Medication Guide App

Fluzone High Dose

Generic Name: influenza virus vaccine (IN-floo-EN-za)
Brand Name: Fluzone High Dose

Fluzone High Dose is used for:

Protecting against certain strains of influenza (flu) in patients 65 years old and older.

Fluzone High Dose is a vaccine. It works by stimulating the body to produce antibodies against certain types of the flu virus, which helps your body fight the infection.

Do NOT use Fluzone High Dose if:

  • you are allergic to any ingredient in Fluzone High Dose, including egg proteins or to egg products
  • you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a prior flu vaccination
  • you are younger than 65 years old

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Fluzone High Dose:

Some medical conditions may interact with Fluzone High Dose. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including rubber or latex
  • if you have a fever, cold, respiratory tract infection, or other infection or recent illness
  • if you have a bleeding problem (eg, hemophilia) or low blood platelet levels
  • if you have immune system problems (eg, HIV, weakened immune system)
  • if you are receiving radiation treatment or chemotherapy, or you have recently received or will be receiving any other vaccines
  • if you have a history of Guillain-Barré syndrome or other nervous system problems

Some MEDICINES MAY INTERACT with Fluzone High Dose. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased
  • Corticosteroids (eg, prednisone) or other medicines that may weaken the immune system because they may decrease Fluzone High Dose's effectiveness. Ask your doctor if you are unsure if any of your medicines may weaken the immune system

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluzone High Dose may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluzone High Dose:

Use Fluzone High Dose as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Fluzone High Dose. Talk to your pharmacist if you have questions about this information.
  • Fluzone High Dose is usually given once a year in September, October, or November.
  • Fluzone High Dose is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Do not use Fluzone High Dose if it has been frozen, contains particles, is cloudy or discolored, or if the syringe is cracked or damaged.
  • If you miss a dose of Fluzone High Dose, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluzone High Dose.

Important safety information:

  • If you have a fever, cold, respiratory tract infection, or other illness, contact your doctor before you receive Fluzone High Dose. You may need to receive your injection at a later time.
  • Fluzone High Dose contains killed viruses. It cannot cause you to develop the flu.
  • Fluzone High Dose is not a cure for the flu. It must be given before you are exposed to the flu in order to be effective.
  • Fluzone High Dose is only effective for 1 flu season. You will need to receive the flu vaccine each year.
  • Fluzone High Dose is not effective against all strains of the flu virus. It may also not protect everyone who receives it.
  • Fluzone High Dose does not protect against other respiratory infections.
  • Tell your doctor if you have recently received or will be receiving any other vaccines.
  • The tip cap of Fluzone High Dose may contain natural rubber latex. If you have ever had an allergic reaction to latex, ask your doctor or pharmacist if your product has latex in it.
  • Fluzone High Dose is not approved for use in patients younger than 65 years old; safety and effectiveness in these patients have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluzone High Dose while you are pregnant. It is not known if Fluzone High Dose is found in breast milk. If you are or will be breast-feeding while you use Fluzone High Dose, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluzone High Dose:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

General body discomfort; headache; mild fever; mild pain, redness, swelling, or tenderness at the injection site; muscle aches; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; red, swollen, blistering, or peeling skin; seizures; severe or persistent headache or fever; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fluzone High Dose:

Fluzone High Dose is usually handled and stored by a health care provider. If you are using Fluzone High Dose at home, store Fluzone High Dose as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information:

  • If you have any questions about Fluzone High Dose, please talk with your doctor, pharmacist, or other health care provider.
  • Fluzone High Dose is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Fluzone High Dose or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fluzone High Dose. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fluzone High Dose. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fluzone High Dose.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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