Afiuria 2015-2016 Formula

Afiuria 2015-2016 Formula is an influenza virus vaccine (also known as the “flu shot”) administered to prevent infection of the influenza virus. This vaccine works by forcing your body to create its own protection (antibodies) against the virus.

Influenza is a viral infection of the throat, bronchial tubes and lungs. This infection causes fever, chills, cough, headache, muscle aches and pains in your back, arms and legs. Additionally, adults and children weakened by other diseases and medical conditions, and people over 50 years of age (even if they are healthy) may get a much more serious illness that may require hospitalization.

There are a variety of influenza viruses, but not all cause problems in a given year. Before the influenza vaccine is produced each year, the World Health Orginization (WHO) and the U.S. and Canadian Public Health Services decide which influenza viruses will be most likely to cause influenza infections that year. The antigens (substances that cause protective antibodies to form) for these viruses are included in the influenza vaccine. Usually, but not always, the U.S. and Canada use the same influenza vaccine.

It is important to receive the influenza vaccine every year, as influenza viruses are normally caused by different viruses and the protection you receive from the vaccination lasts a year.

The best way to help prevent influenza is to get an influenza vaccination every year, normally in early November. Immunization against influenza is approved for infants 6 months of age and older, all children and all adults.

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

This product is available in the following forms:

• Suspension
• Solution

As with all medicines, the risks of using Afiuria 2015-2016 Formula must be compared to how much it will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric: No up-to-date studies have been performed on the relationship of age to the effects of Agriflu, Flucelvax, Flulaval, Fluzone High-Dose, Fluzone Intradermal or Fluzone Intradermal Quadrivalent in children. Safety and efficacy have not been established.

• • Afluria should not be used in children younger than 5 years of age. Safety and efficacy have not been established.
  • No up-to-date studies have 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.
  • No up-to-date studies have been performed on the relationship of age to the effects of Fluarix or Fluarix Quadrivalent in children younger than 3 years of age. Safety and efficacy have not been established.
  • No up-to-date studies have been performed on the relationship of age to the effects of Fluzone or Fluzone Quadrivalent in children younger than 6 months of age. Safety and efficacy have not been established.
• Geriatric Usage: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.No up-to-date studies have been performed on the relationship of age to the effects of Fluzone Intradermal or Fluzone Intradermal Quadrivalent in the geriatric population. Safety and efficacy have not been established.
• Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
• Breastfeeding: Studies in women suggest that this medication poses minimal risk to the infant when used while breastfeeding.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• • Rituximab
• Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems: Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially: 

• • Allergy to eggs, egg products or chicken proteins - Should not be normally used in patients with this condition.
  • Bleeding problems (i.e. hemophilia, thrombocytopenia) - Use with caution. May have an increased risk of bleeding at the injection site.
  • Guillain-Barré syndrome (severe nerve and muscle problem) - Use with caution. May cause the symptoms of this condition to return.
  • Illness with fever (moderate to severe) - You may need to wait until you feel better to receive this vaccine.
  • Immune system problems caused by disease or medication - May not work as well in patients with this condition.
  • Kanamycin, neomycin, or polymyxin allergy - Only certain brands of the influenza vaccine can be used. Talk with your doctor about which brand is right for you.

A nurse or other trained health professional will give you the Afiuria 2015-2016 Formula vaccine. This vaccine is given as a shot into one of your muscles (intramuscular) or into your skin (intradermal), normally in the shoulder area.

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

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

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

Fluzone INtradermal Quadrivalent and Fluzone Quadrivalent comes with a patient information leaflet. Be sure you read and understand this information. Be sure to ask your doctor if you have any questions.

It is important that your child returns to your doctor’s office at the right time if your child needs a second dose of the Afiuria 2015-2016 Formula vaccine. Be sure to inform your doctor of any side effects that may occur after receiving this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis is a life-threatening medical condition that requires immediate medical attention. Tell your doctor immediately if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you receive the injection.

Children who have received a certain brand of this vaccine (Afluria) have developed a fever and, in some cases, fever with seizure-like activity. Be sure to ask your doctor if you have concerns.

The tip cap of the pre-filled syringe for certain brands (Agriflu, Flucelvax, Fluvirin, Fluzone, Fluzone High-Dose) contains dry natural rubber (related to latex), which can cause allergic reactions in people who are sensitive to latex. Inform your doctor if you have a latex allergy before you receive this vaccine.

Make sure your doctor knows if you are using a medication or treatment that weakens your immune system (i.e. steroid, radiation, cancer treatment). This vaccine may not work as well if you are also using these medications. Your doctor may still want you to get the vaccine because it can still offer you some protection from the influenza virus.

Afiuria 2015-2016 Formula may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

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 breathing
• Earache
• Ear congestion
• Loss of voice
• Shivering
• Swelling or puffiness in the face
• Tightness in the chest
• Unusual fatigue or weakness

Rare

• Difficulty swallowing
• Dizziness
• Fast heartbeat (tachycardia)
• 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

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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