Active immunization of patients over 12 months against invasive meningococcal disease caused byNeisseria meningitidis groups A, C, W-135 and Y.
Composition:
1 dose of vaccine (0.5 ml) contains 5 μg of polysaccharideNeisseria meningitidis A group, 5 μg of polysaccharideNeisseria meningitidis C group, 5 μg polysaccharideNeisseria meningitidis W-135 groups and 5 μg polysaccharideNeisseria meningitidis group Y.
Action:
Meningococcal vaccine. Antibodies against the meningococcal polysaccharide coating protect against meningococcal disease by complementing the bactericidal activity of the complement system. The vaccine induces the production of bactericidal antibodies directed against capsular polysaccharides of groups A, C, W-135 and Y, as demonstrated in rabbit (rSBA) or human (hSBA) complement tests.
Contraindications:
Hypersensitivity to the components of the drug.
Precautions:
The safety and efficacy of the vaccine in children below 12 months of age have not been established. (no data available). There are no data on the use of the vaccine in people aged> 55 years. Vaccines must not be administered intravascularly, intradermally or subcutaneously. Vaccination should be preceded by the collection of an accurate medical history (with particular reference to previous vaccinations and side effects that could have been caused by them) and physical examination. It should be absolutely possible to provide appropriate treatment and supervision in the event of rare anaphylactic reactions following the administration of the vaccine. Administration of the vaccine should be postponed in people with acute severe febrile illness. A mild infection, such as a cold, should not lead to postponement of vaccination. The vaccine should be used with caution in patients with thrombocytopenia or bleeding disorders, because of the risk of bleeding after intramuscular administration. It may happen that not everyone vaccinated will get a protective immune response. People who undergo immunosuppressive therapy or immune disorders may not have a normal immune response. Safety and immunogenicity were not assessed in patients with increased sensitivity to meningococcal infection (due to severe deficits of the complement system or functional or anatomical asplennia); there may not be a satisfactory immune response in these people.
Pregnancy and lactation:
The vaccine should be used during pregnancy and during breastfeeding only if clearly necessary, if the possible benefits outweigh the potential risk to the fetus. Data from the use of the vaccine in pregnancy are limited. In animal studies, no direct or indirect harmful effects of the vaccine have been demonstrated on pregnancy, embryonal / fetal development, parturition or postnatal development.
Side effects:
Very common: loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the injection site, fatigue. Common: hematoma at the injection site, gastrointestinal symptoms (including diarrhea, vomiting and nausea). Uncommon: insomnia, crying, weakness of feeling, dizziness, pruritus, rash, muscle pain, limb pain, deterioration of mood, reaction at the injection site (including sclerosis, pruritus, feeling of excessive heat, lack of sensation).
Dosage:
Intramuscularly, in the deltoid muscle or in the anterolateral part of the thigh. Adults, youth and children> 12. mż .: 1 dose (0.5 ml). The need for a booster dose has not been established in people who have been vaccinated with the original vaccine. The vaccine can be given as a booster dose to people who have been previously vaccinated with another polysaccharide vaccine against meningococci.
(C)
