Fluzone

DRUG DESCRIPTION

Fluzone (Influenza Virus Vaccine) for intramuscular injection, Fluzone High-Dose (Influenza Virus Vaccine) for intramuscular injection, and Fluzone Intradermal (Influenza Virus Vaccine) for intradermal injection are inactivated influenza virus vaccines, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, Octylphenol Ethoxylate (Triton® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose and Fluzone Intradermal processes use an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.

Fluzone, Fluzone High-Dose, and Fluzone Intradermal, suspensions for injection, are clear and slightly opalescent in color.

Antibiotics are not used in the manufacture of Fluzone, Fluzone High-Dose or Fluzone Intradermal.

The prefilled syringe tip caps of Fluzone and Fluzone High-Dose may contain natural rubber latex. Vial presentations of Fluzone and the Fluzone Intradermal microinjection system do not contain latex.

Fluzone, Fluzone High-Dose, and Fluzone Intradermal are standardized according to United States Public Health Service requirements and are formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (an A/Perth/16/2009-like strain) (H3N2) and B/Brisbane/60/2008. The amounts of HA and other ingredients per dose of vaccine are listed in Table 8.

Table 8: Fluzone, Fluzone High-Dose, and Fluzone Intradermal Ingredients

Ingredient Quantity (perdose)
Fluzone 0.25 mL Dose Fluzone 0.5 mL Dose Fluzone High-Dose 0.5 mL Dose Fluzone Intradermal 0.1 mL Dose
Active Substance: Split influenza virus, inactivated strainsa: 22.5 mcg HA total 45 mcg HA total 180 mcg HA total 27 mcg HA total
A (H1N1) 7.5 mcg HA 15 mcg HA 60 mcg HA 9 mcg HA
A (H3N2) 7.5 mcg HA 15 mcg HA 60 mcg HA 9 mcg HA
B 7.5 mcg HA 15 mcg HA 60 mcg HA 9 mcg HA
Other:
Sodium phosphate-buffered isotonic sodium chloride solution QSb to appropriate volume QSb to appropriate volume QSb to appropriate volume QSb to appropriate volume
Formaldehyde ? 50 mcg ? 100 mcg ? 100 mcg ? 20 mcg
Octylphenol Ethoxylate ? 75 mcg ? 150 mcg ? 250 mcg ? 50 mcg
Gelatin 0.05% 0.05% None None
Preservative
Single-Dose Presentations None None None None
Multi-Dose Presentation (Thimerosal) N/A 25 mcg mercury N/A N/A
a per United States Public Health Service (USPHS) requirement.
b Quantity Sufficient.
N/A not applicable

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to...

Read All Potential Side Effects and See Pictures of Fluzone »

What are the precautions when taking influenza virus vaccine (Fluzone)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to eggs or chicken products; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex, preservatives like thimerosal found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia,...

Read All Potential Precautions of Fluzone »


Fluzone Consumer (continued)

SIDE EFFECTS: Soreness/redness/swelling/bruising at the injection site may occur and may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur. If any of these effects continue beyond 2 days or become bothersome, inform your doctor.

If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to eggs or chicken products; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex, preservatives like thimerosal found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), seizures (e.g., epilepsy controlled by medication, febrile seizures) or history of other nervous system disorders, vaccination history including previous reactions to any vaccines.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Fluzone Patient Information Including Side Effects

Brand Names: Afluria, Fluarix, FluLaval, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric

Generic Name: influenza virus vaccine (injectable) (Pronunciation: in floo ENZ a VYE rus VAK seen)

  • What is influenza virus injectable vaccine (Fluzone)?
  • What are the possible side effects of influenza virus injectable vaccine?
  • What is the most important information I should know about this vaccine?
  • What should I discuss with my healthcare provider before receiving this vaccine?
  • How is this given?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid before or after receiving this vaccine?
  • What other drugs will affect influenza virus injectable vaccine?
  • Where can I get more information?

What is influenza virus injectable vaccine (Fluzone)?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Influenza virus vaccine is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine.

Influenza virus vaccine works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Influenza virus vaccine will not treat an active infection that has already developed in the body.

Influenza virus vaccine is for use in adults and children who are at least 6 months old.

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual bleeding.

Less serious side effects may include:

  • low fever, chills;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine?

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine. This medication guide addresses only the injectable form of this vaccine.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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  • Fluarix
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