Influenza Inactivated Trivalent Virus Vaccine (Types A and B) (Avian) Solution for injection

What is this medicine?

INFLUENZA VIRUS VACCINE (in floo EN zuh VAHY ruhs vak SEEN) helps to reduce the risk of getting influenza also known as the flu. The vaccine only helps protect you against some strains of the flu. This vaccine does not help to the reduce the risk of getting the pandemic H1N1 flu.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

How should I use this medicine?

This vaccine is for injection into a muscle. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• fever

• headache

• muscle aches and pains

• pain, tenderness, redness, or swelling at site where injected

• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What may interact with this medicine?

• chemotherapy or radiation therapy

• medicines that lower your immune system like etanercept, anakinra, infliximab, and adalimumab

• medicines that treat or prevent blood clots like warfarin

• steroid medicines like prednisone or cortisone

• theophylline

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What if I miss a dose?

This does not apply.

Where should I keep my medicine?

This vaccine is only given in a clinic, pharmacy, doctor's office, or other health care setting and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorder like hemophilia

• fever or infection

• Guillain-Barre syndrome or other neurological problems

• immune system problems

• infection with the human immunodeficiency virus (HIV) or AIDS

• low blood platelet counts

• multiple sclerosis

• an unusual or allergic reaction to influenza virus vaccine, eggs, chicken proteins, thimerosal, neomycin, polymyxin, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Report any side effects that do not go away within 3 days to your doctor or health care professional. Call your health care provider if any unusual symptoms occur within 6 weeks of receiving this vaccine.

You may still catch the flu, but the illness is not usually as bad. You cannot get the flu from the vaccine. The vaccine will not protect against colds or other illnesses that may cause fever. The vaccine is needed every year.