国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated); Bovine coronavirus; Escherichia coli, strain O101:K99:F41, fimbrial adhesin F5 and F41, Inactivated
Intervet Ireland Limited
QI02AL01
Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated); Bovine coronavirus; Escherichia coli, strain O101:K99:F41, fimbrial adhesin F5 and F41, Inactivated
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Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
bovine rotavirus + bovine coronavirus + escherichia
Immunological - Inactivated Vaccine
Authorised
2010-09-24
Registration file / July 2022 SUMMARY OF PRODUCT CHARACTERISTICS Registration file / July 2022 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Rotavec Corona emulsion for injection for cattle DK: Bovilis Rotavec Corona Vet. FI: Bovilis Rotavec Corona vet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES Bovine rotavirus inactivated, strain UK-Compton, serotype G6 P5 874 U 1 Bovine coronavirus inactivated, strain Mebus 340 U 2 _E. coli_ strain CN7985, serotype O101:K99:F41 560 U 3 1 Units as determined in the BRV potency ELISA 2 Units as determined in the BCV potency ELISA 3 Units as determined in the _E. coli_ F5 (K99) potency ELISA ADJUVANTS 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Off-white emulsion. 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_ adhesins F5 (K99) and F41, 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) and F41 - reduce the incidence of scours caused by rotavirus - reduce the shedding of virus by calves infected with rotavirus or coronavirus. _ _ Registration file / July 2022 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 SPEC 阅读完整的文件