Pronunciation:

in-floo-EN-za AY VYE-rus VAX-een, H1N1, lyve

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Influenza virus vaccine, H1N1 is used to prevent an 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.

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 nasal influenza virus vaccine, H1N1 in children up to 2 years of age. Safety and efficacy have not been established.

Children under 5 years of age with one or more episodes of wheezing in the past year should not receive this vaccine.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of nasal influenza virus vaccine, H1N1 in adults 50 years of age and older. 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 eggs, egg products, or gelatin, history of—Should not be used in patients with these conditions.

• Asthma, severe or
• Wheezing—Use with caution. May make these conditions worse.

• 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 nasal spray.

Use the nasal spray only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

Before using the nasal spray, gently blow your nose to clear the nostrils.

Children 2 to 9 years of age who have not received the nasal 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 your child receives this vaccine.

This vaccine should not be given to children and teenagers (2 to 17 years of age) who are also using aspirin or any medicine that contains aspirin (e.g., Aggrenox®, Soma® Compound, Norgesic®, and many cold medicines).

Children under 2 years of age are usually not given the flu vaccine nasal spray. Young children who need the flu vaccine are usually given the flu vaccine injection (a shot).

This vaccine should not be given to pregnant women.

The nasal influenza virus vaccine, H1N1 contains a live virus. 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.

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 receive the vaccine.

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

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

Chills

cough

fever

runny nose

sore throat

stuffy nose

wheezing

Less common

Headache

pain or tenderness around the eyes and cheekbones

shortness of breath or troubled breathing

tightness of the chest

Incidence not known

Bloody nose

difficulty with swallowing

dizziness

fast heartbeat

hives

inability to move the arms and legs

itching

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

skin rash

sudden numbness and weakness in the arms and legs

unusual tiredness or weakness

weakness of the muscles in your face

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

Abdominal or stomach pain

decreased appetite

irritability

muscle aches

tiredness or weakness

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

Earache

redness or swelling in the ear

Incidence not known

Diarrhea

nausea

vomiting

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.