Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)
Intervet Ireland Limited
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)
Unknown
Oral Emulsion
POM
Fish - (Rainbow) Trout
Immunological - Inactivated vaccine
Immunological - Inactivated vaccine
Authorised
2011-06-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT AquaVac ERM Oral. Oral emulsion for rainbow trout. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral Emulsion. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Rainbow trout (_Oncorhynchus mykiss)._ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunization of rainbow trout, 26g and above against Enteric Redmouth disease (ERM) to reduce mortality caused by the Hagerman Type I strain (serotype 01) of _Yersinia ruckeri_. The vaccine is indicated for use in fish that have been vaccinated by immersion with AquaVac ERM within the previous 4 to 6 months. The time to achieve full effect of the vaccination will depend on water temperature. In fish vaccinated by immersion 4.5 months previous to oral vaccination, vaccine efficacy was demonstrated under field conditions at water temperatures of 10°C, 21 days (210 degree days) after completion of the vaccine feeding protocol and protection was observed for the 3 month duration of the field trial. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not vaccinate fish at water temperatures below 5 o C. Only vaccinate healthy fish. ACTIVE SUBSTANCE Inactivated cells of _Yersinia ruckeri _(Hagerman type I strain): RPS*> 60% after vaccination. (*RPS: relative percentage survival in Rainbow trout). For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 01/09/2014_ _CRN 7018774_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The safety and efficacy of AquaVac ERM Oral has only been demonstrated when the product was used after fish had been Baca dokumen lengkapnya