Vaccine Information: FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) (Page 5 of 5)

15 REFERENCES

  1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré 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.
  4. Centers for Disease Control and Prevention. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(33): 1128-1132

16 HOW SUPPLIED/STORAGE AND HANDLING

FLUCELVAX QUADRIVALENT product presentations are listed in Table 11 below:

Table 11: Flucelvax Product Presentations
Presentation Carton NDC Number Components
Pre-filled Syringe 70461-321-03 0.5 mL single dose pre-filled syringe, package of 10 syringes per carton [NDC 70461-321-04]
Multi-dose Vial 70461-421-10 5 mL multi-dose vial, individually packaged in a carton [NDC 70461-421-11]

Store this product refrigerated at 2°C to 8°C (36ºF to 46ºF). Between uses, return the multi-dose vial to the recommended storage conditions. Do not freeze. Protect from light. Do not use after the expiration date.

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients of the potential benefits and risks of immunization with FLUCELVAX QUADRIVALENT.

Educate vaccine recipients regarding the potential side effects; clinicians should emphasize that (1) FLUCELVAX QUADRIVALENT contains non-infectious particles and cannot cause influenza and (2) FLUCELVAX QUADRIVALENT is intended to provide protection against illness due to influenza viruses only and cannot provide protection against other respiratory illnesses.

Instruct vaccine recipients to report adverse reactions to their healthcare provider.

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.

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

Manufactured by: Seqirus Inc. Holly Springs, NC 27540, USA

US License No. 2049

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

1-855-358-8966

Principal Display Panel – 5 mL Carton Label

NDC 70461-421-10

5mL vial

Rx Only

Seqirus

For use in persons 6 months of age and older

For Intramuscular Injection Only

Influenza VaccineFLUCELVAX ®

QUADRIVALENT

2021 — 2022 Formula

Principal Display Panel – 5 mL Carton Label
(click image for full-size original)

Principal Display Panel – 5 mL Vial Label

NDC 70461-421-11

Influenza Vaccine FLUCELVAX ® QUADRIVALENT

2021 — 2022 Formula

5 mL Multi-dose Vial

Principal Display Panel – 5 mL Vial Label
(click image for full-size original)

Principal Display Panel – 0.5 mL Carton Label

NDC 70461-321-03

For use in persons 6 months of age and older

For Intramuscular Injection Only

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

Rx Only

Influenza VaccineFLUCELVAX ® QUADRIVALENT

2021 — 2022 Formula

Principal Display Panel – 0.5 mL Carton Label
(click image for full-size original)

Principal Display Panel – 0.5 mL Syringe Label

0.5 mL FOR IM USE ONLY Rx Only

For use in persons 6 months of age and older

NDC 70461-321-04 US License No. 2049

Influenza Vaccine FLUCELVAX ®
QUADRIVALENT2021 — 2022 Formula

PKVMCK-646

Principal Display Panel – 0.5 mL Syringe Label
(click image for full-size original)
FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:70461-321
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/DARWIN/7/2019 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE
SODIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70461-321-03 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (70461-321-04)
1 NDC:70461-321-04 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (70461-321-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125408 07/02/2020 07/31/2022
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:70461-421
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/DARWIN/7/2019 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE
SODIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
THIMEROSAL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70461-421-10 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (70461-421-11)
1 NDC:70461-421-11 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70461-421-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125408 07/02/2020 07/31/2022
Labeler — Seqirus Inc. (080102141)
Establishment
Name Address ID/FEI Operations
Seqirus Inc. 080102141 API MANUFACTURE, MANUFACTURE, LABEL, PACK, ANALYSIS

Revised: 10/2021 Seqirus Inc.

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