Appropriate medical treatment & supervision should be available in case of anaphylactic reaction following vaccination. Do not administer intravascularly, intradermally or SC. No prevention of disease caused by pathogens other than
Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or HIB. No protection 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 immunisation in individuals suffering from 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. Carefully consider potential benefits & risks if Guillain-Barré syndrome or brachial neuritis occurs following receipt of prior tetanus toxoid-containing vaccine. Possible multiple sclerosis after hepatitis B vaccination. May reduce vaccine immunogenicity by immunosuppressive treatment or immunodeficiency; vaccination of individuals w/ chronic immunodeficiency (eg, HIV) is recommended even if Ab response may be limited. Immune responses to vaccine in context of genetic polymorphism. Possible impaired hepatitis B response in individuals w/ chronic renal failure; consider additional doses of hepatitis B vaccine according to Ab level against HBsAg. Individuals w/ thrombocytopenia or bleeding disorder. Syncope may occur; place procedures to prevent falling & injury. Possible +ve urine test w/in 1-2 wk following vaccination; perform other tests to confirm HIB infection during this period. Contains phenylalanine which may be harmful for individuals w/ phenylketonuria; K 39 mg/dose & Na 23 mg/dose. Not intended for women of childbearing age. Not applicable during pregnancy & lactation. Consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering primary immunisation series to very premature infants (≤28 wk of gestation) & particularly for those w/ history of resp immaturity. Childn >24 mth; preterm infants (≤37 wk of gestation); HIV-exposed infants (infected & uninfected).
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