Instruction for use: Vaccine hepatitis B

Trade name of the drug – H-B-Vax II, The hepatitis B recombinant (rDNA), Surface antigen virus hepatitis B (HBsAg) purified and concentrated, Vaccine hepatitis B recombinant faecis liquid, Regevac B, Shanvac-B, Engerix B, Euvax B

The Latin name of the substance Vaccine hepatitis B

Vaccinum ad prophylaxim hepatitis epidemicae B (genus. Vaccini ad prophylaxim hepatitis epidemicae B)

Pharmacological group:

Vaccines, serums, phages and toxoids

Nosological classification (ICD-10)

B16 Acute hepatitis B: Viral hepatitis B; Hepatitis B; Acute hepatitis; Vaccination against hepatitis B; Subacute hepatitis; Acute viral hepatitis B; Acute lingering hepatitis B

Model clinical-pharmacological article 1

Pharmacotherapy. Vaccine for the prevention of hepatitis B. Forms specific immunity to the hepatitis B virus. When immunized in 98% creates specific immunity to the hepatitis B virus. The average values of antibody titers are in compliance with WHO standards. Antiviral antibodies in the protective caption persist for at least 5 years.

Indication. Hepatitis B (specific immunoprophylaxis of infection caused by all known subtypes of the virus).

Contraindications. Hypersensitivity (including to yeast).

Carefully. Pregnancy, lactation (due to the risk of contracting hepatitis B), multiple sclerosis.

Dosing. IM (adults and children of older age are injected into the deltoid muscle region, children under 2 years old are in the anterior-lateral surface of the thigh), adults and children from 16 years old - 1 ml (20 mcg of the surface antigen of the hepatitis B virus), newborns and children Up to 15 years - 0.5 ml (10 mcg of the surface antigen of the hepatitis B virus).

The following immunization schedule is recommended: 1 dose at the selected date; 2 dose - after 1 month and 3 dose - 6 months after the introduction of 1 dose. Revaccination - 1 dose every 5 years.

For at-risk groups (newborns whose mothers are infected with hepatitis B, patients, people traveling to regions with a high incidence of hepatitis B): 1 dose - on the selected day; 2 and 3 doses - after 1 month and 2 months after the introduction of 1 dose. Revaccination - 1 year after 3 doses of primary immunization.

Before administration, the preparation should be shaken well, since a small amount of precipitate may be formed during storage (white with a clear, colorless supernatant).

Side effect. Rarely - fever, headache, dizziness, weakness, malaise, myalgia, arthritis, nausea, vomiting, transient increase in the activity of "liver" transaminases, skin rash; Very rarely (without establishing an unambiguous connection with vaccination) - polyneuropathy, optic neuritis, paralysis of the facial nerve, exacerbation of multiple sclerosis, Guillain-Barre syndrome, allergic reactions of immediate type.

Local reactions: pain, hyperemia, swelling, densification.

Interaction. The drug is compatible with other vaccines. The effect reduces immunosuppressive therapy.

Special instructions. In diseases accompanied by an increase in body temperature, vaccination should be postponed until recovery.

In immunodeficiency and hemodialysis, additional doses of the vaccine may be required, since in this category of patients after primary immunization, protective antibody titers (> 10 IU / L) may not be induced.

Immunization can be ineffective and even harmful in people who are in the latent or progressing stage of hepatitis B.

When carrying out the vaccination, it is necessary to have the medicines needed to provide emergency assistance in the event of an anaphylactic reaction.