Hep B Vaccine Package Insert
Posted: Fri Mar 23, 2007 4:47 pm
"Hypersensitivity: Anaphylaxis; erythema multiforme including
Stevens-Johnson syndrome;
angioedema; arthritis. An apparent hypersensitivity syndrome (serum
sickness–like) of delayed
onset has been reported days to weeks after vaccination, including:
arthralgia/arthritis (usually
transient), fever, and dermatologic reactions such as urticaria, erythema
multiforme, ecchymoses,
and erythema nodosum (see CONTRAINDICATIONS).
"
Vaccine Package Insert
Ingredients
ALUMINUM, YEAST, TRACE THIMEROSAL (MERCURY), SODIUM CHLORIDE, DISODIUM
PHOSPHATE DIHYDRATE, SODIUM DIHYDROGEN DIHYDRATE, EGENETICALLY ENGINEERED
http://us.gsk.com/products/assets/us_engerixb.pdf
(better formatting at pdf)
ENGERIX-B ®
[Hepatitis B Vaccine (Recombinant)]
DESCRIPTION
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a noninfectious
recombinant DNA
hepatitis B vaccine developed and manufactured by GlaxoSmithKline
Biologicals. It contains
purified surface antigen of the virus obtained by culturing genetically
engineered Saccharomyces
cerevisiae cells, which carry the surface antigen gene of the hepatitis B
virus. The surface
antigen expressed in Saccharomyces cerevisiae cells is purified by several
physicochemical steps
and formulated as a suspension of the antigen adsorbed on aluminum
hydroxide. The procedures
used to manufacture ENGERIX-B result in a product that contains no more
than 5% yeast
protein. No substances of human origin are used in its manufacture.
ENGERIX-B is supplied as a sterile suspension for intramuscular
administration. The vaccine
is ready for use without reconstitution; it must be shaken before
administration since a fine white
deposit with a clear colorless supernatant may form on storage.
Pediatric/Adolescent: Each 0.5-mL dose contains 10 mcg of hepatitis B
surface antigen
adsorbed on 0.25 mg aluminum as aluminum hydroxide. The
pediatric/adolescent vaccine is
formulated without preservatives. The pediatric formulation contains a
trace amount of
thimerosal (37.5°C).
Nervous System: Headache † ; dizziness. †
† Parent or guardian completed forms for children and neonates. Neonatal
checklist did not
include headache, fatigue, or dizziness.
Incidence 19 years) 20 mcg/1.0 mL 0, 1, 6 months
Adult hemodialysis 40 mcg/2.0 mL * 0, 1, 2, 6 months
* Two × 20 mcg in 1 or 2 injections.
For hemodialysis patients, in whom vaccine-induced protection is less
complete and may
persist only as long as antibody levels remain above 10 mIU/mL, the need
for booster doses
should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster
doses with
ENGERIX-B should be given when antibody levels decline below 10 mIU/mL.1
Data show
individuals given a booster with ENGERIX-B achieve high antibody titers.
(See CLINICAL
PHARMACOLOGY.)
There are alternate dosing and administration schedules which may be used
for specific
populations (see Table 2 and accompanying explanations).
been observed. Therefore, subcutaneous administration should be used only
in persons who are
at risk of hemorrhage with intramuscular injections.
Preparation for Administration: Shake well before withdrawal and use.
Parenteral drug
products should be inspected visually for particulate matter or
discoloration prior to
administration. With thorough agitation, ENGERIX-B is a slightly turbid
white suspension.
Discard if it appears otherwise. The vaccine should be used as supplied; no
dilution is necessary.
The full recommended dose of the vaccine should be used. Any vaccine
remaining in a
single-dose vial should be discarded.
Dosing Schedules: The usual immunization regimen (see Table 1) consists of
3 doses of
vaccine given according to the following schedule: first dose: at elected
date; second dose:
1 month later; third dose: 6 months after first dose.
Table 1. Recommended Dosage and Administration Schedules
Group Dose Schedules
Infants born of:
HBsAg-negative mothers 10 mcg/0.5 mL 0, 1, 6 months
HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 6 months
Children:
Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 6 months
Adolescents:
11 through 19 years of age 10 mcg/0.5 mL 0, 1, 6 months
Adults (>19 years) 20 mcg/1.0 mL 0, 1, 6 months
Adult hemodialysis 40 mcg/2.0 mL * 0, 1, 2, 6 months
* Two × 20 mcg in 1 or 2 injections.
For hemodialysis patients, in whom vaccine-induced protection is less
complete and may
persist only as long as antibody levels remain above 10 mIU/mL, the need
for booster doses
should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster
doses with
ENGERIX-B should be given when antibody levels decline below 10 mIU/mL.1
Data show
individuals given a booster with ENGERIX-B achieve high antibody titers.
(See CLINICAL
PHARMACOLOGY.)
There are alternate dosing and administration schedules which may be used
for specific
populations (see Table 2 and accompanying explanations).
Adult Dose
20 mcg/mL in Single-Dose Vials in packages of 1, 10, and 25 vials
NDC 58160-857-01 (package of 1)
NDC 58160-857-11 (package of 10)
NDC 58160-857-16 (package of 25)
20 mcg/mL in Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged
without
needles)
NDC 58160-857-46 (package of 5)
Pediatric/Adolescent Doses
10 mcg/0.5 mL in Single-Dose Vials in packages of 1 and 10 vials
NDC 58160-856-01 (package of 1)
NDC 58160-856-11 (package of 10)
10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes
(packaged without
needles)
NDC 58160-856-46 (package of 5)
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.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License
No. 1617
Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709
ENGERIX-B and TIP-LOK are registered trademarks of GlaxoSmithKline.
RECOMBIVAX HB is a registered trademark of Merck & Co.
