Fluzone Pediatric

Generic Name: influenza virus vaccine (Intradermal route, Intramuscular route)

in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)

Commonly used brand name(s)

In the U.S.

• Afluria


• Fluarix


• Flulaval


• Fluvirin


• Fluzone


• Fluzone High-Dose


• Fluzone Pediatric

Available Dosage Forms:

• Suspension


• Solution

Therapeutic Class: Vaccine

Uses For Fluzone Pediatric

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

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

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 65 years of age and older).

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Fluzone Pediatric

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, or Fluzone® Intradermal in the pediatric population. Safety and efficacy have not been established.

Afluria® is not indicated in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluvirin® in children younger than 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluarix® in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® in children younger than 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of influenza virus vaccine in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® Intradermal in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

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

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

• Immune system problems from a disease or medicine—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. Talk with your doctor about this.

Proper Use of influenza virus vaccine

This section provides information on the proper use of a number of products that contain influenza virus vaccine. It may not be specific to Fluzone Pediatric. Please read with care.

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

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 this medicine, 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.

Precautions While Using Fluzone Pediatric

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

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 or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.

Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.

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

Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine 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®, Fluarix®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.

Make sure your doctor knows if you or your child are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.

Fluzone Pediatric Side Effects

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Cough


• diarrhea


• fever


• headache


• irritability


• loss of appetite


• muscle aches


• redness of the eyes


• sneezing


• sore throat


• stuffy or runny nose


• vomiting

Less common

• Body aches or pain


• chills


• difficulty with breathing


• earache


• ear congestion


• loss of voice


• shivering


• swelling or puffiness of the face


• tightness in the chest


• unusual tiredness or weakness

Rare

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• 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


• shortness of breath


• skin rash


• wheezing

Incidence not known

• Agitation


• back pain, sudden and severe


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, itching, lumps, numbness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site


• blindness


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning, dry, or itching eyes


• change in color vision


• change in walking and balance


• chest pain


• clumsiness or unsteadiness


• cold, clammy skin


• coma


• confusion


• dark urine


• discharge or excessive tearing


• drowsiness


• dryness of the throat


• eye pain


• fainting


• fast, weak pulse


• feeling hot


• feeling of constant movement of self or surroundings


• feeling unusually cold


• general body swelling


• general feeling of discomfort or illness


• hallucinations


• inability to move the arms and legs


• increased sensitivity of the eyes to sunlight


• irritation


• joint pain, stiffness, or swelling


• lack or loss of strength


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• mood or mental changes


• muscle weakness, sudden and progressing


• nausea


• nerve pain


• nosebleeds


• pain, redness, soreness, swelling, tenderness, or warmth on the skin


• painful knees and ankles


• paleness of the skin


• pinpoint red spots on the skin


• redness of the face, neck, arms, and occasionally, upper chest


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• seizures


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• sores, ulcers, or white spots in the mouth or on the lips


• stabbing pain


• stiff neck


• stomach pain, soreness, or discomfort


• sweating


• swelling of the face, hands, or feet


• swelling of the mouth or throat


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• trouble with sleeping


• troubled breathing or swallowing


• unusual bleeding or bruising


• voice changes


• weakness of the muscles in your face


• yellowing of the eyes or skin

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

Incidence not known

• Sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with 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.

See also: Fluzone Pediatric side effects (in more detail)

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More Fluzone Pediatric resources

• Fluzone Pediatric Side Effects (in more detail)
• Fluzone Pediatric Use in Pregnancy & Breastfeeding
• Fluzone Pediatric Drug Interactions
• Fluzone Pediatric Support Group
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