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Generic Name and Formulations:

Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; hepatitis B vaccine (recombinant), aluminum phosphate adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; contains traces of formaldehyde, yeast protein, neomycin, polymyxin B, polysorbate 80.



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Indications for PEDIARIX:

Immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus (types 1, 2, and 3) in infants age 6 weeks up to 7yrs (before 7th birthday) born of HBsAg-negative mothers.


Not recommended.


Each dose is 0.5mL IM in deltoid or anterolateral thigh. Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later; then give 3rd dose 6–8 weeks later (preferably 8 weeks between doses). Previously vaccinated with one or more doses of individual components: see literature. Not for use as booster dose.


Anaphylaxis associated with previous dose. Encephalopathy within 7 days after previous pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).


Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid-containing vaccine. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous DTaP or DTwP vaccine: see literature. Seizure risk (may give antipyretic). Bleeding disorders. Have epinephrine available. Latex allergy (syringes). Immunodeficiency. Pregnancy (Cat.C).

Pharmacological Class:

DTaP + HB + IPV.


Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

Adverse Reactions:

Local reactions (pain, redness, swelling), irritability/fussiness, fever, crying, drowsiness, loss of appetite; rare: seizure, anaphylaxis.

How Supplied:

Single-dose vials—10; Single-dose prefilled syringes—5