Amvax-B [Recombinant Hepatitis B Vaccine] is a noninfectious vaccine . It contains purified Hep.B surface antigen obtained by culturing genetically
engineered Hansunula Polymorpha cells. The surface antigen is purified by several physicochemical steps and formulated as a suspension of the antigen
adsorbed onto aluminium hydroxide. No substances of human origin are used in its manufacture.
Talk with your or your child’s healthcare professional if you have questions about tetanus vaccines.
Information for Healthcare Professionals
Hepatitis-B Vaccine (Amvax-B) recommendations and contraindications; composition,immunogenicity, and efficacy; storage and handling, administration details….
Each 1 mL of Adult dose contains 20 mcg of hepatitis B surface antigen adsorbed onto 0.5 mg aluminium hydroxide. Each 0.5 mL of Pediatric dose contains 10 mcg of hepatitis B surface antigen adsorbed onto 0.25 mg aluminium hydroxide. Both formulations contain 0.012% w/v thimerosal (mercury derivative) as a preservative, sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).
Hepatitis B infection may have serious consequences including acute massive hepatic necrosis, chronic active hepatitis and cirrhosis of the liver. Considering the serious consequences of infection, immunization should be considered for all persons at potential risk of exposure to the hepatitis B virus.
Hep.B carrier Mothers can infect their infants at, or shortly after, birth. Infected infants usually become chronic carriers. The world Health Organization (WHO), the Immunization Practices Advisory Committee (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have endorsed universal infant immunization as part of a comprehensive strategy for the control of hepatitis B infection. There is no specific treatment for acute hepatitis B infection. However, those who develop anti-HBs antibodies after active infection are generally protected against subsequent infection. Antibody titers ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B. Seroconversion is defined as antibody titers ≥1 mIU/mL.
Injection: Amvax-B should be administered by
intramuscular injection. Do not inject intravenously
or intradermally. In adults, the injection should be
given in the deltoid region but it may be preferable
to inject in the anterolateral thigh in neonates and
infants,. Amvax-B should not be administered in
the gluteal region;(Buttock) such injections
may result in suboptimal response. Amvax-B
may be administered subcutaneously to persons
at risk of hemorrhage (e.g., hemophiliacs). Therefore,
subcutaneous administration should be used only
in persons who are at risk of hemorrhage with
intramuscular injections.
Hypersensitivity to yeast or any other component
of the vaccine is a contraindication for use of the
vaccine. Patients experiencing hypersensitivity
after Amvax-B injection should not receive further
injections of Amvax-B.
Generally as with any percutaneous vaccine,
epinephrine should be available for use in case of
anaphylaxis or anaphylactoid reaction.
Store between 2° and 8°C (35° and 46°F).
10 mcg /0.5 ml Ampoule
20 mcg/1.0 ml Ampoule
100 mcg/5.0 ml Vial.
(Multidose Vial)