Rovac -rotavirus bydlęcy, szczep TM-91, serotyp G6P1 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 6,0 log2 (VNT)*;-koronawirus bydlęcy, szczep C-197 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 5,0 log2 (HIT)**;-adhezyna E.coli F5 (K99): 2/3 dawki indukuje ≥ 40% hamowania (ELISA)***;* VNT-Test neutralizacji wirusa,**HIT- Test hamowania hemaglutynacji,***ELISA- enzymatyczny test immunosorpcyjny. Emulsja do wstrzykiwań
Rovac -rotavirus bydlęcy, szczep TM-91, serotyp G6P1 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 6,0 log2 (VNT)*;-koronawirus bydlęcy, szczep C-197 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 5,0 log2 (HIT)**;-adhezyna E.coli F5 (K99): 2/3 dawki indukuje ≥ 40% hamowania (ELISA)***;* VNT-Test neutralizacji wirusa,**HIT- Test hamowania hemaglutynacji,***ELISA- enzymatyczny test immunosorpcyjny. Emulsja do wstrzykiwań
Authorised
- Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
- Bovine coronavirus, strain C-197, Inactivated
- Escherichia coli, fimbrial adhesin F5
Product identification
Medicine name:
Rovac -rotavirus bydlęcy, szczep TM-91, serotyp G6P1 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 6,0 log2 (VNT)*;-koronawirus bydlęcy, szczep C-197 (inaktywowany): 2/3 dawki szczepionki indukuje ≥ 5,0 log2 (HIT)**;-adhezyna E.coli F5 (K99): 2/3 dawki indukuje ≥ 40% hamowania (ELISA)***;* VNT-Test neutralizacji wirusa,**HIT- Test hamowania hemaglutynacji,***ELISA- enzymatyczny test immunosorpcyjny. Emulsja do wstrzykiwań
Active substance:
- Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
- Bovine coronavirus, strain C-197, Inactivated
- Escherichia coli, fimbrial adhesin F5
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bovine rotavirus A, type G6P1, strain TM-91, Inactivated2.58/unknown2.00millilitre(s)
-
Bovine coronavirus, strain C-197, Inactivated
-
Escherichia coli, fimbrial adhesin F540.00/enzyme-linked immunosorbent assay unit2.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection/infusion
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offal0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AL01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Pharmagal spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Pharmagal Bio spol. s r.o.
Responsible authority:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 2607
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Labelling
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in another language below.
Polish (PDF)
Published on: 16/03/2022
Summary of Product Characteristics
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in another language below.
Polish (PDF)
Published on: 16/03/2022
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Polish (PDF)
Published on: 16/03/2022
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