AQUAVAC VIBRIO ORAL
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
17-03-2012
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Active ingredient:
vibrio anguillarumvibrio ordalii 60 % RPS60
Available from:
Intervet Intenational BV
ATC code:
QI10BB01
Pharmaceutical form:
Oral emulsion
Therapeutic group:
Vibrio vaccine
Therapeutic area:
Fish
Authorization date:
2012-01-18
Summary of Product characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS
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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.
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