APVMA VETERINARY USE PERMIT 14172- ILIUM METHOCARBAMOL INJECTION/ HORSES, CATS, DOGS/ MUSCLE RELAXANT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

methocarbamol(100mg/Ml)

Available from:

APVMA PERMIT

INN (International Name):

methocarbamol(100mg/Ml)

Manufactured by:

TROY LABORATORIES

Therapeutic area:

muscle relaxant

Product summary:

For use as directed by prescribing veterinarian for use as a muscle relaxant. The prescribing veterinarian is responsible for safe and effective use of this unregistered product in horses, dogs and cats. (Permit for use by registered veterinary surgeons)The product is contraindicated for use in pregnant or lactating animals. Permit restricted to use by registered veterinary surgeons.

Authorization status:

Registered and available

Authorization date:

2015-08-18

Patient Information leaflet

PER14172
Permit Version 2
Page 1 of 7
PERMIT TO ALLOW POSSESSION AND SUPPLY
OF AN UNREGISTERED AGVET CHEMICAL PRODUCT
PERMIT NUMBER –PER14172
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, 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 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 8 JULY 2013 TO 31 JULY 2017
PERMIT HOLDER AND SUPPLIER:
TROY LABORATORIES PTY LTD
31-35 Glendenning Road
GLENDENNING NSW 2761
PERSONS AUTHORISED BY THIS PERMIT TO POSSESS AND USE THE PRODUCT:
Registered veterinary surgeons, for use in animals under their care,
as permitted under State legislation
in the jurisdiction in which they practice their profession.
PRODUCT TO BE SUPPLIED:
ILIUM METHOCARBAMOL INJECTION
Containing:
100.00 mg/mL METHOCARBAMOL as the only active constituent. This
product is NOT
registered.
JURISDICTION:
ALL STATES
PER14172
Permit Version 2
Page 2 of 7
DIRECTIONS FOR USE:
Permit Holder suggestions based on indications and dosage and
administration derived from NADA
038-838 and product literature for Robaxin V Injection (Fort Dodge), a
100mg/ml methocarbamol
product available in the USA. Dosage and frequency should be based on
the severity of symptoms and
on the therapeutic response noted:
ANIMAL
PURPOSE
DOSE
_Horses_
Use as directed by prescribing
Intravenous injection only
veterinarian for use as a
_Moderate conditions_: 4.4-22mg/kg
muscle relaxant.
bodyweight.
The prescribing veterinaria