Hexaxim

Per 0.5 mL Diphtheria toxoid not <20 IU; tetanus toxoid not <40 IU; Bordetella pertussis antigens: Pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg; inactivated poliovirus: type 1 (Mahoney) 40 D antigen u, type 2 (MEF-1) 8 D antigen u, type 3 (Saukett) 32 D antigen u; HBsAg 10 mcg; H. influenzae type b polysaccharide 12 mcg (polyribosylribitol phosphate) conjugated to tetanus protein 22-36 mcg

Primary & booster vaccination of infants & toddlers from 6 wk to 24 mth against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis & invasive diseases caused by H. influenzae type b (Hib).

IM Primary vaccination 3 doses of 0.5 mL at an interval of at least 4 wk & as per schedules 6, 10, 14 wk; 2, 4, 6 mth; 2, 3, 4 mth. Booster vaccination 2nd yr of life & at least 6 mth after the last priming dose.

History of anaphylactic reaction after previous administration. Hypersensitivity to the active substances, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B), to any pertussis vaccine, or after previous administration of Hexaxim or a vaccine containing the same components or constituents. Encephalopathy of unknown aetiology w/in 7 days following prior vaccination w/ pertussis-containing vaccine (whole cell or acellular pertussis vaccines). Uncontrolled neurologic disorder or uncontrolled epilepsy.

Appropriate medical treatment & supervision should always be readily available in case of an anaphylactic reaction following vaccination. Not to be administered by intravascular, intradermal, or SC inj. Does not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or H. influenzae type b. Does not protect against hepatitis infection caused by other agents eg, hepatitis A, C & E or other liver pathogens; other types of H. influenzae or meningitis of other origins. Postpone immunization in patients w/ moderate to severe acute febrile illness or infection. Carefully consider giving further doses if temp ≥40°C w/in 48 hr of vaccination not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) w/in 48 hr of vaccination; persistent, inconsolable crying lasting ≥3 hr w/in 48 hr of vaccination; convulsions w/ or w/o fever occurring w/in 3 days of vaccination. Post-vaccination in individuals w/ history of febrile convulsions. Guillain-Barre syndrome or brachial neuritis. May reduce vaccine immunogenicity by immunosuppressive treatment or immunodeficiency. Immune response to vaccine in context of genetic polymorphism. Impaired hepatitis B response is observed in individuals w/ chronic renal failure; consider additional doses of hepatitis B vaccine in patients w/ chronic renal failure. Individuals w/ thrombocytopenia or bleeding disorder. Syncope; phenylketonuria. +ve urine test can be observed w/in 1-2 wk following vaccination; perform other tests to confirm HIB infection during this period. Not intended for women of childbearing age. Childn >24 mth. Consider resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & w/ previous history of resp immaturity.

Anorexia (decreased appetite); crying, somnolence; vomiting; inj site pain, erythema, swelling, irritability, pyrexia (≥38°C). Abnormal crying; diarrhoea; inj site induration.

Interference in Ab response w/ varicella vaccine. Co-administration w/ another vaccine should be carried out on separate inj site. Not to be mixed w/ any other vaccines or other parenterally administered medicinal products.

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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