Active immunization of infants and children from 2 to 71 months of age (6 years) against infections caused byHaemophilus influenzae type b. The vaccine does not protect against infectionH. influenzae other than type b, or against other microbes that cause meningitis or septicemia.
Composition:
1 vial (0.5 ml) contains 7.5 μg of polyribiborbitol phosphate (PRP)Haemophilus influenzae type b, adsorbed on aluminum hydroxide, coupled with 125 μg of the outer membrane complex of the outer membrane of group B meningococci.
Action:
Vaccine againstHaemophilus influenzae type b, conjugated. It is prepared from the highly purified capsular polysaccharide (PRP) of the Hib-Ross strain, which is then bound to the outer membrane complex of the cell membrane (OMPC)Neisseria meningitidis serotype B, strain B11. This creates a covalent bond between PRP and OMPC, necessary for achieving PRP immunogenicity.
Contraindications:
Hypersensitivity to any component of the vaccine. Do not administer intravenously.
Precautions:
Vaccination should be postponed in case of acute infection or fever-related illness; this does not apply to situations in which postponing vaccination may pose a greater threat than its implementation. Particular care should be taken in very premature premature babies (born ≤28 weeks of gestation), especially those who have symptoms of respiratory immaturity (the risk of apnea should be considered and the need to monitor respiratory function for 48-72 h); Due to the significant benefits of vaccinating this group of infants, vaccination should not be abandoned or postponed. There is not enough evidence that the vaccine given immediately after contact with the naturalH. influenzae type b prevents the occurrence of disease. It has been shown that there is an immune response against the carrier protein of meningococci, however, the resulting clinical benefits have not been established.
Pregnancy and lactation:
Not applicable - preparation for children.
Side effects:
Most often (> 1%): fever (> 38.3 ° C), irritability, drowsiness, pain or tenderness at the injection site, redness at the injection site, swelling or induration at the injection site, rash, crying of high tone, prolonged crying ( > 4 h), diarrhea, vomiting, otitis media, inflammation of the upper respiratory tract. In addition, there may be: lymphadenopathy, angioneurotic edema, seizures (including febrile convulsions), sterile abscess at the injection site, pain at the injection site, apnea in prematurely born infants (≤ 28 weeks gestation).
Dosage:
Only intramuscularly.Children from 2 to 14 months old. Primary vaccination: the first dose (0.5 ml), preferably just after the completion of 2 months, the Next dose (0.5 ml) after 2 months from the previous (or as soon as possible after this date) or in accordance with the Protective Vaccine Program in force in Poland . When the primary vaccination is completed to 12 months, a supplementary dose between 12 and 15 months should be given, but no earlier than 2 months after the second primary vaccination dose.Children aged 15 months and older: one dose of vaccine (0.5 ml).
(C)
