Afluria

DRUG DESCRIPTION

AFLURIA, Influenza Virus Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA (influenza virus vaccine) is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.

AFLURIA (influenza virus vaccine) is standardized according to USPHS requirements for the 2010-2011 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2010-2011 Northern Hemisphere influenza season: A/California/7/2009, NYMC X-181 (H1N1), A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and B/Brisbane/60/2008. A 0.25 mL dose contains 7.5 mcg HA of each of the same three influenza strains.

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate ( ? 10 ppm), ovalbumin ( ? 1 mcg), neomycin sulfate ( ? 0.2 picograms [pg]), polymyxin B ( ? 0.03 pg), and beta-propiolactone ( < 25 nanograms). A single 0.25 mL dose of AFLURIA contains half of these quantities.

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

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 Afluria »

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

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 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...

Read All Potential Precautions of Afluria »


Afluria 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 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.


Afluria 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 (Afluria)?
  • 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 (Afluria)?

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.

Related Drug Centers
  • Fluarix
  • Fluzone
  • Fluvirin
  • Afluria


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