TOLFEDINE CS INJECTION

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

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Active ingredient:
TOLFENAMIC ACID; BENZYL ALCOHOL
Available from:
Vetoquinol Australia Pty Ltd
INN (International Name):
tolfenamic acid(40mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml; BENZYL ALCOHOL BENZENE Other 1.04 %w/v
Units in package:
100mL; 250mL; 50mL
Class:
VM - Veterinary Medicine
Therapeutic group:
CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
AGALACTIA | ANTI-INFLAMMATORY AGENT | MASTITIS | METRITIS | PNEUMONIA | ANTIPYRETIC | BACTERIAL PNEUMONIA | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MASTITIS-METRITIS-AGALACTIA | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | SUBCLINICAL MASTITIS | TENDON SPRAINS | TRAUMATIC SWELLING
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: Cattle by intramuscular adm inistration: DO NOT USE less than 10 da ys before slaughter for human consumpti on. Cattle by intravenous administratio n: DO NOT USE less than 4 days before slaughter for human consumption. Pigs b y intramuscular administration: DO NOT USE less than 6 days before slaughter f or human consumption. MILK: Cattle by i ntramuscular or intravenous administrat ion: Milk collected from cows within 12 hours (1 milking) following treatment MUST NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves. ESI: DO NOT USE l ess than 21 days (pigs) or 28 days (cat tle) before slaughter for export. The E SI on this label was correct at the tim e of label approval. Before using this product confirm the current ESI from t he registrant on 02 9517 1166 or the AP VMA website (apvma. gov.au/residues/ESI .shtml); Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; A non-steroidal anti-inflammatory analgesic - antipyretic for use in cattle and pigs.See RESTRAINTS & PRECAUTIONS on label.
Authorization status:
Registered
Authorization number:
52850
Authorization date:
2020-07-01

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 1 of 9

Carton - Main Panel

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Tolfedine® CS Injection

Tolfenamic acid 40 mg/mL

Contains 1.04% w/v benzyl alcohol as a preservative.

A non-steroidal anti-inflammatory analgesic-antipyretic for use in cattle

and pigs.

50mL/100mL/250mL

Vetoquinol

APPROVED NON-RLP

AMENDMENT MADE

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 2 of 9

Carton – Ancillary Panels

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

INDICATIONS

For use by or under the direction of a registered veterinarian as an aid in

the treatment of pneumonia and acute mastitis in cattle and metritis-

mastitis-agalactia in pigs.

DIRECTIONS FOR USE

Restraints: DO NOT inject cattle other than into muscle tissue high on

the side of the neck (see leaflet for diagram). Injection of product into

muscles other than as described is likely to result in residues in meat

above the MRL or ESI.

Precautions: Repeat treatments or higher doses could result in residues

above the MRL unless the label withholding period is extended. The

prescribing Veterinarian would need to advise on an extended withholding

period. Safe use of TOLFEDINE CS Injection during pregnancy has not been

established.

Dosage and Administration.

Use the contents within 3 months of first broaching of the vial. Discard

the unused portion.

RE-TREATMENT INTERVAL: A single treatment regime consists of either 1 x

IV injection (cattle) or 2 x IM injections at 48h (cattle) or 1 x IM injection (pigs).

DO NOT repeat treatment less than 21 days after treatment of pigs, or 28

days after last treatment of cattle.

CATTLE -Pneumonia: 2mg/kg (1 mL per 20kg bw) by intramuscular injection

high in the neck (see leaflet for diagram). Treatment may be repeated once

only after 48 hours.

Mastitis: 4mg/kg (1 mL per 10 kg bw) as a single intravenous injection.

PIGS: Metritis-mastitis-agalactia: 2mg/kg (1 mL per 20kg bw) as a single

intramuscular injection.

WITHHOLDING PERIODS

MEAT -

Cattle by intramuscular administration: DO NOT USE less than 10 days

before slaughter for human consumption.

Cattle by intravenous administration: DO NOT USE less than 4 days

before slaughter for human consumption.

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 3 of 9

Pigs by intramuscular administration: DO NOT USE less than 6 days

before slaughter for human consumption.

MILK

Cattle by intramuscular or intravenous administration: Milk collected

from cows within 12 hours (1 milking) following treatment MUST NOT BE

USED for human consumption or processing, or fed to bobby calves.

TRADE ADVICE

EXPORT SLAUGHTER INTERVAL

(

ESI

):

DO NOT USE

less than 21days (pigs) or 28 days (cattle) before slaughter for

export. The ESI on this label was correct at the time of label approval. Before

using this product, confirm the current ESI from the registrant on 02 9517 1166 or

the APVMA website (www.apvma.gov.au/residues/ESI.shtml)

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information

Centre. Phone Australia 131 126.

Distributed By:

Vetoquinol Australia Pty Ltd

ABN 64 006 949 480

Unit 302/2, 6-12 Boronia Road,

DaVinci Business Park, Brisbane Airport, QLD, 4008

Phone: 1800 032 355

sales.australia@vetoquinol.com

www.vetoquinol.com

Manufactured By:

VETOQUINOL S.A., 70204 LURE Cedex (France).

Store below 30

C (Room temperature) away from direct sunlight.

Dispose of empty containers by wrapping with paper and putting in garbage.

Batch

Expiry

APVMA Approval No 52850/49084

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 4 of 9

Immediate Container – Main Panel

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Tolfedine® CS Injection

Tolfenamic acid 40mg/mL

Contains 1.04% w/v benzyl alcohol as a preservative.

