[Hepatitis B Vaccine (Recombinant)]
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. 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 HBsAg expressed in the 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.
Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide.
Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
ENGERIX-B contains the following excipients: Sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).
ENGERIX-B is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.
ENGERIX-B is formulated without preservatives.
What are the precautions when taking hepatitis b vaccine recombinant (Engerix-B)?
Before you receive this vaccine, tell the health care professional if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this vaccine, tell your health care professional your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.
If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If...
Last reviewed on RxList: 9/2/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Engerix-B Information
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