Generic name: CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25[iU] in 0.5mL, CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10[iU] in 0.5mL, BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25ug in 0.5mL, BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25ug in 0.5mL, BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8ug in 0.5mL, HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10ug in 0.5mL, POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40[iU] in 0.5mL, POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8[iU] in 0.5mL, POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32[iU] in 0.5mL
Dosage form: injection
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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.
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 PEDIARIX 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 3 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 (11)] 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 (6.1)]. 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.