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

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Yersinia ruckeri

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI10BB03

INN (שם בינלאומי):

Yersinia ruckeri

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Trout - Golden/Rainbow/Redband/Steelhead

איזור תרפויטי:

Inactivated Bacterial Vaccine

מצב אישור:

Authorized

תאריך אישור:

2009-05-15

מאפייני מוצר

Revised: June 2020
AN. 00218/2020
Page 1 of 5
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.
Revised: June 2020
AN. 00218/2020
Page 2 of 5
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.
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 administer