PROMEX 10 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(10mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

ACEPROMAZINE AS ACEPROMAZINE MALEATE THIAZOLE Active 10.0 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 10 Tranquilliser Tablets
Specification No:
LB-PROMEX1
OIA
Supersedes:
N/A
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUTOF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
PROMEX
10
TABLETS
TRANQUILLISER
Each
tablet
contains:
ACEPROMAZINE MALEATE
EQUIV
ALENT
TO
10mg
ACEPROMAZJNE
BASE
INDICATIONS:
TRANQUILLISER
FOR
SEDATION
AND/OR
PRE-ANAESTHETIC
MEDICATION OF
DOGS
AND
CATS.
(150 Tablets/500 Tablets.)
F:~word\REGO\LABELS\P562LAB.
DOC
Page
1
of
1
29 October 2001
Label;
Self
adhesive
DIRECTIONS FOR
USE:
1/2
TO 1-1/2 TABLETS/5kg BODYWEIGHT
Apex
laboratories
pty
Ltd
61 Chivers Rd,
Somersby
NSW 2250
Australia.
Dispose
of
empty
container
by
wrapping
with
paper
and
putting
in
garbage.
Store
Below
25°C (Air
Conditioning).
NRA:
35680/
C
50
L-
Batch:
Expiry:
MADE IN AUSTRALIA FROM LOCAL
AND
IMPORTED
INGREDIENTS

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