ENGERIX-B (hepatitis b vaccine- recombinant injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (UNII: 9GCJ1L5D1P) (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN - UNII:9GCJ1L5D1P)

Available from:

Dispensing Solutions Inc.

INN (International Name):

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

Composition:

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination. ENGERIX-B will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver. Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis B virus,1 for example: - Infants, Including Those Born of HBsAg-Positive Mothers (See DOSAGE AND ADMINISTRATION.) - Adolescents (See CLINICAL PHARMACOLOGY.) - Healthcare Personnel: Dentists and oral surgeons. Dental, medical, and nursing students. Physicians, surgeons, and podiatrists. Nurses. Paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. Dental hygienists and dental n

Product summary:

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) 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

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ENGERIX-B - HEPATITIS B VACCINE (RECOMBINANT) INJECTION, SUSPENSION
DISPENSING SOLUTIONS INC.
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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.
ENGERIX-B is formulated without preservatives.
PEDIATRIC/ADOLES CENT:
Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen
adsorbed on 0.25 mg aluminum as
aluminum hydroxide. The pediatric formulation contains sodium chloride
(9 mg/mL) and phosphate
buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen
phosphate dihydrate,
0.71 mg/mL).
ADULT:
Each 1-mL adult dose contains 20 mcg of hepatitis B surface antigen
adsorbed on 0.5 mg aluminum as
aluminum hydroxide. The adult formulation contains sodium chloride (9
mg/mL) and phosphate buffers
(disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate
dihydrate, 0.71 mg/mL).
CLINICAL PHARMACOLOGY
Several hepatitis viruses are known to cause a systemic infection
resulting in major pathologic changes
in the liver (e.g., A, B, C, D, E, and G). The estimated lifetime risk
of HBV infection in the United States
varies from almost 1