Prevention of rabies in children and adults. The vaccine can be used before and after exposure as a primary or booster vaccination.Vaccination before exposure. Prevention of rabies in people at high risk of infection with the rabies virus, such as: laboratory workers from the diagnostic, scientific research and production department performing works with the rabies virus; veterinary doctors and their assistants and animal keepers; people who, due to occupation or in their free time, have contact with such species as dogs, cats, skunks, raccoons, bats or other species that can potentially be infected with rabies (these include, for example, foresters, hunters) , forestry workers, speleologists, animal ejectors); Adults and children traveling to or traveling to areas where there is a risk of rabies.Vaccination after exposure. Prevention of rabies in case of the least risk of rabies infection. Post-exposure treatment includes local non-specific wound healing, passive immunization with immunoglobulins (RIGs) and vaccination depending on the type of wound and the condition of the animal.
Composition:
1 dose (0.5 ml) contains at least 2.5 IU. inactivated rabies virus (strain Wistar Rabies PM / WI38 1503-3M) propagated in VERO cells.
Action:
Anti-rabies vaccine, inactivated, whole virus. Administration of the vaccine leads to a specific immune response. An important protective role is played by the neutralization of rabies viruses by antibodies. Anti-rabies antibody titre of ≥0.5 IU / ml (determined by RFFIT) is considered by the WHO as indicating protection against disease.
Contraindications:
In the case of prophylactic vaccination - hypersensitivity to the components of the vaccine, polymyxin B, streptomycin or neomycin; fever, acute infection, progressive chronic disease (vaccination should be postponed) - in all these cases the risk / benefit ratio should be assessed. After exposure - no contraindications. Do not administer intravascularly, subcutaneously or in the gluteal muscle.
Precautions:
Appropriate treatment should be provided in the event of an anaphylactic reaction immediately after vaccination, in particular if vaccinated after exposure to persons with known hypersensitivity to polymyxin B, streptomycin or neomycin. It is necessary to regularly perform serological tests confirming the total neutralization of the test virus using the method of fluorescence inhibition (RFFIT): every 6 months for people from constant risk of exposure; every 2-3 years after each booster dose in people at risk groups who are periodically exposed to the exposure. When the level of antibodies is below the protective level, ie: <0.5 IU / ml, a booster dose should be given. In patients with immunodeficiency (due to disease or ongoing immunosuppressive therapy), antibody testing should be performed 2-4 weeks after vaccination; in case the antibody level is <0.5 IU / ml, an additional dose is justified. The risk of apnea and the need to monitor respiratory function for 48-72 h should be considered when administering primary immunization doses to very premature premature babies (born ≤28 weeks of gestation), especially for children with symptoms of immaturity of the respiratory system; Due to the significant benefits of vaccinating this group of infants, vaccination should not be withheld or deferred.
Pregnancy and lactation:
Data from a limited number of vaccine applications during pregnancy do not indicate a harmful effect on pregnancy or on the health of the fetus. Due to the severity of the disease, the vaccination schedule should not be changed during pregnancy. The vaccine can be used during breast-feeding.
Side effects:
The following may occur: reactions at the injection site (pain, redness, swelling, pruritus, induration), moderate fever, chills, malaise, tiredness, headache, dizziness, muscle and joint pain, gastrointestinal disturbances (nausea, abdominal pain) . Very rare: anaphylactoid reaction, urticaria, rash. Very apnea premature babies (born ≤28 weeks of gestation) may experience apnea.
Dosage:
Intramuscularly (adults - in the deltoid muscle, infants and young children - in the muscles of the anterolateral thigh area). The vaccine can be given to adults and children according to the same pattern.Vaccination before exposureprimary vaccination including 3 doses given on days 0, 7 and 28 (possibly on day 21); supplementary dose 1 year after primary vaccination; booster doses every 5 years. The vaccine may be given as a booster dose after primary vaccination with a vaccine prepared in cultures of VERO cells or human diploid cells (HDCV).Vaccination after exposure: 5 doses are given to non-immune patients at 0, 3, 7, 14 and 28 days. Treatment may be discontinued if the result of an animal brain test (if the animal is dead and the brain is available) or the result of veterinary observation of the animal towards rabies virus infection is negative. In the case of a single or multiple bite, scrapes passing through the entire thickness of the skin, drooling of mucous membranes should also be given immunoglobulin against rabies (human - 20 IU / kg or horse - 40 IU / kg). Whenever possible, the vaccine should be injected in a place on the opposite side to the site of immunoglobulin injection. In special cases (areas with enzones, the severity of certain injuries and their location, eg proximity to the central nervous system, late reporting to the doctor, immunodeficiency) it is justified to give two doses on the first day. Previously immunized patients who received a full vaccination course and have anti-rabies virus titre ≥ 0.5 IU / ml are given two doses on days 0 and 3; in this case, the administration of anti-rabies immunoglobulins (RIGs) is not necessary and should not be made. If more than 5 years have passed since the previous vaccination or if the previous vaccination was incomplete, full post-exposure treatment should be started (5 doses of vaccine on the 0th, 3rd, 7th, 14th and 28th day, if necessary also with immunoglobulin).