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PEDIARIX® is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).
DOSAGE AND ADMINISTRATION
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. Attach a sterile needle and administer intramuscularly.
The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.
Do not administer this product intravenously, intradermally, or subcutaneously.
Recommended Dose And Schedule
Immunization with PEDIARIX consists of 3 doses of 0.5 mL each, by intramuscular injection, at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks). The first dose may be given as early as 6 weeks of age. Three doses of PEDIARIX constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis and the complete vaccination course for hepatitis B.
Modified Schedules In Previously Vaccinated Children
Children Previously Vaccinated With Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP)
PEDIARIX may be used to complete the first doses of the DTaP series in children who have received 1 or 2 doses of INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), manufactured by GlaxoSmithKline, identical to the DTaP component of PEDIARIX [see DESCRIPTION] and are also scheduled to receive the other vaccine components of PEDIARIX. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.
Children Previously Vaccinated With Hepatitis B Vaccine
PEDIARIX may be used to complete the hepatitis B vaccination series following 1 or 2 doses of another hepatitis B vaccine (monovalent or as part of a combination vaccine), including vaccines from other manufacturers, in children born of HBsAg-negative mothers who are also scheduled to receive the other vaccine components of PEDIARIX.
A 3-dose series of PEDIARIX may be administered to infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth. However, data are limited regarding the safety of PEDIARIX in such infants [see ADVERSE REACTIONS]. There are no data to support the use of a 3-dose series of PEDIARIX in infants who have previously received more than one dose of hepatitis B vaccine.
Children Previously Vaccinated With Inactivated Poliovirus Vaccine (IPV)
PEDIARIX may be used to complete the first 3 doses of the IPV series in children who have received 1 or 2 doses of IPV from a different manufacturer and are also scheduled to receive the other vaccine components of PEDIARIX.
Booster Immunization Following PEDIARIX
Children who have received a 3-dose series with PEDIARIX should complete the DTaP and IPV series according to the recommended schedule.1 Because the pertussis antigens contained in INFANRIX and KINRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine), manufactured by GlaxoSmithKline, are the same as those in PEDIARIX, these children should receive INFANRIX as their fourth dose of DTaP and either INFANRIX or KINRIX as their fifth dose of DTaP, according to the respective prescribing information for these vaccines. KINRIX or another manufacturer's IPV may be used to complete the 4-dose IPV series according to the respective prescribing information.
Dosage Forms And Strengths
PEDIARIX is a suspension for injection available in 0.5-mL single-dose prefilled TIP-LOK® syringes.
Storage And Handling
PEDIARIX is available in 0.5 mL single-dose disposable prefilled TIP-LOK syringes (packaged without needles):
NDC 58160-811 -43 Syringe in Package of 10: NDC 58160-811-52
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.
1. Centers for Disease and Control and Prevention. Recommended immunization schedules for persons aged 0-18 years—United States, 2010. MMWR 2010;58(51&52).
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617, and Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, US License 1754 Distributed by GlaxoSmithKline Research Triangle Park, NC 27709This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/13/2015
Additional Pediarix Information
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