AquaVac Relera Concentrate for Dip Suspension or Suspension for Injection for Rainbow Trout

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Yersinia ruckeri

Tilgjengelig fra:

Intervet International BV

ATC-kode:

QI10BB03

INN (International Name):

Yersinia ruckeri

Legemiddelform:

Suspension for injection

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Trout (Rainbow)

Terapeutisk område:

Inactivated Bacterial Vaccine

Autorisasjon status:

Authorized

Autorisasjon dato:

2009-05-15

Preparatomtale

Revised: June 2014
AN. 00918/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AquaVac Relera
Concentrate for dip suspension or suspension for injection for Rainbow
Trout
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Inactivated cells of _Yersinia ruckeri_
(Hagerman type 1 strain)
≥ 75% RPS*
Inactivated cells of _Yersinia ruckeri_
(EX5 biotype strain)
≥ 75% RPS*
EXCIPIENT
Residual Formaldehyde
≤ 0.05% w/v
*RPS : relative percentage of survival in Rainbow Trout
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for dip suspension or suspension for injection
Suspension in brown aqueous liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rainbow trout (Oncorhynchus mykiss)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunization against Enteric Redmouth disease (ERM) to reduce
mortality caused by Hagerman type 1 and EX5 biotype strains of
Yersinia ruckeri.
Immersion route:
Onset of immunity:
336 degree days (28 days at 12°C) for Hagerman type 1 and for EX5
biotype.
Duration of immunity:
6 months (205 days at 12°C) for the Hagerman type 1.
4 months (133 days at 12°C) for the EX5 biotype.
Please note that the level of protection against the EX5 biotype wanes
during the
indicated period.
Page 1 of 5
Revised: June 2014
AN. 00918/2013
Injection route (only for booster vaccination):
Duration of immunity:
Immunity has not been studied beyond 28 days (336 degree days).
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The minimum weights for fish before vaccination must be respected (see
section
4.9 of the SPC).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only vaccinate healthy fish.
Do not vaccinate if the water temperature is below 12°C.
Avoid stress at the time of the handling of fish, as well as
temperature variations,
in particular between the vaccine suspension and the water of the
holding area.
Special precautions to be taken by the persons administering the
vete