Infanrix Hexa - Injection Diptheria + tetanus + pertussis + hepatitis B + inactivated polio vaccine + Haemophilus influenza type B (HIB) Vaccine - 1 Injection(s) / Injection Glaxo SmithKline Pharmaceuticals Ltd Indication: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, HIB Child Dose: Primary Immunization Deep IM inj Primary vaccination 3 or 2 doses of 0.5 mL w/ at least 1-mth interval between doses. Booster vaccination Given at least 6 mth after last priming dose between 11 & 13 mth of age (after 2 doses) or before 18 mth of age (after 3 doses). Contraindication: Hypersensitivity. Encephalopathy of unknown etiology occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine. Mode of Action: Vaccine is used for the active immunisation of Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis & HIB. Production of specific antibodies to tetanus, diphtheria, and pertusis (active immunity). Conveys active immunity via stimulation of production of endogenously produced antibodies Precaution: Hypersensitivity to neomycin & polymyxin. Do not administer intravascularly or intradermally. Postpone vaccination in patients w/ acute severe febrile illness. Temp >40°C, collapse or shock-like state, persistent & inconsolable crying lasting >3 hr w/in 48 hr of vaccination. Convulsions w/ or w/o fever w/in 3 days of vaccination. Progressive neurological disorders including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Anaphylactic event & syncope may occur. Thrombocytopenia or bleeding disorder. History of febrile convulsions. Consider risk of apnea & resp monitoring for 48-72 hr in very premature infants (>28 wk of gestation) & those w/ history of resp immaturity. False +ve... Side Effect: Loss of appetite; irritability, abnormal crying, restlessness, nervousness; vomiting, diarrhea; pruritus. Fever, fatigue, inj site reactions including pain, redness, local swelling & induration. Pregnancy Category Note: Pregnancy Not approved for use in individuals >5 years No human or animal data are available to assess vaccine-associated risks in pregnancy Lactation Not approved for use in individuals >5 years No human or animal data are available to assess the impact on milk production, its presence in breast milk, or its effects on the breastfed infant