Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Bovine rotavirus, Inactivated; Bovine coronavirus, Inactivated; Escherichia Coli (Inactivated)
FORTE Healthcare Ltd
QI02AL01
Bovine rotavirus, Inactivated; Bovine coronavirus, Inactivated; Escherichia Coli (Inactivated)
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
bovine rotavirus + bovine coronavirus + escherichia
Authorised
2022-04-08
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 Read the complete document