TYLOMIX 100 TYLOSIN TARTRATE PREMIX

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

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Active ingredient:
TYLOSIN AS TARTRATE
Available from:
ABBEY LABORATORIES PTY LTD
INN (International Name):
tylosin as tartrate(100g/kg)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
TYLOSIN AS TARTRATE ANTIBIOTIC Active 100.0 g/kg
Units in package:
10kg; 15kg; 20kg
Class:
VM - Veterinary Medicine
Manufactured by:
ABBEY LABORATORIES
Therapeutic group:
PIGS | BOAR | GILT | PIGLET | SOW | SWINE
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ENTERIC DISEASES SUSCEPTIBLE TO TYLOSIN | IMPROVE FEED EFFICIENCY | PROMOTE ANIMAL GROWTH | SWINE DYSENTERY | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN
Product summary:
Poison schedule: 4; Withholding period: WHP: nil; Host/pest details: PIGS: [ENTERIC DISEASES SUSCEPTIBLE TO TYLOSIN, SWINE DYSENTERY]; For use as an aid in controlling enteric diseases susceptible to tylosin and as an aid in stimulating growth and improving feed efficiency in pigs.FOR USE IN PIG FEED ONLY. TYLOMIX 100 TYLOSIN TARTRATE PREMIX MUST BE THOROUGHLY MIXED IN FEED BEFORE USE.
Authorization status:
Registered
Authorization number:
53703
Authorization date:
2020-07-01

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Tylomix 100 Tylosin Tartrate Premix Page 1 of 3

Company Name:

Abbey Laboratories Pty Ltd

Product Name:

Tylomix 100 Tylosin Tartrate Premix

APVMA Approval No:

53703/RV0318E

Label Name:

Tylomix 100 Tylosin Tartrate 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:

100 g/kg TYLOSIN as the tartrate

Claims:

For use as an aid in controlling enteric diseases susceptible to tylosin.

Net Contents:

20kg NET [10kg, 15kg]

Directions for Use:

Refer to Page 3.

Restraints:

Prior to prescribing

Tylomix 100 Tylosin Tartrate Premix investigate the use of

non-antibiotic options. If Tylomix 100 Tylosin Tartrate

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.

Contraindications:

Precautions:

Side

Effects:

RLP

APPROVED

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Tylomix 100 Tylosin Tartrate Premix Page 2 of 3

Dosage and

Administration:

Refer to Page 3.

General

Directions:

FOR USE IN PIG FEED ONLY

Withholding

Periods:

Trade

Advice:

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 PVC gloves

and disposable mask. 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 and contaminated clothing.

First

Aid Instructions:

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

Australia 131116; New Zealand 03 474 7000.

First

Warnings:

Additional User

Safety:

Environmental

Statements:

Disposal:

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

chemicals on site. Puncture or shred and bury empty bags in a local authority

landfill. If not available bury the bag below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots.

Empty bags and product should not be burnt.

Storage:

Store below 30

C (Room Temperature) in a dry place.

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Tylomix 100 Tylosin Tartrate Premix Page 3 of 3

DIRECTIONS FOR USE:

FOR USE IN PIG FEED ONLY

IMPORTANT: TYLOMIX 100 TYLOSIN TARTRATE PREMIX MUST BE THOROUGHLY

MIXED IN FEED BEFORE USE.

RECOMMENDED LEVELS FOR USE:

Amount of Tylomix 100

Tylosin Tartrate Premix

mixed per tonne of feed

Tylosin equivalent Per

tonne of feed

1-

For controlling diseases susceptible

to tylosin:

For young piglets, birth to 20kg, and

breeding, growing and introduced pigs.

1.0kg

100g

2-

For prevention of swine dysentery:

For breeding and growing pigs birth to

20kg liveweight

For breeding and growing pigs from 20kg

to market weight

1.0kg

0.4kg

100g

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 1 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 1 - Identification of The Material and Supplier

Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Building T2A, Nirimba Education Precinct

Eastern Road, Quakers Hill NSW 2763

Chemical nature:

Tylosin as Tylosin Tartrate in a meal based substrate.

Trade Name:

TYLOMIX 100 TYLOSIN TARTRATE PREMIX

APVMA Code:

53703

Product Use:

For use as an aid in controlling enteric diseases susceptible to Tylosin and as an aid

in stimulating growth and improving feed efficiency in pigs.

Creation Date:

November, 2016

This version issued:

November, 2016

and is valid for 5 years from this date.

Poisons Information Centre: Phone 13 1126 from anywhere in Australia

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Xn, Harmful. Xi, Irritating. Hazardous according to the criteria of SWA.

Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria.

SUSMP Classification:

ADG Classification:

None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG)

Code, IATA or IMDG/IMSBC criteria.

UN Number:

None allocated

GHS Signal word: WARNING

Acute Toxicity Oral Category 4

Skin Corrosion /Irritation Category 2

Skin Sensitisation Category 1

Serious eye damage/eye irritation Category 2B

Specific Target Organ Toxicity - Single Exposure Category 3

HAZARD STATEMENT:

H302: Harmful if swallowed.

