Vaccine Information: Flulaval Quadrivalent 2019/2020 (Page 4 of 4)

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

FLULAVAL QUADRIVALENT is available in 0.5-mL single-dose disposable prefilled TIP-LOK syringes (packaged without needles) and in 5-mL multi-dose vials containing 10 doses (0.5-mL each).

NDC 19515-906-41 Syringe in Package of 10: NDC 19515-906-52

NDC 19515-897-01 Multi-Dose Vial (containing 10 doses) in Package of 1: NDC 19515-897-11

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. Once entered, a multi-dose vial should be discarded after 28 days.

17 PATIENT COUNSELING INFORMATION

Provide the following information to the vaccine recipient or guardian:

Inform of the potential benefits and risks of immunization with FLULAVAL QUADRIVALENT.
Educate regarding potential side effects, emphasizing that (1) FLULAVAL QUADRIVALENT contains non-infectious killed viruses and cannot cause influenza, and (2) FLULAVAL 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 FLULAVAL 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, FLULAVAL, HAVRIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to the respective owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured by ID Biomedical Corporation of Quebec

Quebec City, QC, Canada, U.S. License 1739

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

©2020 GSK group of companies or its licensor.

FVQ: 9PI

PRINICIPAL DISPLAY PANEL

NDC 19515-897-11

Influenza Vaccine

FLULAVAL QUADRIVALENT

2019/2020 Formula

Rx only

For 6 Months of Age and Older

5 mL Multi-Dose Vial (10 doses)

Dose: 0.5 mL

gsk

©2019 GSK group of companies or its licensor.

Made in Canada

Rev. 3/19

497090

Flulaval Quadrivalent 2019-2020 5 mL carton
(click image for full-size original)

PRINICIPAL DISPLAY PANEL

NDC 19515-906-52

Influenza Vaccine

FLULAVAL QUADRIVALENT

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

gsk

Made in Canada

©2019 GSK group of companies or its licensor.

Rev. 3/19

497264

Flulaval Quadrivalent 2019-2020 10 count syringe carton
(click image for full-size original)
FLULAVAL QUADRIVALENT 2019/2020 influenza virus vaccine suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:19515-897
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 (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
POTASSIUM CHLORIDE
.ALPHA.-TOCOPHEROL SUCCINATE, D-
POLYSORBATE 80
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:19515-897-11 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (19515-897-01)
1 NDC:19515-897-01 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (19515-897-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125163 07/02/2019 06/30/2020
FLULAVAL QUADRIVALENT 2019/2020 influenza virus vaccine suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:19515-906
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 (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
POTASSIUM CHLORIDE
.ALPHA.-TOCOPHEROL SUCCINATE, D-
POLYSORBATE 80
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:19515-906-52 10 SYRINGE in 1 CARTON contains a SYRINGE (19515-906-41)
1 NDC:19515-906-41 0.5 mL in 1 SYRINGE This package is contained within the CARTON (19515-906-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125163 07/02/2019 06/30/2020
Labeler — ID Biomedical Corporation of Quebec (243368284)

Revised: 02/2020 ID Biomedical Corporation of Quebec

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