Infanrix Hexa

Per 0.5 mL Adsorbed diptheria toxoid not <30 IU, adsorbed tetanus toxoid not <40 IU, adsorbed pertusis toxoid 25 mcg, adsorbed filamentous haemagglutinin 25 mcg, adsorbed pertactin 8 mcg, adsorbed recombinant HBsAg 10 mcg, 40 D-antigen U of type 1 (Mahoney), 8 D-antigen U of type 2 (MEF-1) & 32 D-antigen U of type 3 (Saukett) of the inactivated poliovirus, adsorbed polysaccharide of HiB (PRP) 10 mcg (conjugated to tetanus toxoid approx 25 mcg), adsorbed on Al hydroxide hydrated (Al(OH)₃ 0.5 mg Al³⁺, adsorbed on Al phosphate (AlPO₄) 0.32 mg Al³⁺

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.

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 etiology, occuring 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. Childn w/ progressive neurological disorders, eg, infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Thrombocytopenia or bleeding disorder. A 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. Potential risk of apnoea & need for resp monitoring for 48-72 hr in very premature infant (born ≤28 wk).

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 lost & 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.

G