ULTRAVIST 240 SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IOPROMIDE

Dostępny od:

BAYER INC

Kod ATC:

V08AB05

INN (International Nazwa):

IOPROMIDE

Dawkowanie:

50%

Forma farmaceutyczna:

SOLUTION

Skład:

IOPROMIDE 50%

Droga podania:

INTRAVASCULAR

Sztuk w opakowaniu:

50/200ML

Typ recepty:

Ethical

Dziedzina terapeutyczna:

ROENTGENOGRAPHY

Podsumowanie produktu:

Active ingredient group (AIG) number: 0125805001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2019-04-16

Charakterystyka produktu

ULTRAVIST
®
(IOPROMIDE INJECTION)
ULTRAVIST
® 300
(IOPROMIDE INJECTION 62% W/V, 300 MG I/ML)
ULTRAVIST
® 370
(IOPROMIDE INJECTION 77% W/V, 370 MG I/ML)
Nonionic Iodinated Radiographic Contrast Medium
For Professional Use Only
Bayer Inc.
Date of Revision:
2920 Matheson Boulevard East
January 22, 2020
Mississauga, Ontario
L4W 5R6
Canada
http://www.bayer.ca
Submission Control No. 234206
® TM see www.bayer.ca/tm-mc
© 2019, Bayer Inc.
_ULTRAVIST Product Monograph _
_Page 2 of 60_
ULTRAVIST
®
(IOPROMIDE INJECTION)
ULTRAVIST
® 300
(IOPROMIDE INJECTION 62% W/V, 300 MG I/ML)
ULTRAVIST
® 370
(IOPROMIDE INJECTION 77% W/V, 370 MG I/ML)
Nonionic Iodinated Radiographic Contrast Medium
For Professional Use Only
ACTION AND CLINICAL PHARMACOLOGY
ULTRAVIST (iopromide) is a nonionic iodinated, water-soluble,
radiographic contrast
medium which is available in two stable, ready-to-use solutions of
different
concentrations. Following intravascular injection, iopromide provides
radiographic
opacification of the vasculature and extracellular space in the path
of flow of the agent,
allowing diagnostic assessment of the limbs and internal organs until
significant dilution
occurs. For example, after intravenous injection, opacification of the
renal parenchyma
begins within 1 minute. Excretion of the contrast agent becomes
apparent in
1 to 3 minutes with optimal contrast in the calyces and collecting
system occurring
between 5 and 15 minutes. In nephropathic conditions, particularly
when excretory
capacity has been altered, the excretion rate varies unpredictably and
opacification may
be delayed for several hours after injection.
_ULTRAVIST Product Monograph _
_Page 3 of 60_
The pharmacokinetics of iopromide are similar to those of other ionic
and nonionic
contrast media. Immediately following intravascular injection,
iopromide reaches peak
plasma concentrations and is then rapidly distributed throughout the
extracellular fluid
compartment. It is excreted unchanged by the kidneys mainly by
glomerular filtration.
About 90% of the inj