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IXIARO Japanese Encephalitis Vaccine (inactivated, adsorbed) - Recall of Lot JEV09L37C - For the Public
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(PDF Version - 1, 306 K)Contact: Biologics and Genetic Therapies Directorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on IXIARO Japanese Encephalitis Vaccine (inactivated, adsorbed)
March 8, 2011
Subject: Important information regarding IXIARO® Japanese Encephalitis vaccine (inactivated, adsorbed), Lot JEV09L37C
Intercell AG and Novartis Pharmaceuticals Canada Inc. (Novartis), in consultation with Health Canada, are advising people who were vaccinated with one or both doses of lot JEV09L37C of IXIARO® after December 23, 2010, that this specific lot may not provide full protection against Japanese Encephalitis. Therefore, lot JEV09L37C IXIARO® is being recalled in Canada.
- Individuals who were vaccinated with a Japanese Encephalitis vaccine after December 23rd, 2010, should check if they were vaccinated with IXIARO® Lot JEV09L37C.
- If so, they should return to their Health Care Professional to be re-vaccinated, if they are still at risk of exposure to Japanese Encephalitis.
Novartis' Japanese Encephalitis vaccine, IXIARO® (inactivated, adsorbed) Lot JEV09L37C is being recalled in Canada (DIN 02333279, UPC Code 0 63601 18546 0), because this specific lot may not produce the desired protection against Japanese Encephalitis in individuals who were vaccinated with one or both doses after December 23, 2010.
There is no evidence of a safety concern with this lot. No other lots of IXIARO® are affected by this recall. New supply is available and free replacement product is available up to April 30, 2011. Please contact your health care professional if you were vaccinated with Japanese Encephalitis vaccine after December 23, 2010.
IXIARO® is manufactured by Intercell AG and distributed in Canada by Novartis. Intercell AG and Novartis reiterate their commitment to the delivery of quality pharmaceutical products.
Managing marketed health product-related adverse events depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse events are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse events for vaccines in patients receiving IXIARO® should be reported to Novartis or the Public Health Agency of Canada at the following addresses:
385 Bouchard Blvd.,
Dorval, QC H9S 1A9
e-mail address: drug.safety@novartis.com
Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road,
Address Locator: 6502A
Ottawa, ON K1A OK9
Telephone: 1-866-844-0018
Fax: 1- 866-844-5931
caefi@phac-aspc.gc.ca
How to report a suspected Adverse Event following Immunization:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to the local health department in 
your province or territory. The list of contacts is also provided below.
If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at:
Telephone: 613-954-5590, 1-866-844-0018
Fax: 613-954-9874; 1-866-844-5931
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section.
For other health product inquiries related to this communication, please contact Health Canada at:
Biologics and Genetic Therapies Directorate (BGTD)
E-mail: BGTD_ORA_Enquiries@hc-sc.gc.ca
Telephone: 613-957-1722
If you have any questions regarding this important information, please contact your Health Care Professional or Novartis Customer Relations at 1-800-465-2244. For medical inquiries, please contact Novartis Medical Information at 1-800-363-8883.
A copy of this Public Communication and Health Care Professional Recall letter are available at www.novartis.ca/products/en/vaccines-diagnostics.shtml and www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/index-eng.php.
Sincerely,
original signed by
Kerstin Westritschnig, M.D.
Medical Officer
Intercell AG
Jean-Marie Leclerc, M.D., FRCP(C)
Chief Scientific Officer and Senior Vice-President
Clinical and Regulatory Affairs
Novartis Pharmaceuticals Canada Inc.
IXIARO® is a registered trademark.
Provincial/Territorial Contacts for Adverse Events Following Immunization Form
Alberta
Alberta Health and Wellness
Community Health Branch
Immunization Program
10025 Jasper Ave NW
PO Box 1360
Edmonton, AB T5J 2N3
Phone: 780-415-2824
Web site: www.albertahealthservices.ca/
British Columbia
BC Centre for Disease Control
Epidemiology Services
655 West 12th Avenue
Vancouver, BC, V5Z 4R4
Phone: 604-707-2517
Fax: 604-707-2516
Web site: www.bccdc.ca
Manitoba
Manitoba Health & Healthy Living
Communicable Disease Control Branch
4th Floor-300 Carlton Street
Winnipeg, MB R3B 3M9
Phone: 204-788-6737 Fax: 204-948-3044
Web site: www.gov.mb.ca/health/publichealth/sri/docs/aefi_form.pdf
New Brunswick
Office of the Chief Medical Officer of Health
P.O. Box 5100, Carleton Place
Fredericton, NB E3B 5G8
Phone: 506-453-2323
Web site: http://www.gnb.ca/0051/0053/index-e.asp
Newfoundland and Labrador
Public Health
Dept. of Health and Community Services
PO Box 8700
St. John's NL A1B 4J6
Phone: 709-729-5019; 709-729-0115
Fax: 709-729-0730
Web site: http://www.health.gov.nl.ca/health/divisions/publichealth/default.htm
Nova Scotia
Nova Scotia Health Promotion and Protection
Summit Place, 6th Floor
1601 Lower Water Street, P.O. Box 487
Halifax, NS B3J 2R7
Phone: 902-424-8160
Fax: 902-424-0550
Web site: http://www.gov.ns.ca/hpp/contact.html
Northwest Territories
Office of the Chief Medical Health Officer
Dept. of Health and Social Services
Box 1320
Yellowknife, NT X1A 2L9
Phone: 867-920-8646
Fax: 867-873-0442
Web site: http://www.hlthss.gov.nt.ca/default.htm
Nunavut
Office of the Chief Medical Health Officer
Dept. of Health and Social Services
Box 1000, Station 1000
Iqaluit, Nunavut, X0A 0H0
Phone: 867-975-5700
Fax: 867-979-3190
Ontario
Direct all forms to your local public health unit. Contact information for each health unit can be found on the following webpage:
http://www.health.gov.on.ca/english/public/contact/phu/phuloc_mn.html
Phone: PHD Info line 1-866-532-3161
TTY: 1-800-387-5559
Prince Edward Island
Office of Chief Health Officer
Department of Health
Box 2000
Charlottetown, PEI C1A 7N8
Tel: 902-368-4996
Fax: 902-620-3354
Web site: http://www.gov.pe.ca/health/index.php3
Quebec
Phone: Call Info Santé in your region
Web site: http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?accueil_en
Saskatchewan
Saskatchewan Health
Population Health Branch
3475 Albert Street
Regina, SK S4S 6X6
Phone: 1-800-667-7766
Web site: http://www.health.gov.sk.ca/
Vaccine Program Manager
Yukon Territorial Government
Health & Social Services
# 2 Hospital Road
Whitehorse, YT Y1A 3H8
Phone: (867) 667-8330
Web site:
http://www.hss.gov.yk.ca 