Flulaval

FluLaval is part of the drug class:

• Influenza vaccines

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.

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.

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.

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine. This medication guide addresses only the injectable form of this vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

Becoming infected with influenza is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

If your child misses a booster dose of this vaccine, call your doctor for instructions.

Preparation for Administration

Shake the multi-dose vial vigorously each time before withdrawing a dose of vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Between uses, return the multi-dose vial to the recommended storage conditions, between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Once entered, a multi-dose vial, and any residual contents, should be discarded after 28 days.

It is recommended that small syringes (0.5-mL or 1-mL) be used to minimize any product loss.

Recommended Dose and Schedule

Flulaval should be administered as a single 0.5-mL injection by the intramuscular route preferably in the region of the deltoid muscle of the upper arm.

The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. A needle length of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

Do not administer this product intravenously, intradermally or subcutaneously.

Do not administer Flulaval to anyone with known systemic hypersensitivity reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous administration of any influenza vaccination [see Description (11)].

An overdose of FluLaval is unlikely to occur.

FluLaval vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction to FluLaval after the first shot. Keep track of any and all side effects you have after receiving FluLaval. If you ever need to receive FluLaval in the future, you will need to tell your doctor if the previous shot caused any side effects. Get emergency medical help if you have any signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);

• a light-headed feeling, like you might pass out;

• high fever;

• seizure (convulsions); or

• unusual bleeding.

Less serious FluLaval side effects may include:

• low fever, chills;

• mild fussiness or crying;

• redness, bruising, pain, swelling, or a lump where the vaccine was injected;

• headache, tired feeling; or

• joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.