Vaccine Information: FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (Page 6 of 6)

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;339:1797-802.
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 AS, Ward-Gardner A. 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

16.1 How Supplied

Single-dose, prefilled syringe (pink plunger rod), without needle, 0.25 mL (NDC 49281-181-00) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-181-25).

Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-320-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-320-50).

Multi-dose vial, 5 mL (NDC 49281-336-78) (not made with natural rubber latex). Supplied as package of 1 (NDC 49281-336-15). A maximum of ten doses can be withdrawn from the multi- dose vial.

16.2 Storage and Handling

Store all Fluzone Quadrivalent Southern Hemisphere presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.

Do not use after the expiration date shown on the label.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information). Inform the vaccine recipient or guardian:

  • Fluzone Quadrivalent Southern Hemisphere contains killed viruses and cannot cause influenza.
  • Fluzone Quadrivalent Southern Hemisphere stimulates the immune system to protect against influenza, but does not prevent other respiratory infections.
  • Annual influenza vaccination is recommended by the World Health Organization.
  • Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.
  • Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Quadrivalent Southern Hemisphere during pregnancy. Women who receive Fluzone Quadrivalent Southern Hemisphere during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463.

Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Fluzone is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Patient Information Sheet
Fluzone® Quadrivalent Southern Hemisphere Influenza Vaccine

Please read this information sheet before getting Fluzone Quadrivalent Southern Hemisphere vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.

What is Fluzone Quadrivalent vaccine?

Fluzone Quadrivalent Southern Hemisphere is a vaccine that helps protect against influenza illness (flu) caused by strains circulating in the southern hemisphere. Fluzone Quadrivalent Southern Hemisphere vaccine is for people who are 6 months of age and older.

Vaccination with Fluzone Quadrivalent Southern Hemisphere vaccine may not protect all people who receive the vaccine.

Who should not get Fluzone Quadrivalent vaccine?

You should not get Fluzone Quadrivalent Southern Hemisphere vaccine if you:

  • ever had a severe allergic reaction to eggs or egg products.
  • ever had a severe allergic reaction after getting any flu vaccine.
  • are younger than 6 months of age.

Tell your healthcare provider if you or your child have or have had:

  • Guillain-Barré syndrome (severe muscle weakness) after getting a flu vaccine.
  • problems with your immune system as the immune response may be diminished.

How is the Fluzone Quadrivalent Southern Hemisphere vaccine given?

Fluzone Quadrivalent Southern Hemisphere vaccine is a shot given into the muscle of the arm.

For infants, Fluzone Quadrivalent Southern Hemisphere vaccine is a shot given into the muscle of the thigh.

What are the possible side effects of Fluzone Quadrivalent Southern Hemisphere vaccine?

The most common side effects of Fluzone Quadrivalent Southern Hemisphere vaccine are:

  • pain, redness, and swelling where you got the shot
  • muscle aches
  • tiredness
  • headache
  • fever

These are not all of the possible side effects of Fluzone Quadrivalent Southern Hemisphere vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.

Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent Southern Hemisphere during pregnancy. Women who receive Fluzone Quadrivalent Southern Hemisphere during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463.

What are the ingredients in Fluzone Quadrivalent Southern Hemisphere vaccine?

Fluzone Quadrivalent Southern Hemisphere vaccine contains 4 killed flu virus strains.

Inactive ingredients include formaldehyde and octylphenol ethoxylate. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent Southern Hemisphere vaccine.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

0.5 mL Dose
IM only

Influenza Vaccine
Fluzone® Quadrivalent
Southern Hemisphere

2020 Formula
No PreservativeMfd by: Sanofi Pasteur Inc.

Rx only

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

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Package

NDC 49281-320-50
2020 Formula

10 single-dose
prefilled syringes
(0.5 mL each)

Rx only

4
STRAINS

Influenza Vaccine
Fluzone® Quadrivalent
Southern Hemisphere

For 6 months of age and olderFor intramuscular injection only

SANOFI PASTEUR

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

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe label

For 6-35 months of age
IM only

Influenza Vaccine
Fluzone® Quadrivalent
Southern Hemisphere

2020 Formula
No Preservative:
Pediatric (0.25 mL) DoseMfd by: Sanofi Pasteur Inc.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Package

NDC 49281-181-25
2020 Formula

PEDIATRIC DOSE
FOR 6-35 MONTHS OF AGE

10 single-dose
prefilled syringes
(0.25 mL each)

Rx only

4
STRAINS

Influenza Vaccine
Fluzone® Quadrivalent
Southern Hemisphere

For 6-35 months of ageFor intramuscular injection only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial label

NDC 49281-336-78
Flu

Influenza
Vaccine
5 mL
Fluzone®
Quadrivalent
SouthernHemisphere

Contains Preservative

Rx only

4 STRAINS

PRINCIPAL DISPLAY PANEL -- 5 mL Vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Package

NDC 49281-336-15
2020 Formula

For 6 months of age and older
For intramuscular injection only

5 mL multi-dose vial

Rx only

4
STRAINS

Influenza Vaccine
Fluzone® QuadrivalentSouthern Hemisphere

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Package
(click image for full-size original)
FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/south australia/34/2019 ivr-197 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-320
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/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) 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 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
OCTOXYNOL-9
FORMALDEHYDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-320-50 10 SYRINGE, GLASS in 1 PACKAGE contains a SYRINGE, GLASS (49281-320-88)
1 NDC:49281-320-88 0.5 mL in 1 SYRINGE, GLASS This package is contained within the PACKAGE (49281-320-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103914 09/30/2019
FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/south australia/34/2019 ivr-197 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-181
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) 7.5 ug in 0.25 mL
INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 7.5 ug in 0.25 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 ANTIGEN (FORMALDEHYDE INACTIVATED) 7.5 ug in 0.25 mL
INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) 7.5 ug in 0.25 mL
Inactive Ingredients
Ingredient Name Strength
OCTOXYNOL-9
FORMALDEHYDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-181-25 10 SYRINGE, GLASS in 1 PACKAGE contains a SYRINGE, GLASS (49281-181-00)
1 NDC:49281-181-00 0.25 mL in 1 SYRINGE, GLASS This package is contained within the PACKAGE (49281-181-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103914 09/30/2019
FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/south australia/34/2019 ivr-197 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-336
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/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) 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 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
OCTOXYNOL-9
FORMALDEHYDE
THIMEROSAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-336-15 10 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (49281-336-78)
1 NDC:49281-336-78 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (49281-336-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103914 09/30/2019
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE (49281-320), MANUFACTURE (49281-181), MANUFACTURE (49281-336)

Revised: 02/2020 Sanofi Pasteur Inc.

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