TYLECO 250 GRANULAR

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

03-04-2018

Summary of Product characteristics (SPC)

03-04-2018

Active ingredient:

TYLOSIN AS THE PHOSPHATE

Available from:

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD

INN (International Name):

tylosin as phosphate(250g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TYLOSIN AS THE PHOSPHATE ANTIBIOTIC Active 250.0 g/kg

Units in package:

25kg

Class:

VM - Veterinary Medicine

Manufactured by:

IAHP

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Nil (at 100g or less tylosin per tonne of final feed). Milk: Nil.; Host/pest details: CATTLE - BEEF: [LIVER ABSCESS]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE, ILEITIS, SWINE DYSENTERY]; Pigs: for increased growth stimulation and improved feed efficiency. For prevention of swine dysentery and control of other enteric diseases caused by organisms sensitive to tylosin. For prevention of ileitis. Cattle: for reduction of liver abscesses.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRODUCT NAME: Tyleco 250 Granular Page 1 of 4
Company Name:
International Animal Health Products Pty Ltd
Product Name:
TYLECO 250 GRANULAR
APVMA Approval No:
53752/RV0318F
Label Name:
TYLECO 250 GRANULAR
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 tylosin phosphate)
Claims:
For prevention of swine dysentery (vibrionic) and control of other
enteric
diseases caused by organisms sensitive to tylosin in pigs.
For prevention and treatment of ileitis in pigs. For reduction in the
incidence of
liver abscess in cattle.
Net Contents:
25kg NET
Directions for Use:
Refer to Page 4.
Restraints:
‘
Prior to prescribing TYLECO 250 GRANULAR investigate the use of non-
antibiotic options. If TYLECO 250 GRANULAR 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.
’
Contraindications:
Precautions: RLP APPROVED
PRODUCT NAME: Tyleco 250 Granular Page 2 of 4
Side
Effects:
Dosage and
Administration:
Refer to Page 4.
General
Directions:
This product should not be resold in this concentration except if this
is for use by
feed formulators preparing medicated premixes. The product used as
recommended by the formulators and according to the directions for
use, will
provide necessary level of tylosin phosphate in the feed.
Withholding
Periods:
MEAT-NIL (at 100 g or less tylosin per tonne of final feed).
MILK-NIL.
Any variation by the 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): This product does not have an ESI
established. For advice on the ESI contact the manufacturer on (02)
9672 7944
befor

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Summary of Product characteristics

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD
Chemwatch Hazard Alert Code: 3
TYLECO 250 GRANULAR
Chemwatch: 4856-65
Version No: 4.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 20/04/2018
Print Date: 23/04/2018
S.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY
/ UNDERTAKING
PRODUCT IDENTIFIER
PRODUCT NAME
Tyleco 250 Granular
SYNONYMS
Not Available
OTHER MEANS OF
IDENTIFICATION
Not Available
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
RELEVANT IDENTIFIED USES
For prevention of swine dysentery (vibrionic) and control of other
enteric diseases caused by organisms sensitive to
tylosin in pigs. For prevention and treatment of ileitis in pigs. For
reduction in the incidence of liver abscess in cattle.
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
REGISTERED COMPANY
NAME
INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD
ADDRESS
18 Healey Circuit Huntingwood NSW 2148 Australia
TELEPHONE
+61 2 9672 7944
FAX
+61 2 9672 7988
WEBSITE
www.iahp.com.au
EMAIL
info@iahp.com.au
EMERGENCY TELEPHONE NUMBER
ASSOCIATION /
ORGANISATION
AUSTRALIA POISON INFORMATION CENTRE
EMERGENCY TELEPHONE
NUMBERS
13 11 26 (24 Hours)
OTHER EMERGENCY
TELEPHONE NUMBERS
New Zealand: National Poisons Centre 0800 764 766 (24 hours)
SECTION 2 HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
HAZARDOUS CHEMICAL. NON-DANGEROUS GOODS. ACCORDING TO THE WHS
REGULATIONS AND THE ADG CODE.
POISONS SCHEDULE
S4
CLASSIFICATION
[1]
Skin Corrosion/Irritation Category 2, Serious Eye Damage Category 1,
Skin Sensitizer Category 1, Specific target organ
toxicity - single exposure Category 3 (respiratory tract irritation),
Acute Aquatic Hazard Category 2
_LEGEND:_
_1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3.
Classification drawn from EC Directive 1272/2008 -_
_Annex VI_
CONTINUED...
LABEL ELEMENTS
HAZARD PICTOGRAM(S)
SIGNAL WORD
DANGER
HAZARD STATEMENT(S)
H315
Causes skin irritation.
H318
Causes serious eye damage.
H317
May cause an allergic skin

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