14.4 FLUARIX QUADRIVALENT Concomitant Administration with Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX)
In an open-label, randomized clinical trial (NCT 01954251) in adults aged 50 years and older, there was no evidence for interference in antibody responses (HI antibodies and anti-gE antibodies) to FLUARIX QUADRIVALENT or the coadministered vaccine, SHINGRIX [see Adverse Reactions (6.1)].
- Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res. 2004;103:133-138.
- Hobson D, Curry RL, Beare AS, et al. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb. 1972;70:767-777.
NDC 58160-896-41 Syringe in Package of 10: NDC 58160-896-52
Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.
Provide the following information to the vaccine recipient or guardian:
- Inform of the potential benefits and risks of immunization with FLUARIX QUADRIVALENT.
- Educate regarding potential side effects, emphasizing that: (1) FLUARIX QUADRIVALENT contains non‑infectious killed viruses and cannot cause influenza and (2) FLUARIX QUADRIVALENT is intended to provide protection against illness due to influenza viruses only and cannot provide protection against all respiratory illness.
- Encourage women exposed to FLUARIX QUADRIVALENT during pregnancy to enroll in the pregnancy registry [see Use in Specific Populations (8.1)].
- Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 prior to each immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
- Instruct that annual revaccination is recommended.
FLUARIX, HAVRIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
Manufactured by GlaxoSmithKline Biologicals , Dresden, Germany,
a branch of SmithKline Beecham Pharma GmbH & Co. KG , Munich, Germany
Licensed by GlaxoSmithKline Biologicals, Rixensart, Belgium, U.S. License 1617
Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709
©2020 GSK group of companies or its licensor.
PRINCIPAL DISPLAY PANEL
For 6 Months of Age and Older
10 Disposable Single-Dose Prefilled Tip-Lok Syringes each containing one 0.5 mL dose
TIP-LOK syringes are compatible with LUER-LOK needles
NEEDLES NOT INCLUDED
©2019 GSK group of companies or its licensor.
|FLUARIX QUADRIVALENT 2019/2020 influenza virus vaccine suspension|
|Labeler — GlaxoSmithKline Biologicals SA (372748392)|
Revised: 03/2020 GlaxoSmithKline Biologicals SA
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