Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Infanrix
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Infanrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications:

Revise the Package Insert to add a warning regarding apnea in premature infants.
Revise the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX.
Fifth dose at 4-6 years of age after 4 prior doses of Infanrix.
Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP.

open here, please:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM124514.pdf

open here, please:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm