Država: Velika Britanija
Jezik: engleski
Izvor: VMD (Veterinary Medicines Directorate)
Bovine coronavirus, Bovine rotavirus, Escherichia coli
Kernfarm B.V.
QI02AL01
Bovine coronavirus, Bovine rotavirus, Escherichia coli
Emulsion for injection
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle
Inactivated Viral and Bacterial Vaccine
Expired
2015-12-07
Issued: December 2015 AN: 00343/2015 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rotavec Corona Emulsion for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 2 ml dose: ACTIVE SUBSTANCES Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated) ¼ 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. 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pregnant cows and heifers) 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. Issued: December 2015 AN: 00343/2015 Page 2 of 5 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 pooled colostrum, protection will continue until colostrum feeding ceases. In naturally suckled calves, protection against rotavirus will persist for at least 7 days and against coronavirus for at least 14 days. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE P Pročitajte cijeli dokument