Fencovis

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Escherichia coli, strain 08:K35, fimbrial adhesin F5, Inactivated; Bovine rotavirus, strain TM-91, Inactivated; Bovine coronavirus strain c-197 (inactivated)

可用日期:

Boehringer Ingelheim Vetmedica GmbH

ATC代码:

QI02AL01

INN（国际名称）:

Escherichia coli, strain 08:K35, fimbrial adhesin F5, Inactivated; Bovine rotavirus, strain TM-91, Inactivated; Bovine coronavirus strain c-197 (inactivated)

药物剂型:

Suspension for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

bovine rotavirus + bovine coronavirus + escherichia

授权日期:

2022-08-19

产品特点

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fencovis suspension for injection (AT, BE, CZ, DE, EL, ES, FR, IE, IT,
LU, NL, PT, UK(NI))
Fencovis RCE vet suspension for injection (FI, NO, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated
_E. coli_
expressing F5 (K99) adhesin,
strain O8:K35
RP ≥ 1*
Inactivated bovine rotavirus, serotype G6P1, strain TM-91
RP ≥ 1*
Inactivated bovine coronavirus, strain C-197
RP ≥ 1*
*
Relative potency (RP): level of antibodies in sera of vaccinated
guinea pigs as determined by ELISA
in comparison with the reference serum obtained after vaccination of
guinea pigs with a vaccine
batch that has successfully passed the challenge test in the target
animals.
ADJUVANTS:
Aluminium hydroxide
6 mg
Quillaja saponin (Quil A)
≤ 0.4 mg
EXCIPIENTS:
Thiomersal
0.2 mg
Formaldehyde
≤ 1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Appearance: orange, pink to deep pink liquid with whitish sediment,
which is homogenously dispersed
after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pregnant heifers and cows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pregnant heifers and cows in order to stimulate
the development of antibodies
against bovine rotavirus, bovine coronavirus and
_E. coli_
expressing F5 (K99) adhesin and to increase
the level of passive immunity of calves against neonatal diarrhoea
caused by bovine rotavirus, bovine
coronavirus and
_E. coli_
expressing F5 (K99) adhesin.
In calves fed with colostrum and milk from vaccinated cows for the
first week of life, laboratory studies
conducted with heterologous challenge strains (a G6 BRV strain, a BCV
strain and a K99
_E. coli_
strain)
have demonstrated that these antibodies:
-
prevent neonatal diarrhoea caused by bovine rotavirus and
_E. coli_
expressing F5 (K99) adhesin,
-
reduce the incidence and severity of neonatal diarrhoea caused by
bovine coronavirus,
-
reduce faecal shed