Vaccine Information: PREHEVBRIO (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Single dose vial, 1.0 mL (NDC number 75052-001-01)

Supplied as a package of 10 single dose vials (NDC number: 75052-001-10)

The vial stoppers are not made with natural rubber latex.

16.2 Storage Conditions

Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light.

Do not freeze ; discard if the vaccine has been frozen.

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

17 PATIENT COUNSELING INFORMATION

  • Inform vaccine recipient of the potential benefits and risks associated with vaccination with PREHEVBRIO, as well as the importance of completing the immunization series.
  • Emphasize that PREHEVBRIO contains non-infectious purified HBsAg and cannot cause hepatitis B infection.
  • Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov.
  • Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Principal Display Panel — 10 mcg/mL Carton Label

NDC 75052-001-10

Hepatitis B Vaccine (Recombinant)

PreHevbrio

Rx only

For adults 18 years or older

10
mcg/mL

10 x 1 mL
single-dose vials

For
intramuscular
administration

VBI VACCINES

Principal Display Panel -- 10 mcg/mL Carton Label
(click image for full-size original)

Principal Display Panel — 10 mcg/mL Vial Label

NDC 75052-001-01

Hepatitis B Vaccine (Recombinant)

PreHevbrio

For IM administration

Rx only

Storage:
2°C to 8°C

1
Dose(1 mL)

Principal Display Panel -- 10 mcg/mL Vial Label
(click image for full-size original)
PREHEVBRIO hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:75052-001
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) 10 ug in 1 mL
RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC) 10 ug in 1 mL
RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC) 10 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE -8450 ug/mL
POTASSIUM CHLORIDE -20 ug/mL
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE -380 ug/mL
MONOBASIC POTASSIUM PHOSPHATE -20 ug/mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
ALUMINUM HYDROXIDE -1500 ug/mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75052-001-10 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (75052-001-01)
1 NDC:75052-001-01 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (75052-001-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125737 12/01/2021
Labeler — VBI Vaccines (Delaware) Inc. (103812236)
Establishment
Name Address ID/FEI Operations
SciVac Ltd 514477301 API MANUFACTURE, ANALYSIS, PACK, LABEL, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Hy-Labs 600013676 ANALYSIS
Establishment
Name Address ID/FEI Operations
BioReliance 505004556 ANALYSIS
Establishment
Name Address ID/FEI Operations
IMI TAMI Institute for Research and Development Ltd. 600045280 ANALYSIS
Establishment
Name Address ID/FEI Operations
Envigo CRS (Israel) Limited 514627793 ANALYSIS

Revised: 11/2021 VBI Vaccines (Delaware) Inc.

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