Influenza A Virus Vaccine, H5N1, Adjuvanted (in-floo-EN-za VYE-rus VAX-een, H5N1, AD-joo-van-ted)

Helps prevent infection with influenza (flu) virus.

Brand Name(s):

Audenz

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• The vaccine is given as a shot into a muscle, usually in the upper arm. The shot could be given in the thighs for babies 6 to 11 months.
• A nurse or other health provider will give you this medicine.
• You will need two doses of this vaccine for it to work properly. Make sure you follow your doctor's instructions on when you or your child should come back for the second dose. The second dose is usually given 21 days after the first dose.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you are using a medicine or treatment that weakens your immune system, including a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. However, your doctor may still want you to get the vaccine because it can give you some protection.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding or if you have a weak immune system.
• Tell your doctor if you ever had an unusual reaction to a flu shot, including Guillain-Barré syndrome.
• This flu vaccine may not protect everyone who receives it. This vaccine will not treat flu symptoms if you have already been infected with the virus.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever
• Severe muscle weakness

If you notice these less serious side effects, talk with your doctor:

• Headache, joint or muscle pain, tiredness
• Irritability, sleepiness, tenderness, loss of appetite (in children)
• Redness, pain, swelling, soreness, or a lump where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088