BOVIGEN SCOUR Emulsion for injection for cattle

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Bovine coronavirus strain c-197 (inactivated); Bovine rotavirus strain TM-91, serotype G6P1 (inactivated). ; Escherichia coli strain EC/17, (inactivated) expressing F5(K99) adhesin

Dostupno od:

FORTE Healthcare Ltd

ATC koda:

QI02AL01

INN (International ime):

Bovine coronavirus strain c-197 (inactivated); Bovine rotavirus strain TM-91, serotype G6P1 (inactivated). ; Escherichia coli strain EC/17, (inactivated) expressing F5(K99) adhesin

Doziranje:

.

Farmaceutski oblik:

Emulsion for injection

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Cattle

Područje terapije:

bovine rotavirus + bovine coronavirus + escherichia

Terapijske indikacije:

Immunological - Inactivated Vaccine

Status autorizacije:

Authorised

Datum autorizacije:

2015-05-01

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVIGEN SCOUR
(AT, BE, CY, DE, EE, EL, FR, HR, IE, IT, LV, LT, LU, MT, NL, PT, RO,
SI,UK)
BOVIGEN RCE VET
(DK, FI, NO, SE)
BOVISAN DIAR
(ES)
Emulsion for injection for cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of the vaccine (3 ml) contains:
ACTIVE SUBSTANCE:
Bovine rotavirus strain TM-91, serotype G6P1 (inactivated)
≥ 6.0 log2 (VNT)*
Bovine coronavirus strain C-197 (inactivated)
≥ 5.0 log2 (HIT)**
_Escherichia coli_
strain EC/17 (inactivated)
expressing F5 (K99) Adhesin
≥ 44.8 % of inhibition (ELISA)***
*VNT – virus neutralisation test (rabbit serology induced by 2/3
dose of vaccine)
**HIT – haemagglutination inhibition test (rabbit serology induced
by 2/3 dose of vaccine)
***ELISA – Enzyme-linked immunosorbent assay (rabbit serology
induced by 2/3 dose of vaccine)
ADJUVANT:
Montanide ISA 206 VG 1.6 ml
EXCIPIENTS:
Formaldehyde
max. 1.5 mg
Thiomersal
max. 0.36 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White liquid emulsion which may form a sediment during storage.
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 _
adhesion F5
(K 99) antigen, rotavirus and coronavirus. When calves are fed
colostrum from vaccinated cows during
the first week of life, these antibodies have been demonstrated to
reduce the severity of diarrhoea caused
by bovine rotavirus, bovine coronavirus and enteropathogenic
_E. coli_
F5 (K99) and to reduce the
shedding of virus by calves infected with bovine rotavirus or bovine
coronavirus.
Onset of immunity: Passive immunity commences with colostrum feeding
and is dependent on calves
receiving sufficient colostrum after birth.
2
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS