Usual Pediatric Dose for Poliomyelitis Prophylaxis

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• Administer at 6- to 8-week intervals, preferably 8 weeks.
• First dose may be given as early as 6 weeks of age.
• Three doses of this vaccine constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

Usual Pediatric Dose for Diphtheria Prophylaxis

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• Administer at 6- to 8-week intervals, preferably 8 weeks.
• First dose may be given as early as 6 weeks of age.
• Three doses of this vaccine constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

Usual Pediatric Dose for Pertussis Prophylaxis

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• Administer at 6- to 8-week intervals, preferably 8 weeks.
• First dose may be given as early as 6 weeks of age.
• Three doses of this vaccine constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

Usual Pediatric Dose for Tetanus Prophylaxis

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• Administer at 6- to 8-week intervals, preferably 8 weeks.
• First dose may be given as early as 6 weeks of age.
• Three doses of this vaccine constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

Usual Pediatric Dose for Hepatitis B Prophylaxis

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:

• Administer at 6- to 8-week intervals, preferably 8 weeks.
• First dose may be given as early as 6 weeks of age.
• Three doses of this vaccine constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Children previously vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP):

• May use this vaccine to complete the first 3 doses of DTaP in patients who received 1 or 2 doses and who are scheduled to receive the other components of this vaccine.
• Data on safety and effectiveness of using this vaccine after other DTaP products are not available.

Children previously vaccinated with hepatitis B vaccine:

• May use this vaccine to complete hepatitis B in patients who received 1 or 2 doses of another hepatitis B vaccine and who are scheduled to receive the other components of this vaccine.
• The 3-dose series may be given to infants of HBsAg-negative mothers who received a hepatitis B vaccine dose at or shortly after birth, but safety data in these patients is limited; no data supports using the 3-dose series in those who received more than one dose of hepatitis B vaccine.

Children previously vaccinated with inactivated poliovirus vaccine (IPV):

• May use this vaccine to complete IPV series in patients who received 1 or 2 doses of another hepatitis B vaccine and who are scheduled to receive the other components of this vaccine.

Booster immunization following PEDIARIX(R):

• This vaccine may be used at the fourth DTaP dose after the 3 dose PEDIARIX series.
• This vaccine or KINRIX(R) may be used as the fifth DTaP dose.

Precautions

CONTRAINDICATIONS:

• Severe allergic reactions (e.g. anaphylaxis) to previous diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine or any component of this vaccine, including neomycin or polymyxin B
• Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) within 7 days of a previous pertussis-containing vaccine without an identifiable cause
• Progressive neurological disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until neurologic status is clarified and stabilized

Safety and efficacy have not been established in patients younger than 6 weeks or older than 6 years (prior to seventh birthday); this drug is not recommended for use in these patients.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intramuscular use only.
• The anterolateral aspect of the thigh is the preferred administration site for children under 1 year old.
• Older children may be vaccinated in the deltoid muscle.
• Do not administer in the gluteal area or areas where a major nerve trunk may be.
• Gluteal administration may cause suboptimal hepatitis B immune response.
• Do not administer intravenously, intradermally, or subcutaneously.

Storage requirements: Refrigerate; do not freeze.

Reconstitution/preparation techniques:

• Shake vigorously to obtain a homogenous, turbid white suspension.