Influenza A (H1N1) 2009 monovalent vaccine Suspension for injection

What is this medicine?

H1N1 INFLUENZA (SWINE FLU) VACCINE is a vaccine to protect from an infection with the pandemic H1N1 flu, also known as the swine flu. The vaccine only helps protect you against this one strain of the flu. This vaccine does not help to the reduce the risk of getting other types of flu. You may also need to get the seasonal influenza virus vaccine.

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

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

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

• Guillain-Barre syndrome
• immune system problems
• an unusual or allergic reaction to influenza vaccine, eggs, neomycin, polymyxin, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

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. Special care may be needed. While this drug may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Overdosage: If you think you've 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 if I miss a dose?

If needed, keep appointments for follow-up (booster) doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• anakinra
• medicines for organ transplant
• medicines to treat cancer
• other vaccines
• rilonacept
• steroid medicines like prednisone or cortisone
• tumor necrosis factor (TNF) modifiers like adalimumab, etanercept, infliximab, golimumab, or certolizumab

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 should I watch for while using this medicine?

Report any side effects to your doctor right away.

This vaccine lowers your risk of getting the pandemic H1N1 flu. You can get a milder H1N1 flu infection if you are around others with this flu. This flu vaccine will not protect against colds or other illnesses including other flu viruses. You may also need the seasonal influenza vaccine.

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
• breathing problems
• muscle weakness
• unusual drooping or paralysis of face

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

• chills
• cough
• headache
• muscle aches and pains
• runny or stuffy nose
• sore throat
• stomach upset
• tiredness

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.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.