A.C.P. 10 ANAESTHETIC PREMEDICATION, TRANQUILLISER AND TRAVEL SICKNESS STERILE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

01-07-2013

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

ACEPROMAZINE MALEATE

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

acepromazine as maleate(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ACEPROMAZINE MALEATE THIAZOLE Active 13.5 mg/ml

Units in package:

100mL; 20mL

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

Therapeutic area:

CENTRAL NERVOUS SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): DO N OT USE less than 28 days before slaught er for human consumption. MEAT: DO NOT USE less than 2 days before slaughter f or human consumption. Milk collected fr om cows/ewes/does within 48 hours follo wing treatment MUST NOT BE USED for hum an consumption or processing or fed to bobby calves. TRADE ADVICE: EXPORT LAAUGTER INTERVAL(ESI): This product d oes not have an ESI established. For a dvice on ESI contact Ceva Animal Heal th on (61) 2 9652 7000 before using thi s 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: ; Host/pest details: CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIGS: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]; Anaesthetic premedication, tranquilliser & travel sickness sterile injection for horses, cattle, pigs & sheep.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FILE NAME: ACP 10 20ML INJECTION LABEL 40076/20/0108
Date: 25/6/08
Label Dimensions (in mm): 87 X 35
Scale when printed on A4 paper: 100% . COLOUR: 144C
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
A.C.P. 10
ANAESTHETIC PREMEDICATION
TRANQUILLISER & TRAVEL SICKNESS
STERILE INJECTION
Each mL contains:
ACEPROMAZINE MALEATE 13.5MG
EQUIVALENT TO ACEPROMAZINE 10MG
20ML

APPROVED
LABEL

Info

PEST

Verified

FILE NAME: ACP 10 100ML INJECTION LABEL 40076/100/0108
Date: 25/6/08
Label Dimensions (in mm): 87 X 35
Scale when printed on A4 paper: 100% . COLOUR: 144C
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
A.C.P. 10
ANAESTHETIC PREMEDICATION
TRANQUILLISER & TRAVEL SICKNESS
STERILE INJECTION
Each mL contains:
ACEPROMAZINE MALEATE 13.5MG
EQUIVALENT TO ACEPROMAZINE 10MG
100ML

APPROVED
LABEL

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Summary of Product characteristics

PRODUCT NAME: A.C.P. ANAESTHETIC PREMEDICATION TRANQUILLISER & TRAVEL
SICKNESS STERILE INJECTION
PAGE: 1 OF 5
THIS REVISION ISSUED: OCTOBER, 2008
MATERIAL SAFETY DATA SHEET
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POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800 764 766 IN NEW ZEALAND)
SECTION 1  IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
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SUBSTANCE:
Active ingredient is a phenothiazine derivative.
TRADE NAME:
A.C.P. ANAESTHETIC PREMEDICATION TRANQUILLISER & TRAVEL SICKNESS
STERILE INJECTION
OTHER NAMES:
Note: This MSDS is intended for both A.C.P. 2 and A.C.P. 10 Injectable products.
PRODUCT CODE:
APVMA 36680 (A.C.P. 2) and 40076 (A.C.P. 10)
PRODUCT USE:
Injectable anaesthetic premedication, tranquilliser and travel sickness medication for
animals.
CREATION DATE:
OCTOBER, 2008
THIS REVISION ISSUED:
OCTOBER, 2008
SECTION 2  HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Not classified as hazardous according to the criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.
RISK PHRASES: Not Hazardous  No criteria found.
SAFETY PHRASES: S25. Avoid contact with eyes.
SUSDP CLASSIFICATION: S4
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER: None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR: Clear, light yellow (ACP 2) or orangeyellow (ACP 10) liquid.
ODOUR: No data; expected to be almost odourless.
MAJOR HEALTH HAZARDS: no significant risk factors have been found for thi

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