Fluad 2017-2018 Formula (Intramuscular)

Influenza virus vaccine, adjuvanted is used to prevent infection caused by influenza virus subtypes A and types B in patients who are 65 years old and older. The vaccine helps your body create its own protection (antibodies) against the disease.

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

Be sure to inform your doctor about any side effects that happen after you get this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Contact your doctor right away if you experience a rash, itching, swelling of the tongue and throat, or difficulty breathing after the injection.

Fluad® Quadrivalent may not protect everyone who gets the vaccine. Additionally, this vaccine will not treat flu symptoms if you already have the virus.

Let your doctor know if you are taking any medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as effectively if you are also using these medicines. However, your doctor may still recommend that you get the vaccine because it can provide some protection.

In deciding to use a vaccine, you and your doctor need to think about the risks of the vaccine compared to the benefits. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, such as 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 age affects the use of Fluad® Quadrivalent in children. Its safety and effectiveness for this age group have not been established.

Geriatric

Studies conducted so far have not found specific problems in elderly patients that would limit the use of Fluad® Quadrivalent.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. If there is a potential interaction, your doctor may adjust the dose or take other precautions. Inform 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 taken near the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

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

Along with its necessary effects, Fluad 2017-2018 Formula (Intramuscular) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

Less common

• Fever or chills

Incidence not known

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Cough
• Difficulty swallowing
• Dizziness
• Fainting
• Fast heartbeat
• Hives, itching, or rash
• Inability to move the arms and legs
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Sudden numbness and weakness in the arms and legs
• Tightness in the chest
• Unusual bleeding or bruising
• Unusual tiredness or weakness

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 Fluad. Additionally, your health care professional may be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Headache
• Joint or muscle pain
• Pain at the injection site

Less common

• Diarrhea
• Loss of appetite
• Nausea or vomiting
• Redness or swelling at the injection site

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your health care 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.

• Fluad
• Fluad 2017-2018 Formula

Available Dosage Forms:

• Emulsion

Therapeutic Class: Vaccine

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

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