APVMA VETERINARY USE PERMIT 13801- CAMELPLAS/ CAMELIDS/ INCREASE GAMMA GLOBULINS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

camel gamma globulins(15g/L)

Available from:

APVMA PERMIT

INN (International Name):

camel gamma globulins(15g/L)

Manufactured by:

PLASVACC

Therapeutic area:

immunomodifying agent

Product summary:

To increase the gamma globulin levels in Camelid neonates, especially cases of failure of passive transfer.

Authorization status:

Registered and available

Authorization date:

2015-12-24

Patient Information leaflet

PER13801
Permit Version 2
Page 1 of 5
PERMIT TO ALLOW SUPPLY AND USE OF AN UNREGISTERED VETERINARY
CHEMICAL PRODUCT
PERMIT NUMBER –PER13801
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, 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 16 JANUARY 2013 TO 16 JANUARY 2019.
PERMIT HOLDER AND SUPPLIER:
PLASVACC PTY LTD
RIGBY 6066 CUNNINGHAM HIGHWAY
KALBAR QLD 4309
PERSONS WHO CAN USE THE PRODUCT UNDER THIS PERMIT:
To be used by or under the supervision of a registered veterinary
surgeon.
CONDITIONS OF USE
PRODUCT TO BE USED:
CAMELPLAS Camelid Gamma Globulins
Containing: 15g/L Camel Gamma Globulins as the only active
constituent.
ANIMAL
PURPOSE
DOSE
Camelids
To increase the gamma globulin levels in Camelid
neonates, especially cases of failure of passive
transfer
As directed by a
registered veterinary
surgeon
PER13801
Permit Version 2
Page 2 of 5
WITHHOLDING PERIOD: Meat: NIL
JURISDICTION:
ALL STATES
CONDITIONS
SUPPLY
1.
PLASVACC P/L must ensure that the donor animals are tested for Johne's
disease, Blue
Tongue and Enzootic Bovine Leucosis before entry to the property in
Queensland and at
each plasma collection.
2.
The product must not be supplied, sold or used if it does not pass all
the quality control
testing.
3.
PLASVACC P/L must supply the product in a container that complies with
the
requirements of section 18(1) of the Agricultural