AUREOMYCIN SOLUBLE CONCENTRATE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

CHLORTETRACYCLINE HYDROCHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

chlortetracycline HCl(900g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

CHLORTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 900.0 g/kg

Units in package:

20kg; 50kg

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT Therapeutic Use: Remove all medicated water 7 days before slaughter for human consumption. Prophylactic U se: a) Pigs - remove all medicated wate r 5 days before slaughter for human con sumption and b) Poultry - remove all m edicated water 4 days before slaughter for human consumption. EGGS: NIL; Host/pest details: PIGS: [BACTERIAL ENTERITIS, PNEUMONIA, SECONDARY INFECTION]; POULTRY: [CORYZA, HEXAMITIASIS, MYCOPLASMOSIS, NON-SPECIFIC BACTERIAL ENTERITIS, PASTEURELLA MULTOCIDA, SALMONELLA, STAPHYLOCOCCUS SPP.]; Poison schedule: 4; Withholding period: ; Host/pest details: PIGS: [BACTERIAL ENTERITIS, PNEUMONIA, SECONDARY INFECTION]; POULTRY: [CORYZA, HEXAMITIASIS, MYCOPLASMOSIS, NON-SPECIFIC BACTERIAL ENTERITIS, PASTEURELLA MULTOCIDA, SALMONELLA, STAPHYLOCOCCUS SPP.]; For prevention or treatment of diseases of poultry and pigs caused by micro-organisms sensitive to chlortetracycline.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FORT DODGE AUSTRALIA DRAFT LABEL
Product
Name: AUREOMYCIN SOLUBLE CONCENTRATE
DATE:
1
s
September 2003
Page 1
of
2
Product
Size:
20 kg and 50 kg
Descriplion:
PRIMARY LABEL - FRONT PANEL,
SIDE PANELS 1
&
2
PRODUCT
CODE:
Version:
AUSTRALIA
File number:
REVISION
#:2
DATE OF APPROVAL:
APPROVAL
DATE:
REASON:
Repack application of
Aureomvcin 950 Soluble Concentrate
Text above this line is not included in the label
copy,
_Frontpanel_
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
AUREOMYCIN*
SOLUBLE CONCENTRATE
Active
constituent:
900
glkg
CHLORTETRACYCLINE
hydrochloride
For prevention or treatment of diseases of poultry and pigs caused by
micro-organisms sensitive to chlortetracycline, such as:
POULTRY:
Mycoplasrnosis (especially when complicated by secondary infections
caused by
_E._
coli
or other bacteria),
coryza,
salmonellosis, staphylococcosis,
fowl
cholera,
hexamitiasis and non-specific bacterial
enteritis.
PIGS:
Bacterial
enteritis,
bacterial
pneumonia and secondary bacterial
infections.
Fort
Dodge
Australia
Pty
Limited
Parkview Business Centre,
1 Maitland Place, BAULKHAM HILLS NSW 2153
APVMA
APPROVED
LABEL
COpy
CONTENTS
20
KG/50
KG
BATCH NO.
APVMA Approval
NO.58255/50KG/0104
_Side_
_panel]_
PRODUCT NO.
EXPIRY DATE
DIRECTIONS FOR USE
AUREOMYCIN SOLUBLE CONCENTRATE should be administered in drinking
water
of poultry.
For pigs,
use as a drench or administer in the drinking water,
milk or milk
replacer,
at the rates shown below.
Prepare fresh solutions daily and ensure that full
dose is consumed within 24 hours.
Continue treatment until
symptoms are relieved.
If no improvement is evident
after five
days treatment,
re-appraise the diagnosis.
During treatment, do not
supply liquid
which is not medicated until
the medicated liquid has been consumed.
Where poultry or pigs are in conditions likely to predispose towards
disease,
or are
subjected to stress such as prolonged transport,
AUREOMYCIN SOLUBLE
CONCENTRATE should be administered prophylactically as directed,
for periods up to
2

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Summary of Product characteristics

PRODUCT NAME: AUREOMYCIN® SOLUBLE CONCENTRATE
PAGE: 1 OF 5
THIS REVISION ISSUED: JULY, 2012
SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: 1800 814 883
Fax: (02) 9850 3399
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Tetracycline antibiotic in soluble form
TRADE NAME:
AUREOMYCIN
® SOLUBLE CONCENTRATE
OTHER NAMES:
Chlortetracycline Hydrochloride
APVMA CODE:
58255
PRODUCT USE:
Prevention and treatment of certain diseases of poultry and pigs. See
label for details.
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
JULY, 2012
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
N, Dangerous to the environment. Not classified as hazardous according
to the
criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R53. May cause long term adverse effects in the aquatic environment.
SAFETY PHRASES:
S22, S36, S24/25. Do not breathe dust. Wear suitable protective
clothing. 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
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Finely divided tan to dark brown powder with granules.
ODOUR:
Mild fermented odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This
product is an antibiotic.
Any person with a history of allergies to this class of substances
should avoid all contact with this product as it may
cause sensitisation.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F

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