Pronunciation:

in-floo-EN-za AY VYE-rus VAX-een, H5N1, in-AK-ti-vay-ted

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Influenza virus vaccine, H5N1 is used to prevent an infection caused by the H5N1 influenza virus subtype. The vaccine works by causing your body to produce its own protection (antibodies) against the disease . It is also known as avian influenza vaccine or avian flu shot.

This vaccine is only available from public health officials, and will be used to prevent a major outbreak of avian flu .

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H5N1 in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies on the relationship of age to the effects of influenza virus vaccine, H5N1 have not been performed in the geriatric population. Safety and efficacy have not been established .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to chicken or egg products, history of—Use with caution. This vaccine contains small amounts of chicken and egg proteins .

• Guillain Barré syndrome, history of—Use with caution. This vaccine may cause a recurrence of the symptoms of the condition .

• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have weak immune system .

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles .

You will need two doses of this vaccine for it to work properly. Make sure you follow your doctor's instructions on when you should come back for the second dose. The second dose is usually given 28 days after the first dose .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

It is very important that you return to your doctor's office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you receive this vaccine .

This vaccine will not treat flu symptoms if you already have the virus .

Side Effects of This Medicine:

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

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

More common

Fever

Less common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

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 or are bothersome or if you have any questions about them:

More common

Nausea

pain, redness, swelling, or tenderness at injection site

Less common

Diarrhea

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.