DRAXIMAGE SODIUM IODIDE I131 CAPSULES, USP THERAPEUTIC

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SODIUM IODIDE 131 I

Available from:

JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA

ATC code:

V10XA01

INN (International Name):

SODIUM IODIDE 131 I

Dosage:

7400MBq

Pharmaceutical form:

CAPSULE

Composition:

SODIUM IODIDE 131 I 7400MBq

Administration route:

ORAL

Units in package:

1

Prescription type:

Schedule C

Therapeutic area:

RADIOACTIVE AGENTS

Product summary:

Active ingredient group (AIG) number: 0152597028; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-07-10

Summary of Product characteristics

_DRAXIMAGE_
_®_
_ SODIUM IODIDE I 131 CAPSULES / SOLUTION, USP THERAPEUTIC _
_Product Monograph Page 1 of 25 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DRAXIMAGE
®
SODIUM IODIDE I 131 CAPSULES, USP THERAPEUTIC
(Sodium Iodide I 131 Capsules, USP for oral use)
Capsule, 74 MBq to 7400 MBq
DRAXIMAGE
®
SODIUM IODIDE I 131 SOLUTION, USP THERAPEUTIC
(Sodium Iodide I 131 Solution, USP for oral use)
Solution, 74 MBq to 7400 MBq per vial
Therapeutic 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 THERAPEUTIC _
_Product Monograph Page 2 of 25 _
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, 7.1.3 Pediatrics
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS ..........................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIO