APVMA VETERINARY USE PERMIT 12575- CUSTOM INACTIVATED STREPTOCOCCUS SUIS VACCINE/ PIGS/ PROTECTION AGAINST STREPTOCOCCUS SUIS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

Streptococcus suis

Available from:

APVMA PERMIT

INN (International Name):

Streptococcus suis

Manufactured by:

ANIMAL CONSULT. ENT.

Therapeutic area:

vaccine

Product summary:

To control disease caused by Streptoococcus suis in pigs using an unregistered product

Authorization status:

Registered and available

Authorization date:

2016-01-20

Patient Information leaflet

PER12575
Permit Version 3
Page 1 of 4 PERMIT TO ALLOW SUPPLY AND MINOR USE
OF AN AGVET CHEMICAL PRODUCT
PERMIT NUMBER - PER12575
This permit is issued to the Permit Holder in response to an
application granted by the APVMA
under section 112 of the Agvet Codes of the jurisdictions set out
below. This permit allows a
Supplier (as indicated) to possess the product for the purposes of
supply and to supply the
product to a person who can use the product under permit. This permit
also 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 21 JANUARY 2011 TO 31 MARCH 2020.
PERMIT HOLDER:
ANIMAL CONSULTING ENTERPRISES
20 Gildea lane
BENDIGO EAST VIC 3550
SUPPLIER:
ANIMAL CONSULTING ENTERPRISES
20 Gildea lane
BENDIGO EAST VIC 3550
CONDITIONS
PERSONS WHO CAN USE THE PRODUCT UNDER THIS PERMIT:
Registered veterinary surgeons and persons acting under their
direction.
PRODUCT TO BE USED (THE PRODUCT):
Custom inactivated _Streptococcus suis_ vaccine for pigs
Containing 0.5– 1.5 x10
9
cfu/mL _Streptococcus suis _as the only active constituent.
DIRECTIONS FOR USE:
ANIMAL PURPOSE DOSE
Pigs To control disease caused by As directed by the veterinarian
_Streptococcus suis_
PER12575
Permit Version 3
Page 2 of 4
SUPPLY
1.
Animal Consulting Enterprises may supply custom inactivated
_Streptococcus suis_
vaccine for pigs to registered veterinarians if:
a.
The preparation of the Product is restricted to cultures of
microorganisms which
have been inactivated and are non-toxic.
b.
The Product must be prepared in a GMP category 1 (immunobiologicals)
licensed
facility.
c.
Where imported biological materials are used, evidence of current
Department of
Agriculture and Water Resources biological import permit must be
provided on
request.
d.
In-process
con