Страна: Велика Британія
мова: англійська
Джерело: VMD (Veterinary Medicines Directorate)
Yersinia ruckeri
MSD Animal Health UK Limited
QI10BB03
Yersinia ruckeri
Concentrate for dip suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Trout - Golden/Rainbow/Redband/Steelhead
Inactivated Bacterial Vaccine
Authorized
2004-08-03
Revised: August 2020 AN: 00299/2020 PAGE 1 OF 4 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. Revised: August 2020 AN: 00299/2020 PAGE 2 OF 4 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS Only vaccinate healthy fish. 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 manipulations such as sorting and transportation during the periods shortly before and after vaccination SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Personal protective equipment consisting of rubber gloves should be worn during all vaccination operations. 4.6 ADVERSE REACTIONS (FREQ Прочитайте повний документ