Страна: Франція
мова: англійська
Джерело: HMA (Heads of Medicines Agencies)
vibrio anguillarumvibrio ordalii 60 % RPS60
Intervet Intenational BV
QI10BB01
Oral emulsion
Vibrio vaccine
Fish
2012-01-18
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 5 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT AQUAVAC VIBRIO ORAL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES QUANTITY Inactivated cells of _Listonella_ (_Vibrio_)_ anguillarum_ strain 78-SKID RPS 60 (*) > 60% after administration Inactivated cells of_ Vibrio) ordalii_ _1_ strain MSC275 RPS 60 (*) > 60% after administration _(*) _ _RPS_ _60_ _ : relative percentage survival in vaccinates, at time of 60% of mortality in controls, after _ _oral vaccination and subsequent challenge _ EXCIPIENT Formaldehyde < 0.5 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral emulsion Pale yellow emulsion 4. CLINICAL PARTICULARS: 4.1 TARGET SPECIES Rainbow Trout (_Oncorhynchus mykiss_) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For Rainbow Trout, 12g or over: For the active immunisation of fish to reduce mortality due to vibriosis caused by _Listonella (Vibrio) anguillarum_ and _Vibrio ordalii_. Onset of immunity: 336 degree-days in case of use of Aquavac Vibrio Oral as a primary vaccine. A duration of immunity has not been demonstrated beyond this. For fish vaccinated by immersion with Aquavac Vibrio Immersion and Injection and revaccinated with Aquavac Vibrio Oral, protection was seen after 336 degree days. 4.3 CONTRAINDICATIONS Do not vaccinate fish during the incubation period of vibriosis. Do not vaccinate if the water temperature is below 10°C. 4. Прочитайте повний документ