Influenza virus vaccine recombinant (intramuscular route)


      Brand Name

      US Brand Name

      Flublok

      Flublok 2015-2016 Formula

      Flublok 2016-2017 Formula

      Flublok 2017-2018 Formula

      Flublok Quadrivalent 2016-2017 Formula

      Flublok Quadrivalent 2017-2018 Formula


      Description

      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".

      Influenza is a virus infection of the throat, bronchial tubes, and lungs. It 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 older, 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.

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

      This product is available in the following dosage forms:

      • Solution

      Before Using

      In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 influenza virus vaccine in children younger than 3 years 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.

      Breastfeeding

      There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

      Drug Interactions

      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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

      Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Atidarsagene Autotemcel
      • Elivaldogene Autotemcel
      • Teplizumab-mzwv
      • Ublituximab-xiiy
      • Warfarin

      Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Carbamazepine

      Other Interactions

      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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

      • Guillain-Barré syndrome (severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.
      • Immune system problems—This condition may decrease the useful effects of the vaccine.

      Proper Use

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

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


      Precautions

      Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

      This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

      This vaccine may not protect everyone who receives it. This vaccine will not treat flu symptoms if you already have the virus.

      Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

      Tell your doctor if you are using a medicine or treatment that weakens your immune system.


      Side Effects

      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

      • Headache
      • muscle pain
      • unusual tiredness or weakness

      Less common

      • Chills
      • joint pain

      Rare

      • Fever

      Incidence not known

      • Chest tightness
      • cough
      • difficulty swallowing
      • dizziness
      • fainting
      • fast heartbeat
      • hives, itching, skin rash
      • inability to move the arms and legs
      • puffiness or swelling around the eyes, face, lips, or tongue
      • sudden numbness and weakness in the arms and legs
      • weakness of the muscles in your face

      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:

      More common

      • Nausea
      • pain, redness, or swelling at the injection site

      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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