DiarrVac RCE Emulsion for injection for cattle.

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

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

Διαθέσιμο από:

FORTE Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

QI02AL01

INN (Διεθνής Όνομα):

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

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

bovine rotavirus + bovine coronavirus + escherichia

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2022-04-08

Αρχείο Π.Χ.Π.

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