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.
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.
- 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).
Manufactured by: VBI Vaccines Inc.
160 Second St., 3rd Floor, Cambridge, MA, USA, 02142
U.S. License No. 2219
©2021 VBI Vaccines. All rights reserved.
Principal Display Panel — 10 mcg/mL Carton Label
Hepatitis B Vaccine
For adults 18 years or older
10 x 1 mL
Principal Display Panel — 10 mcg/mL Vial Label
Hepatitis B Vaccine (Recombinant)
For IM administration
2°C to 8°C
Dose (1 mL)
|PREHEVBRIO hepatitis b vaccine (recombinant) injection, suspension|
|Labeler — VBI Vaccines (Delaware) Inc. (103812236)|
|SciVac Ltd||514477301||api manufacture, analysis, pack, label, manufacture|
|IMI TAMI Institute for Research and Development Ltd.||600045280||analysis|
|Envigo CRS (Israel) Limited||514627793||analysis|
Revised: 12/2022 VBI Vaccines (Delaware) Inc.
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