Resistance against infections caused by all known subtypes of hepatitis B virus.
Composition:
A vaccine for children: 1 vial of 0.5 ml (1 dose) contains 10 μg of hepatitis B surface antigen.Vaccine for adults: 1 vial 1 ml (1 dose) contains 20 μg of hepatitis B surface antigen.
Action:
Vaccine for active immunization against hepatitis B. The antigen is adsorbed on aluminum hydroxide.
Contraindications:
Hypersensitivity to the components of the vaccine. Do not administer vascularly and in the gluteal muscle.
Precautions:
In patients with acute febrile illness, vaccination should be postponed. In patients with multiple sclerosis, each stimulation may exacerbate the disease. The benefit of vaccination and the risk of exacerbation should be considered. Vaccination of patients with latent or chronic hepatitis B infection may not affect the course of the disease.
Pregnancy and lactation:
In pregnancy, it can only be used if there is a definite necessity. There are no contraindications for use during breastfeeding.
Side effects:
Very common: pain at the injection site disappearing within 2 days. Common: hematoma, redness, induration, swelling at the injection site, receding within 2 days; slight increase in body temperature, crying for no apparent reason, stomach ache, reduced appetite, diarrhea, vomiting, irritability, insomnia, lethargy, malaise. Uncommon: intestinal colic, neonatal jaundice, thrush (oral mycosis), rhinitis, rash, macula rash, rosacea. Rarely: increase in body temperature above 38.8 degrees Celsius, weakness, headache and dizziness, transient increase in aminotransferase activity, muscle pain, arthralgia. Apnea was recorded in premature infants (≤ 28 weeks of gestation). The causal relationship between vaccination and accidental occurrence of disseminated neuritis, optic neuritis, facial nerve palsy, exacerbation of multiple sclerosis and Guillain-Barre syndrome has not been established.
Dosage:
Intramuscularly, in the deltoid muscle or in the anterolateral part of the thigh in newborns, infants and younger children. Newborns, infants and children up to 15 years of age: 10 μg HBsAg in 0.5 ml. Children from 16 years and adults: 20 μg HBsAg in 1 ml. The first dose is given at any time, the second month later, and the third dose 6 months after the first dose. The use of booster doses is not recommended in people who have responded correctly to 3 doses of vaccine because they are protected against the disease for 15 years. Despite the decrease in antibody titers, the vaccinated person is protected against hepatitis B due to the generated immunological memory. In the case of newborn infants born to HBsAg antigen carriers, people exposed to this virus or people traveling to areas with a high risk of infection, the following vaccination schedule may be used: first dose at any time, second month later and the third two months after the first dose. A booster dose should be given after 12 months. Additional doses of the vaccine may be necessary for patients on hemodialysis or with immunodeficiency. In these patients, the determination of antibody titres is recommended. In cases of known or suspected exposure to hepatitis B virus (eg infection through injured skin or mucosa, in a newborn infant born to the HBs antigen), the first dose of the vaccine is recommended to simultaneously administer human immunoglobulin against hepatitis B virus (HBIg). These injections must be made in two different places.
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