País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
BOVINE ROTAVIRUS, BOVINE CORONAVIRUS INACTIVATED, E.COLI K99 ANTIGEN
Intervet Ireland Limited
QI02AL01
BOVINE ROTAVIRUS, BOVINE CORONAVIRUS INACTIVATED, E.COLI K99 ANTIGEN
Unknown
Emulsion for Injection
POM
Bovine
Inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escheri
Immunological - Inactivated vaccine
Authorised
2010-09-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rotavec Corona. Emulsion for injection for cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Emulsion for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pregnant cows and heifers). _per 2 ml dose_ ACTIVE SUBSTANCES Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated) 1/4 dose of vaccine stimulates a virus neutralising antibody titre: 7.7 log 2 /ml (guinea pigs). Bovine coronavirus, strain Mebus (inactivated) 1/20 dose of vaccine stimulates an ELISA antibody titre: 3.41 log 10 /ml (guinea pigs). _E. coli _F5 (K99) adhesin 1/20 dose of vaccine stimulates an ELISA antibody (OD492):> 0.64 (guinea pigs). ADJUVANT Light Mineral Oil / emulsifier 1.40 mL Aluminium hydroxide 2.45 - 3.32 mg EXCIPIENTS Thiomersal 0.032 - 0.069 mg Formaldehyde 0.34 mg For a full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/07/2015_ _CRN 7019280_ _page number: 1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pregnant cows and heifers to raise antibodies against _E. coli _adhesin F5 (K99) antigen, rotavirus and coronavirus. While calves are fed colostrum from vaccinated cows during the first two to four weeks of life, these antibodies have been demonstrated to: reduce the severity of diarrhoea caused by _E. coli _F5 (K99) reduce the incidence of scours caused by rotavirus reduce the shedding of virus by calves infected with rotavirus or coronavirus. Onset of Immunity: Passive protection against all active substances will commence from the start of colostrum feeding Duration of Immunity: In calves artificially fed with po Leer el documento completo