Rotavec Corona Emulsion for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Available from:

Kernfarm B.V.

ATC code:

QI02AL01

INN (International Name):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Pharmaceutical form:

Emulsion for injection

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Inactivated Viral and Bacterial Vaccine

Authorization status:

Expired

Authorization date:

2015-12-07

Summary of Product characteristics

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