Vaccine Information: FLUARIX QUADRIVALENT 2019/2020 (Page 5 of 5)

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)].

15 REFERENCES

1.
Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res. 2004;103:133-138.
2.
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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

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.

FLQ:14PI

PRINCIPAL DISPLAY PANEL

NDC 58160-896-52

FLUARIX QUADRIVALENT

Influenza Vaccine

2019/2020 Formula

Rx only

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.

Rev. 4/19

497261

Fluarix Quadrivalent 2019-2020 10 count carton
(click image for full-size original)
FLUARIX QUADRIVALENT 2019/2020 influenza virus vaccine suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-896
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
OCTOXYNOL-9
.ALPHA.-TOCOPHEROL SUCCINATE, D-
POLYSORBATE 80
POTASSIUM CHLORIDE
SODIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-896-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-896-41)
1 NDC:58160-896-41 0.5 mL in 1 SYRINGE This package is contained within the CARTON (58160-896-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125127 07/02/2019 06/30/2020
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 03/2020 GlaxoSmithKline Biologicals SA

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