Generic Name: influenza virus vaccine (Intramuscular route)
in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Vaccine
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 over, all children, and all adults (including 65 years of age and older).
Influenza virus vaccine may not protect all persons given the vaccine.
This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of Afluria®, Agriflu®, Fluarix®, Flulaval™, or Fluzone® High-Dose in the pediatric population. 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 below 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 Fluzone® in children below 6 months of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of influenza virus vaccine in the elderly.
|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.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
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:
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 this vaccine. This vaccine is given as a shot into one of your muscles.
Some children may need a second dose of the vaccine.
It is very important that your child return to your doctor’s office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.
It is very important to tell your doctor if you are allergic to rubber. The prefilled syringe of some brands of this vaccine contains dry natural latex rubber, which may cause an allergic reaction if you have a latex allergy.
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 have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.
Avoid contact with people who are sick or at increased risk of getting the infection after you receive this vaccine. Talk to your doctor about this if you have concerns.
Influenza virus vaccine may not protect all persons given the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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, the “swine flu” virus has not been used in influenza vaccines, and there has been no recurrence of GBS that was associated with influenza vaccinations.
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 immediately if any of the following side effects occur:More common
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
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.
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