ILIUM PYRAQUANTAL ALLWORMER TABLETS FOR DOGS

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

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Active ingredient:
OXANTEL EMBONATE; PYRANTEL EMBONATE; PRAZIQUANTEL
Available from:
TROY LABORATORIES PTY LTD
INN (International Name):
oxantel embonate(542mg/Tb)+pyrantel pamoate(143mg/Tb) + others
Pharmaceutical form:
ORAL TABLET
Composition:
OXANTEL EMBONATE ANTHELMINTIC Active 542.0 mg/Tb; PYRANTEL EMBONATE ANTHELMINTIC Active 143.0 mg/Tb; PRAZIQUANTEL ANTHELMINTIC Active 50.0 mg/Tb
Units in package:
100 Tabs; 4 Tablets; 6 Tablets
Class:
VM - Veterinary Medicine
Manufactured by:
TROY LABORATORIES
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
PARASITICIDES
Therapeutic indications:
HOOKWORM | HOOKWORM - BUNOSTOMUM SPP. | HYDATID TAPEWORM | ROUNDWORM | TAPEWORM | WHIPWORM - TRICHURIS VULPIS | ANCYLOSTOMA BRAZILIENSE | ANCYLOSTOMA CANINUM | DIPYLIDIUM CANINUM | TAENIA HYDATIGENA | TAENIA OVIS | TAENIA PISIFORMIS | TAENIA SPP. | TOXOCARA MYSTAX | TOXOCARA SPP. | UNCINARIA STENOCEPHALA
Product summary:
Poison schedule: 5; Withholding period: WHP: N/A.; Host/pest details: DOG: [HOOKWORM, HOOKWORM - BUNOSTOMUM SPP., HYDATID TAPEWORM, ROUNDWORM, TAPEWORM, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 5; Withholding period: ; Host/pest details: DOG: [HOOKWORM, HOOKWORM - BUNOSTOMUM SPP., HYDATID TAPEWORM, ROUNDWORM, TAPEWORM, WHIPWORM - TRICHURIS VULPIS]; For the control of roundworms, whipworms, hookworms and tapeworms and the hydatid tapeworm in dogs.
Authorization status:
Registered
Authorization number:
48495
Authorization date:
2020-07-01

Label image proudly supplied by

infopest@dpi.qld.gov.au

Draft Text Label:

Ilium Pyraquantal Alfwcnner Tablets

Immediate Label: Ancillary Panel

Text appearing above the Headerand below the Footer lines is not includedin the label

DIRECTIONS FOR USE:

Weigh dog before treatment.

Fasting is NOT necessary.

DOSE RATE;

One tablet per 10 kg bodyweight.

Dosing should be rounded up to the nearest quarter

tablet.

Use the following table as a guide.

Bodyweight

1.2-2.5kg

2.5 -

5.0 kg

5.1-10.0

Over 10kg

1 tablet for every 10 kg

FREQUENCY:

Hydatid Tapeworm .Treat every 6 weeks

Other Tapeworms:

Treat every 3 months and treat

dog regUlarly for fleas.

Roundworms and Hookworms:

Treat

at 2, 4, 8 and 12 weeks of age and thereafter every 3

months.

Whipworms

: Treat every 6 to 8 weeks after 3 months of age.

Pregnant

and Lactating Bitches: Treat prior to mating,

10 days before,

and 4 weeks after,

whelping.

ZONE

CONTROL:

Dogs can easily be reinfested with these parasites,

so it is particularly important

not only to treat

the dog,

also to control

the environment.

This can be achieved by daily disposal

of droppings and flea control.

Dogs in country areas should never be fed offal

from any source.

DISPOSAL;

Dispose of container by wrapping with paper and putting in garbage.

TROY LABORATORIES PTY.

LIMITED

98 Long Street,

Smithfield,

N.S.W. 2164 Australia

Store

below 30°C (Room Temperature),

protected from moisture.

