Index of drugs

Active immunization against infections caused by all known subtypes of the hepatitis B virus in patients exposed to the hepatitis B virus. The vaccine should also prevent hepatitis D. People who should be vaccinated due to the risk of infection should be determined based on official recommendations.

1 vial of 0.5 ml contains 5 μg; 1 vial 1 ml contains 10 μg; 1 1 ml vial contains 40 μg of hepatitis B surface antigen.

A recombinant hepatitis B vaccine. Induces specific antibodies to the surface hepatitis B virus antigen (anti-HBs). Antibody titres equal to or higher than 10 IU / L 1-2 months after the last dose of vaccine provide protection against hepatitis B. The duration of protective antibody levels in healthy subjects after administration of the hepatitis B vaccine is not determined 5-9 years of observation of about 3,000 people from the high-risk group vaccinated with a vaccine containing an antigen isolated from plasma indicates no clinical cases of hepatitis B.

Hypersensitivity to the active substance or other ingredients of the preparation or traces of other compounds (eg formaldehyde and potassium thiocyanate). Severe diseases with fever or acute infection (the vaccination deadline should be postponed).

The vaccine does not protect against infections caused by other factors, such as hepatitis A, type C and type E viruses and other infectious agents of the liver. Clinical or laboratory findings of immunocompromised individuals or those exposed to or suspected to be exposed to the hepatitis B virus should be monitored. For the first vaccination course of infants born prematurely (at 28 weeks gestation or earlier), consideration should be given the potential risk of apnea and the need to monitor the patient for 48 to 72 hours, especially in premature infants with a history of immaturity in the respiratory system; vaccination should not be neglected or postponed. Due to the long incubation period of hepatitis B, an unrecognized infection may be present during the administration of the vaccine; in such cases, the vaccine may not prevent hepatitis B. Caution should be exercised when vaccinating latex-sensitive people, because the syringe plunger and lid contain a natural dry latex rubber that can cause allergic reactions. In addition, the vaccine may contain traces of formaldehyde and potassium thiocyanate that are used in the manufacturing process; there is a possibility of hypersensitivity reactions.

Clinical data on the use of the vaccine in pregnant women are not available. The vaccine can be given during pregnancy only if the potential benefits justify the potential risk to the fetus. There are no clinical data on the use of the vaccine in breast-feeding women.

Common: local reactions (at the injection site) - transient pain, erythema, induration. Very rare: fatigue, fever, general malaise, flu-like symptoms, thrombocytopenia, lymphadenopathy; serum sickness, anaphylaxis, nodular arteritis; paraesthesia, paralysis (including Bell palsy, facial nerve palsy), peripheral neuropathies (polycystitis, Guillain-Barre syndrome), neuritis (including optic neuritis), inflammation of the spinal cord (including spinal inflammation), encephalitis , CNS demyelinating disease, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness, fainting; uveitis; lowering blood pressure, vasculitis; symptoms similar to bronchospasm; vomiting, nausea, diarrhea, abdominal pain; elevation of liver enzymes; skin rash, alopecia, pruritus, urticaria, erythema multiforme, angioneurotic edema, eczema; joint pain, arthritis, muscle pain, limb pain. In addition, apnea may occur in premature babies (at 28 weeks gestation or earlier).

Intramuscularly.Children and adolescents (from birth to 15 years): at each selected date, 1 dose of 5 μg vaccine should be administered.Adults and adolescents from 16 years: at each selected date, 1 dose of 10 μg vaccine should be administered. For both doses, the same vaccination schedules apply.Basic vaccination. Vaccination should consist of at least 3 doses of vaccine. One of the following basic diagrams is recommended: 0, 1, 6 months (2 doses given 1 month apart, then the third dose given after 6 months after the first dose); 0, 1, 2, 12 months (three doses administered at intervals of one month, followed by a fourth dose given 12 months after the first dose). An accelerated vaccination schedule may earlier induce immunity in a slightly higher percentage of vaccinates.Booster dose. In people with normal immunity, it has not been determined whether there is a need for a booster dose. For people with immunodeficiency (eg dialysis patients, patients after transplantation, HIV infection), an additional dose of the vaccine should be considered if the level of antibodies (anti-HBs) is below 10 IU / L. In people whose primary immunization did not induce immunity, administration of one booster dose results in an adequate level of antibodies in 15-25% of vaccinated individuals, and three additional doses in 30-50% of vaccinations. However, due to insufficient data on the safety of the hepatitis B vaccine at doses above the recommended vaccination schedule, the booster dose at the end of the baseline vaccination is not routinely recommended. The booster dose should be considered for those at high risk, after prior evaluation of the benefit versus the potential risk of severe local reactions or general side effects. Children born from mothers who carry the hepatitis B virus: 1 dose of immunoglobulin against hepatitis B should be administered immediately after birth (within 24 hours); the first vaccine dose (5 μg) should be administered within 7 days of birth, subsequent doses of the vaccine should be administered according to the local vaccination schedule.Adults patients before dialysis and dialysis: one dose of 40 μg vaccine should be administered at each selected date. Basic vaccination. Vaccination should consist of at least 3 doses of vaccine. The following schedule is recommended: 0, 1, 6 months (2 doses given 1 month apart, then the third dose given 6 months after the first dose). Booster dose. In these patients, a booster dose may be considered if the antibody (anti-HBs) level achieved is less than 10 IU / L. If hepatitis B virus is found or suspected (eg, a needle-pricked needle), hepatitis B immunoglobulin should be administered as soon as possible after hepatitis B infection (within 24 hours); the first dose of the vaccine should be given within 7 days of contact; vaccination can be carried out simultaneously with the administration of an immunoglobulin against hepatitis B virus at various injection sites. It is also recommended to perform serological tests and to administer subsequent doses of the vaccine if necessary (ie in accordance with the results of the serological examination in the patient), in order to ensure short and long-term protection. For unvaccinated or incomplete vaccination, additional doses should be given according to the recommended vaccination schedule. An accelerated vaccination schedule can be proposed with a booster dose after 12 months. In adults, children and adolescents, the vaccine should be administered in the deltoid muscle, in newborns and infants in the anterolateral thigh. In exceptional cases, the vaccine may be given subcutaneously to patients with thrombocytopenia or patients with bleeding disorders.