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 poliomyelitis 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 Approved Ages 6 months - 6 years (prior to 7th birthday) 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 toxoid, 10 Lf u Pertussis Toxin, 25 mcg Filamentous hemagglutinin, 25 mcg Pertactin, 8 mcg HbsAg, 10 mcg Type 1 poliovirus, 40 DU Type 2 poliovirus, 8 DU Type 3 poliovirus, 32 DU Excipients Aluminum salts, 0.85 mg Al Sodium Chloride, 4.5 mg Formaldehyde, ≤100 mcg Polysorbate 80 (Tween 80), ≤100 mcg Neomycin Sulfate, ≤0.05 ng Polymyxin B, ≤0.01 ng Yeast, ≤5% Adjuvant Aluminum salts, 0.85 mg Al Allergens Stopper vial may contain dry natural latex rubber Neomycin, ≤0.05 ng Polymyxin B, ≤0.01 ng  Preservatives None 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 Package Insert Date August 2010 updated January 2011
This page was last updated on October 03, 2011 © 2011 Institute for Vaccine Safety