Flucelvax 2015-2016 Formula (Intradermal, Intramuscular)

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

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

You need to get an influenza vaccine injection every year, since influenza infections are usually caused by different types of viruses and the protection from the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. It leads to 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 could require hospital treatment. Each year, thousands of people die from influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination every year, typically 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 must be given only by or under the direct supervision of your doctor or another health care professional.

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

This vaccine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after 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. Talk to your doctor if you have concerns about this.

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

The influenza virus vaccine may not protect everyone who gets it. It will also 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 people sensitive to latex. Inform your doctor if you or your child have a latex allergy before receiving this vaccine.

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

In deciding to use a vaccine, you and your doctor will consider the risks of taking the vaccine against the benefits it may provide. For this vaccine, please think about the following:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent affect children. Safety and effectiveness have not been established.

Studies have not been done to determine how Fluvirin® affects children younger than 4 years old. Safety and effectiveness have not been established.

Studies have not been done to determine how Fluarix® affects children younger than 3 years old. Safety and effectiveness have not been established.

Studies have not been done to determine how Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent affect children younger than 6 months old. Safety and effectiveness have not been established.

Geriatric

So far, studies have not found any specific problems in older adults that would limit the usefulness of the influenza virus vaccine.

Studies have not been done to determine how Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent affect older adults. Safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose or take other precautions. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted due to their potential significance and may not include all possible interactions.

Receiving this vaccine with any of the following medicines may increase the risk of side effects, but using both may still be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtimes or with certain types of food because interactions might occur. Using alcohol or tobacco with some medicines can also cause interactions. Speak with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this vaccine works. Make sure to tell your doctor if you have any other medical problems, 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 a higher risk of bleeding at the injection site.

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

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

• Immune system problems from a disease or medicine—This vaccine may not work as well in patients with this condition.

• 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 disease that can lead to paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million people who received the vaccine developed GBS, this was 6 times higher than what was normally expected. Most people who got GBS recovered fully.

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

Along with its intended effects, a medicine can cause some unwanted effects. Not all side effects may happen, but if they do, they may 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 in 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 with breathing
• earache
• ear congestion
• loss of voice
• shivering
• swelling or puffiness of the face
• unusual tiredness or weakness

Rare

• Difficulty with 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
• back pain, sudden and severe
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• chest pain
• clumsiness or unsteadiness
• confusion
• drowsiness
• dryness of the 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 occasionally, 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 of the muscles in your face
• yellowing of the eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may offer ways to prevent or reduce some of these side effects. Consult your health care professional if any of the following side effects continue, are bothersome, or if you have questions about them:

More common

• Difficulty in 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 may 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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