Infanrix Hexa

Primary vaccination of infants & booster vaccination of toddlers against DPT, hepatitis B, poliomyelitis & HIB.

Deep IM inj Primary vaccination Full-term infant 3 doses or 2 doses, w/ an interval of at least 1 mth between primary doses. Booster dose may be given at least 6 mth after last priming dose & preferably between 11 & 13 mth of age (2 doses) & before 18 mth of age (3 doses). Preterm infant born after at least 24 wk of gestation 3 doses w/ an interval of at least 1 mth between primary doses. Booster dose may be given at least 6 mth after last priming dose & preferably before 18 mth of age. Where a dose of hepatitis B vaccine is given at birth, Infanrix Hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of 6 wk.

Hypersensitivity to the active substances or to any of the excipients or residues or after previous administration of DPT, hepatitis B, polio or HIB vaccines. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis containing vaccines.

Hypersensitivity to neomycin & polymyxin. Postpone vaccination in patients w/ acute severe febrile illness. Not for prevention against diseases caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB. Do not administer intravascularly or intradermally. Temp of ≥40°C; collapse or shock-like state (hypotonic-hyporesponsive episode); persistent, inconsolable crying lasting ≥3 hr, occurring w/in 48 hr of vaccination; convulsions w/ or w/o fever, occurring w/in 3 days of vaccination. Thrombocytopenia or bleeding disorder. Protective immune response may not be elicited in all vaccinees. Immunosuppressed patients. Syncope (fainting) may occur. A +ve urine test can be observed w/in 2 wk following vaccination. Patients w/ history of febrile convulsions or family history of convulsions or Sudden Infant Death syndrome should be closely followed-up. Increased reporting rates of convulsions & hypotonic hyporesponsive episode w/ concomitant administration w/ Prevenar 13. Possible lower immune response for some antigens in premature infants. Consider potential risk of apnoea & need for resp monitoring for 48-72 hr in very premature infant (≤28 wk of gestation) & those w/ history of resp immaturity, when administering primary immunization series. Not intended for use in adults. Pregnancy & lactation. Defer pertussis immunization in childn w/ progressive neurological disorders including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.

Loss of appetite; irritability, abnormal crying, restlessness; somnolence; pain, redness, local swelling at the inj site (≤50 mm), fever ≥38°C. Nervousness; vomiting, diarrhoea; pruritus; inj site swelling (>50 mm) & reactions including induration, fever >39.5°C.

Co-administration w/ pneumococcal conjugate vaccine may increase rate of febrile reactions. Adequate response may not be achieved in patients receiving immunosuppressants. More frequent occurrence of fever, pain at inj site, appetite loss & irritability when co-administered w/ MenB vaccine & 7-valent pneumococcal conjugate vaccine.

Vaccines, Antisera & Immunologicals

J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.

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