BOVIGEN SCOUR EMULSION FOR INJECTION FOR CATTLE
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
12-03-2016
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Viambatanisho vya kazi:
BOVINE ROTAVIRUS STRAIN TM-91 (INACTIVATED), BOVINE CORONAVIRUS STRAIN C-197 (INACTIVATED), ESCHERICHIA COLI ADHESION F5 (K99) (INACTIVATED)
Inapatikana kutoka:
FORTE Healthcare Ltd
ATC kanuni:
QI02AL01
INN (Jina la Kimataifa):
BOVINE ROTAVIRUS STRAIN TM-91 (INACTIVATED), BOVINE CORONAVIRUS STRAIN C-197 (INACTIVATED), ESCHERICHIA COLI ADHESION F5 (K99) (
Kipimo:
Unknown
Dawa fomu:
Emulsion for Injection
Dawa ya aina:
POM
Kundi la matibabu:
Bovine
Eneo la matibabu:
Inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escheri
Matibabu dalili:
Immunological - Inactivated vaccine
Idhini hali ya:
Authorised
Idhini ya tarehe:
2015-05-01
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVIGEN SCOUR
Emulsion for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of the vaccine (3 ml) contains:
ACTIVE SUBSTANCES:
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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
_______________
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