 320 in
normal volunteers, the
mean peak plasma concentration occurred at two minutes, reaching a
concentration of 2.13
mg/mL. Fifty percent of the intravenously administered dose was
recovered in the urine at 2
hours, and approximately 90% was recovered at 24 hours.
Injectable iodinated contrast agents are excreted either through the
kidneys or through the
liver. These two excretory pathways are not mutually exclusive, but
the main route of
excretion seems to be related to the affinity of the contrast medium
for serum albumin.
Ioxaglate salts are poorly bound to serum albumin, and are excreted
mainly through the
kidneys. The liver and small intestine provide the major alternate
route of excretion.
Hexabrix
appe