Bovilis Rotavec Corona emulsion for injection for cattle

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated); Bovine coronavirus; Escherichia coli, strain O101:K99:F41, fimbrial adhesin F5 and F41, Inactivated

Disponibbli minn:

Intervet Ireland Limited

Kodiċi ATC:

QI02AL01

INN (Isem Internazzjonali):

Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated); Bovine coronavirus; Escherichia coli, strain O101:K99:F41, fimbrial adhesin F5 and F41, Inactivated

Dożaġġ:

.

Għamla farmaċewtika:

Emulsion for injection

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupp terapewtiku:

Cattle

Żona terapewtika:

bovine rotavirus + bovine coronavirus + escherichia

Indikazzjonijiet terapewtiċi:

Immunological - Inactivated Vaccine

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2010-09-24

Karatteristiċi tal-prodott

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