Milky white homogenous emulsion for injection. One dose (2ml) of the inactivated vaccine contains:
Active substances:
Escherichia coli strain P4 (F6 adhesins), ≥ 1 RP*
Escherichia coli strain P5 (F18ab adhesins), ≥ 1 RP *
Escherichia coli strain P6 (F4ac adhesins), ≥ 1 RP *
Escherichia coli strain P9 (F18ac adhesins), ≥ 1 RP*
Escherichia coli strain P10 (F5 + F41 adhesins), ≥ 1 RP*
beta toxoid of Clostridium perfringens Type C (CZV13) ≥ 10 IU** of β antitoxin/ml of rabbit serum
* RP: Relative potency for each antigen according to a reference vaccine with satisfactory result in the immunogenicity test (Ph. Eur. monograph 0962).
** IU: International units of beta toxin (Ph. Eur. monograph 0363)
Adjuvant:
Light mineral oil 0.760 ml
Montanide 103 0.0425 ml
Sorbitan oleate 0.0425 ml
Excipients:
Thiomersal 0.2 mg