Influenza A virus vaccine, h1n1, live (Into the nose)

Brand Name(s)

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also using any other medicines given through your nose, or any medicine that weakens the immune system (such as steroids, cancer treatments, or radiation).
• Make sure you doctor knows if you are also using medicine to treat influenza virus infections (such as amantadine, oseltamivir, rimantadine, zanamivir, Flumadine®, Relenza®, Symmetrel®, or Tamiflu®). Wait at least 48 hours after your last dose of antiviral medicine before receiving this vaccine. It is best to wait at least 2 weeks after receiving this vaccine before using any antiviral medicines. Talk with your doctor if you are concerned about this.
• You should not receive any other vaccines at the same time that you receive the flu vaccine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have severe asthma or other breathing problems. Tell your doctor if you have HIV or AIDS, cancer, problems with your immune system, or a history of Guillain-Barré syndrome (a severe nerve and muscle problem).
• 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 with breathing after you receive the vaccine.
• Avoid people who are sick or have infections.
• 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 medicine will not treat flu symptoms if you already have 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
• Ear pain or discharge.
• Fever, chills, cough, sore throat, and body aches.
• Trouble with breathing.
• Unusual tiredness or weakness.

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

• Drowsiness.
• Headache, or pain around the eyes and cheekbones.
• Irritability.
• Loss of appetite.
• Muscle pain.
• Sneezing, or stuffy or runny nose
• Stomach pain.

Introduction

Influenza A Virus Vaccine, H1N1, Live (in-floo-EN-za AY VYE-rus VAX-een, H1N1, lyve)

Keeps you from getting sick with an influenza A (H1N1) 2009 virus ("catching the flu").

How to Use This Medicine

Spray

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• A nurse or other trained health professional will give you this medicine.
• This medicine is for use 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 medicine, 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.

If a dose is missed:

• Most people need only one dose of this medicine.
• If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment for the second dose, make another appointment as close to that date as possible.

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