PROMEX 25 TABLETS TRANQUILLISER

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ACEPROMAZINE AS ACEPROMAZINE MALEATE

Available from:

Dechra Veterinary Products (Australia) Pty. Ltd.

INN (International Name):

acepromazine as maleate(25mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

ACEPROMAZINE AS ACEPROMAZINE MALEATE THIAZOLE Active 25.0 mg/Tb

Units in package:

150 Tabs; 500 Tabs

Class:

VM - Veterinary Medicine

Manufactured by:

APEX LABORATORIES

Therapeutic group:

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

Therapeutic area:

CENTRAL NERVOUS SYSTEM

Therapeutic indications:

PRE-ANAESTHETIC | TRANQUILLISER | ANAESTHETIC PREMEDICANT | CALMING AGENT | SEDATIVE

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [PRE-ANAESTHETIC, TRANQUILLISER]; DOG: [PRE-ANAESTHETIC, TRANQUILLISER]; Tranquilliser for sedation and/or pre-anaesthetic medication of dogs and cats.

Authorization status:

Stopped

Authorization date:

2018-06-30

Patient Information leaflet

Apex Laboratories Pty Ltd
Promex 25 Tranquilliser Tablets
Specification No: LB-PROMEX25/A
Supersedes:
N/A
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
PROMEX
25
TABLETS
TRANQUILLISER
EACH
TABLET
CONTAINS:
ACEPROMAZINE
MALEATE
EQUIV
ALENT
TO
25mg
ACEPROMAZINE
BASE
PER
TABLET
INDICATIONS:
TRANQUILLISER
FOR
SEDATION
AND/OR
PRE-ANAESTHETIC
MEDICATION OF DOGS AND
CATS.
(150
Tablets/500
Tablets)
F:\WOrd\REGO\LABEL~4LAB.DOC
Page 1 of
1
29 October 2001
Label: Self adhesive
DIRECTIONS
FOR
USE:
Y2
TO 1
Y2
TABLETS/12.5KG
BODYWEIGHT.
APEX
LABORATORIES
PTY
LTD
61
Chivers Rd Somersby
NSW
2250
Australia
Dispose of
empty
container
by
wrapping
in
paper
and
putting
in
garbage.
Store Below 25°C (Air Conditioning)
NRA:
_35682/0SD'L_
Batch:
Expiry:
MADE IN
AUSTRALIA
FROM
IMPORTED
AND LOCAL
INGREDIENTS
N
..
R.
..
A.
~::~~:E~;~k;~~
.
Date:
_.J§":_
_.._
l
~.J-:?~.·
signatureA:
..
/-
' ....
I
I
_V_

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PROMEX TRANQUILLISER 10MG & 25MG TABLETS
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Promex Tranquilliser 10mg & 25mg Tablets
Recommended Use
Tranquillisation, travel sickness, preanaesthetic medication.
Supplier Details
Apex Laboratories Pty. Ltd.
ACN Number
000 397 240
Street
61 Chivers Road
Suburb
Somersby
State
NSW
Country
Australia
Post Code
2250
Phone
[phone] (Business hours – 8.30am – 5.00pm)
Fax
[phone] (fax)
Website
http://www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
Classification
Not classified as hazardous according to the criteria of NOHSC
Risk Phrases
None allocated
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
INGREDIENTS
CAS NO
PROPORTION
TWA MG/M3
STEL MG/M3
Acepromazine
3598-37-6
<10%
not set
not set
Other non hazardous ingredients
NA
to 100%
NA
NA
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a normal 8 hour working day
for a 5 day
working week over an entire working lifetime. The TWA exposure
standard set by Worksafe Australia for dusts not otherwise specified
is 10mg/m3. The
STEL (Short Term Exposure Limit) is an exposure value that should not
be exceeded for more than 15 minutes and should not be repeated for
more than 4
times per day. There should be at least 60 minutes between successive
exposures at the STEL.
Ingestion
Rinse mouth with water, give water to drink and seek medical advice.
Eye
Irrigate with copious quantities of lukewarm water for 10 minutes and
seek
medical advice.
Skin
Wash well with soap and water and if concerned seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and seek
medical
advice.
Extinguishing Media
Dry chemical powder, water fog, mist or spray, carbon dioxide. As
appropriate for surrounding material.
Combustion Hazards
Toxic fumes may be emitted under fire conditions.
Precautions fo