H315: Causes skin irritation.

H317: May cause an allergic skin reaction.

H320: Causes eye irritation.

H335: May cause respiratory irritation.

PREVENTION

P102: Keep out of reach of children.

P261: Avoid breathing dusts.

P262: Do not get in eyes, on skin, or on clothing.

P264: Wash contacted areas thoroughly after handling.

P270: Do not eat, drink or smoke when using this product.

P272: Contaminated work clothing should not be allowed out of the workplace.

P280: Wear protective gloves, protective clothing and eye or face protection.

RESPONSE

P362: Take off contaminated clothing and wash before reuse.

P301+P312: IF SWALLOWED: Call a POISON CENTRE or doctor if you feel unwell.

P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P302+P352: IF ON SKIN: Wash with plenty of soap and water.

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 2 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.

P333+P313: If skin irritation or rash occurs: Get medical advice.

P337+P313: If eye irritation persists: Get medical advice.

P370+P378: In case of fire, use carbon dioxide, dry chemical, foam, water fog.

STORAGE

P410: Protect from sunlight.

P411: Store at temperatures not exceeding 30°C.

P402+P404: Store in a dry place. Store in a closed container.

DISPOSAL

P501: Dispose of contents and containers as specified on the registered label.

Emergency Overview

Physical Description & Colour

: An off white to pale buff flowing powder.

Odour:

No more than a slight odour.

Major Health Hazards:

irritating to eyes and skin, harmful if swallowed, possible skin sensitiser. This is an

antibiotic preparation. Any person with a history of allergies to this class of substances should avoid all contact with

this product as it may cause sensitisation. This is a physiologically active product and so contact should be minimised,

especially if the user is taking a form of medication, as interactions can sometimes give unexpected and undesired

results.

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Tylosin as Tylosin Tartrate

74610-55-2

100g/kg

not set

not set

Other non hazardous ingredients

secret

to 100

not set

not set

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

hazardous ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day

for a 5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no

longer than 15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures

at the STEL. The term "peak "is used when the TWA limit, because of 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 you feel that you may have been poisoned, burned or irritated by

this product. The number is 13 1126 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all

times. Have this SDS with you when you call.

Inhalation:

No first aid measures normally required. However, if inhalation has occurred, and irritation has

developed, remove to fresh air and observe until recovered. If irritation becomes painful or persists more than about

30 minutes, seek medical advice.

Skin Contact:

Quickly and gently brush away excess particles. Wash gently and thoroughly with warm water (use

non-abrasive soap if necessary) for 10-20 minutes or until product is removed. Under running water, remove

contaminated clothing, shoes and leather goods (e.g. watchbands and belts) and completely decontaminate them

before reuse or discard. If irritation persists, repeat flushing and seek medical attention.

Eye Contact:

Quickly and gently brush particles from eyes. Immediately flush the contaminated eye(s) with

lukewarm, gently flowing water for 15 minutes or until the product is removed, while holding the eyelid(s) open. Take

care not to rinse contaminated water into the unaffected eye or onto the face. Obtain medical attention immediately.

Take special care if exposed person is wearing contact lenses.

Ingestion:

If swallowed, do NOT induce vomiting. Wash mouth with water and contact a Poisons Information

Centre, or call a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

: The major hazard in fires is usually inhalation of heated and toxic or oxygen

deficient (or both), fire gases. There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 3 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

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

Extinguishing Media

: In case of fire, use carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

No data

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

No data.

Section 6 - Accidental Release Measures

Accidental release

: In the event of a major spill, prevent spillage from entering drains or water courses. Wear full

protective clothing including eye/face protection. All skin areas should be covered. See below under Personal

Protection regarding Australian Standards relating to personal protective equipment. No special recommendations for

clothing materials. Eye/face protective equipment should comprise as a minimum, protective goggles. If there is a

significant chance that dusts are likely to build up in cleanup area, we recommend that you use a suitable dust mask.

Otherwise, not normally necessary.

Stop leak if safe to do so, and contain spill. Sweep up and shovel or collect recoverable product into labelled

containers for recycling or salvage, and dispose of promptly. Consider vacuuming if appropriate. Recycle containers

wherever possible after careful cleaning. Refer to product label for specific instructions. After spills, wash area

preventing runoff from entering drains. If a significant quantity of material enters drains, advise emergency services.

Full details regarding disposal of used containers, spillage and unused material may be found on the label. If there is

any conflict between this SDS and the label, instructions on the label prevail. Ensure legality of disposal by consulting

regulations prior to disposal. Thoroughly launder protective clothing before storage or re-use. Advise laundry of nature

of contamination when sending contaminated clothing to laundry.

Section 7 - Handling and Storage

Handling

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

Section 8 of this SDS for details of personal protective measures, and make sure that those measures are followed.

The measures detailed below under "Storage" should be followed during handling in order to minimise risks to

persons using the product in the workplace. Also, avoid contact or contamination of product with incompatible

materials listed in Section 10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage

of this schedule of poison. Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight. Make sure that the product does not come into contact with substances listed

under "Incompatibilities" in Section 10. Check packaging - there may be further storage instructions on the label.

