Vaccine Information: ENGERIX-B (Page 4 of 4)

15 REFERENCES

1.
Centers for Disease Control and Prevention. Hepatitis B. In: Atkinson W, Wolfe C, Humiston S, Nelson R, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 6th ed. Atlanta, GA: Public Health Foundation; 2000:207-229.
2.
Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of Infants, Children, and Adolescents, MMWR. 2005;54(RR-16):1-23.
3.
Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001;344(5):327-332.
4.
Confavreux C, Suissa S, Saddier P, et al. Vaccination and the risk of relapse in multiple sclerosis. N Engl J Med. 2001-344(5):319-326.
5.
Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 2: Immunization of Adults, MMWR. 2006;55(RR-16):1-25.
6.
André FE, Safary A. Clinical experience with a yeast-derived hepatitis B vaccine. In: Zuckerman AJ, ed. Viral Hepatitis and Liver Disease. New York, NY: Alan R Liss, Inc.; 1988:1025-1030.
7.
Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA. 1989;261(22):3278-3281.
8.
Bush LM, Moonsammy GI, Boscia JA. Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another. Vaccine. 1991;9(11):807-809.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1706

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients and parents or guardians of the potential benefits and risks of immunization with ENGERIX-B.
Emphasize, when educating vaccine recipients and parents or guardians regarding potential side effects, that ENGERIX-B contains non-infectious purified HBsAg and cannot cause hepatitis B infection.
Instruct vaccine recipients and parents or guardians to report any adverse events to their healthcare provider.
Give vaccine recipients and parents or guardians the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

ENGERIX-B and TIP-LOK are registered trademarks of the GSK group of companies. The other brand listed is a trademark of the respective owner and is not a trademark of 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 GlaxoSmithKline Biologicals

Rixensart, Belgium, US License No. 1617

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

©2016 the GSK group of companies. All rights reserved.

ENG:56PI

Hepatitis B Vaccine (Recombinant)

Label ImageLabel Image
ENGERIX-B
hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-1706(NDC:58160-820)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1706-0 10 VIAL in 1 CARTON contains a VIAL (50090-1706-9)
1 NDC:50090-1706-9 .5 mL in 1 VIAL This package is contained within the CARTON (50090-1706-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103239 04/25/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1706)

Revised: 01/2020 A-S Medication Solutions

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