AQUAVAC ERM ORAL

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)

Mevcut itibaren:

Intervet Ireland Limited

INN (International Adı):

YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN)

Doz:

Unknown

Farmasötik formu:

Oral Emulsion

Reçete türü:

POM

Terapötik grubu:

Fish - (Rainbow) Trout

Terapötik alanı:

Immunological - Inactivated vaccine

Terapötik endikasyonlar:

Immunological - Inactivated vaccine

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2011-06-23

Ürün özellikleri

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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/09/2014_
_CRN 7018774_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The safety and efficacy of AquaVac ERM Oral has only been demonstrated when the product was used after fish had
been