Pronunciation:

in-floo-EN-za AY VYE-rus VAX-een, H1N1, in-AK-ti-vay-ted

Uses of This Medicine:

Influenza virus vaccine, H1N1 is used to prevent infection caused by the influenza A (H1N1) 2009 virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a "flu shot".

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

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, H1N1 in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in children below 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in children below 6 months of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of influenza virus vaccine, H1N1 in the elderly.

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 eggs, egg products, or chicken products, history of—Should not be used in patients with these conditions.

• Guillain-Barré syndrome, history of—May cause the symptoms of this condition to return.

• 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 or your child this vaccine. This vaccine is given as a shot into one of your muscles.

Some children who have not received the vaccine before should receive 2 doses at least 1 month apart.

Precautions While Using This Medicine:

It is very important that your child 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 or your child receive this vaccine.

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

Avoid contact with people who are sick or at increased risk of getting the infection after you receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza virus vaccine, H1N1 may not protect all persons given the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Difficulty with moving

fever

general feeling of discomfort or illness

joint pain

muscle aching or cramping

muscle pains or stiffness

swollen joints

unusual tiredness or weakness

Incidence not known

Back pain, sudden and severe

black, tarry stools

bleeding gums

blindness

blistering, peeling, or loosening of the skin

blood in the urine or stools

blue-yellow color blindness

blurred vision

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, tingling, numbness or pain in the hands, arms, feet, or legs

chest pain

chills

congestion

convulsions

cough

decreased vision

diarrhea

difficult or labored breathing

difficulty with swallowing

dizziness

dryness or soreness of the throat

eye pain

fainting

fast heartbeat

feeling faint, dizzy, or lightheadedness

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

hives

hoarseness

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle weakness, sudden and progressing

pain in the arms or legs

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

redness of the face, neck, arms, and occasionally, upper chest

redness, soreness, or itching skin

runny nose

sensation of pins and needles

shortness of breath

skin rash

sneezing

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sores, welting, or blisters

stabbing pain

stuffy nose

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tender, swollen glands in the neck

tightness in the chest

trouble with swallowing

unusual bleeding or bruising

voice changes

weakness of the muscles in your face

wheezing

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

Incidence not known

Lack or loss of strength

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.