Vaccine Information: Afluria Quadrivalent (Page 6 of 6)

16.2 Storage and Handling

  • Store refrigerated at 2-8°C (36-46°F).
  • Do not freeze. Discard if product has been frozen.
  • Protect from light.
  • Do not use AFLURIA QUADRIVALENT beyond the expiration date printed on the label.
  • Between uses, return the multi-dose vial to the recommended storage conditions.
  • Once the stopper of the multi-dose vial has been pierced the vial must be discarded within 28 days.
  • No more than 10 doses (0.25 mL or 0.5 mL) should be withdrawn from the multi-dose vial.

17 PATIENT COUNSELING INFORMATION

  • Inform the vaccine recipient or guardian of the potential benefits and risks of immunization with AFLURIA QUADRIVALENT.
  • Inform the vaccine recipient or guardian that AFLURIA QUADRIVALENT is an inactivated vaccine that cannot cause influenza but stimulates the immune system to produce antibodies that protect against influenza, and that the full effect of the vaccine is generally achieved approximately 3 weeks after vaccination.
  • Instruct the vaccine recipient or guardian to report any severe or unusual adverse reactions to their healthcare provider.
  • Encourage women who receive AFLURIA QUADRIVALENT while pregnant to enroll in the pregnancy registry. Pregnant women can enroll in the pregnancy registry by calling 1-855-358-8966 or sending an email to Seqirus at us.medicalinformation@seqirus.com.
  • Provide the vaccine recipient Vaccine Information Statements prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
  • Instruct the vaccine recipient that annual revaccination is recommended.

Manufactured by:
Seqirus Pty Ltd. Parkville, Victoria, 3052, Australia
U.S. License No. 2044

Distributed by:
Seqirus USA Inc. 25 Deforest Avenue, Summit, NJ 07901, USA
1-855-358-8966

AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates.
PharmaJet ® and STRATIS ® are registered trademarks of PharmaJet.
Luer-Lok™ is a trademark of Becton, Dickinson and Company Corporation.

Principal Display Panel — 0.25 mL Kankakee Carton Label

NDC 33332-219-20

PEDIATRIC
DOSE

For 6-35
MONTHS OF AGE

Influenza Vaccine afluria® Quadrivalent

2019 — 2020 Formula

Pediatric Dose

For use in children 6-35 months of age

Rx only

10 Pre-Filled Syringes

each containing a single 0.25 mL dose

Store between 2 — 8°C (36 — 46°F).

Refrigerate. Do not freeze.

Protect from light. SHAKE WELL.

Seqirus™

Principal Display Panel -- 0.25 mL Kankakee Carton Label
(click image for full-size original)

Principal Display Panel — 0.5 mL Kankakee Carton Label

NDC 33332-319-01

Influenza Vaccineafluria ® Quadrivalent

2019 — 2020 Formula

For use in persons 3 years and older

Rx only

10 Pre-Filled Syringes

each containing a single 0.5 mL dose

Store between 2 — 8°C (36 — 46°F).

Refrigerate. Do not freeze.

Protect from light. SHAKE WELL.

Seqirus™

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

Principal Display Panel — 0.5 mL Marburg Carton Label

NDC 33332-319-01

Influenza Vaccineafluria ® Quadrivalent

2019 — 2020 Formula

For use in persons 3 years and older

Rx only

10 Pre-Filled Syringes

each containing a single 0.5 mL dose

Store between 2 — 8°C (36 — 46°F).

Refrigerate. Do not freeze.

Protect from light. SHAKE WELL.

Seqirus™

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

Principal Display Panel — 5 mL Carton Label

NDC 33332-419-10

Influenza Vaccine

afluria ® Quadrivalent

2019 — 2020 Formula

For use in person 6 monthsand older

5 mL Multi-dose vial

Rx only

Seqirus™

Principal Display Panel -- 5 mL Carton Label
(click image for full-size original)
AFLURIA QUADRIVALENT influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated), influenza b virus b/maryland/15/2016 antigen (propiolactone inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:33332-319
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 (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 4.1 mg in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 80 ug in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 300 ug in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 20 ug in 0.5 mL
POTASSIUM CHLORIDE 20 ug in 0.5 mL
CALCIUM CHLORIDE 0.5 ug in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33332-319-01 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (33332-319-02)
1 NDC:33332-319-02 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (33332-319-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125254 09/28/2016 07/31/2020
AFLURIA QUADRIVALENT influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated), influenza b virus b/maryland/15/2016 antigen (propiolactone inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:33332-419
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 (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 4.1 mg in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 80 ug in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 300 ug in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 20 ug in 0.5 mL
POTASSIUM CHLORIDE 20 ug in 0.5 mL
CALCIUM CHLORIDE 0.5 ug in 0.5 mL
WATER
THIMEROSAL 24.5 ug in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33332-419-10 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (33332-419-11)
1 NDC:33332-419-11 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (33332-419-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125254 08/16/2017 07/31/2020
AFLURIA QUADRIVALENT influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated), influenza b virus b/maryland/15/2016 antigen (propiolactone inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:33332-219
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 (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 7.5 ug in 0.25 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 7.5 ug in 0.25 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 7.5 ug in 0.25 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 7.5 ug in 0.25 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 2.05 ug in 0.25 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 40 ug in 0.25 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 150 ug in 0.25 mL
POTASSIUM PHOSPHATE, MONOBASIC 10 ug in 0.25 mL
POTASSIUM CHLORIDE 10 ug in 0.25 mL
CALCIUM CHLORIDE 0.25 ug in 0.25 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33332-219-20 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (33332-219-21)
1 NDC:33332-219-21 0.25 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (33332-219-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125254 07/02/2019 07/31/2020
Labeler — Seqirus Pty Ltd. (747286735)

Revised: 01/2020 Seqirus Pty Ltd.

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