©2005, GlaxoSmithKline. All rights reserved.
December 2005 EB:L36
Stevens-Johnson syndrome;
angioedema; arthritis. An apparent hypersensitivity syndrome (serum
sickness–like) of delayed
onset has been reported days to weeks after vaccination, including:
arthralgia/arthritis (usually
transient), fever, and dermatologic reactions such as urticaria, erythema
multiforme, ecchymoses,
and erythema nodosum (see CONTRAINDICATIONS).
"
Vaccine Package Insert
Ingredients
ALUMINUM, YEAST, TRACE THIMEROSAL (MERCURY), SODIUM CHLORIDE, DISODIUM
PHOSPHATE DIHYDRATE, SODIUM DIHYDROGEN DIHYDRATE, EGENETICALLY ENGINEERED
http://us.gsk.com/products/assets/us_engerixb.pdf
(better formatting at pdf)
ENGERIX-B ®
[Hepatitis B Vaccine (Recombinant)]
DESCRIPTION
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a noninfectious
recombinant DNA
hepatitis B vaccine developed and manufactured by GlaxoSmithKline
Biologicals. It contains
purified surface antigen of the virus obtained by culturing genetically
engineered Saccharomyces
cerevisiae cells, which carry the surface antigen gene of the hepatitis B
virus. The surface
antigen expressed in Saccharomyces cerevisiae cells is purified by several
physicochemical steps
and formulated as a suspension of the antigen adsorbed on aluminum
hydroxide. The procedures
used to manufacture ENGERIX-B result in a product that contains no more
than 5% yeast
protein. No substances of human origin are used in its manufacture.
ENGERIX-B is supplied as a sterile suspension for intramuscular
administration. The vaccine
is ready for use without reconstitution; it must be shaken before
administration since a fine white
deposit with a clear colorless supernatant may form on storage.
Pediatric/Adolescent: Each 0.5-mL dose contains 10 mcg of hepatitis B
surface antigen
adsorbed on 0.25 mg aluminum as aluminum hydroxide. The
pediatric/adolescent vaccine is
formulated without preservatives. The pediatric formulation contains a
trace amount of
thimerosal (37.5°C).
Nervous System: Headache † ; dizziness. †
† Parent or guardian completed forms for children and neonates. Neonatal
checklist did not
include headache, fatigue, or dizziness.
Incidence 19 years) 20 mcg/1.0 mL 0, 1, 6 months
Adult hemodialysis 40 mcg/2.0 mL * 0, 1, 2, 6 months
* Two × 20 mcg in 1 or 2 injections.
For hemodialysis patients, in whom vaccine-induced protection is less
complete and may
persist only as long as antibody levels remain above 10 mIU/mL, the need
for booster doses
should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster
doses with
ENGERIX-B should be given when antibody levels decline below 10 mIU/mL.1
Data show
individuals given a booster with ENGERIX-B achieve high antibody titers.
(See CLINICAL
PHARMACOLOGY.)
There are alternate dosing and administration schedules which may be used
for specific
populations (see Table 2 and accompanying explanations).
been observed. Therefore, subcutaneous administration should be used only
in persons who are
at risk of hemorrhage with intramuscular injections.
Preparation for Administration: Shake well before withdrawal and use.
Parenteral drug
products should be inspected visually for particulate matter or
discoloration prior to
administration. With thorough agitation, ENGERIX-B is a slightly turbid
white suspension.
Discard if it appears otherwise. The vaccine should be used as supplied; no
dilution is necessary.
The full recommended dose of the vaccine should be used. Any vaccine
remaining in a
single-dose vial should be discarded.
Dosing Schedules: The usual immunization regimen (see Table 1) consists of
3 doses of
vaccine given according to the following schedule: first dose: at elected
date; second dose:
1 month later; third dose: 6 months after first dose.
Table 1. Recommended Dosage and Administration Schedules
Group Dose Schedules
Infants born of:
HBsAg-negative mothers 10 mcg/0.5 mL 0, 1, 6 months
HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 6 months
Children:
Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 6 months
Adolescents:
11 through 19 years of age 10 mcg/0.5 mL 0, 1, 6 months
Adults (>19 years) 20 mcg/1.0 mL 0, 1, 6 months
Adult hemodialysis 40 mcg/2.0 mL * 0, 1, 2, 6 months
* Two × 20 mcg in 1 or 2 injections.
For hemodialysis patients, in whom vaccine-induced protection is less
complete and may
persist only as long as antibody levels remain above 10 mIU/mL, the need
for booster doses
should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster
doses with
ENGERIX-B should be given when antibody levels decline below 10 mIU/mL.1
Data show
individuals given a booster with ENGERIX-B achieve high antibody titers.
(See CLINICAL
PHARMACOLOGY.)
There are alternate dosing and administration schedules which may be used
for specific
populations (see Table 2 and accompanying explanations).
Adult Dose
20 mcg/mL in Single-Dose Vials in packages of 1, 10, and 25 vials
NDC 58160-857-01 (package of 1)
NDC 58160-857-11 (package of 10)
NDC 58160-857-16 (package of 25)
20 mcg/mL in Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged
without
needles)
NDC 58160-857-46 (package of 5)
Pediatric/Adolescent Doses
10 mcg/0.5 mL in Single-Dose Vials in packages of 1 and 10 vials
NDC 58160-856-01 (package of 1)
NDC 58160-856-11 (package of 10)
10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes
(packaged without
needles)
NDC 58160-856-46 (package of 5)
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.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License
No. 1617
Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709
ENGERIX-B and TIP-LOK are registered trademarks of GlaxoSmithKline.
RECOMBIVAX HB is a registered trademark of Merck & Co.
©2005, GlaxoSmithKline. All rights reserved.
December 2005 EB:L36