DiarrVac RCE Emulsion for Injection for Cattle

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: VMD (Veterinary Medicines Directorate)

Ակտիվ բաղադրիչ:

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Հասանելի է:

Forte Healthcare Ltd

ATC կոդը:

QI02AL01

INN (Միջազգային անվանումը):

Bovine coronavirus, Bovine rotavirus, Escherichia coli

Դեղագործական ձեւ:

Emulsion for injection

Ռեկվիզորի տեսակը:

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

Թերապեւտիկ խումբ:

Cattle

Թերապեւտիկ տարածք:

Inactivated Viral and Bacterial Vaccine

Լիազորման կարգավիճակը:

Authorized

Հաստատման ամսաթիվը:

2022-03-11

Ապրանքի հատկությունները

Revised: February 2024
AN: 02354/2023
Page 1 of 5
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 log
2
(VNT)*
Bovine coronavirus strain C-197 (inactivated)
≥ 5.0 log
2
(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
Revised: February 2024
AN: 02354/2023
Page 2 of 5
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for