COOPERS PERMATRACE COPPER CAPSULES FOR ADULT SHEEP & GOATS

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

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Active ingredient:
CUPRIC OXIDE
Available from:
Intervet Australia Pty Limited
INN (International Name):
copper oxide(390g/kg)
Pharmaceutical form:
ORAL CAPSULE
Composition:
CUPRIC OXIDE MINERAL-COPPER Active 390.0 g/kg
Units in package:
500 Caps
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
GOAT | SHEEP | BILLY | BUCK | CAPRA HIRCUS | DOE | EWE | HOGGET | KID | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
MINERAL AND NUTRITIONAL ADDITIVE | ACETONAEMIA | ACTINOBACILLOSIS | AMINO ACID SUPPLEMENT | AMINO ACIDS | BONE FRAGILITY | BONE GROWTH | CALCIUM SUPPLEMENT | CARTILAGE STRENGTH | COPPER DEFICIENCY | EGG SHELL | FATTY ACID DEFICIENCY | FATTY LIVER | GLUCOSE | GRASS TETANY | HEPATOTOXIC DRUGS | HYPOCALCAEMIA | HYPOMAGNESAEMIA | ILEITIS | IODINE DEFICIENCIES | LACTATING | LAXATIVE | L-CARNITINE SUPPLEMENT | LIVER ABSCESS | LIVER DAMAGE | LYSINE DEFICIENCIES | MILK FEVER | MINERAL ADDITIVE | MYOPATHIES | MYOSITIS SYNDROME | PANGAMIC ACID | PHOSPHOROUS SUPPLEMENT | RICKETS | SELENIUM DEFICIENCY | SHELL STRENGTH | SOFT BONE DISEASE | VITAMIN B12 | VITAMIN D SUPPLEMENT | VITAMIN E DEFICIENCIES | ZINC DEFICIENCIES
Product summary:
Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: GOAT: [MINERAL AND NUTRITIONAL ADDITIVE]; SHEEP: [MINERAL AND NUTRITIONAL ADDITIVE]; Poison schedule: 0; Withholding period: ; Host/pest details: GOAT: [MINERAL AND NUTRITIONAL ADDITIVE]; SHEEP: [MINERAL AND NUTRITIONAL ADDITIVE]; Sustained release copper capsules for prevention and treatment of copper deficiency. Each capsule contains 2.5 g sustained release copper particles.See precautions on label etc.
Authorization status:
Registered
Authorization number:
47637
Authorization date:
2020-07-01

Coopers Permatrace Copper Capsules for Adult Sheep & Goats 47637_57678 RLP_highlighted V2.

Page 1

TEMPLATE

FOR

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

New Product (include all applicable RLPs) OR

Variation (highlight instructions that are being varied). Approval no. of label being

varied:

47637/500/1104

Signal heading:

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

Product name:

Coopers

®

Permatrace

®

Copper Capsules for Adult Sheep & Goats.

Active

constituent/s:

390g/kg Copper Oxide (CuO). (Each capsule contains 2.5g sustained

release copper particles).

Statement of

claims:

Sustained

release

copper

capsules

for

prevention

and

treatment

of

copper deficiency.

Net contents:

500 Pellets

Directions for Use

Heading:

Directions for Use

Restraints:

Not applicable

Contraindications:

Use of this product is contraindicated in:

sheep and goats of unknown copper status or those treated with

other sources of copper

conjunction with selenium supplementation unless deficiency of

both copper and selenium has been confirmed

sheep or goats suffering from jaundice and other liver disorders

such

as

liver

fluke,

or

stock

grazing

plants

containing

toxic

alkaloids,

eg:

Heliotrope,

Ragwort,

Patersons

Curse

(Salvation

Jane)

lambs or kids less than 2 months of age.

sheep or goats treated with this copper supplement less than 12

months earlier.

Precautions:

Seek advice of veterinary or sheep husbandry specialist to ascertain

copper deficiency and type of treatment required for sheep or goats under

consideration.

Important: Do not use excessive force when dosing in order to avoid

trauma and damage to the throat of the animal.

Side effects:

Not applicable

Dosage &

administration:

Adult Sheep or Goat - 1 capsule.

General directions:

Container Label Only:

Dose ewes or does early in pregnancy to allow protection of young lambs or kids

against copper deficiency.

Unless

corrective

treatment

required

immediately,

preferred

time

treatment is late Winter or early Spring.

