The vaccine is intended for the immunization of non-immunized adults and adolescents from 16 years of age, exposed to hepatitis A and B viruses.
Composition:
1 dose (1 ml) of the vaccine contains: 720 units of inactivated hepatitis A virus adsorbed to aluminum hydroxide and 20 μg of recombinant HBsAg surface antigen adsorbed on aluminum phosphate.
Action:
An inactivated, combined vaccine against hepatitis A and hepatitis B, obtained by mixing purified and inactivated hepatitis A viruses and a purified, recombinant HBsAg surface antigen. The vaccine induces the production of specific anti-HAV and anti-HBs antibodies. The protective effect appears 2-4 weeks after vaccination.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients or neomycin. Hypersensitivity after prior administration of hepatitis A and / or hepatitis B vaccines. Administration of the vaccine should be postponed during acute and severe feverish diseases.
Precautions:
The vaccine should in no case be administered intravascularly. A vaccine administered intradermally or in the gluteal muscle may not elicit an optimal immune response, and therefore should be avoided by these routes. It is not recommended to administer the vaccine as part of post-exposure prophylaxis. It can not be ruled out that some patients during the vaccination period may be in the incubation phase of hepatitis A or hepatitis B - it is not known whether administration of the vaccine during this period may prevent the development of infection. In dialysis patients who receive immunosuppressive therapy or immune dysfunction, the basic vaccination schedule may not be sufficient to achieve appropriate titres of anti-HAV and anti-HBs antibodies. In these cases, additional doses of the vaccine may be required; these patients may fail to produce a sufficient response. It was found that obesity (defined as BMI ≥30 kg / m2) may weaken the immune response to hepatitis A vaccines. The following factors have been found to lower the immune response to hepatitis B vaccination: older age, male gender, obesity, nicotinism, the route of administration of the vaccine, as well as some concomitant chronic illnesses. Serologic testing should be considered for people who may not get seroprotection after a full vaccination course, and consider adding additional doses to those who have not responded to vaccination or received a lower immune response.
Pregnancy and lactation:
Data on the course of pregnancy in a limited number of vaccinated women do not indicate a harmful effect of the vaccine on the course of pregnancy or on the health of the fetus / newborn. However, it is recommended to postpone vaccination until after delivery, unless there is an urgent need to immunize the mother against hepatitis B infection. It is not known whether the vaccine is excreted in human milk. When deciding to continue / terminate breastfeeding or to continue / stop the administration of the vaccine, the benefits of breastfeeding for the child and the benefit of vaccination for the mother should be taken into account.
Side effects:
Very common (≥1 / 10): headache, pain and redness at the injection site, fatigue. Common (≥1 / 100, <1/10): gastrointestinal symptoms, diarrhea, nausea, malaise, injection site reactions such as swelling, hematoma, bruising. Uncommon (≥1 / 1000, <1/100): dizziness, vomiting, abdominal pain, muscle pain, infection of the upper respiratory tract, fever (≥ 37.5 degrees C). Rare (≥1 / 10,000, <1/1000): generalized enlargement of the lymph nodes, weakness of skin sensation, paresthesia, rash, pruritus, joint pain, decreased appetite, hypotension, flu-like symptoms, chills. Very rare (<1 / 10,000): urticaria.In addition, during vaccine use may occur: thrombocytopenia, thrombocytopenic purpura, encephalitis, encephalitis, neuritis, neuropathy, paralysis, convulsions, angioneurotic edema, lichen planus, erythema multiforme, arthritis, muscle weakness, meningitis, vasculitis, anaphylaxis, allergic reactions including anaphylactoid reactions and similar to serum sickness, abnormal liver function tests, multiple sclerosis, inflammation of the spinal cord, facial nerve palsy, polyneuritis such as Guillain-Barre syndrome (with ascending paresis), optic neuritis.
Dosage:
Intramuscularly (in the deltoid muscle, exceptionally, patients with thrombocytopenia or blood coagulation disorders, the vaccine may be administered subcutaneously - with this route the optimal immune response may not be obtained). Adults and adolescents from 16 years. Primary vaccination: the first dose is given at any time, second month later, the third six months after the first dose. In exceptional cases (eg before travel) you can administer 3 doses of vaccine on days 0, 7, 21 and supplementary the fourth dose 12 months from the first. Revaccination: it has not been established whether a booster dose is necessary. In patients at risk (hemodialyzed patients or those with impaired immune system function) anti-HBs levels ≥10 IU / L should be maintained. Anti-HAV antibodies persist for at least 10 years. If a booster dose is required both against hepatitis A and hepatitis B, a Twinrix Adult or a monovalent vaccine can be used.
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