Index of drugs

Primary and supplemental vaccination of children against diphtheria, tetanus, pertussis, hepatitis B,polio and infections caused byHaemophilus influenzae type b.

1 dose (0.5 ml) after reconstitution contains: not less than 30 IU diphtheria toxoid adsorbed on aluminum hydroxide; not less than 40 IU tetanus toxoid adsorbed to aluminum hydroxide; antigensBordatella pertusis (25 μg of pertussis toxoid adsorbed to aluminum hydroxide, 25 μg of filamentous hemagglutinin adsorbed to aluminum hydroxide, 8 μg of pertactin adsorbed on aluminum hydroxide); 10 μg surface antigen of the recombinant virushepatitis B adsorbed on aluminum phosphate; inactivated poliovirus - 40 units of polio virus type 1 antivirus (Mahoney strain propagated in Vero cell culture), 8 j. Polio type 2 antigen D virus (strain MEF-1 propagated in Vero cell culture), 32 j. polio virus D antigen type 3 (Saukett strain grown in Vero cell culture); 10 μg of polysaccharideHaemophilus influenzae type b (polysibosylribitol phosphate) adsorbed on aluminum phosphate, bound to about 25 μg of tetanus toxoid as a protein carrier.

DTPa-HBV-IPV-Hib vaccine. Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA) vaccine,polio (inactivated) andHaemophilus influenzae type b, (conjugated), adsorbed.

Hypersensitivity to the active substances or to any of the excipients or to formaldehyde, neomycin and polymyxin B. Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines. Established encephalopathy of unknown aetiology that occurred within 7 days after administration of a vaccine containing pertussis antigens (these children should stop pertussis vaccination and continue vaccination with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines). acute and severe febrile illness (a mild infection is not a contraindication to the use of a vaccine).

Do not inject intravascularly or intradermally. Administer with caution to persons with thrombocytopenia or bleeding disorders, due to the risk of bleeding after intramuscular injection. Before administering the vaccine, a medical history should be carried out, with particular reference to current vaccinations and possible adverse reactions. Provision should be made for immediate treatment in the event of an anaphylactic reaction following vaccination. The decision about the Next dose of the pertussis-containing vaccine should be carefully considered if any of the following symptoms appeared temporally with vaccination with the vaccine containing the pertussis component: fever ≥ 40.0st.C within 48 h after vaccination, not caused by any, identifiable factor; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h after vaccination; chronic, persistent crying lasting ≥ 3 h, occurring within 48 h after vaccination; convulsions with or without fever, occurring within 3 days after vaccination. In some circumstances, such as high exposure to pertussis, the potential benefits may outweigh the risks. Past convulsions with fever, convulsions in the family or sudden infant death syndrome (SIDS) is not a contraindication to the use of the vaccine. Vaccinated children with a history of febrile convulsions should be closely monitored as such side effects may occur within 2-3 days after vaccination. If pneumococcal therapy was administered concomitantly, more seizures (with or without fever) and hypotonic-hyporesponsive episodes and feverish reactions have been reported. Antipyretic treatment should be included according to local recommendations.The potential risk and benefit of administering the vaccine or postponing this vaccination should be carefully considered in infants and children with a currently diagnosed or progressive severe neurological disorder. HIV infection is not a contraindication; however, patients with immune disorders may not have a normal immune response. The vaccine may be given to premature babies, but in this case the immune response may be weaker and the degree of clinical protection remains unknown. The risk of apnea and the need to monitor respiratory function for 48-72 h should be considered when administering the 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. The vaccine does not protect against diseases caused by other pathogens thanCorynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B, polyovirus orHaemophilus influenzae type b. It can be expected that vaccination may protect against hepatitis D (caused by the delta) which does not occur without concomitant infection with hepatitis B. As with any vaccine, it may happen that not all vaccinated people will receive a protective immune response. The safety and efficacy of the vaccine in children> 36 months has not been determined.

Not applicable - the vaccine is not intended for use in adults.

Very common: loss of appetite, unusual crying, irritability, anxiety, fever ≥38 ° C, localized edema at the injection site ≤50 mm, redness, pain, fatigue. Common: nervousness, diarrhea, vomiting, fever> 39.5 degrees C, induration at the injection site, localized edema at the injection site> 50 mm. Uncommon: drowsiness, cough, swollen swelling of the limb, in which the vaccine was given (sometimes with a neighboring joint). Rare: generalized enlargement of lymph nodes, anaphylactic reactions, anaphylactoid reactions (including urticaria), allergic reactions (including pruritus), collapse or shock-like state (hypotonic-hyporesponsive episode), apnea, rash, angioneurotic edema, swelling of the entire limb, the vaccine was given, extensive swelling, infiltration at the injection site, vesicles at the injection site. Very rare: seizures (with or without fever), dermatitis. The occurrence of edema after the booster dose is more likely in children who received a vaccine with an acellular component of pertussis as primary vaccination, compared with children vaccinated with a vaccine containing a full-cell component of pertussis; these reactions disappear on average after 4 days. In case of co-administration with pneumococcal saccharron, conjugated, and adsorbed vaccine (Prevenar), more frequent convulsions (with or without fever) and hypotonic-hyporesponsive episodes and febrile reactions have been reported. In extremely rare cases, symptoms such as paralysis, neuropathy, Guillain-Barre syndrome, encephalopathy, encephalitis and meningitis have been reported (no causal relationship established with the vaccine). After vaccination against hepatitis B, thrombocytopenia (thrombocytopenia) has been reported.

Deep intramuscularly (each subsequent dose should be administered in a different place). The vaccination schedule should follow the official recommendations.Primary vaccination: 3 doses of 0.5 ml (given in one of the diagrams: in the 2nd, 3rd and 4th month, in the 3rd, 4th and 5th months, in the 2nd, 4th and 6th months) or 2 doses (given in the 3rd and 5th month). Observe at least 1-month intervals between individual doses. If an EPI (Expanded Program on Immunisation) schedule is planned for the 6th, 10th, 14th week of life, a new hepatitis B vaccine should be given to the newborn immediately after birth. If a child has been vaccinated with a dose of hepatitis B vaccine shortly after birth, Infanrix hexa can be given for 6 weeks instead of subsequent doses of hepatitis B. If a second dose of hepatitis B is required before reaching this age, a monovalent Hepatitis B vaccine should be used.Supplementary vaccination: after vaccination with 2 doses (eg in the 3rd and 5th month of life) - the supplementary dose must be given at least 6 months apart from the last dose, preferably between 11 and 13. mż. After vaccination with 3 doses (eg in the 2nd, 3rd and 4th month, at the 3rd, 4th, 5th month, 2nd, 4th and 6th months) - the supplementary dose must be given at least 6 months from the last dose, ideally before the age of 18 months. Supplementary vaccination should be carried out in accordance with current recommendations, however, as a minimum, the dose of conjugated Hib vaccine should be given. Infanrix hexa can be used as a booster if its composition corresponds to official vaccination recommendations.