Engerix-B suspension for injection 20 mcg vial 1 ml for adults No. 10

Engerix™-B, a vaccine for the prevention of viral hepatitis B, recombinant - sterile suspension containing purified major surface antigen of the virus, obtained using recombinant DNA technology and adsorbed on aluminum hydroxide.

Engerix™-B is indicated for active immunization for the prevention of disease caused by all known subtypes of HBV in patients of all ages at risk of infection.

Warehouse

Polysorbate 20 is present in trace amounts as a result of the manufacturing process.

Contraindication

Engerix™-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 Engerix™-B vaccine.

HIV infection is not a contraindication to hepatitis B vaccine prophylaxis.

As with other vaccines, the administration of Engerix™-B should be postponed in patients with acute febrile illnesses. The presence of a mild infection is not a contraindication.

Method of application

Vaccine for adults

A dose of 20 mcg (1.0 ml) is recommended for adults (aged 20 years and over). This dose can be used for immunoprophylaxis in patients aged 11 years and over, including adolescents aged 15 years and over, by administering 2 doses of the vaccine according to the schedule below, if the risk of hepatitis B infection is low and the patient can be assured of receiving this two-dose vaccination course.

Vaccine for children

A dose of 10 mcg (0.5 ml) is recommended for newborns, children, and individuals under 19 years of age.

Application features

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of Engerix™-B, as with all other injectable vaccines. Therefore, patients should remain under medical supervision for at least 30 minutes after vaccination.

Pregnant women

Engerix™-B, like other inactivated vaccines, does not have a negative effect on the fetus. During pregnancy, Engerix™-B should be administered only if clearly needed and taking into account the benefits of immunization against the possible risk to the fetus.

Children

Possible use for the gifted.

Drivers

The vaccine is unlikely to affect your ability to drive or use machines.

Overdose

According to post-licensure pharmacovigilance, cases of overdose have been reported. Adverse reactions, if any, were non-specific but were similar to those seen with routine vaccination.

Side effects

Circulatory and lymphatic system: lymphadenopathy.

Metabolism and digestive disorders: loss of appetite.

Mental disorders: irritability

Nervous system: headache (very common when using a dose of 10 mcg), drowsiness.

Storage conditions

The vaccine must be stored at a temperature of 2 to 8°C.