TERRAMYCIN 200 FEED SUPPLEMENT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

OXYTETRACYCLINE HYDROCHLORIDE

Available from:

PHIBRO ANIMAL HEALTH PTY LIMITED

INN (International Name):

oxytetracycline HCl(200g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 200.0 g/kg

Units in package:

25kg

Class:

VM - Veterinary Medicine

Manufactured by:

PHIBRO ANIMAL HEALTH

Therapeutic group:

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A.; Host/pest details: CALF: [ANTIBIOTIC - ANTI-INFECTIVE]; CATTLE: [ANTIBIOTIC - ANTI-INFECTIVE]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE]; POULTRY: [ANTIBIOTIC - ANTI-INFECTIVE]; SHEEP: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [ANTIBIOTIC - ANTI-INFECTIVE]; CATTLE: [ANTIBIOTIC - ANTI-INFECTIVE]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE]; POULTRY: [ANTIBIOTIC - ANTI-INFECTIVE]; SHEEP: [ANTIBIOTIC - ANTI-INFECTIVE]; Broad spectrum antibiotic feed supplement for the treatment and prevention of diseases associated with oxytetracycline sensitive organisms.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

COPY
INTHE
HEADER
AND
FOOTER
WILL
NOT
APPEAR
ON
THE
FINAL
PRINTED
LABEL
Replaces
601-9002-01
a
Prepared
18/0312002
Approved
NRA.
DRAFT
LABEL
LAB-601-9002-01
b.doc
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TERRAMYCIN* 200
FEED SUPPLEMENT
200G/KG OXYTETRACYCLINE HYDROCHLORIDE
equivalent,
as
the
quaternary
salt
N.R.A.
APPROVED
LABEL
(TEXT)
Label
No:
:f.j~3.'?.1-~::>.~
Date:
..
'7.
/.o:?-.<;?;?.
Signature:
.
Broad
spectrum
antibiotic
feed
supplement
for
the
treatment
and
prevention
of
diseases
associated with
oxytetracycline
sensitive
organisms.
DIRECTIONS FOR USE:
DO NOT ADMINISTER TO POULTRY LAYING EGGS FOR HUMAN CONSUMPTION
TERRAMYCIN
200
is indicated
for
in-feed
dosage
of
poultry,
pigs,
sheep,
calves
and cattle
for
the
treatment
and
prevention
of
diseases
due
to,
or
associated
with
Terramycin
sensitive organisms.
SPECIES
DISEASE/CONDITION
DIRECTIONS
Poultry
For treatment and as an aid in
Add 1-2 kg ofTERRAMYCIN 200 per
prevention of Chronic Respiratory
tonne of feed (200-400 g active per
Disease (CRD Air- Sac Infection);
1000 kg feed) according to severity of
Infectious Coryza;
Infectious Sinusitis;
infection.
Infectious Synovitis;
Hexamatiasis;
Fowl Cholera;
Bacterial
Enteritis
(Scours);
Salmonellosis;
Stress due to
beak trimming,
vaccination,
etc
Pigs
For treatment
and as an aid in
Add 2.5-5 kg TERRAMYCIN 200 per
prevention of Leptospirosis
tonne of feed for 7-14 days before
farrowing.
Prevention should be based
on vaccination.
Enzootic Pneumonia,
Bacterial
Enteritis
Add 1-2 kg TERRAMYCIN 200 per
(Scours);
Piglet
Pneumonia;
Gut
tonne of feed according to severity of
Oedema
infection.
Sheep
&
For treatment
of Bacterial
Enteritis;
Provide 2.5 g TERRAMYCIN 200 per
Calves
Salmonellosis;
Calf Diphtheria;
50 kg bodyweight per head per day and
Pasteurellosis;
Pneumonia
continue to treat
until
24 hours after
symptoms disappear
Cattle.
Bacterial
diseases associated with
Provide 5 g TERRAMYCIN 200 per
stresses such as transport,
relocation,
head per day in the feed for the first
f

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Summary of Product characteristics

PRODUCT NAME: TERRAMYCIN 200
PAGE: 1 OF 5
THIS REVISION ISSUED: JANUARY, 2012

MATERIAL SAFETY DATA SHEET
Issued by: Phibro Animal Health Pty Ltd
Phone: (02) 9896 4666
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
PHIBRO ANIMAL HEALTH PTY LTD
PHONE:
02 9896 4666
UNIT 4, 129 MAGOWAR RD
FAX
02 9896 4544
GIRRAWEEN, NSW 2145
AFTER HOURS: 0418 213 734
CHEMICAL NATURE:
Blend of ingredients. Active ingredient is an antibiotic.

TRADE NAME:
TERRAMYCIN 200

PRODUCT USE:
For the treatment and prevention of diseases associated with
oxytetracycline
sensitive organisms in poultry, pigs and cattle.

CREATION DATE:
FEBRUARY, 2007
THIS VERSION ISSUED:
JANUARY, 2012 and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Not classified as hazardous according
to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: Not Hazardous - No criteria found.
SAFETY PHRASES: S22. Do not breathe dust.
SUSMP CLASSIFICATION: S4
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code.
UN NUMBER: None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR: Light brown coloured powder.
ODOUR: Mild, characteristic odour.
MAJOR HEALTH HAZARDS: no significant risk factors have been found for
this product. A major ingredient is an
antibiotic. Any person with a history of allergies to this class of
substances should avoid contact with this product as it
may cause sensitisation.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE: Long term inhalation of high amounts of
any nuisance dust may overload lung clearance
mechanism. Available data indicates that this product is not harmful.
However product may be mildly irritating,
although unli

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