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Novartis begins shipment of seasonal influenza vaccines to US market
Date:8/21/2013

d within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX should be based on careful consideration of the potential benefits and risks.
  • Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Altered Immunocompetence: After vaccination with FLUCELVAX, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
  • Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX may not protect all vaccine recipients against influenza disease.
  • Most Common Adverse Reactions

    • The most common (>10 %) solicited adverse reactions occurring in adults 18-64 years of age within 7 days of vaccination with FLUCELVAX were pain at the injection site, erythema at the injection site, headache, fatigue, myalgia  and malaise.  The most common (>10%) solicited adverse reactions occurring in adults >65 years of age within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise.

    Disclaimer
    The foregoing release contains forward-looking statements that can be identified by terminology such as "begins," "plans," "offers," "has begun," "potential," "could," or similar expressions, or by express or implied discussions regarding potential future revenues from Fluvirin and Flucelvax. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results
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