Generic name: CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10[iU] in 0.5mL, CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25[iU] in 0.5mL, BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25ug in 0.5mL, BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25ug in 0.5mL, BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8ug in 0.5mL
Dosage form: injection, suspension
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Preparation for Administration
Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Dose and Schedule
A 0.5-mL dose of INFANRIX is approved for intramuscular administration in infants and children 6 weeks to 7 years of age (prior to the seventh birthday) as a 5-dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The first dose may be given as early as 6 weeks of age.
The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 12 months of age and the deltoid muscle of the upper arm for most children 12 months of age to 7 years of age.
Do not administer this product intravenously, intradermally, or subcutaneously.
Use of INFANRIX With Other DTaP Vaccines
Sufficient data are not available on the safety and effectiveness of interchanging INFANRIX and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers for successive doses of the DTaP vaccination series. Because the pertussis antigen components of INFANRIX and PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] are the same, INFANRIX may be used to complete a DTaP vaccination series initiated with PEDIARIX.