NRA Approval

No.: 48495/

0<603

Batch:

July

2003

Expiry:

Page2 of

Draft Text

Label:

Ilium

Pyraquantal

Atrwonner

Tablets

Carton:

Main Panel

Text

appearing

above the

Header

and below the Footerlines is not

incruded

in the label

CAUTION

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

ILIUM

PYRAQUANTAL

ALLWORMER TABLETS FOR DOGS

Active Constituents:

Each tablet contains:

OXANTEL EMBONATE

PYRANTEL EMBONATE,

PRAZIQUANTEL

For the control

Roundworms

(Toxocara

canis and

Toxascaris leonina),

Whipworms

(Trichuris vulpis),

Hookworms

(Ancylostoma caninum,

Ancylostoma

braziliense

Uncinaria stenocephala),

andTapeworms

(Dipylidium csninum,

Taenia ovts,

Taenia

hydaUgena,

Taenia pisiformis)

and the HYDATID Tapeworm

(Echinococcus granulosus)

July 2003

ILIUM

4/6/100

Tablets

Page3 of

"

Draft Text Label:

Ilium

Pyraquantal

AllwonnerTablets

Carton: Ancillary Panels

Text

appearing

above the Headerand below the Footerlines is not

included

in the label

DIRECTIONS FOR USE:

Weigh dog before treatment.

Fasting is NOT necessary.

DOSE RATE:

One tablet per 10 kg bodyweight.

Dosing should be rounded up to the nearest quarter

tablet.

following table as a guide.

Bodvweight

-2.5

2.6 -

5.0 kg

5.1-10.0kg

Over 10kg

Tablet

1 tablet for every 10 kg

FREQUENCY:

Hydatid Tapeworm .Treat every 6 weeks

Other

Tapeworms:

Treat

every 3 months and treat

dog regularly for fleas.

Roundworms and Hookworms:

Treat

at 2, 4,

8 and 12 weeks of age and thereafter every 3

months.

Whipworms : Treat

every 6 to 8 weeks after 3 months of age.

Pregnant and Lactating

Bitches:

Treat

prior to mating,

10 days before,

and 4 weeks after,

whelping.

ZONE

CONTROL:

Dogs can easily be reinfested with these parasites,

so it is particularly important

only to treat the dog,

but also to control

the environment.

This can be achieved by daily disposal

of droppings

flea control.

Dogs in country areas should never be fed offal

from any source.

DISPOSAL:

Dispose of container by wrapping with paper and putting in garbage.

TROY

LABORATORIES PTY.

LIMITED

98 Long Street,

Smithfield, N.S.W. 2164 Australia

Store

below 30°C (Room Temperature),

protected from moisture.

NRA Approval

No.:

48495/

c?.>

Batch:

25 July 2003

Expiry:

Page4

MATERIAL SAFETY DATA SHEET

Product Name: Ilium Pyraquantal Allwormer Tablets for Dogs

Page: 1 of 4

This revision issued: March, 2015

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

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

Section 1 - Identification of The Material and Supplier

Troy Laboratories Australia Pty. Ltd

ABN: 21 000 283 769

Tel:

(02)9677 9000

31-35 Glendenning Road

Fax:

(02) 9677 9300

Glendenning NSW 2761

Chemical nature:

Blend of ingredients. Includes anthelmintic ingredients.

Trade Name:

Ilium Pyraquantal Allwormer Tablets for Dogs

Product Code:

3642

Product Use:

Control of a range of parasitic worms in dogs.

Creation Date:

August, 2005

This version issued:

March, 2015

and is valid for 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of SWA Australia.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S20, S25. When using, do not eat or drink. Avoid contact with eyes.

SUSDP Classification:

ADG Classification:

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

UN Number:

None allocated

Emergency Overview

Physical Description & Colour

: Yellow round tablets with small dark specks; flat with double breakbar on one

side.

Odour:

Meaty odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Potential Health Effects

This is a pharmacologically active preparation, and contact should be avoided except in actual use. If you have come

into contact with this product, seek medical attention if you feel drowsy or experience any unusual symptoms.

Inhalation

Short Term Exposure:

Significant inhalation exposure is considered to be unlikely. 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.

Skin Contact:

Short Term Exposure:

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

normal use. However product may be mildly irritating, but is unlikely to cause anything more than mild discomfort

which should disappear once contact ceases.

