APVMA VETERINARY USE PERMIT 80239- YERSINIVAC-B VACCINE/ SALMONIDS / YERSINIA RUCKERI

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

Yersinia ruckeri

Available from:

APVMA PERMIT

INN (International Name):

Yersinia ruckeri

Manufactured by:

INTERVET AUSTRALIA

Therapeutic area:

vaccine

Product summary:

To aid in the control of Yersinia ruckeri of salmonid fish farmed in Tasmanian waters.

Authorization status:

Registered and available

Authorization date:

2015-04-14

Patient Information leaflet

PERMIT TO ALLOW SUPPLY AND USE OF AN UNREGISTERED VETERINARY
CHEMICAL PRODUCT
PERMIT NUMBER – PER80239
This permit is issued to the Permit Holder under Section 112 of the
Agricultural and Veterinary
Chemicals Code, scheduled to the _Agricultural and Veterinary
Chemicals Code Act 1994_ (the
Agvet Code) of the jurisdictions set out below. This permit allows a
Supplier (as indicated) to
possess The Product for the purposes of supply, the doing of which
would otherwise be an
offence under section 78 of the Agvet Code, and to supply The Product
to a person who can use
The Product under permit. This permit allows a person, as stipulated
below, to use The Product
in the manner specified in this permit in the designated
jurisdictions. This permit also allows
the Permit Holder, the Supplier (if not one and the same) and any
person stipulated below to
claim that The Product can be used in the manner specified in this
permit.
THIS PERMIT IS IN FORCE FROM 14 APRIL 2015 TO 30 MARCH 2020.
PERMIT HOLDER:
INTERVET AUSTRALIA PTY LIMITED
91-105 Harpin Street
BENDIGO EAST VIC 3550
PERSONS AUTHORISED BY THIS PERMIT TO SUPPLY THE PRODUCT AND MAKE
CLAIMS:
INTERVET AUSTRALIA PTY LIMITED
91-105 Harpin Street
BENDIGO EAST VIC 3550
PERSONS AUTHORISED BY THIS PERMIT TO USE THE PRODUCT AND MAKE CLAIMS:
All registered veterinarians and people under their direction
PRODUCT TO BE USED:
YERSINIVAC-B VACCINE
(INACTIVATED)
containing Yersinia ruckeri 1 x 10
10
cells/mL
as the only active constituent.
DIRECTIONS FOR USE:
ANIMAL
PURPOSE
DOSE
Salmonids farmed in
Tasmanian waters
To aid in the control of
Yersinia ruckeri of salmonid
fish
See attached label
(Attachment 1)
CRITICAL USE COMMENTS:

Fish should weigh not less than 2g.

Monitoring: Intensive monitoring for the initial 24 hours post
vaccination with
continued monitoring for two weeks post vaccination.
WITHHOLDING PERIOD:
NIL
JURISDICTION:
Tasmania
CONDITIONS
SUPPLY
1)
Intervet (Australia) Pty Ltd must supply the product in a container
that must:
a.
be impervious to, and incapable of