APVMA VETERINARY USE PERMIT 83551-MYCOBACTERIUM/ CATTLE / TUBERCULOSIS

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes ativos:

tuberculin ppd (bovine)+M. paratuberculosis

Disponível em:

APVMA PERMIT

DCI (Denominação Comum Internacional):

tuberculin ppd (bovine)+M. paratuberculosis

Fabricado por:

ASSUREQUALITY AUST

Área terapêutica:

vaccine

Resumo do produto:

For testing for bovine tuberculosis in cattle

Status de autorização:

Registered and available

Data de autorização:

2017-02-22

Folheto informativo - Bula

PER 83551
Permit Version 1
Page 1 of 6
PERMIT TO ALLOW USE AND SUPPLY
OF AN UNREGISTERED AGVET CHEMICAL PRODUCT
PERMIT NUMBER –PER83551
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
person, as stipulated below, to use the product in the manner
specified in this permit in the
designated jurisdictions. This permit also allows any person to claim
that the product can be
used in the manner specified in this permit.
THIS PERMIT IS IN FORCE FROM 22 FEBRUARY 2017 TO 31 MARCH 2020.
PERMIT HOLDER AND SUPPLIER:
ASSUREQUALITY AUSTRALIA PTY LTD
28 Mareno Road
Tullamarine VIC 3043
PERSONS WHO CAN USE THE PRODUCT UNDER THIS PERMIT:
Registered Veterinary surgeons
In Queensland for animals destined for export all tests must be
conducted by a registered veterinarian in
AQIS approved facilities / feedlots.
In all other states supply must be approved by the Chief Veterinary
Officer or delegated state veterinary
officer.
CONDITIONS OF USE
PRODUCT TO BE USED:
OBSERVE BOVINE TUBERCULIN PPD 30,000 IU/mL
Containing: 30,000 IU/mL MYCOBACTERIUM BOVIS AN5 STRAIN as the only
active
constituent.
OBSERVE AVIAN TUBERCULIN 25,000 IU/mL
Containing: 25,000 IU/mL MYCOBACTERIUM AVIUM D4ER STRAIN as the only
active
constituent
PER 83551
Permit Version 1
Page 2 of 6
DIRECTIONS FOR USE:
ANIMAL
PURPOSE
DOSE
CATTLE
TESTING FOR BOVIVE
TUBERCULOSIS
intradermal injection of 0.1mL
CRITICAL USE COMMENTS:

Apply in STRICT accordance with information listed in ATTACHMENTS 1.
WITHHOLDING PERIOD: NIL
JURISDICTION: ALL States
ADDITIONAL CONDITIONS:
PERSONS who wish to prepare for use and/or use the products for the
purposes specified in
this permit must read, or have read to them, the permit particularly
the information included in
DETAILS OF PERMIT and CONDITIONS OF PERMIT.
Issued by Australian Pesticides and Veterinary Medicines Authority
PER 83551
Permit Version 1
Page 3 of 6
ATTACHMENT 1
THIS IS NOT A REGISTERED LA