ESKALIN 500 FEED PREMIX

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

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Active ingredient:
VIRGINIAMYCIN
Available from:
PHIBRO ANIMAL HEALTH PTY LIMITED
INN (International Name):
virginiamycin(500g/kg)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
VIRGINIAMYCIN ANTIBIOTIC Active 500.0 g/kg
Units in package:
25kg
Class:
VM - Veterinary Medicine
Manufactured by:
PHIBRO ANIMAL HEALTH
Therapeutic group:
CATTLE | POULTRY BROILERS (MEAT FOR HUMAN CONSUM) | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF |
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
NECROTIC ENTERITIS | REDUCE ACIDOSIS
Product summary:
Poison schedule: 4; Withholding period: WHP: NIL.; Host/pest details: CATTLE: [REDUCE ACIDOSIS]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [NECROTIC ENTERITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [REDUCE ACIDOSIS]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [NECROTIC ENTERITIS]; For use in complete rations for cattle to reduce acidosis due to high grain diets. For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens.Do not feed to laying birds.
Authorization status:
Registered
Authorization number:
51354
Authorization date:
2019-07-01

Copy

the header and footer will not appear on the final printed label

NOTE: Label deletions are marked

striketf:lro~:~gh

and will not appear

the final label,

insertions (marked)

underlined will appear on the final label, however

they

will not

underlined.

Prepared: ..

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Primary

Immediate Container Labe

FR.ONT

PANEL .........................

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Page

PRESCRIPTION

ANIMAL

REMEDY

KEEP

OF REACH OF CHILDREN

READ

SAFETY

DIRECTIONS BEFORE OPENING

USING

ANIMAL

TREATMENT

ONLY

Eskalin

500 Feed Premix

500g/kg

RGINIAMYCIN

RLP

APPROVED

For use in complete rations

cattle to reduce acidosis due to high grain diets.

For prevention

necrotic enteritis caused

Clostridium perfringens

susceptible to

virginiamycin

broiler chickens.

25 kg NET

Phibro Animal Health [logo]

Page 1

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Copy in the header and footer will not appear on

tile

final printed label

NOTE: Label deletions are marked

slriketAI'!lU§~

and will not appear on the final label,

insertions (marked)

underlined will appear on the final label, however they

will

not be underlined.

Prepared:

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9/10/2013

Primary Pack

Immediate Container

FRONT PANEL ........................................................................................................................................

Page

DIRECTION FOR USE

CATTLE AND POULTRY

Restraints

PRUDENT USE

Prior to using ESKALIN 500* investigate the use

non antibiotic options.

virginlamycin is indicated and selected for use, prescription must be consistent with the

AVA Code

Practice for Prescription and Use

Products which Contain Antimicrobial

Agents. Dosage regimens should be designed for each situation with an appropriate

duration

frequency to minimize treatment failure while minimizing the emergence

antimicrobial resistance. Review farm records on the use

product containing

virginiamycin to ensure compliance with prescribing instructions.

NOT FEED TO LAYING BIRDS

NOT TO BE USED FOR

PURPOSE,

ANY MANNER, CONTRARY TO

THIS

LABEL

CATTLE

ESKALIN* 500 is used in complete feeds (dry mash

pellet) to supply an average

daily dose rate

0.5mg virginiamycin per

bodyweight

reduce the risk

acidosis

caused by high levels

grain in the feed.

Free access

large

quantities

grain in the

first

days

feeding

recommended

engorgement

result,

especially

drought

affected

stock,

cattle

familiar

with

high

grain

diets. Feeding

with

prior

introduction

recommended.

Mixed

feed

should

used

within

days

after

mixing.

ESKALIN*soo

degrades

quickly

feed

wet. Remove

feed

daily.

MIXING DIRECTIONS

Dose Rate:

Eskalin* 500 per tonne

finished feed.

Prepare

Intermediate Premix:

ESKALIN* 500 must be thoroughly mixed in

the feed to assure even distribution.

Prepare an INTERMEDIATE PREMIX by mixing

the required amount

ESKALIN*500 with

least 10

a finely ground feed

ingredient such as pollard, mineral mix or

mill

run.

Intermediate

Premix

To Final Feed:

Add to mixer and mix thoroughly

ensure even distribution. Grain should be rolled

hammermilled

assist even mixing

in final feed, and may be pelleted after mixing.

Maintain

Distribution

In Final Feed:

It is important that Eskalin* 500 (and

premixes) remain evenly distributed.

