Vaccine Information: FLUAD QUADRIVALENT (Page 3 of 3)

15 REFERENCES

  1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998; 339(25): 1797-1802.

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

  3. Hobson D, Curry RL, Beare A, et. al. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972; 767-777.

16 HOW SUPPLIED/STORAGE AND HANDLING

FLUAD QUADRIVALENT is supplied in the product presentation listed below:

Presentation Carton NDC Number Components
Pre-Filled Syringe 70461-120-03 0.5 mL dose in a pre-filled syringe (needle not supplied), package of 10 syringes per carton [NDC 70461-120-04]

Store FLUAD QUADRIVALENT refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.

The syringe, syringe plunger stopper and tip cap are not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

  • Inform vaccine recipients of the potential benefits and risks of immunization with FLUAD QUADRIVALENT.
  • Educate vaccine recipients regarding the potential side effects. Clinicians should emphasize that (1) FLUAD QUADRIVALENT contains non-infectious particles and cannot cause influenza and (2) FLUAD QUADRIVALENT is intended to help provide protection against illness due to influenza viruses only.
  • Instruct vaccine recipients to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov. Provide vaccine recipients with the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
  • Inform vaccine recipients that annual vaccination is recommended.

FLUAD QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

MF59® is a trademark of Novartis AG.

Manufactured by: Seqirus Inc., 475 Green Oaks Parkway, Holly Springs, NC 27540, USA

Distributed by: Seqirus USA Inc., 25 Deforest Avenue, Summit, NJ 07901, USA

Tel: 1-855-358-8966

US License No. 2049

Principal Display Panel – Carton Label

NDC 70461-120-03

2020-2021 Formula

Influenza
Vaccine,
Adjuvanted

FLUAD®
QUADRIVALENT

FOR ADULTS

65 YEARS AND OLDER

For Intramuscular Injection only

Ten 0.5 mL, single-dose, pre-filled syringes

Rx Only

Seqirus™

Principal Display Panel – Carton Label
(click image for full-size original)

Principal Display Panel – Syringe Label

Influenza Vaccine,Adjuvanted

FLUAD ® QUADRIVALENT

2020 – 2021 Formula

NDC 70461-120-04

Principal Display Panel – Syringe Label
(click image for full-size original)
FLUAD QUADRIVALENT influenza vaccine, adjuvanted injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:70461-120
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
potassium chloride
potassium phosphate, monobasic
sodium phosphate, dibasic, dihydrate
magnesium chloride
calcium chloride
citric acid monohydrate
sorbitan trioleate
trisodium Citrate dihydrate
water
squalene
polysorbate 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70461-120-03 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (70461-120-04)
1 NDC:70461-120-04 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (70461-120-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125510 02/21/2020 07/31/2021
Labeler — Seqirus, Inc. (080102141)

Revised: 11/2020 Seqirus, Inc.

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