To be effective the capsule must be swallowed. It is recommended that

capsules be administered using the Coopers® Sheep Pellet Applicator. It is

RLP

APPROVED

Coopers Permatrace Copper Capsules for Adult Sheep & Goats 47637_57678 RLP_highlighted V2.

Page 2

important to carefully read the applicator use instruction leaflet enclosed in

container before use.

In areas where Liver Fluke are endemic stock should be treated with a highly

effective flukicide at least 3 weeks before dosing with this copper supplement

It is recommended that a steel grinder be administered when treating sheep with

the combination of Permatrace pellets outlined in the table below. This will keep

the surface of the relevant pellets clean and active by preventing a coating

building up on the surface of the pellet. Steel grinders are available from

Coopers Animal Health.

Situation

Steel Grinder Recommended

Permatrace Copper only

Permatrace Copper and Cobalt only

Permatrace Copper and Selenium only

Permatrace

Copper,

Cobalt

Selenium

Container Insert Only:

COOPERS

SHEEP PELLET APPLICATOR

INSTRUCTIONS FOR USE

Instructions relating to use of the COOPERS

SHEEP PELLET APPLICATOR

outlined

below.

safe

effective

administration

COOPERS

PERMATRACE

sheep

pellets

capsules,

these

instructions

must

followed:

Sheep Pellet and Capsule Applicator Instructions for Use:

To be effective, sheep pellets and capsules must be swallowed. It is

recommended that pellets be administered using the COOPERS

SHEEP PELLET APPLICATOR (See picture).

When loading the applicator, use slight pressure to pass each pellet

underneath the plastic retaining tube into the base of the nozzle.

Stretch the animal’s head forward and insert the nozzle of the

applicator into the side of the sheep’s mouth and over the base of the

tongue. Care should be taken to ensure the animal is not allowed to

chew on the tube.

The pellet should be deposited in the gullet, at the back of the tongue

and the sheep observed for a short time to ensure the pellet has been

swallowed. Tilting the animal’s head slightly upwards will assist this

operation (See picture of correct administration).

Coopers Permatrace Copper Capsules for Adult Sheep & Goats 47637_57678 RLP_highlighted V2.

Page 3

Under no circumstances should undue force be applied if any

obstruction to ejection of the pellets or capsules is encountered.

Withdrawing the applicator slightly and re-positioning it correctly will

ensure easy and safe pellet administration.

Withholding

Period/s:

Zero (0) Days.

Trade Advice:

EXPORT SLAUGHTER INTERVAL (ESI):

Zero (0) Days

Safety Directions:

May irritate the eyes and skin. Avoid contact with the eyes and skin. Wash

hands after use.

First Aid:

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

Australia 131126.

Additional user

safety:

Not applicable

Environmental

statements:

Not applicable

Disposal:

DISPOSE of empty container by wrapping with paper and putting in garbage.

Storage:

STORE below 30

C (Room Temperature). Store in original container in a well

ventilated area. Do not store for prolonged periods in direct sunlight. Keep out

of reach of children

Batch & Expiry

Batch, Expiry

Name & address:

COOPERS ANIMAL HEALTH

Intervet Australia Pty Ltd

91-105 Harpin Road, Bendigo VIC 3550

The following is for APVMA use only:

APVMA

approval

APVMA No: 47637/57678

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 1 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Substance:

Active ingredient is copper oxide.

Trade Name:

Coopers Permatrace Copper Capsules for Adult Sheep & Goats

Recommended Use:

Sustained release copper supplement for adult sheep and goats.

APVMA No:

47637

This version issued:

is valid for 5 years from this date.

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:

S25. Avoid contact with eyes.

SUSDP Classification:

None allocated.

ADG Classification:

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

UN Number:

None allocated

Physical Description & Colour:

Red tapered cylindrical capsules containing copper oxide.

Odour:

None

Major Health Hazards:

no significant risk factors have been found for this product.

Inhalation:

Short Term Exposure:

Available data indicates that this product is not harmful. In addition product is unlikely to

cause any discomfort or irritation.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

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

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term Exposure:

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

Potential Health Effects

Emergency Overview

Section 2 - Hazards Identification

Section 1 - Identification of Chemical Product and Company

Issued by: Intervet Australia Pty Limited

(known as MSD Animal Health)

91-105 Harpin Street

Tel: 1800 226 511 (Business hours)

Bendigo East, Vic 3550, AUSTRALIA

Fax: 1800 810 511

Company ABN: 79 008 467 034

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 2 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Eye Contact:

Short Term Exposure

: This product may be mechanically irritating. If exposure is minor or brief, no long term effects

should result. However, if material is not removed promptly, scratches to surface of the eye may result with long term

consequences.

