FluLaval

FluLaval is an inactivated vaccine used to prevent influenza ("the flu") in patients 6 months of age and older. This vaccine works by causing your body to produce antibodies against 4 types of influenza viruses. It is important to note that FluLaval contains killed viruses and cannot cause "the flu".

FluLaval is available in an injectable form to be given directly into the muscle by a healthcare professional. You can get your influenza vaccine at your doctor's office, and often you can find them available at your local health department, pharmacy, urgent care clinic, school, college health center, or work.

Flu vaccines, like FluLaval, are designed to protect against the main flu viruses that research suggests will be the most common during the upcoming season. For this reason, and because the body’s immunity to influenza viruses declines over time, it is necessary to receive an influenza vaccine injection each year.

Common FluLaval side effects include pain at the injection site, muscle aches, headache, and fatigue.

FluLaval is a vaccine used to prevent influenza. It is approved for use in persons 6 months of age and older. 

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported with FluLaval. See the "FluLaval Precautions" section.

Common side effects of FluLaval include the following:

• soreness, redness, or swelling where the shot was given
• hoarseness
• sore, red, or itchy eyes
• cough
• fever
• muscle aches
• headache
• itching
• fatigue
• drowsiness
• loss of appetite

This is not a complete list of FluLaval side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• corticosteroids
• medicines that suppress your immune system
• other vaccinations

This is not a complete list of FluLaval drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with FluLaval including the following:

• Hives or a bad rash
• Trouble breathing
• Swelling of the face, tongue, or throat
• Guillain-Barre Syndrome
• Brief fainting spells can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting and injuries caused by a fall. Tell the person giving you the vaccine if you feel dizzy, or have vision changes or ringing in the ears.
• Severe shoulder pain and reduced range of motion in the arm where the shot was given can happen, very rarely, after a vaccination.
• Severe allergic reactions from a vaccine are very rare. If one were to occur, it would usually be within a few minutes to a few hours after the vaccination.
• Young children who get the flu vaccine and the pneumococcal vaccine at the same time may be at increased risk for seizures caused by fever. Ask your doctor for more information.
• As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

Do not get FluLaval if you:

• have known severe allergic reactions (anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine
• ever had Guillain-Barre Syndrome (a severe, paralyzing illness, also called GBS). Some people with a history of GBS should not get this vaccine.
• are not feeling well. It is usually okay to get flu vaccine when you have a mild illness, but you might be advised to wait until you feel better. 

Some inactivated flu vaccines contain a very small amount of a mercury-based preservative called thimerosal. Studies have not shown thimerosal in vaccines to be harmful, but flu vaccines that do not contain thimerosal are available.

Medications and vaccines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of FluLaval, there are no specific foods that you must exclude from your diet when receiving this vaccine.

Before receiving FluLaval, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to FluLaval or to any component of the vaccine including egg protein
• have had Guillain-Barre Syndrome
• have a weakened immune system 
• have problems with your heart, kidneys, or lungs
• have diabetes
• are pregnant or nursing
• have a bleeding disorder or are on anticoagulant therapy

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

FluLaval falls into category B. There are no well-done studies that have been done in humans with FluLaval. FluLaval should be given to a pregnant woman only if clearly needed. 

A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not taken medicine duringpregnancy.

A pregnancy exposure registry has been set up to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Flulaval during pregnancy. Women who receive Flulaval during pregnancy are encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether FluLaval is excreted in human milk. Because some viruses are excreted in human milk, caution should be exercised when FluLaval is administered to a nursing woman.

Receive FluLaval exactly as prescribed.

It is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional, and should be administered every year.

• The preferred site for intramuscular injection for persons aged 12 months and older is the deltoid muscle of the upper arm.
• The preferred site for intramuscular injection for children aged 6 through 11 months is the thigh. 

FluLaval is an inactivated vaccine that cannot cause influenza but stimulates the immune system to produce antibodies that protect against influenza. The full effect of the vaccine is generally achieved approximately 2 weeks after vaccination, and protection lasts through the flu season.

Use this vaccination exactly as prescribed by your healthcare provider.

The dose your doctor recommends will be based on age and if the influenza vaccine was given in a previous season:

A single dose of FluLaval is 0.5ml. The dose and schedule for FluLaval is as follows:

• 6 months through 8 years: 
  • not previously vaccinated with influenza vaccine: two doses (0.5ml each) at least 4 weeks apart
  • vaccinated with influenza vaccine in a previous season: one or two doses (0.5ml each)
• Age 9 years and older: one dose

FluLaval is administered by a healthcare provider in a medical setting, therefore it is unlikely that an overdose will occur. However, if over dose is suspected, seek emergency medical attention.