TELEBRIX 38 ORAL SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

MEGLUMINE IOXITALAMATE; SODIUM IOXITALAMATE

Доступно од:

LIEBEL-FLARSHEIM CANADA INC

АТЦ код:

V08AA05

INN (Међународно име):

IOXITALAMIC ACID

Дозирање:

513MG; 255MG

Фармацеутски облик:

SOLUTION

Састав:

MEGLUMINE IOXITALAMATE 513MG; SODIUM IOXITALAMATE 255MG

Пут администрације:

ORAL

Јединице у пакету:

120ML

Тип рецептора:

Ethical

Терапеутска област:

ROENTGENOGRAPHY

Резиме производа:

Active ingredient group (AIG) number: 0226824001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2020-08-07

Карактеристике производа

Page 1 of 21
PRESCRIBING INFORMATION
NAME OF DRUG:
TELEBRIX
®
38 ORAL
PROPER NAME:
Meglumine Ioxitalamate and Sodium
Ioxitalamate Oral Solution 77%
PHARMACOLOGY
CLASSIFICATION:
Oral Radiopaque Contrast Medium for
Dilution
Liebel-Flarsheim Canada Inc.
Pointe-Claire, Quebec, H9R 5H8
Canada
Control No.
203737 Revised:
August 24
, 2017
Page 2 of 21
NAME OF DRUG
Telebrix
®
38 Oral
(Meglumine Ioxitalamate and Sodium Ioxitalamate Oral Solution 77% w/v)
THERAPEUTIC CLASSIFICATION
Oral Radiopaque Contrast Medium for Dilution
ACTION
When diluted to a 2% solution as directed, Telebrix
®
38 Oral is an oral contrast medium for use
as a bowel opacifier during CT scanning of the abdomen and pelvis. A
bowel lumen which is
adequately opacified with contrast medium facilitates interpretation
of the anatomy of the image
and permits differentiation of bowel loops from soft tissue masses.
INDICATION
Telebrix
®
38 Oral is indicated as a bowel opacifier during CT scanning of the
abdomen and
pelvis.
CONTRAINDICATIONS

Hypersensitivity to ioxitalamate acid salts or to any of the
excipients

Severe oliguria or anuria

History of major immediate or delayed skin reaction (see ADVERSE
REACTIONS
section) to Telebrix
®
38 Oral administration

If
a
broncho-esophageal
fistula
or
a
risk
of
aspiration
is
suspected,
hyperosmolar
monomeric ionic contrast agents are contraindicated because of the
risk of intra-alveolar
edema

Manifest thyrotoxicosis
WARNINGS
THIS MEDICINAL PRODUCT MUST NOT BE INJECTED.
Allergic reaction is possible regardless of the administration route
and dose.
Administration
by
oral
route
generally
leads
to
very
limited
systemic
diffusion;
if
the
gastrointestinal mucosa is normal, only 5% maximum of the dose
administered is found in the
urine, the remainder being eliminated with the feces. However, if the
gastrointestinal mucosa is
altered, absorption is increased; it becomes total and rapid in the
event of perforation, with
passage into the peritoneal cavity. The medicinal product is then
eliminated with the u