ILIUM ATIPAMEZOLE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ATIPAMEZOLE HYDROCHLORIDE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

atipamezole HCl(5mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ATIPAMEZOLE HYDROCHLORIDE UNGROUPED Active 5.0 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

ANTIDOTES

Therapeutic indications:

MEDETOMIDINE REVERSING AGENT&ANTAGONIST

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; DOG: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; DOG: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; For parenteral use in reversing and abolishing the effects of medetomidine hydrochloride in dogs and cats.Not for use in pregnant bitches. See PRECAUTIONS & SIDE EFFECTS on product leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
ILIUM ATIPAMEZOLE INJECTION
66256/126372
Label Name:
ILIUM ATIPAMEZOLE INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
5 mg/mL ATIPAMEZOLE HYDROCHLORIDE
Claims:
For parenteral use in reversing and abolishing the effects of
medetomidine hydrochloride in
dogs and cats.
Atipamezole is a selective α2 adrenergic receptor antagonist which is
capable of reversing
and abolishing the effects of medetomidine hydrochloride in dogs and
cats.
Net Contents:
10 mL
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated for use in pregnant bitches.
Precautions:
Due to the potent pharmacological activity of atipamezole, skin
contact with Ilium
Atipamezole Injection should be avoided. Wipe any excessive spillage
from the animal’s
skin.
Side Effects:
In dogs, a transient hypotensive effect has been observed during the
first 10 minutes post-
injection.
Vomiting and panting after atipamezole injection have been reported,
but these effects
appear to be rare.
Transient over-alertness and tachycardia may be observed after a
possible overdosage. RLP APPROVED
Dosage and
Administration:
Use the contents of this vial within 3 months of initial use. Discard
any unused portion.
Administer by intramuscular injection.
(Table)
Ilium Atipamezole Injection is quickly absorbed and is generally
administered 15 to 60
minutes after the medetomidine dose.
This section contains file attachment.
General Directions:
Withholding Periods:
Trade Advice:
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131126.
First Aid Warnings:
Additional User
Safety:
Environmental
Statements:
Disposal:
Dispose of container by wrapping with paper and putting in garbage.
Storage:
Store below 30 °C (room temperature). Protect from light. Store the
vial upright.
DOSAGE AND ADMINISTRATION
ANIMAL
DOSE (ΜG/KG)
QUANTITY
DOG
5 times that of the
previous me

Summary of Product characteristics

SAFETY DATA SHEET
PRODUCT NAME: ILIUM ATIPAMEZOLE INJECTION
PAGE: 1 OF 5
THIS REVISION ISSUED: DECEMBER, 2012
SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
[phone]
31-35 GLENDENNING ROAD
FAX:
[phone]
GLENDENNING NSW 2761
CHEMICAL NATURE:
Atipamezole is a synthetic alpha2-adrenergic antagonist in water
solution for injection.
TRADE NAME:
ILIUM ATIPAMEZOLE INJECTION
PRODUCT USE:
For use as a reversing agent of medetomidine in dogs and cats.
CREATION DATE:
DECEMBER, 2012
THIS VERSION ISSUED:
DECEMBER, 2012
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S45, S24/25. In case of accident or if you feel unwell, contact a
doctor or Poisons Information
Centre immediately (show this MSDS where possible). Avoid contact with
skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
RESPONSE
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, colourless solution, free of lint, dirt or suspended
particulate matter.
ODOUR:
No data re odour.
MAJOR HEALTH HAZARDS:
no significant risk factors hav