NOT ADD DIRECTLY TO GRAIN-ONLY

SUPPLEMENTS

mixing is unlikely to be uniform, and segregation may occur.

Page 2

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in

the

header

and

footer

'Nill

not

appear

on

the

final

printed

label

NOTE:

label

deletions

marked

strike!Rr<JYgll

will

appear

on

final

label,

insertions

(marked)

underlined

will

appear

final

label,

however

they

will

underlined.

Prepared:

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0/2013

Primary Pack

Immediate Container Labe

FRONT

PANEL

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Page

SPECIAL DIRECTIONS FOR USE

Response may vary widely

nutritional or other reasons including feedlot

management, disease and physiological status

the animals, diet and biological

variation.

While

ESKAUN®

500 used strictly in accordance with the instructions will

reduce the risk

acidosis it should not be used as a replacement for good

management.

POULTRY

For prevention of necrotic enteritis

broiler chickens caused by Clostridium perfringens susceptible to

virginiamycin.

at40g

Eskalin 500 (equivalent to 20g/t virginiamycin) per tonne of feed. Feed continuously as the

only ration during the period that birds are considered

at risk

the disease. Most outbreaks

necrotic enteritis occur

broilers from 2 to

weeks of age.

important that the treatment period appropriately reflects the period during which the fiock Is

risk

from necrotic enteritis. Specific environmental and other epidemiological factors relevant

the particular

situation should be considered by the prescribing veterinarian prior to treatment.

WITHHOLDING PERIOD NIL

SAFETY DIRECTIONS:

Irritate the eyes and skin.

Avoid

contact

with

eyes and

skin.

Repeated

exposure

cause

allergic

disorders.

Sensitive

workers

should

protective

clothing.

inhale

dust.

When using the

product

wear

elbow-length

gloves.

When

using

enclosed

areas

wear

elbow-length

gloves

disposable

respirator. Wash

hands

after

use.

After

each

day's

use, wash

gloves.

Additional

information

listed

Material Safety Data Sheet.

FIRST AID:

poisoning

occurs,

contact

doctor

Poisons

Information

Centre.

Phone

131126.

DISPOSAL:

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

site. Puncture and bury empty containers

a local authority landfill.

If not available bury the containers

below 500mm

a disposal pit specifically marked and set up for this purpose clear

waterways,

vegetation and roots.

Empty containers and product should not be burnt.

APVMA Approval No.51354/1 00002

STORE BELOW

25'C

(Air Conditioning).

PROTECT FROM MOISTURE.

Exp:

Phibro

Animal

Health

Unit

Magowar Rd,

Girraween, NSW, 2145

*Registered Trademark

ofPhibro

Animal Health Pty. Ltd.

Page

ProductName: Eskalin 500 FeedPremix

Page: 1 of 5

This revisionissued: March, 2012

SAFETY DATASHEET

Issued by: Phibro Animal Health PtyLtd Phone: (02) 9896 4666

Section 1 - Identification ofThe Material and Supplier

Phibro Animal Health PtyLtd Phone: 02 9896 4666

Unit 4, 129 Magowar Rd Fax 02 9896 4544

Girraween, NSW 2145 After hours: 0418 213 734

Chemical nature: Virginiamycin, the active constituent, isan antibiotic.

Trade Name: Eskalin 500 Feed Premix

Product Use: Antibiotic feedadditive for use incompleterations for cattle to reduce acidosisdue to

high grain diets. For the prevention of necroticenteritis caused byClostridium

perfringenssusceptible to virginiamycinin broiler chickens.

Creation Date: February, 2007

This version issued: March, 2012and is validfor 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This productis classifiedas:Not classified ashazardous according to the criteria of SWA.

Not a Dangerous Good according to theAustralian DangerousGoods (ADG) Code.

Risk Phrases:Not Hazardous -No criteria found.

SafetyPhrases:S20, S22, S25. Whenusing, do not eat or drink.Do not breathedust. Avoid contact with eyes.

SUSMP Classification:S4

ADG Classification:None allocated.Not a Dangerous Good under the ADG Code.

UN Number:Noneallocated

Emergency Overview

Physical Description & colour: Small beige granules.

Odour:Small clear beigegranules.

Major HealthHazards:no significant risk factors have been found for this product.

Potential Health Effects

Inhalation:

Short termexposure:Long term inhalation of highamounts of any nuisance dust may overload lung clearance

mechanism. Available data indicates that this product isnot harmful. However productmay be mildly irritating,

although unlikely to causeanything more than mild transient discomfort.

