AquaVac ERM Oral. Oral emulsion for rainbow trout

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Yersinia ruckeri cells inactivated (Hagerman type 1 stain)

Available from:

Intervet Ireland Limited

ATC code:

QI10BB03

INN (International Name):

Yersinia ruckeri cells inactivated (Hagerman type 1 stain)

Dosage:

.

Pharmaceutical form:

Oral emulsion

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Trout

Therapeutic area:

yersinia

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2006-03-01

Summary of Product characteristics

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
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