Long Term Exposure:

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

Eye Contact:

Short Term Exposure

: Exposure via eyes is considered to be unlikely. This product may be irritating to eyes, but is

unlikely to cause anything more than mild transient discomfort.

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

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.

Product Name: Ilium Pyraquantal Allwormer Tablets for Dogs

Page: 2 of 4

This revision issued: March, 2015

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

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

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 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Oxantel embonate

68813-55-8

542mg

not set

not set

Pyrantel embonate

22204-24-6

143mg

not set

not set

Praziquantel

55268-74-1

50mg

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 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 should not be exceeded for more than 15 minutes and should

not be repeated for 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 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:

Gently brush away excess solids. Irritation is unlikely. However, if irritation does occur, flush with

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

Eye Contact:

Quickly and gently brush particles from eyes. No effects expected. If irritation does occur, flush

contaminated eye(s) with lukewarm, gently flowing water for 5 minutes or until the product is removed. Obtain medical

advice if irritation becomes painful or lasts more than a few minutes.

Ingestion:

If product is swallowed or gets in mouth, 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 5 - Fire Fighting Measures

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 harmful if inhaled. Take suitable protective measures.

Extinguishing Media

: Preferred extinguishing media are 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

:

Not flammable.

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. As a

minimum, wear overalls, goggles and gloves. Suitable materials for protective clothing include cotton, rubber, PVC.

Eye/face protective equipment should comprise as a minimum, protective glasses and, preferably, 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. Use a P1 mask, designed for use against mechanically generated particles eg silica & asbestos.

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. After spills, wash area preventing runoff from entering drains. If a significant

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

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.

Product Name: Ilium Pyraquantal Allwormer Tablets for Dogs

Page: 3 of 4

This revision issued: March, 2015

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

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

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 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

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

of this schedule of poison. Keep containers dry and away from water. 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, 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.

The ADI for Praziquantel is set at 0.02mg/kg/day. The corresponding NOEL is set at 20mg/kg/day. ADI means

Acceptable Daily Intake and NOEL means No-observable-effect-level. Values from Australian ADI List, Dec 2004.

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 dusts are minimised.

Eye Protection:

Eye protection such as protective glasses or goggles is recommended when product is being used.

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:

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.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Yellow round tablets with small dark specks; flat with double breakbar on one

side.

Odour:

Meaty odour.

Boiling Point:

No specific data. Expected to decompose before boiling.

Freezing/Melting Point:

No specific data. Solid at normal temperatures.

Volatiles:

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

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Tablet disintegrates in water.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Coeff Oil/water Distribution

No data

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:

Containers should be kept dry. Protect this product from light. Store in the closed original

container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

water, acids, strong oxidising agents.

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

Product Name: Ilium Pyraquantal Allwormer Tablets for Dogs

Page: 4 of 4

This revision issued: March, 2015

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

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

smoke. Nitrogen and its compounds, and under some circumstances, oxides of nitrogen. Occasionally hydrogen

cyanide gas. 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:

none known

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

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

Section 12 - Ecological Information

Insufficient data to be sure of status.

Section 13 - Disposal Considerations

Disposal:

Containers should be emptied as completely as practical before disposal. If possible, recycle containers

either in-house or send to recycle company. If this is not practical, send to a commercial waste disposal site. This

product should be suitable for landfill. However, check with local Waste Disposal Authority before sending there. Note

that product properties may have been changed in use, significantly altering it's suitability for landfill. Please do NOT

dispose into sewers or waterways.

Section 14 - Transport Information

ADG Code:

This product is not classified as a Dangerous Good. 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 ingredients: Oxantel embonate, Pyrantel embonate, Praziquantel, are mentioned in the SUSDP.

Section 16 - Other Information

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, 7th Edition

AICS

Australian Inventory of Chemical Substances

CAS Number

Chemical Abstracts Service Registry Number

IARC

International Agency for Research on Cancer

SWA

Safe Work Australia, formerly ASCC and NOHSC

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

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:2011(2003)]

Copyright © Kilford & Kilford Pty Ltd, March, 2015.

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

Phone (02)9251 4532

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