GASTROGRAFIN SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Dostępny od:

BRACCO IMAGING CANADA

Kod ATC:

V08AA01

INN (International Nazwa):

DIATRIZOIC ACID

Dawkowanie:

66%; 10%

Forma farmaceutyczna:

SOLUTION

Skład:

DIATRIZOATE MEGLUMINE 66%; DIATRIZOATE SODIUM 10%

Droga podania:

ORAL

Sztuk w opakowaniu:

30ML/120ML

Typ recepty:

Ethical

Dziedzina terapeutyczna:

ROENTGENOGRAPHY

Podsumowanie produktu:

Active ingredient group (AIG) number: 0201807001; AHFS:

Status autoryzacji:

MARKETED

Data autoryzacji:

1978-12-30

Charakterystyka produktu

_Product Monograph _
_ _
_GASTROGRAFIN_
_®_
_ (diatrizoate meglumine and diatrizoate sodium solution) _
_Page 1 of 17_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
GASTROGRAFIN®
Diatrizoate meglumine and diatrizoate sodium solution, USP
Solution, Diatrizoate meglumine 66 % and Diatrizoate sodium 10 %, Oral
and rectal
Radiopaque Contrast Agent
ATC code: V08AA01
Watersoluble, nephrotropic, high osmolar X-ray contrast media
Bracco Imaging Canada
11065 boul. Louis-H.-Lafontaine
Montreal, Quebec
Canada H1J 2Z4
Date of Initial Authorization:
Jul 2, 1996
Date of Revision:
Apr 28, 2022
Submission Control Number: 258529
_ _
_Product Monograph _
_ _
_GASTROGRAFIN_
_®_
_ (diatrizoate meglumine and diatrizoate sodium solution) _
_Page 2 of 17_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment......