Components of DTaP, Hep B and IPV Vaccine	Excipients Table Allergens Table Components Table
Indication For active immunization against diphtheria, tetanus, pertussis, all known subtypes of hepatitis B virus, and 3 types of poliomyelitis, as a 3-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age Proprietary Name Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B [Recombinant] and Inactivated Poliovirus Vaccine) Manufacturer GlaxoSmithKline Viability Inactivated Microorganism Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani, Saccharomyces cerevisiae Dose 0.5 mL Route Intramuscular Dose form Suspension Appearance Turbid White Suspension after shaking. Concentration (per 0.5 mL) Diphtheria, 25 Lf u Tetanus, 10 Lf u Pertussis Pertussis Toxin, 25 mcg Filamentous hemagglutinin, 25 mcg Pertactin, 8 mcg Preservatives Polysorbate 80 (Tween 80), ≤100 mcg Adjuvant Aluminum Hydroxide, ≤0.625 mg Excipients Sodium Chloride, 4.5 mg Formaldehyde, ≤100 mcg Polysorbate 80 (Tween 80), ≤100 mcg Thimerosal, <12.5 ng mercury per dose Neomycin Sulfate, ≤0.05 ng Polymyxin B, ≤0.01 ng Yeast, ≤5% Allergens Stopper vial may contain dry natural latex rubber Neomycin, ≤0.05 ng Polymyxin B, ≤0.01 ng  Media   Bordetella pertussis Modified Stainer-Scholte liquid medium PT detoxified using Glutarealdehyde. FHA and Pertactin detoxified using Formaldehyde Corynebacterium diphtheriae Fenton medium containing bovine extract Detoxified using formaldehyde Clostridium tetani Modified Lantham medium derived from bovine casein Detoxified using Formaldehyde Saccharomyces cerevisiae Purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. The purified HBsAg undergoes dialysis with cysteine to remove residual thimerosal Packaging Single-dose (0.5 mL) vials and disposable prefilled syringes Routine storage 2 to 8° C (36-46° F) Do Not Freeze updated July 2005
This page was last updated on November 07, 2012 © 2005 Institute for Vaccine Safety