Veterinary Medicines

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
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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, Inactivated
    2.58
    unknown
    /
    2.00
    millilitre(s)
  • Bovine coronavirus, strain C-197, Inactivated
  • Escherichia coli, fimbrial adhesin F5
    40.00
    enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection/infusion
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

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:

Documents

Labelling

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Polish (PDF)
Published on: 16/03/2022
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Summary of Product Characteristics

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Polish (PDF)
Published on: 16/03/2022
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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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