Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)
Intervet Ireland Limited
QI10BB03
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)
Unknown
Concentrate for dip suspension
POM
Fish - (Rainbow) Trout
Yersinia vaccine
Immunological - Inactivated vaccine
Authorised
2010-10-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT AquaVac ERM. Concentrate for dip suspension for Rainbow trout. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE : Inactivated cells of _Yersinia ruckeri_ (Hagerman type I strain) RPS(*) ≥ 75% after vaccination EXCIPIENT: Formaldehyde: ≤ 0.5 mg/ml *RPS : relative percentage of survival in Rainbow Trout For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for dip suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Rainbow trout (_Oncorhynchus mykiss)._ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In Rainbow Trout of 2 grams weight or over: Active immunization against Enteric Redmouth disease (ERM) to reduce mortality caused by the Hagerman Type I strain of _Yersinia ruckeri._ 336 degree days are required for the development of full immunity (28 days at a water temperature of 12°C). The time for development of protective immunity will depend on water temperature. A duration of immunity of 78 days has been shown under laboratory conditions. Under field conditions, protection may be expected for at least 6 months. A booster vaccination administered 4 months after primary vaccination may induce a better level of protection. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only vaccinate healthy fish. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/10/2010_ _CRN 7008490_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS During vaccination, the temperature of the diluted vaccine should not differ from the water temperature in the holding area by more than ± 5 o C. Fish should be subject to the minimum of mani Прочитайте повний документ