Influenza a virus vaccine, h5n1, adjuvanted (Intramuscular)

Influenza A virus vaccine, H5N1, adjuvanted is used to prevent an infection from the H5N1 influenza virus subtype. The vaccine helps your body create its own defense (antibodies) against the disease.

This vaccine should only be given by or under the supervision of your doctor or another health care professional.

It is very important that you or your child go back to your doctor's office at the right time for the second dose. Make sure to inform your doctor about any side effects that happen after you receive this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Tell your doctor right away if you or your child experience a rash, itching, swelling of the tongue or throat, or trouble breathing after getting the injection.

Audenz™ may not protect everyone who gets the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Let your doctor know if you are taking any medicine or treatment that weakens your immune system, like a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are using these medicines. However, your doctor may still recommend that you get the vaccine because it can provide some protection.

In deciding to use a vaccine, you and your doctor must consider the risks of taking the vaccine against the benefits it provides. For this vaccine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on the effects of Audenz™ in children younger than 6 months old. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of Audenz™.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause symptoms of this condition to return.

• Immune system problems from a disease or medicine—May not work as well in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Fever

Incidence not known

• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• General feeling of discomfort or illness
• Hives, itching, or skin rash
• Inability to move the arms and legs
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Sudden numbness and weakness in the arms and legs
• Tightness in the chest
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty in moving
• Headache
• Irritability, sleepiness, tenderness, loss of appetite (in children)
• Joint pain
• Muscle pain or stiffness
• Nausea
• Redness, pain, or swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Audenz

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles, usually in the upper arm. The shot could be given in the thighs for babies 6 to 11 months.

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.