Fluzone 2013-2014 Formula (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by prompting your body to produce its own protection (antibodies) against the disease. It is also called a “flu shot”.

There are many types of influenza viruses, but not all will cause problems each year. Before the influenza vaccine is made each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses are most likely to cause influenza infections that year. The antigens, which are substances that trigger protective antibodies, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine, but they are not required to do so.

It is necessary to receive an influenza vaccine injection each year because influenza infections are often caused by different types of viruses, and the protection from the vaccine lasts for less than a year.

Influenza is a viral infection of the throat, bronchial tubes, and lungs. It causes fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Additionally, adults and children who are weakened by other diseases or medical conditions, as well as people 50 years of age and older, even if they are healthy, may experience a much more serious illness that may require hospitalization. Each year, thousands of people die due to influenza infections.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including those 65 years of age and older).

This vaccine should only be given by or under the direct supervision of your doctor or another health care professional.

It is very important for your child to return to the doctor's office at the right time if a second dose of the vaccine is needed. Make sure to inform your doctor of any side effects that happen after you or your child get this vaccine.

This vaccine can cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of the hands, face, or mouth after getting the injection.

Children who have received a specific brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have developed a fever, and in some cases, a fever with seizures. Discuss any concerns with your doctor.

If you are very sick and have a high fever, you will likely need to wait until you are better before getting this vaccine.

The influenza virus vaccine may not protect everyone who gets it. It will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Flucelvax®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in those who are sensitive to latex. Inform your doctor if you or your child have a latex allergy before getting this vaccine.

Let your doctor know if you or your child are taking any medicine or treatment that weakens your immune system, including steroids, radiation, or cancer treatment. This vaccine may not work as well if you are also undergoing these treatments. Your doctor may still recommend getting the vaccine because it can provide some protection.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have had any unusual or allergic reaction to this vaccine or any other medications. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent in children. Safety and effectiveness have not been established.

There have not been enough studies on the effects of Fluvirin® in children younger than 4 years. Safety and effectiveness have not been established.

There have not been enough studies on the effects of Fluarix® in children younger than 3 years. Safety and effectiveness have not been established.

There have not been enough studies on the effects of Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent in children younger than 6 months. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of the influenza virus vaccine.

There have not been enough studies on the effects of Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent in older adults. Safety and effectiveness have not been established.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this vaccine while breastfeeding. Weigh the possible benefits against the potential risks before taking this vaccine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if there might be an interaction. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the following medicines while receiving this vaccine. The following interactions are significant but not necessarily all-inclusive.

Receiving this vaccine with the following medicine may increase the risk of side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or how often you take one or both medicines.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Allergy to eggs, egg products, or chicken proteins, history of—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. There may be an increased risk of bleeding at the injection site.

• Guillain-Barré syndrome (severe nerve and muscle problem), history of—Use with caution. This may cause symptoms of the condition to return.

• Illness with moderate or severe fever—You may need to wait until you feel better before receiving the vaccine.

• Immune system problems from a disease or medicine—The vaccine may not work as well in these patients.

• Kanamycin, neomycin, or polymyxin allergy, history of—Only certain brands of the influenza vaccine can be used. Discuss this with your doctor.

In 1976, some people who got the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), a condition that can lead to paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million vaccine recipients actually developed GBS, this number was 6 times higher than what was normally expected. Most people who got GBS fully recovered.

It is believed that the “swine flu” virus in the 1976 vaccine caused this issue, but this has not been proven. Since then, studies have indicated that the risk of getting GBS from an influenza vaccine is very low (one out of every million people).

While a medicine can provide benefits, it may also cause some unwanted effects. Not all side effects will occur, but if they do, they might need medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Bruising, hard lump, redness, or pain at the injection site
• cough
• diarrhea
• fever
• headache
• irritability
• large, flat, blue or purplish patches on the skin
• loss of appetite
• muscle aches
• redness of the eyes
• sneezing
• sore throat
• stuffy or runny nose
• vomiting

Less common

• Body aches or pain
• chest tightness
• chills
• difficulty breathing
• earache
• ear congestion
• loss of voice
• shivering
• swelling or puffiness of the face
• unusual tiredness or weakness

Rare

• Difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, lips, or tongue

Incidence not known

• Agitation
• sudden and severe back pain
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling sensations
• burning, dry, or itchy eyes
• chest pain
• clumsiness or unsteadiness
• confusion
• drowsiness
• dry throat
• fainting
• feeling hot
• increased sensitivity of the eyes to sunlight
• inflammation, rash, swelling, or tenderness at the injection site
• lightheadedness
• nosebleeds
• pain, redness, soreness, swelling, tenderness, or warmth on the skin
• pinpoint red spots on the skin
• redness of the face, neck, arms, and sometimes upper chest
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welts, or blisters
• stomach pain, soreness, or discomfort
• sweating
• trouble sleeping
• unusual bleeding or bruising
• voice changes
• weakness in the muscles of your face
• yellowing of the eyes or skin

Some side effects may happen that usually do not require medical attention. These side effects might go away as your body adjusts to the medicine. Your healthcare professional may also have suggestions to help prevent or lessen some of these side effects. Contact your healthcare professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

More common

• Difficulty moving
• joint pain
• muscle aches, cramping, pains, or stiffness
• swollen joints

Incidence not known

• Sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Afluria 2015-2016 Formula
• Fluarix Quadrivalent 2013-2014 Formula
• Fluarix Quadrivalent 2015-2016 Formula
• Flucelvax 2015-2016 Formula
• Flulaval Quadravalent 2013-2014 Season
• FluLaval Quadrivalent 2015-2016 Formula
• Fluvirin 2015-2016 Formula
• Fluzone 2013-2014 Formula
• Fluzone 2015-2016 Formula
• Fluzone High Dose 2015-2016 Formula
• Fluzone Intradermal Quadrivalent 2014-2015 Formula
• Fluzone Intradermal Quadrivalent 2015-2016 Formula

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you or your child this vaccine. It is given as a shot into one of your muscles or into your skin, usually in the upper arm.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of the vaccine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Fluzone® Intradermal Quadrivalent and Fluzone® Quadrivalent come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

• How and where is a flu shot injection given?
• Flu Vaccines and Egg Allergy: Which Are Safe?
• Which flu vaccines are available this year?
• Where Can I Get a Flu Shot Near Me?
• How well does the flu vaccine work?
• How can I get a flu vaccine without a needle?
• What is the difference between Flublok and Flublok Quadrivalent?

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