OMNIPAQUE 180 SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IOHEXOL

Disponibbli minn:

GE HEALTHCARE CANADA INC

Kodiċi ATC:

V08AB02

INN (Isem Internazzjonali):

IOHEXOL

Dożaġġ:

388MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

IOHEXOL 388MG

Rotta amministrattiva:

SUBARACHNOIDAL

Unitajiet fil-pakkett:

20ML VIAL

Tip ta 'preskrizzjoni:

Ethical

Żona terapewtika:

ROENTGENOGRAPHY

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0116846002; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2023-02-21

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
OMNIPAQUE
(iohexol injection USP)
OMNIPAQUE 180
(iohexol injection USP 39% w/v, 180 mg I/mL)
OMNIPAQUE 240
(iohexol injection USP 52% w/v, 240 mg I/mL)
OMNIPAQUE 300
(iohexol injection USP 65% w/v, 300 mg I/mL)
OMNIPAQUE 350
(iohexol injection USP 76% w/v, 350 mg I/mL)
Non-ionic radiographic contrast medium
GE Healthcare Canada Inc. Date of Revision:
1919 Minnesota Court,
Mississauga, Ontario January 12, 2021
L5N 0C9
Control Number: 242219

2

NAME OF DRUG
OMNIPAQUE
(iohexol injection USP)
OMNIPAQUE 180
(
iohexol injection USP, 39% w/v, 180 mg I/mL
)
OMNIPAQUE 240
(
iohexol injection USP, 52% w/v, 240 mg I/mL)
OMNIPAQUE 300
(
iohexol injection USP, 65% w/v, 300 mg I/mL
)
OMNIPAQUE 350
(
iohexol injection USP, 76% w/v, 350 mg I/mL
)
THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION
Non-ionic radiographic contrast medium.
ACTION AND CLINICAL PHARMACOLOGY
A. GENERAL
Immediately following rapid intravascular injection, Omnipaque
(iohexol) reaches peak
plasma concentration and is then rapidly distributed throughout the
extracellular fluid

3

compartment. Iohexol does not normally cross the blood-brain barrier
to any significant
extent. It is excreted unchanged by the kidneys, mainly by glomerular
filtration; tubular
secretion plays a minor role, and a very small quantity (1-2%) is
excreted via the bile.
About 80-90% of the injected dose is excreted in the first 24 hours,
with peak urine
concentrations occurring in the first hour.
Pharmacokinetic studies of iohexol following i.v. injection in healthy
male volunteers showed,
using a three-compartment open model, that its distribution half-life
(alpha phase) is 22
minutes, excretion half-life (beta phase) 2.1 hours, and first-order
terminal elimination half-life
(gamma phase) 12.6 hours. The volume of distribution of the central
compartment is
165-270 mL/kg, the mean renal clearance 120 mL/min., and the mean
total body clearance
is 131 mL/min.
In the presence of impaired renal function, the excretion of iohexol
by the kidneys will b