Clinical Information
Gen. Code and Des.
62737 hep B vaccine/dp(a)t-polio/PF INTRAMUSC SYRINGE 10-25-25
GCN and Des.
98511 hep B vaccine/dp(a)t-polio/PF INTRAMUSC SYRINGE 10-25-25
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
80080000 TOXOIDS
Active Ingredients
7715 diphtheria,pertussis (acell),tetanus,polio vaccine
8320 hepatitis B virus vaccine, recombinant
9870 preservative free
Inactive Ingredients
2551 polysorbates 9005645
8921 latex
8922 milk
9283 beef derived (bovine)
PEDIARIX- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen (formaldehyde inactivated), hepatitis b virus subtype adw2 hbsag surface protein antigen, poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated) and poliovirus type 3 antigen (formaldehyde inactivated) injection, suspension
GlaxoSmithKline Biologicals SA
1 INDICATIONS AND USAGE
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).
2 DOSAGE AND ADMINISTRATION
2.1 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.
2.2 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.