DRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP DIAGNOSTIC

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

SODIUM IODIDE 131 I

Fáanlegur frá:

JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA

ATC númer:

V09FX03

INN (Alþjóðlegt nafn):

SODIUNM IODIDE 131 I

Skammtar:

925MBq

Lyfjaform:

SOLUTION

Samsetning:

SODIUM IODIDE 131 I 925MBq

Stjórnsýsluleið:

ORAL

Einingar í pakka:

1ML

Gerð lyfseðils:

Schedule C

Lækningarsvæði:

ROENTGENOGRAPHY

Vörulýsing:

Active ingredient group (AIG) number: 0152597031; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2009-07-10

Vara einkenni

_DRAXIMAGE_
_®_
_ SODIUM IODIDE I 131 CAPSULES / SOLUTION, USP DIAGNOSTIC _
_Product Monograph Page 1 of 23 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DRAXIMAGE
®
SODIUM IODIDE I 131 CAPSULES, USP DIAGNOSTIC
(Sodium Iodide I 131 Capsules, USP for oral use)
Capsule, 3.7 MBq
DRAXIMAGE
®
SODIUM IODIDE I 131 SOLUTION, USP DIAGNOSTIC
(Sodium Iodide I 131 Solution, USP for oral use)
Solution, 74 MBq to 925 MBq / vial
Diagnostic Radiopharmaceutical Agent
Jubilant DraxImage Inc., dba Jubilant Radiopharma
TM
16 751 TransCanada Highway
Kirkland, Quebec H9H 4J4 Canada
1-888-633-5343
www.jubilantradiopharma.com
Date of Initial Authorization:
June 30, 2009
Date of Revision:
November 24, 2023
Submission Control No: 276845
_DRAXIMAGE_
_®_
_ SODIUM IODIDE I 131 CAPSULES / SOLUTION, USP DIAGNOSTIC _
_Product Monograph Page 2 of 23 _
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS
6/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
6/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breastfeeding
6/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
6/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS ........................................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS ......................................................