TELEBRIX 38 ORAL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEGLUMINE IOXITALAMATE; SODIUM IOXITALAMATE

Available from:

LIEBEL-FLARSHEIM CANADA INC

ATC code:

V08AA05

INN (International Name):

IOXITALAMIC ACID

Dosage:

513MG; 255MG

Pharmaceutical form:

SOLUTION

Composition:

MEGLUMINE IOXITALAMATE 513MG; SODIUM IOXITALAMATE 255MG

Administration route:

ORAL

Units in package:

120ML

Prescription type:

Ethical

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-08-07

Summary of Product characteristics

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