TYLOPHOS 250 PREMIX

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
TYLOSIN
Available from:
ABBEY LABORATORIES PTY LTD
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
TYLOSIN ANTIBIOTIC Active 250.0 g/kg
Units in package:
20kg; 25kg
Class:
VM - Veterinary Medicine
Therapeutic area:
ANTIBIOTIC & RELATED
Product summary:
Poison schedule: 4; Withholding period: MEAT (Pigs, Cattle, Poultry): Zero days (at 100g or less Tylosin/tonne of final feed). MILK: Zero (0) days. EGGS: Zero (0) days. Any variation by prescribing veterinarian to the approved dose, frequ ency, duration, route, disease or target species may result in the need to exten d the approved withholding period. EXPO RT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this product. N ote- observing the meat withholding peri od may not be sufficient to mitigate pot ential risks to export trade. Trade advi ce should be sought from Abbey Animal He alth Pty Ltd on 02 8088 0720 before usin g this product.; Host/pest details: CATTLE: [LIVER ABSCESS]; PIGS: [ILEITIS, SWINE DYSENTERY]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [NECROTIC ENTERITIS]; PULLET - REPLACEMENT: [NECROTIC ENTERITIS]
Authorization status:
Registered
Authorization number:
86555
Authorization date:
2019-09-05

TYLOPHOS 250 PREMIX

86555/121725

Product Name:

Application No:

Label Name:

TYLOPHOS 250 PREMIX

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Constituent

Statements:

250 g/kg TYLOSIN AS THE PHOSPHATE

Claims:

For use as an aid in controlling enteric diseases caused by organisms susceptible to

Tylosin in pigs. For the treatment and prevention of ileitis in pigs. For reduction in the

incidence of liver abscess in cattle. As an aid in control of necrotic enteritis caused by

Clostridium perfringens in broiler and replacement chickens.

NOTE: This product is not for resale in this form and directions for use are given as

guidance only. This pack is intended for use by feed formulators for incorporation in

medicated premixes and, when utilised as recommended by the formulator, will supply

registered levels of Tylosin in the feed.

Net Contents:

20kg; 25kg

Directions for Use:

Restraints:

Contraindications:

Precautions:

Side Effects:

RLP

APPROVED

Dosage and

Administration:

This section contains file attachment.

General Directions:

Prior to prescribing TYLOPHOS 250 PREMIX investigate the use of non-antibiotic options.

If TYLOPHOS 250 PREMIX is indicated and selected for use, prudent prescribing practices

(appropriate dose, duration and frequency to minimise treatment failure while minimising

the emergence of antimicrobial resistance) must be adhered to.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS

LABEL UNLESS AUTHORIZED UNDER APPROPRIATE LEGISLATION.

Withholding Periods:

MEAT (Pigs, Cattle, Poultry): Zero days (at 100g or less Tylosin/tonne of final feed). MILK:

Zero (0) days.

EGGS: Zero (0) days.

Any variation by prescribing veterinarian to the approved dose, frequency, duration, route,

disease or target species may result in the need to extend the approved withholding period.

Trade Advice:

EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this product.

Note- observing the meat withholding period may not be sufficient to mitigate potential risks

to export trade. Trade advice should be sought from Abbey Animal Health Pty Ltd on 02

8088 0720 before using this product.

Safety Directions:

Harmful if swallowed. Will irritate the eyes and skin. Avoid contact with eyes and skin.

Repeated exposure may cause allergic disorders. Do not inhale dust. When opening the

container and mixing into premixes, wear cotton overalls buttoned to the neck and wrist and

a washable hat, elbow-length chemical resistant gloves, goggles and disposable dust

facemask covering mouth and nose. After use and before eating, drinking or smoking, wash

hands, arms and face thoroughly with soap and water. After each day’s use, wash gloves,

goggles and contaminated clothing.

First Aid Instructions:

If poisoning occurs contact a doctor or Poisons Information Centre, Phone Australia 131

126.

First Aid Warnings:

Additional User

Safety:

Additional information is listed in the safety data sheet.

Environmental

Statements:

Disposal:

Shake and empty bags into medicated feed. Do not dispose of undiluted chemicals on-

site. Break, crush, or puncture empty bags and deliver to an approved waste management

facility. If an approved waste management facility is not available, bury the punctured bags

500 mm below the surface in a disposal pit specifically marked and set up for this purpose

clear of waterways, vegetation and tree roots, in compliance with relevant local, state or

territory government regulations. Do not burn empty bags or product.

Storage:

Store below 30⁰C (Room temperature) in a dry place. Protect from light. Keep container

tightly closed.

Version Controlled Label

TYLOPHOS 250 PREMIX

Page 1 of 2

DOSAGE AND ADMINISTRATION

Mixing

directions:

IMPORTANT-

TYLOPHOS

PREMIX MUST

THOROUGHLY

MIXED IN FEED BEFORE USE AT MAXIMUM USE RATE OF 0.4KG TYLOPHOS 250

PREMIX PER TONNE OF FINAL FEED.

PIGS

Claim

TYLOPHOS 250

PREMIX

/tonne per

feed

Tylosin equivalent/tonne

per feed

As an aid in controlling enteric-diseases

caused by organism susceptible to Tylosin:

For young piglets, birth to 20kg and for

breeding, growing and introduced pigs

0.4kg

100g

As an aid in prevention of swine dysentery:

a) For growing pigs, birth to 20kg

b) For breeding and growing pigs, 20kg to

market

0.4kg

0.16 kg

100g

40 g

For the treatment of ileitis. Feed for 21 days

0.4 kg

100 g

For the prevention of ileitis

0.16 kg

40 g

CATTLE

For reduction in the incidence of Liver Abscess:

In complete feeds: 11 ppm Tylosin, i.e. 0.044kg TYLOPHOS 250 PREMIX / tonne of feed.

Supplementary feeds: Dependent on total dry matter intake of animal and supplementary

feeding rate. Ensure that amount of TYLOPHOS 250 PREMIX fed does not exceed 11ppm of

total dry matter intake (supplement plus all other feeds consumed per day). As an example, for

dairy cows, addition according to the following table provides 150mg Tylosin/head/day.

Supplementary feeding

rate (kg/head/day)

TYLOPHOS 250 PREMIX

/

tonne of feed

Tylsoin equivalent / tonne of feed

0.6 kg

150.0 g

0.3 kg

75.0 g

0.15 kg

37.5 g

0.1 kg

25.0 g

0.075 kg

18.75 g

Make changes to diet gradually. Increase Tylosin in feed up to desired dose over 5-7 days.

POULTRY

For control of necrotic enteritis:

Thoroughly mix TYLOPHOS 250 PREMIX in feed at a rate of 100 mg Tylosin per kg (0.4 kg

TYLOPHOS 250 PREMIX per tonne) of feed. Medicated feed should be provided as the sole

ration to growing chickens for a period of 7 days when necrotic enteritis has been identified or

can be predicted to occur.

Version Controlled Label

TYLOPHOS 250 PREMIX

Page 2 of 2

Additional measure to manage necrotic enteritis in broilers:

Clean and disinfect buildings between batches of birds, maintain dry litter, ensure proper

ventilation, avoid overcrowding. Reduce immunosuppressive stress and disease. Use effective

coccidiosis control. Evaluate bird nutrition, particularly protein and cereal sources and fibre

content

feed.

Comprehensive

necrotic

enteritis

management

should

planned

consultation with veterinary and nutritional poultry expertise.

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