ENGERIX-B (Page 5 of 5)

Known or Presumed Exposure to Hepatitis B Virus:

Unprotected individuals with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, others experiencing percutaneous or permucosal exposure) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with ACIP recommendations1 and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (see above).

STORAGE

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze ; discard if product has been frozen. Do not dilute to administer.

HOW SUPPLIED

ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK® syringes.

They are supplied by Dispensing Solutions Inc. as follows:

Adult Dose (Preservative Free Formulation)

NDC Strength Quantity/Form Color Source NDC
68258-3042-1 20 ug/1 mL 1 ml Single Dose Vial WHITE 58160-821-11

This product was Manufactured By:

GlaxoSmithKline Biologicals
Rixensart, Belgium, US License No. 1617
Distributed by GlaxoSmithKline
Research Triangle Park, NC 27709

And Repackaged By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

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. Beasley RP, Hwang L-Y, Stevens CE, et al. Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of hepatitis B virus carrier state: final report of a randomized double-blind, placebo-controlled trial. Hepatology. 1983;3(2):135-141. 3. Centers for Disease Control and Prevention. New vaccine information materials for hepatitis B, haemophilus influenzae type B (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Federal Register. February 23, 1999;64(35):9044-9045. 4. Chang M-H, Chen C-J, Lai M-S, et al. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. N Engl J Med. 1997;336(26):1855-1859. 5. Lee M-S, Kim D-H, Kim H, et al. Hepatitis B vaccination and reduced risk of primary liver cancer among male adults: a cohort study in Korea. Int J Epidemiol. 1998;27(2):316-319. 6. Centers for Disease Control and Prevention. Effectiveness of a seventh grade school entry vaccination requirement ― statewide and Orange County, Florida, 1997-1998. MMWR. 1998;47(34):711-715. 7. American Academy of Pediatrics. Universal hepatitis B immunization. Pediatrics. 1992;89(4):795-800. 8. Centers for Disease Control and Prevention. Immunization of adolescents: recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR. 1996;45(RR-13):1-16. 9. American Academy of Pediatrics. Immunization of adolescents: recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. Pediatrics. 1997;99(3):479-488. 10. André FE and 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. 11. 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. 12. Stevens CE, Alter HJ, Taylor PE, et al. Hepatitis B vaccine in patients receiving hemodialysis. N Engl J Med. 1984;311(8):496-501. 13. Hauser P, Voet P, Simoen E, et al. Immunological properties of recombinant HBsAg produced in yeast. Postgrad Med J. 1987;63(suppl 2):83-91. 14. 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. 15. Goilav C, Prinsen H, Safary A, et al. Immunization of homosexual men with a recombinant DNA vaccine against hepatitis B: immunogenicity and protection. In: Zuckerman AJ, ed. Viral Hepatitis and Liver Disease. New York, NY: Alan R Liss, Inc.; 1988:1057-1058. 16. Centers for Disease Control and Prevention. 1998 Guidelines for treatment of sexually transmitted diseases. MMWR. 1998;47(RR-1):102. 17. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994;43(RR-1):1-38. 18. Centers for Disease Control. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR. 1988;37(13):197-200. 19. Public Health Service. National Vaccine Injury Compensation Program: revision of the vaccine injury table. Federal Register. February 8, 1995;60(26):7694.

________________________

* Yeast-derived, Hepatitis B Vaccine, MSD.

ENGERIX-B and TIP-LOK are registered trademarks of GlaxoSmithKline.

RECOMBIVAX HB is a registered trademark of Merck & Co.

Principal Display Panel 20 mcg/ 1 ml Vial

Label Image For 20 mcg/ 1 ml Vial Carton
(click image for full-size original)
ENGERIX-B
hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3042(NDC:58160-821-11)
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 20 ug in 1 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:68258-3042-1 1 VIAL (VIAL) in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (68258-3042-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103239 05/28/2009
Labeler — Dispensing Solutions Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions Inc. 066070785 repack, relabel

Revised: 03/2010 Dispensing Solutions Inc.

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