ACESEDATE 10 MG/ML INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ACEPROMAZINE MALEATE

Available from:

JUROX PTY LIMITED

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ACEPROMAZINE MALEATE THIAZOLE Active 13.55 mg/ml

Units in package:

20 mL; 50 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

CENTRAL NERVOUS SYSTEM

Product summary:

Poison schedule: 4; Withholding period: MEAT (HORSES): DO NOT USE less than 28 d ays before slaughter for human consumpti on. MEAT (CATTLE, PIGS, SHEEP): DO NOT USE less than 2 days before slaughter fo r human consumption. MILK: Milk collect ed from cows/ewes within 48 hours follow ing treatment MUST NOT BE USED for human consumption or processing, or fed to bo bby calves. An ESI has not been establi shed for this product. Note—observing t he meat withholding period may not be su fficient to mitigate potential risks to export trade. Trade advice should be sou ght from Jurox Pty Limited on 1800 023 3 12 before using this product.; Host/pest details: CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIGS: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: MEAT (HORSES): DO NOT USE less than 28 d ays before slaughter for human consumpt ion. MEAT (CATTLE, PIGS, SHEEP): DO NOT USE less than 2 days before slaughter f or human consumption. MILK: Milk colle cted from cows/ewes within 48 hours foll owing treatment MUST NOT BE USED for hu man consumption or processing, or fed to bobby calves. An ESI has not been esta blished for this product. Note—observin g the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice should be sought from Jurox Pty Limited on 1800 0 23 312 before using this product.; Host/pest details: CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIGS: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
ACESEDATE 10 MG/ML INJECTION
88055 / 120152
Label Name:
ACESEDATE 10 MG/ML INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Acepromazine maleate 13.55 mg/mL (equivalent to acepromazine 10.0
mg/mL)
Claims:
Anaesthetic Premedication, Tranquiliser and Travel Sickness Sterile
Injection for horses,
cattle, pigs and sheep
Net Contents:
20 mL
50 mL
Directions for Use:
Restraints:
FOR USE ONLY BY OR UNDER the direction of a registered veterinary
surgeon.
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
Use the contents of the vial within 28 days of first broaching of the
vial. Discard any unused
portion.
Horses, cattle, pigs and sheep: 0.25 mL to 0.5 mL per 50 kg body
weight I.M. or slow I.V.
Administer 1 - 3 minutes prior to the desired effect and await
clinical signs of tranquillisation
before travel or subsequent administration of anaesthetic. For
tranquillisation adjust dosage
to maintain desired effect for the duration of travel or procedure. RLP APPROVED
General Directions:
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS
LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION
Withholding Periods:
MEAT (HORSES): DO NOT USE less than 28 days before slaughter for human
consumption.
MEAT (CATTLE, PIGS, SHEEP): DO NOT USE less than 2 days before
slaughter for
human consumption.
MILK: Milk collected from cows/ewes within 48 hours following
treatment MUST NOT BE
USED for human consumption or processing, or fed to bobby calves.
Trade Advice:
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product.
Note—observing the meat withholding period may not be sufficient to
mitigate potential
risks to export trade. Trade advice should be sought from Jurox Pty
Limited on 1800 023
312 before using this product.
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 13 11
26.
Firs