Active substance

Vaccine to prevent viral hepatitis B (Vaccine hepatitis B)


J07BC01 Hepatitis B virus purified antigen

Pharmacological group


  • Vaccines, sera, phages and toxoids


Composition and form of release


1 ml of adult vaccine contains 10 mcg of hepatitis B surface antigen adsorbed on about 0.5 mg of aluminum hydroxide; in bottles of 1 or 3 dosages, in a box 1 bottle.

0.5 ml vaccine for children – 5 mcg, adsorbed somewhere on 0.25 mg of aluminum hydroxide; in vials of 1 dose, in a box 1 vial.

1 ml of vaccine for patients on dialysis – 40 mcg, adsorbed somewhere on 0.5 mg of aluminum hydroxide; in vials of 1 dose, in a box 1 vial.



Hepatitis B vaccine, recombinant. A non-infectious viral vaccine containing the surface antigen (HBsAg, or Australian antigen) of the hepatitis B virus produced by yeast cells.

pharmachologic effect

Pharmacological effect – immunostimulating.

Forms specific immunity to the hepatitis B virus.

Indications for HB-VAKS II


Specific immunoprophylaxis of infection caused by all known subtypes of the hepatitis B virus.




Use during pregnancy and lactation


Not suggested, but likely if the potential benefit to the mother justifies the risk to the fetus.

Side effects


Fever, chills, weakness, malaise, sweating, headache, dizziness, sleep disturbance, paresthesia, peripheral neuropathy (including Bell’s palsy, optic neuritis), pain or tinnitus, pharyngitis, rhinitis, cough, dysuria, hypotension, nausea, diarrhea, vomiting, myalgia, arthralgia, lymphadenopathy, increased ESR, angioedema, urticaria, skin rash; at the injection site: pain, soreness, erythema, swelling, induration, itching.

Dosage and administration


V / m. Adults over 20 years: 3 injections of 1 ml (10 mcg) into the deltoid muscle; for newborns (children born to women with a negative HBsAg result) and children under 10 years old: 3 injections of 0.25 ml (2.5 mcg) in the anterolateral part of the thigh; for adolescents (from 11 to 19 years): 3 injections of 0.5 ml (5 mcg). The interval between injections should be at least 1 month.

For patients on dialysis: initially, after 1 month and 6 months – 1 ml (40 mcg). Neonates (children of HBsAg positive women): within 7 days 1st dose 0.5 ml (5 mcg), concomitantly with hepatitis B immune globulin 0.5 ml (anterolateral opposite thigh), after 1 and 6 months – 0.5 ml (5 mcg).

Precautionary measures


It is forbidden to enter in / in or in / to. Caution should be exercised in cardiopulmonary failure and in patients at high risk of adverse effects in the development of a febrile or systemic reaction. In the case of severe acute infection, it is advisable to postpone vaccination, except in situations where the delay is of great danger. Against the background of immunodeficiency and the appointment of immunosuppressive therapy, a higher dosage of the vaccine is required.

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