Long Term exposure:No data for health effectsassociatedwith long term inhalation.

Skin Contact:

Short termexposure:Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikelyto cause anydiscomfort in normal use.

Long Term exposure:No data for health effectsassociatedwith long term skin exposure.

Eye Contact:

Short termexposure:This product may be mildly irritating to eyes,but is unlikely to cause anything more than

mild discomfort which should disappear once product isremoved.

Long Term exposure:No data for health effectsassociatedwith long term eye exposure.

Ingestion:

Short termexposure:Significant oral exposure isconsideredtobe unlikely. However, this product may be

irritating to mucous membranes but is unlikely tocause anything more thantransient discomfort.

Long Term exposure:No data for health effectsassociatedwith long term ingestion.

Carcinogen Status:

SWA:No significant ingredient is classified as carcinogenic by SWA.

NTP:No significant ingredient is classified as carcinogenic by NTP.

ProductName: Eskalin 500 FeedPremix

Page: 2 of 5

This revisionissued: March, 2012

SAFETY DATASHEET

Issued by: Phibro Animal Health PtyLtd Phone: (02) 9896 4666

IARC:No significant ingredient isclassified ascarcinogenic by IARC.

Section 3 - Composition/Information on Ingredients

Ingredients CAS No Conc,% TWA (mg/m 3 ) STEL (mg/m 3 )

Virginiamycin 11006-76-1 50 not set not set

Other non hazardous ingredients secret to 100 not set not set

This isa commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardousingredients arealso possible.

The SWA TWA exposure value is the averageairborne concentration of a particular substance whencalculated over a normal 8 hourworkingday

for a 5 dayworkingweek. The STEL (ShortTermExposure Limit) isan exposure value that maybeequalled (but should not be exceeded) forno

longer than 15minutes and should not be repeated more than4 timesper day. There should be at least 60 minutes between successive exposures

at the STEL.Theterm "peak "is used when theTWA limit, becauseof the rapid action of the substance, should never be exceeded, even briefly.

Section 4 - First Aid Measures

General Information:

You should call The Poisons Information Centre if youfeel that you may have been poisoned, burned orirritated by

this product. The number is13 1126 fromanywhere inAustralia (0800 764 766 inNew Zealand) and is available at all

times.Have thisMSDS withyou when you call.

Inhalation:First aid isnot generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:Gently brush away excess solids. Irritation isunlikely. However, if irritation doesoccur, flush with

lukewarm, gently flowing water for 5 minutes oruntil chemical is removed.

Eye Contact:Quickly and gently brush particles fromeyes. Noeffects expected. If irritation does occur, flush

contaminatedeye(s) with lukewarm, gently flowing water for 5 minutes oruntil the product is removed. Obtain medical

advice if irritation becomespainful or lasts more thana few minutes. Take special care if exposedpersonis wearing

contact lenses.

Ingestion:If product isswallowed or gets in mouth, doNOT induce vomiting; washmouth with water and give some

water to drink. If symptoms develop, or if in doubtcontact a Poisons InformationCentre or a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards: Thereis no risk ofan explosionfrom this product under normal circumstances if it is

involved in a fire. Thisproduct, if scattered, may form flammable orexplosive dust clouds in air.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media:Preferred extinguishing media are carbondioxide, dry chemical, foam, water fog.

Fire Fighting:If a significant quantity of this productis involved ina fire, call thefire brigade. Do not scatter spilled

materialwith high pressurewater jets.

Flash point: No data. Believed to be combustible.

Upper FlammabilityLimit:No data.

Lower FlammabilityLimit:No data.

Autoignitiontemperature:No data.

Flammability Class:No data.

Section 6 - Accidental Release Measures

Accidental release:In the event of a majorspill, prevent spillage from entering drains or water courses. As a

minimum, wear overalls, gogglesand gloves. Suitable materials for protective clothing include rubber, PVC. Eye/face

protective equipment should comprise asa minimum,protective goggles. If there is a significant chance thatdusts are

likely to buildup in cleanuparea, werecommendthat you use asuitable Dust Mask. Use a P1 mask, designed for

use against mechanically generated particleseg silica & asbestos.

Stop leak if safe to do so, and containspill. Sweep upandshovelor collect recoverable product into labelled

containers for recycling orsalvage, anddispose of promptly. Consider vacuuming if appropriate. Recycle containers

wherever possible aftercareful cleaning.After spills, wash area preventing runoff from entering drains. If a significant

quantity of material enters drains, advise emergency services. This materialmaybe suitable for approved landfill.

