DiarrVac RCE Emulsion for injection for cattle.

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Bovine rotavirus, Inactivated; Bovine coronavirus, Inactivated; Escherichia Coli (Inactivated)

可用日期:

FORTE Healthcare Ltd

ATC代码:

QI02AL01

INN（国际名称）:

Bovine rotavirus, Inactivated; Bovine coronavirus, Inactivated; Escherichia Coli (Inactivated)

药物剂型:

Emulsion 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

授权状态:

Authorised

授权日期:

2022-04-08

产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DIARRVAC RCE
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.
4.3
CONTRAINDICATIONS
None.
2
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the