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Adacel/Adacel Polio

Adacel/Adacel Polio Description

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Description
Adacel: ADACEL appears as a cloudy white suspension.
1 dose (0.5 mL) contains: Tetanus Toxoid 5 Lf. Diphtheria Toxoid 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.
Excipients/Inactive Ingredients: Aluminum Phosphate (adjuvant), 2-phenoxyethanol.
This vaccine may contain traces of formaldehyde and glutaraldehyde which are used during the manufacturing process (see Contraindications and Precautions).
Adacel Polio: 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: 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) 40 D-antigen units*, Type 2 (MEF-1) 8 D-antigen units*, Type 3 (Saukett) 32 D-antigen units*.
*or the equivalent antigen quantity, determined by suitable immunochemical method.
Excipients/Inactive Ingredients: 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.
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