Proposal for Ketoprofen

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Veterinary Drugs Directorate
Holland Cross Complex
Ground floor, Suite 14
11 Holland Avenue
Address Locator: 3000A
Ottawa, ON K1A OK9

File No: 9450-5-17

January 24, 2005

Dear Stakeholder:

The Veterinary Drugs Directorate (VDD) of Health Products and Food Branch, Health Canada is considering regulatory amendments which may be of interest to your organization. As the designated contact person of your organization, I would appreciate your collaboration in distributing this information to the attention of all interested parties in your organization to solicit their comments.

More specifically, the Veterinary Drugs Directorate is proposing to establish Maximum Residue Limits (MRLs) in Table III to Division 15, Part B of the Food and Drug Regulations for Ketoprofen in edible tissues of food producing animals as indicated in the following table:

Column I	Column II	Column III	Column IV
Common Name (or Brand Name of Drug)	Name Of Substance for Drug Analysis Purposes	MRL p.p.m.	Foods
Ketoprofen	Ketoprofen	0.1	0.5
		Muscle of swine	Kidney of swine

Ketoprofen is a non-steroidal anti-inflammatory agent (NSAID), belonging to the arylpropionic acid group, showing a good analgesic, anti-inflammatory and antipyretic activity. It is used in swine as anti-inflammatory, analgesic and antipyretic drug in case of respiratory infections and Mastitis- Metritis-Agalactia syndrome in the sow.

VDD has established an ADI of 240 µg/day/person. The withdrawal period is seven days for swine.

The result of our Health Risk Assessment shows that residues at the above noted concentrations will not pose any undue health risk for consumers. These proposed MRLs will be published in the Canada Gazette, Part I, after consideration of comments from stakeholders.

I would appreciate receiving your comments on this proposal by April 25, 2005. Comments should be sent to the attention of Dhurata Ikonomi, Public Involvement Officer, at the above noted address.

Thank you for your cooperation in this matter.

Yours sincerely,

Diane Kirkpatrick
Director General