Section 8 - Exposure Controls and Personal Protection

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

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

set 2008, Industrial Eye Protection: AS1336 and AS/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 any of the significant ingredients in this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are

for bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

This product should only be used in a well ventilated area. If natural ventilation is inadequate, use of a

fan is suggested.

Eye Protection:

Protective glasses or goggles should be worn when this product is being used. Failure to protect

your eyes may cause them harm. Emergency eye wash facilities are also recommended in an area close to where

this product is being used.

Skin Protection:

If you believe you may have a sensitisation to this product or any of its declared ingredients, you

should prevent skin contact by wearing impervious gloves, clothes and, preferably, apron. Make sure that all skin

areas are covered. See below for suitable material types.

Protective Material Types:

We suggest that protective clothing be made from the following materials: PVC.

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 4 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Respirator:

If there is a significant chance that dusts are likely to build up in the area where this product is being

used, we recommend that you use a suitable dust mask. Otherwise, not normally necessary.

Eyebaths or eyewash stations and safety deluge showers should, if practical, be provided near to where this product

is being handled commercially.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

An off white to pale buff flowing powder.

Odour:

No more than a slight odour.

Boiling Point:

Not applicable.

Freezing/Melting Point:

Decomposes before melting.

Volatiles:

No data.

Vapour Pressure:

No data.

Vapour Density:

Not applicable.

Specific Gravity:

No data.

Water Solubility:

No data.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

Not applicable.

Coeff Oil/water Distribution

No data

Viscosity:

Not applicable.

Autoignition temp:

No data.

Refractive index:

Not applicable.

Optical rotation:

Not applicable.

Section 10 - Stability and Reactivity

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have

any doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight.

Incompatibilities:

water, strong acids, strong bases, oxidising agents.

Fire Decomposition:

No specific data. Based on composition of proteins and fats, the following might be expected:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and possibly smoke. Nitrogen and its compounds,

and under some circumstances, oxides of nitrogen. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and other

sulfur compounds; also water. Carbon monoxide poisoning produces headache, weakness, nausea, dizziness,

confusion, dimness of vision, disturbance of judgment, and unconsciousness 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 indicating any particular target organs.

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

Potential Health Effects

Inhalation:

Short Term Exposure:

Available data indicates that this product is not harmful. However product may be mildly

irritating, although unlikely to cause anything more than mild transient discomfort.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 5 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Skin Contact:

Short Term Exposure:

Classified as a potential sensitiser by skin contact. Exposure to a skin sensitiser, once

sensitisation has occurred, may manifest itself as skin rash or inflammation, and in some individuals this reaction can

be severe. In addition product is a skin irritant. Symptoms may include itchiness and reddening of contacted skin.

Other symptoms may also become evident, but all should disappear once exposure has ceased.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: This product is an eye irritant. Symptoms may include stinging and reddening of eyes and

watering which may become copious. Other symptoms may also become evident. If exposure is brief, symptoms

should disappear once exposure has ceased. However, lengthy exposure or delayed treatment may cause permanent

damage.

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. Available data shows that this

product is harmful, but symptoms are not available. However, this product may be irritating to mucous membranes but

is unlikely to cause anything more than transient discomfort.

Long Term Exposure

: No data for health effects associated with 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.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Section 12 - Ecological Information

Insufficient data to be sure of status. Expected to not be an environmental hazard.

Section 13 - Disposal Considerations

Disposal:

Special help is available for the disposal of Agricultural Chemicals. The product label will give general

advice regarding disposal of small quantities, and how to cleanse containers. However, for help with the collection of

unwanted rural chemicals, contact ChemClear 1800 008 182 http://www.chemclear.com.au/ and for help with the

disposal of empty drums, contact DrumMuster http://www.drummuster.com.au/ where you will find contact details for

your area.

Section 14 - Transport Information

UN Number:

This product is not classified as a Dangerous Good by ADG, IATA or IMDG/IMSBC criteria. No special

transport conditions are necessary unless required by other regulations.

Section 15 - Regulatory Information

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredient: Tylosin as Tylosin Tartrate, is mentioned in the SUSMP.

Section 16 - Other Information

This SDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

Product Name: TYLOMIX 100 TYLOSIN TARTRATE PREMIX

Page: 6 of 6

This version issued: November, 2016

SAFETY DATA SHEET

Issued by: Abbey Laboratories Pty Ltd

Phone: 02 8088 0720 (office hours)

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

SUSMP

Standard for the Uniform Scheduling of Medicines & Poisons

UN Number

United Nations Number

THIS SDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND HOW

TO SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS SDS IN THE CONTEXT OF HOW

THE PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE,

THE USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT

TO OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This SDS is prepared in accord with the SWA document “Preparation of Safety Data Sheets for Hazardous

Chemicals - Code of Practice” (Feb 2016)

Copyright © Kilford & Kilford Pty Ltd, November, 2016.

http://www.kilford.com.au/

Phone (02)9251 4532

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