Bovilis Rotavec Corona Emulsion for Injection for Cattle

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Disponibbli minn:

MSD Animal Health UK Limited

Kodiċi ATC:

QI02AL01

INN (Isem Internazzjonali):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Għamla farmaċewtika:

Emulsion for injection

Tip ta 'preskrizzjoni:

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

Grupp terapewtiku:

Cattle

Żona terapewtika:

Inactivated Viral and Bacterial Vaccine

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

2000-03-16

Karatteristiċi tal-prodott

Revised: December 2023
AN: 03273/2022
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).
Revised: December 2023
AN: 03273/2022
Page 2 of 6
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.
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 SPECIES
Vaccinate healthy animal