Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Product name:

DRAXIMAGE GLUCEPTATE

Description:

KIT FOR THE PREPARATION OF TECHNETIUM TC 99M GLUCEPTATE INJECTION / STANNOUS GLUCEPTATE INJECTION

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02342006

Product Monograph/Veterinary Labelling:

Date: 2015-05-08 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
16751 Trans Canada Hwy
Kirkland
Quebec
Canada H9H 4J4

Class:

Radiopharmaceutical

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

2

Schedule(s):

Schedule C

 

American Hospital Formulary Service (AHFS): See footnote 3

36:68.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

V09CA04 TECHNETIUM (99m Tc) GLUCEPTATE

Active ingredient group (AIG) number:See footnote5

0260550001

List of active ingredient(s)
Active ingredient(s) Strength
CALCIUM GLUCOHEPTONATE 25 MG / VIAL
STANNOUS CHLORIDE DIHYDRATE 3 MG / VIAL
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