An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Partnerships: Enhancing Science Through Collaborations With FDA, The History of FDA's Fight for Consumer Protection and Public Health. Flublok Quadrivalent vaccine is given to people 18 years of age and older. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 2 Sep 2020), Cerner Multum™ (updated 1 Sep 2020), Wolters Kluwer™ (updated 31 Aug 2020) and others. Do not administer this product intravenously, intradermally, or subcutaneously. Fluzone Quadrivalent Southern Hemisphere should not be combined through reconstitution or mixed with any other vaccine. If any of these defects or conditions exist, Fluzone Quadrivalent Southern Hemisphere should not be administered. February 4, 2019 Approval Letter - Fluzone Quadrivalent -Sourthern Hemisphere (PDF - 33KB) To include the 2019 Southern Hemisphere FluzoneQuadrivalent formulation and associated labeling revisions. Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Let us know. Other brands: Fluzone, Afluria, Fluad, Fluzone High-Dose, ... +13 more, Fluzone, Tamiflu, Afluria, Fluad, oseltamivir, Fluzone High-Dose. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. Fluzone Quadrivalent Dosage and Administration Product Information. The site is secure. STN: BL 103914Proper Name: Influenza VaccineTradename: Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern HemisphereManufacturer: Sanofi Pasteur Inc.Indication: An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Package Insert - Fluzone High-Dose Quadrivalent, Package Insert - Fluzone Intradermal Quadrivalent, Package Insert - Fluzone Quadrivalent Southern Hemisphere, July 2, 2020 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent, April 1, 2020 Approval Letter - Fluzone Quadrivalent, February 7, 2020 Approval Letter - Fluzone Quadrivalent Southern Hemisphere, November 4, 2019 Approval Letter - Fluzone High-Dose Quadrivalent, July 2, 2019 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose, February 4, 2019 Approval Letter - Fluzone Quadrivalent Southern Hemisphere, January 23, 2019 Approval Letter - Fluzone Quadrivalent, January 18, 2019 Summary Basis of Regulatory Action, Statistical Review and Evaluation - Fluzone Quadrivalent, June 29, 2018 Approval Letter- Fluzone-Quadrivalent, January 10, 2018 Approval Letter - Fluzone, February 9, 2017 Approval Letter - Fluzone Southern Hemisphere Formulation, Supporting Documents older than three years - Fluzone Quadrivalent, Fluzone, Fluzone High-Dose and Fluzone Intradermal. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The .gov means it’s official.Federal government websites often end in .gov or .mil.
The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. one Southern Hemisphere formulation is licensed by FDA (Fluzone Quadrivalent Southern Hemisphere, Sanofi Pasteur), and it is generally not commercially available in the U.S. Generic name: INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15ug in 0.5mL, INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15ug in 0.5mL, INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 15ug in 0.5mL, INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) 15ug in 0.5mLDosage form: suspension for intramuscular injection. The dose and schedule for Fluzone Quadrivalent Southern Hemisphere are presented in Table 1. You have bookmarked a page that has moved. The site is secure. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Fluzone ® Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.. Fluzone Quadrivalent Southern Hemisphere is approved for use in persons 6 months of age and older. The .gov means it’s official.Federal government websites often end in .gov or .mil. Select one or more newsletters to continue. The dose and schedule for Fluzone Quadrivalent Southern Hemisphere are presented in Table 1. We’re sorry. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Or try one of these helpful links to FDA topics: Are you sure this is the right web address? Available for Android and iOS devices. Flublok Quadrivalent, Fluzone Quadrivalent, and Fluzone High-Dose vaccines are given to help prevent influenza disease caused by influenza A and B strains contained in each vaccine. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. Could the Flu Shot Lower Your Risk for Alzheimer's? Before sharing sensitive information, make sure you're on a federal government site.
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