Adacel Polio Description

ADACEL-POLIO (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine) is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate, combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3, and suspended in water for injection. The acellular pertussis vaccine is composed of five purified pertussis antigens (PT, FHA, PRN and FIM).
Each dose (0.5 mL) is formulated to contain: Active Ingredients: Tetanus Toxoid: Not less than 20 International Units (5 Lf); Diphtheria Toxoid: Not less than 2 International Units (2 Lf); Acellular Pertussis: Pertussis Toxoid (PT) 2.5 µg, Filamentous Haemagglutinin (FHA) 5 µg, Pertactin (PRN) 3 µg, Fimbriae Types 2 and 3 (FIM) 5 µg; Inactivated Poliomyelitis Vaccine: Type 1 (Mahoney)¹ 29 D-antigen units², Type 2 (MEF-1)¹ 7 D-antigen units², Type 3 (Saukett)¹ 26 D-antigen units².
¹ Cultivated on Vero cells.
² These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another similar/comparable/equivalent/ corresponding immunochemical method.
Excipients/Inactive Ingredients: Excipients: Aluminum Phosphate (adjuvant) 1.5 mg, 2-phenoxyethanol 0.6% v/v, Polysorbate 80 <5 μg, Water for Injection q.s. 0.5 mL.
Manufacturing Process Residuals: Bovine serum albumin, formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B are present in trace amounts.