Bovilis Rotavec Corona Emulsion for Injection for Cattle

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Dostupné s:

MSD Animal Health UK Limited

ATC kód:

QI02AL01

INN (Mezinárodní Name):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Léková forma:

Emulsion for injection

Druh předpisu:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutické skupiny:

Cattle

Terapeutické oblasti:

Inactivated Viral and Bacterial Vaccine

Stav Autorizace:

Authorized

Datum autorizace:

2000-03-16

Charakteristika produktu

Revised: November 2022
AN: 02109/2021 and 02111/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Rotavec Corona emulsion for injection for cattle
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
Revised: November 2022
AN: 02109/2021 and 02111/2021
Page 2 of 6
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.
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 FOR EACH TARGET