Vaccine Information: Flublok Quadrivalent (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

Lot: XXXXXX

Exp.: XXXXXXX

Influenza Vaccine
FLUBLOK® Quadrivalent
2019/2020 Formula

No Preservative1 Dose (0.5 mL)

NDC 49281-719-88

Rx only

For Intramuscular Injection

Mfd by: Protein Sciences Corp.

CP-1901

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton

NDC 49281-719-10

Influenza Vaccine
FLUBLOK® Quadrivalent

2019 / 2020 Formula

10 prefilled syringes0.5 mL each

Rx only

For 18 Years of Age and Older

For Intramuscular Administration Only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton
(click image for full-size original)
FLUBLOK QUADRIVALENT influenza a virus a/brisbane/02/2018 (h1n1) recombinant hemagglutinin antigen, influenza a virus a/kansas/14/2017 (h3n2) recombinant hemagglutinin antigen, influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen, and influenza b virus b/maryland/15/2016 recombinant hemagglutinin antigen injection
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-719
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
SODIUM CHLORIDE
POLYSORBATE 20
OCTOXYNOL-9
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-719-10 10 SYRINGE in 1 CARTON contains a SYRINGE (49281-719-88)
1 NDC:49281-719-88 0.5 mL in 1 SYRINGE This package is contained within the CARTON (49281-719-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125285 07/01/2019
Labeler — Sanofi Pasteur Inc. (086723285)

Revised: 02/2020 Sanofi Pasteur Inc.

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