The Engerix-B Vaccines is used to prevent hepatitis B in adults. Hepatitis is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death. Hepatitis B is a liver disease that is spread through blood or bodily fluids, sexual contact or sharing caviar with an infected person, or during childbirth when the mother is infected. Engerix-B works by exposing you to a small amount of the virus, which causes the body to develop immunity to this disease. Engerix-B will not treat an active infection that has already developed in the body.
active substance: HBsAg;
the dose of vaccine (1.0 ml) contains: 20 μg HBsAg1,2;
1 adsorbed on aluminum hydroxide, hydrated 0.50 mg of Al3 + 2 produced in the cells of the yeast culture Saccharomyces cerevisiae by recombinant DNA technology;
the dose of vaccine (0.5 ml) contains: 10 μg HBsAg1,2;
1 adsorbed on aluminum hydroxide, hydrated with 0.25 mg of Al3 + 2 produced in yeast culture cells Saccharomyces cerevisiae by recombinant DNA technology;
excipients: aluminum hydroxide; sodium chloride; disodium phosphate, dihydrate; monosubstituted 2-aqueous sodium phosphate; water for injections.
Polysorbate 20 is present in trace amounts as a result of the production process.
Engerix-B Dosage form
Suspension for injection.
Main physicochemical properties: Egerix ™ -B, vaccine for the prevention of hepatitis B virus, recombinant – sterile suspension containing purified basic surface antigen of the virus, obtained by recombinant DNA technology and adsorbed on aluminum hydroxide. The antigen is isolated from a culture of yeast cells (Saccharomyces cerevisiae), which have a gene encoding the main surface antigen of hepatitis B virus (HBsAg). This surface antigen of yeast cells is thoroughly purified by several physicochemical methods applied sequentially. The surface antigen is spontaneously transformed into spherical particles with a diameter of 20 nm, which contain non-glycosylated antigen polypeptides and a lipid matrix consisting mainly of phospholipids. A large number of careful studies have shown that these particles have properties characteristic of natural HBsAg. Standardization of fermentation and purification methods allowed to ensure high stability of the composition of the vaccine Enderix ™ -B. The vaccine is highly purified and meets WHO requirements for recombinant hepatitis B vaccines. Substances of human origin are not used for its production.
Antiviral vaccines. Purified hepatitis B virus antigen ATX code J07B C01.
The Enderix ™ -B vaccine stimulates the production of specific humoral antibodies against HBsAg (the main surface antigen of the hepatitis B virus). The titer of antibodies against HBsAg, higher than 10 IU / l, correlates with a sufficient degree of immune protection against infection caused by hepatitis B virus (HBV).
Effectiveness of immune protection
Risk groups. In large-scale studies in neonates, children and adults at risk, 95 – 100% immunological efficacy was demonstrated.
Immunological efficacy was 95% in neonates HBsAg-positive mothers immunized according to regimens at 0, 1 and 2 or 0, 1 and 6 months without concomitant administration of HBIg (immunoglobulin against HBV) at birth. However, with the simultaneous introduction of HBIg and vaccine at birth, the immunological efficiency increased to 98%.
Enderix ™ -B is indicated for active immunization to prevent disease caused by all known HBV subtypes in patients of any age at risk of infection.
In areas with low endemicity of hepatitis B, it is recommended to immunize with the vaccine Enderix ™ -B newborns, children and adolescents, as well as persons at high risk of infection, such as:
police officers, fire brigades, servicemen;
patients who underwent blood transfusions;
persons living in special institutions and staff serving them;
people who have an increased risk of morbidity due to their sexual orientation;
injecting drug users;
people who go to areas with high endemic hepatitis B;
children whose mothers are carriers of the hepatitis B virus;
natives of areas with high endemic hepatitis B;
patients with sickle cell anemia;
patients waiting for organ and tissue transplantation;
persons with chronic liver disease or persons at risk of developing chronic liver disease (eg carriers of hepatitis C virus, persons who abuse alcohol);
persons in family (domestic and sexual) contact with a representative of any of the above groups and with patients with acute or chronic hepatitis B;
all other persons who may be infected with HBV as a result of their activities or lifestyle.
In areas with a medium or high incidence of hepatitis B, where there is a risk of infection for the majority of the population, vaccination should be given to all newborns, children and adolescents.
Hepatitis D can also be prevented by immunizing with Engerix ™ -B vaccine, as hepatitis D does not occur in the absence of HBV infection.
Immunization to prevent hepatitis B reduces not only the incidence of hepatitis B, but also the manifestations of chronic active hepatitis B and hepatitis B, which depend on the course of the disease, with chronic complications (eg liver cirrhosis).
When carrying out immunization on the territory of Ukraine regarding the scheme of use, contraindications and interaction with other drugs, the current orders of the Ministry of Health of Ukraine regarding preventive vaccinations should be followed.
Enderix ™ -B should not be administered to individuals with known hypersensitivity to any component of the vaccine, as well as to yeast, or to patients with hypersensitivity reactions after previous administration of Enderix ™ -B.
HIV infection is not a contraindication to hepatitis B vaccine prophylaxis.
As with other vaccines, the use of Enderix ™ -In patients with acute febrile illness should be delayed. The presence of a mild infection is not a contraindication.