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. However, this product may be mildly

irritating to mucous membranes but is unlikely to cause anything more than mild 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.

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

copper II oxide

1317-38-0

390g/kg

not set

not set

Polyethylene glycol

25322-68-3

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.

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 11 26 from anywhere in Australia (0800 764 766 in New Zealand) and is

available at all times. Have this MSDS with you when you call.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Irritation is unlikely. However, if irritation does occur, flush with lukewarm, gently flowing water for 5

minutes or until chemical is removed.

Eye Contact:

Immediately flush the contaminated eye(s) with lukewarm, gently flowing water until the particles are

removed, while holding the eyelid(s) open. Obtain medical attention if irritation persists, or if particles are lodged in surface

of the eye(s). Take special care if exposed person is wearing contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; wash mouth with water and give some

water to drink. If symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor.

Section 3 - Composition/Information on Ingredients

Section 4 - First Aid Measures

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 3 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Fire and Explosion Hazards:

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Only small quantities of decomposition products are expected from this products at temperatures normally achieved in a

fire.

Fire decomposition products from this product are likely to be irritating if inhaled.

Extinguishing Media

: Does not sustain combustion. Use extinguishing media suited to burning materials.

Fire Fighting

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

Flash point

:

Does not burn.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability Class:

Does not burn.

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, clean up, rinsing to sewer and put empty container in garbage. Although no

special protective clothing is normally necessary because of occasional minor contact with this product, it is good practice

to wear impermeable gloves when handling chemical products. In the event of a major spill, prevent spillage from entering

drains or water courses and call emergency services.

Handling

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

8 of this MSDS 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

: Store packages of this product in a cool place. Keep containers dry and away from water. Make sure that the

product does not come into contact with substances listed under "Incompatibilities" in Section 10. Some liquid

preparations settle or separate on standing and may require stirring before use. Check packaging - there may be further

storage instructions on the label.

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

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, 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:

No special ventilation requirements are normally necessary for this product. However make sure that the

work environment remains clean and that vapours and mists are minimised.

Section 8 - Exposure Controls and Personal Protection

Section 7 - Handling and Storage

Section 5 - Fire Fighting Measures

Section 6 - Accidental Release Measures

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 4 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt, wear

suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

We suggest that protective clothing be made from the following materials: cotton,

rubber, PVC.

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned above.

Physical Description & Colour

Red tapered cylindrical capsules containing copper oxide.

Odour:

None.

Boiling Point:

Not available.

Freezing/Melting Point:

No specific data. Solid at normal temperatures.

Volatiles:

No specific data. Expected to be low at 100°C.

Vapour Pressure:

Negligible at normal ambient temperatures.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Capsule is soluble, copper oxide is not.

pH:

No data.

Volatility:

Negligible at normal ambient temperatures.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

Not applicable - does not burn.

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:

This product should be kept in a cool place, preferably below 30°C. Containers should be kept

dry.

Incompatibilities:

water, acids.

Fire Decomposition:

Only small quantities of decomposition products are expected from this products at

temperatures normally achieved in a fire. Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke.

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 9 - Physical and Chemical Properties

Section 10 - Stability and Reactivity

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 5 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Local Effects:

Target Organs:

There is no data to hand indicating any particular target organs.

Ingredient

Risk Phrases

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

This product has a biodegradable capsule. Contents inorganic and insoluble. It will not accumulate in the soil or water or

cause long term problems. Expected to not be an environmental hazard.

Disposal:

Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For larger

quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary unless

required by other regulations.

AICS:

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

This MSDS 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

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

Classification of Hazardous Ingredients

Section 11 - Toxicological Information

Section 12 - Ecological Information

Section 13 - Disposal Considerations

Section 14 - Transport Information

Section 15 - Regulatory Information

Section 16 - Other Information

Product Name: Coopers Permatrace Copper Capsules for Adult

Sheep & Goats

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2014

Page: 6 of 6

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

THIS MSDS 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 MSDS 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 MSDS is prepared in accord with the SWA document “National Code of Practice for the

Preparation of Material Safety Data Sheets” 2nd Edition [NOHSC:2001(2003)]

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