Fluzone quad package insert

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      Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. Page 4 of 40 . 3 DOSAGE FORMS AND STRENGTHS. Fluzone Quadrivalent is a suspension for injection.


    • [PDF File]Fluzone High Dose - Sanofi

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      The safety of FLUZONE® High-Dose compared to FLUZONE® was evaluated in 3,833 adults (65 year s of age) in a clinical trial conducted in the United States. (3) The most common injection site reaction reported in participants ®receiving either FLUZONE High-Dose or FLUZONE® was pain, while myalgia was the most frequent systemic reaction. Onset ...


    • [PDF File]Influenza Vaccine Products for the 2021-2022 Influenza Season

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      • Fluzone 0.25 mL or 0.5 mL 4. Afluria is approved by the Food and Drug Administration for intramuscular administration with the PharmaJet Stratis Needle-Free Injection System for persons age 18 through 64 years. Influenza Vaccine Products for the 2021–2022 Influenza Season


    • [PDF File][Product Monograph Template - Standard]

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      Each carton contains 10 single dose syringes in two trays, and one package insert. Multi-dose Vial Multi-dose type 1 glass vial. The multi-dose vial is closed with a stopper and sealed with an aluminium crimp and plastic Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients IM Suspension for IM injection


    • [PDF File]Package leaflet: Information for the user Quadrivalent ...

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      Package leaflet: Information for the user Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated) Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.


    • [PDF File]PACKAGE LEAFLET - Electronic Medicines Compendium

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      Package leaflet: Information for the user Fluad 2020/2021, suspension for Injection in Pre-filled Syringe . Influenza Vaccine Surface Antigen, Inactivated, Adjuvanted with MF59C.1 . Read all of this leaflet carefully before you receive this vaccine because it contains important information for you. - Keep this leaflet. You may need to read it ...



    • [PDF File]Package Insert - Flublok Quadrivalent

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      Package Insert BLA STN 125285 Flublok Quadrivalent PI (V1.3), 2016 Page 1 of 18 HIGHLIGHTS OF PRESCRIBING INFORMATION weeks of receipt of a prior influenza vaccine, the . These highlights do not include all the information needed to use Flublok ® Quadrivalent safely and effectively. See full prescribing information for Flublok Quadrivalent.


    • [PDF File]2019-2020 Influenza (Flu) Resources for Health Care ...

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      Drug Names . Payment Allowance Effective Dates . 90653 . Seqirus Inc ; Fluad (2019/2020) $59.530 : 08/01/2019 – 07/31/2020 90662 . Sanofi Pasteur Fluzone High-Dose


    • [PDF File]Package Insert for FluMist® Quadrivalent (Influenza ...

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      The 1976 swine influenza vaccine (inactivated) was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for causal relation of GBS with other influenza vaccines is inconclusive; if an


    • [PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do ...

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      Fluzone Quadrivalent is supplied in 4 presentations: 1) Prefilled single-dose syringe (pink syringe plunger rod), 0.25 mL, for persons 6 months through 35 months of age. 2) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older.


    • [PDF File]FLUZONE Quadrivalent

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      FLUZONE® Quadrivalent [Influenza Virus Vaccine Quadrivalent Types A and B (Split Virion)] for intramuscular use, is a sterile suspension containing four strains of influenza viruses propagated in embryonated chicken eggs, inactivated with formaldehyde, concentrated and


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      For intramuscular use only . 2.1 Dose and Schedule Fluzone High-Dose Quadrivalent should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 years of age and older.


    • [PDF File]Vaccine Excipient Summary

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      package insert (PI) as being contained in the final formulation of each vaccine. Substances used in the manufacture of a vaccine but not listed as contained in the final product (e.g., culture media) can be found in each PI, but are not shown on this table. Each PI, which can be found on the FDA’s website (see below)


    • [PDF File]FLUCELVAX QUADRIVALENT - Seqirus Inc. 1.14.1.3 US Package ...

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      FLUCELVAX QUADRIVALENT - Seqirus Inc. 1.14.1.3 US Package Insert 07/2018 (Revision 2) Page 5 of 17 The most common (≥10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), ...


    • [PDF File]FluLaval Package Insert - Henry Schein

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      US-licensed trivalent, inactivated influenza virus vaccine (FLUZONE) (N = 279). The Canadian study compared 4 vaccine groups: FLULAVAL, a similar investigational formulation of FLULAVAL with reduced thimerosal, and 2 Canadian-licensed trivalent influenza vaccines. Among recipients of FLULAVAL, 56.6% were women; 92.4% of subjects were white, 3


    • [PDF File]Vaccine Excipients

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      Amino Acid Medium Nutrient Gardasil 9 HPV Amount not specified in Package Insert Amino Acid Medium Nutrient Havrix HepA Amino acid supplement - 0.3% w/v ... Formaldehyde Inactivating Agent FluZone Quad Influenza ≤100 mcg Formaldehyde Inactivating Agent Havrix HepA ≤0.1 mg formalin Formaldehyde Inactivating Agent Hiberix Hib


    • [PDF File]Latex in Vaccine Packaging

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      Appendix B Appendix B-11 B Appendix B_Web.indd 11 11/1/2021 10:27:00 AM Latex in Vaccine Packaging “Immediate-type allergic reactions due to latex allergy have been described after vaccination, but such reactions


    • [PDF File]FLUARIX QUADRIVALENT (Influenza Vaccine) injectables ...

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      1 . HIGHLIGHTS OF PRESCRIBING INFORMATION . These highlights do not include all the information needed to use FLUARIX QUADRIVALENT prior influenza vaccine, the decision to give safely and effectively.


    • [PDF File]Fluzone Package Insert - Henry Schein

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      Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3).]


    • [PDF File]2021-2022 Influenza Vaccination Recommendations and ...

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      Influenza Vaccine Package Insert Language Concerning Previous Allergic Reactions to Influenza Vaccines Egg-based IIV4s and LAIV4: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine.


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