Ensure legality of disposal by consultingregulationspriorto disposal. Thoroughly launder protective clothingbefore

storage orre-use. Advise laundry of nature of contaminationwhen sending contaminatedclothing to laundry.

ProductName: Eskalin 500 FeedPremix

Page: 3 of 5

This revisionissued: March, 2012

SAFETY DATASHEET

Issued by: Phibro Animal Health PtyLtd Phone: (02) 9896 4666

Section 7 - Handling and Storage

Handling:Keep exposureto this product to a minimum, and minimise the quantities kept in work areas. Check

Section 8 of this MSDS for details of personal protectivemeasures,and make sure that those measures arefollowed.

The measuresdetailed below under "Storage" shouldbe followed during handling in order tominimise risks to

personsusing the productin the workplace. Also, avoidcontact or contamination of productwith incompatible

materials listed in Section 10.

Storage:This product is aScheduled Poison. Observe all relevantregulations regardingsale, transport and storage

of this schedule of poison.Store in the closed original container ina dry, cool,well-ventilated area out of direct

sunlight. Make sure that the product does not come into contactwith substances listed under"Incompatibilities" in

Section 10. Check packaging - there may be further storage instructions onthe label.

Section 8 - Exposure Controls and Personal Protection

The followingAustralian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment:AS/NZS 1715, Protective Gloves:AS 2161, OccupationalProtective Clothing: AS/NZS 4501

set 2008, Industrial Eye Protection:AS1336andAS/NZS 1337, Occupational Protective Footwear:AS/NZS2210.

SWA Exposure Limits TWA (mg/m 3 ) STEL (mg/m 3 )

Exposure limits have not been established by SWA for anyof the significant ingredients in this product.

The ADI for Virginiamycin isset at 0.2mg/kg/day. ThecorrespondingNOEL isset at 25mg/kg/day. ADI means

AcceptableDaily Intake and NOEL means No-observable-effect-level. Valuestaken from Australian ADI List, Sept

2011.

No special equipment is usually neededwhenoccasionallyhandlingsmall quantities. The following instructions are

for bulk handling or where regularexposure in an occupational setting occurswithout propercontainment systems.

Ventilation:No special ventilation requirements arenormally necessary for thisproduct. Howevermake sure that

the work environment remainsclean and that dusts are minimised.

Eye Protection:Eye protection isnot normally necessary whenthis product is being used.However, if in doubt,

wearsuitableprotective glasses or goggles.

Skin Protection:The information at hand indicates that this productis not harmful and that normally no special skin

protection isnecessary. However, we suggest that you routinely avoid contactwith all chemical productsand that you

wearsuitablegloves (preferably elbow-length)whenskin contact islikely.

Protective Material Types:We suggest that protective clothingbemade from the following materials:rubber,

PVC.

Respirator:If there is a significant chance that dusts are likelyto build up in the areawherethis product is being

used, we recommendthat you use asuitable Dust Mask.

Section 9 - Physical and Chemical Properties:

Physical Description & colour:Small beige granules.

Odour: Small clear beige granules.

Boiling Point:Not applicable.

Freezing/Melting Point:Decomposes before melting.

Volatiles: No specific data. Expectedto be low at 100°C.

Vapour Pressure: Negligible at normal ambient temperatures.

Vapour Density:No data.

Specific Gravity:No data.

Water Solubility: No specific data for products. Some components aresoluble, others not.

pH: No data. Expected to be neutral.

Volatility: Negligible at normal ambient temperatures.

Odour Threshold:No data.

Evaporation Rate:No data.

Coeff Oil/water distribution: No data

Autoignition temp:No data.

Section 10 - Stabilityand Reactivity

Reactivity:This product isunlikely to react ordecompose undernormal storage conditions. However, if you have

any doubts, contact the supplier for advice onshelf life properties.

ProductName: Eskalin 500 FeedPremix

Page: 4 of 5

This revisionissued: March, 2012

SAFETY DATASHEET

Issued by: Phibro Animal Health PtyLtd Phone: (02) 9896 4666

Conditions to Avoid:Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:water, strong acids, strong bases, strong oxidising agents.

