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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Dear Health Care Provider Letter: Fluvirin and Agriflu (Influenza Virus Vaccine) Pre-Filled Syringes

Novartis Vaccines and
Diagnostics, Inc.
350 Massachusetts Ave.
Cambridge, MA 02139

IMPORTANT DRUG WARNING

FLUVIRIN® and AGRIFLU® (Influenza Virus Vaccine) pre-filled syringes

July 20, 2010

Dear Health Care Provider,

Novartis Vaccines and Diagnostics, Inc. is requesting that Healthcare Providers be aware that the tip caps of the pre-filled syringes of 2010/2011 FLUVIRIN and AGRIFLU influenza vaccine may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. Any provider who administers vaccines should have procedures in place for the emergency care of a person who experiences an anaphylactic reaction. Epinephrine and equipment for maintaining an airway should be available for immediate use. All vaccine providers should be familiar with the office emergency plan, and should be certified in cardiopulmonary resuscitation. The syringe plunger of FLUVIRIN and AGRIFLU pre-filled syringes, and the stoppers of FLUVIRIN multi-dose vials, do not contain natural rubber latex
Novartis Vaccines is making this notification to Healthcare Providers with the full knowledge of and in coordination with the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). The presence of natural latex rubber in the tip caps of the pre-filled syringe doses of FLUVIRIN and AGRIFLU is a potential risk only to patients who are latex allergic.

Multi-dose vial presentations of FLUVIRIN are NOT affected by this notification, and no action with respect to any doses from multi-dose vials is required.

The US Package Inserts for Fluvirin and Agriflu are being updated to include this information and will be posted at: www.novartisvaccinesdirect.com. If you have any questions, please contact Novartis Vaccines at 800-244-7668. For questions with respect to existing orders select Customer Service (option 2), for questions of a medical nature select Medical Communications (option 1).

We appreciate your immediate attention to this notice and sincerely regret any inconvenience this has caused.

Regards,

/signature/

Jeffrey J. Stoddard, MD
Head, Medical Affairs (US)
Novartis Vaccines