Flucelvax Influenza Virus Vaccine

Flucelvax is a new flu vaccine that helps protect you against influenza. Flucelvax is now approved for people aged 18 and older.

Patient Guide

Learn about the flu and flu vaccines.

Find out how Flucelvax can help protect you against the flu.

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Flu Facts

Fact #1

Influenza, commonly referred to as the flu, is a contagious disease of the respiratory tract (nose, throat and lungs).

* Source: Centers for Disease Control and Prevention. Questions & answers: seasonal flu vaccine. CDC Web site. http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed May 31, 2011.

Fact #2

Flu activity most commonly peaks in the U.S. in January or February. However, seasonal flu activity can begin as early as October and continue to occur as late as May.

* Source: Centers for Disease Control and Prevention. Questions & answers: seasonal flu vaccine. CDC Web site. http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed May 31, 2011.

Fact #3

Between 15 million and 60 million Americans have suffered from influenza in an average year with symptoms including fever, headaches, extreme tiredness, cough, sore throat, nasal congestion, and body aches.

* Source: Centers for Disease Control and Prevention. Questions & answers: seasonal flu vaccine. CDC Web site. http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed May 31, 2011.

Fact #4

The immune protection you receive from a flu shot declines over time. Influenza strains typically change from year to year. Getting a flu shot each year is the best way to help protect yourself from the flu.

* Source: Centers for Disease Control and Prevention. Questions & answers: seasonal flu vaccine. CDC Web site. http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed May 31, 2011.

Safety Information

Understand the risks of the Flucelvax vaccination.

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Prescribing Information

Your guide to Flucelvax's Prescribing Information.

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Patient Guide

Flu Facts

Safety Information

Prescribing Information

FLUCELVAX is indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX is now approved for use in persons 18 years of age and older.

Patient Guide

Help your patients learn how new Flucelvax may help protect them from influenza.

Download the Patient Guide

Safety Information

Important Safety Information for Flucelvax.

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Prescribing Information

Read full Prescribing Information for Flucelvax.

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Patient Guide

Safety Information

Prescribing Information

FLUCELVAX Professional Important Safety Information

Indication and Usage for FLUCELVAX® (Influenza Virus Vaccine)

FLUCELVAX is indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX is approved for use in persons 18 years of age and older.

Important Safety Information for FLUCELVAX

Contraindication

Do not administer FLUCELVAX to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

Warnings & Precautions

Guillain-Barré Syndrome (GBS): If GBS has occurred 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.

Please see accompanying US Full Prescribing Information for FLUCELVAX.

FLUCELVAX Consumer Important Safety Information

What is FLUCELVAX (Influenza Virus Vaccine)?

FLUCELVAX is a vaccine that helps protect against influenza (flu). FLUCELVAX is for people aged 18 and older. Vaccination with FLUCELVAX may not protect all people who receive the vaccine.

Important Safety Information for FLUCELVAX

Who should not get FLUCELVAX?

You should not get FLUCELVAX if you have had a severe allergic reaction to any of the ingredients in the vaccine

Who may not be able to get FLUCELVAX?

Tell your healthcare provider if you:

have ever had Guillain-Barrè Syndrome (severe muscle weakness) after getting a flu shot
have an allergy to rubber latex

What if I have a weakened immune system?

Tell your healthcare provider if you have problems with your immune system, as your immune response to the vaccine may be less.

What are the most common side effects of FLUCELVAX?

pain or redness where you got the shot
headache
tiredness
muscle aches
feeling unwell (malaise)

These are not all of the possible side effects of FLUCELVAX. You can ask your healthcare provider for a complete list of possible side effects.

Ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Events Reporting System (VAERS) by calling 1-800-822-7967 or by going to http://vaers.hhs.gov.

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Vaccines at 1-877-683-4732 or VAERS at 1 800 822 7967 and www.vaers.hhs.gov.

Please see accompanying US Full Prescribing Information for FLUCELVAX.

For Healthcare Professionals

The information contained in this section of Fluecelvax.com was specifically created for United States healthcare professionals. If you are not a US healthcare professional and would like to return to the consumer section of the site, please click the return button below.