Fire Decomposition:Carbondioxide,and if combustion isincomplete, carbonmonoxide and smoke. Nitrogenand

its compounds, and undersomecircumstances, oxides ofnitrogen. Occasionallyhydrogencyanide gas inreducing

atmospheres. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and other sulfur compounds. Most willhave a

foul odour. Water. Carbonmonoxide poisoning producesheadache, weakness, nausea, dizziness, confusion,

dimness of vision, disturbance of judgment, andunconsciousness followed by coma and death.

Polymerisation:This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

Local Effects:

Target Organs: There is no data to hand indicatingany particulartarget organs.

Classification of Hazardous Ingredients

IngredientRisk Phrases

Virginiamycin:LD

Oral, Rat 10,000mg/kg LD

Oral, Mouse = >5,000mg/kg

Oral, Dog = >4,000mg/kg

Section 12 - Ecological Information

This product isbiodegradable. It will notaccumulatein the soil orwater orcause long term problems.

An earthworm toxicology study utilisingred earthwormsin soil containing virginiamycin-mediated poultry litter

indicated noadverse effects. Viginiamycin is lipophilic.Residue studieshave found that very low levelsof

Virginiamycinare present suggesting poor absorptionacross the gastrointestinaltract.

Section 13 - Disposal Considerations

Disposal:There are manypiecesof legislation covering waste disposal and theydiffer in each state and territory, so

each user must refer to laws operating intheir area. In someareas, certain wastesmust be tracked. TheHierarchy of

Controlsseems to be common - the usershould investigate: Reduce, Reuse, and Recycle and only if all else fails

should disposal be considered. Note thatproperties of a product may change in use, so that the followingsuggestions

may not always be appropriate. The following may help you inproperly addressing this matter for thisproduct. You

should not attempt to reclaim or recycle this product. We suggest that, subject to the regulations in yourarea, this

product should be disposedin landfill.

Section 14 - Transport Information

ADG Code:This productis not classified as aDangerousGood. No special transport conditions are necessary

unless required by other regulations.

Section 15 - RegulatoryInformation

AICS:All of the significant ingredients inthis formulation arecompliant with NICNAS regulations.

The followingingredients:Virginiamycin,are mentioned in the SUSMP.

Section 16 - Other Information

This MSDS contains onlysafety-related information. For other data see product literature.

Acronyms:

ADG Code Australian Code for the Transport of Dangerous Goods by Roadand Rail, 7th Edition

AICS Australian Inventory of Chemical Substances

SWA Safe WorkAustralia, formerlyASCC and NOHSC

CAS number Chemical Abstracts Service Registry Number

HazchemNumber Emergency action code ofnumbers andlettersthat provide information to emergency

servicesespecially firefighters

IARC International Agency forResearch onCancer

NOS Not otherwisespecified

ProductName: Eskalin 500 FeedPremix

Page: 5 of 5

This revisionissued: March, 2012

SAFETY DATASHEET

Issued by: Phibro Animal Health PtyLtd Phone: (02) 9896 4666

NTP National Toxicology Program (USA)

R-PhraseRisk Phrase

SUSMP Standard for the Uniform Scheduling ofMedicines & Poisons

UN NumberUnited Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGEOFTHEHEALTHAND SAFETYHAZARD INFORMATION OFTHEPRODUCTAND

HOW TOSAFELYHANDLE ANDUSE THE PRODUCT INTHE WORKPLACE.EACH USER MUSTREVIEW THIS MSDS IN THECONTEXTOF

HOW THE PRODUCT WILLBE HANDLEDANDUSED IN THE WORKPLACE.

IF CLARIFICATIONORFURTHER INFORMATION IS NEEDED TOENSURETHATAN APPROPRIATE RISK ASSESSMENT CANBE MADE,

THE USER SHOULD CONTACTTHIS COMPANY SOWE CAN ATTEMPT TOOBTAIN ADDITIONALINFORMATION FROMOUR SUPPLIERS

OURRESPONSIBILITYFOR PRODUCTS SOLDISSUBJECT TO OUR STANDARDTERMS ANDCONDITIONS, ACOPYOF WHICH IS SENT

TOOUR CUSTOMERS AND IS ALSOAVAILABLEONREQUEST.

Please readall labels carefully before using product.

This MSDSisprepared in accord withtheSWAdocument“National Code ofPractice for the Preparation of

Material Safety Data Sheets” 2nd Edition[NOHSC:2011(2003)]

Copyright © Kilford & Kilford Pty Ltd, March, 2012.

http://www.kilford.com.au/ Phone (02)9251 4532

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