A non-steroidal anti-inflammatory analgesic-antipyretic for use in cattle

and pigs.

50mL/100mL/250mL

Vetoquinol

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 5 of 9

Immediate Container – Ancillary Panels

READ THE CARTON OR ENCLOSED LEAFLET BEFORE USING THIS

PRODUCT

For use by or under the direction of a registered veterinarian as an aid in the

treatment of pneumonia and acute mastitis in cattle and metritis-mastitis-

agalactia in pigs.

DIRECTIONS FOR USE

RESTRAINTS: DO NOT inject cattle other than into muscle tissue high

on the side of the neck (see leaflet for diagram). Injection of product

into muscles other than as described is likely to result in residues in

meat above the MRL or ESI.

Dosage and Administration:

Use the contents within 3 months of first broaching of the vial. Discard the

unused portion.

RE-TREATMENT INTERVAL: Pigs – 21 days; Cattle – 28 days.

CATTLE - Pneumonia: 2mg/kg (1 mL per 20 kg bw) by intramuscular

injection high in the neck (see leaflet for diagram). Treatment may be

repeated once only after 48 hours.

Mastitis: 4mg/kg (1 mL per 10 kg bw) as a single intravenous injection.

PIGS - Metritis-mastitis-agalactia: 2mg/kg (1 mL per 20 kg bw) as a single

intramuscular injection.

WITHHOLDING PERIODS

MEAT: Cattle – 10 days IM injection, 4 days IV injection; Pigs – 6 days

MILK – 12 hours.

TRADE ADVICE

ESI: Pigs – 21 days; Cattle – 28 days.

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information

Centre. Phone Australia 131 126.

Distributed By:

Vetoquinol Australia Pty Ltd

ABN 64 006 949 480

Unit 302/2, 6-12 Boronia Road,

DaVinci Business Park, Brisbane Airport, QLD, 4008

Phone: 1800 032 355

sales.australia@vetoquinol.com

www.vetoquinol.com

Manufactured By:

VETOQUINOL S.A., 70204 LURE Cedex (France).

Store below 30

C (Room temperature) away from direct sunlight.

Dispose of empty containers by wrapping with paper and putting in garbage.

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 6 of 9

Batch

Expiry

APVMA Approval No 52850/49084

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 7 of 9

Leaflet

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Tolfedine® CS Injection

Tolfenamic acid 40mg/mL

Sterile aqueous solution containing 4.0% w/v tolfenamic acid as active ingredient and

1.04 % w/v benzyl alcohol as preservative.

Pharmacological properties and pharmacokinetic particulars:

Tolfenamic acid (N-(2-methyl-3-chforophenyl) anthranilic acid) is a non-steroidal

antiinflammatory drug (NSAID) belonging to the fenamate group. Tolfenamic acid

exerts antiinflammatory, analgesic and antipyretic activities. The anti-inflammatory

activity of tolfenamic acid is mainly due to an inhibition of cyclo-oxygenase and thus

to a reduction of the synthesis of prostaglandins and thromboxanes, which are

important inflammatory mediators.

In cattle a mean maximum plasma concentration of about 1.2 mg/ml was obtained at

about 1 hour and in pigs a mean maximum plasma concentration 2.3 mg/ml of about

was obtained at about 1 hour. The volume of distribution is about 1.3 L/kg in cattle

and pigs. Tolfenamic acid -is extensively bound to plasma albumin (> 97%).

Tolfenamic acid is distributed in all the organs with a higher concentration in the

plasma, digestive tract, liver, lungs and kidneys, on the other hand the concentration

in the brain is low. Tolfenamic acid and its metabolites cross the placenta poorly.

Tolfenamic acid distribution involves extracellular fluids where concentrations similar

to plasma are achieved both in healthy and inflamed peripheral tissues. It also

appears in milk in the active form, mainly associated with the curds.

Tolfenamic acid undergoes extensive enterohepatic recirculation which results in

prolonged concentrations being found in plasma. In cattle and pigs, tolfenamic acid

is eliminated mainly unchanged in faeces (- 30%) and urine (- 70%).

INDICATIONS

For use by or under the direction of a registered veterinarian as an aid in

the treatment of pneumonia and acute mastitis in cattle and metritis-

mastitis-agalactia in pigs.

DIRECTIONS FOR USE

Restraints: DO NOT inject cattle other than into muscle tissue high on

the side of the neck (see leaflet for diagram). Injection of product into

muscles other than as described is likely to result in residues in meat

above the MRL or ESI.

Tolfedine CS Injection – 52850/49084.

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 8 of 9

Precautions: Repeat treatments or higher doses could result in residues

above the MRL unless the label withholding period is extended. The

prescribing Veterinarian would need to advise on an extended withholding

period. Safe use of TOLFEDINE CS Injection during pregnancy has not been

established.

Dosage and Administration:

Use the contents within 3 months of first broaching of the vial. Discard

the unused portion.

RE-TREATMENT INTERVAL: A single treatment regime consists of either 1 x

IV injection (cattle) or 2 x IM injections at 48h (cattle) or 1 x IM injection (pigs).

DO NOT repeat treatment less than 21 days after treatment of pigs, or 28

days after last treatment of cattle.

CATTLE -Pneumonia: 2mg/kg (1 mL per 20kg bw) by intramuscular injection

high in the neck (see diagram). Treatment may be repeated once only after

48 hours.

Mastitis: 4mg/kg (1 mL per 10 kg bw) as a single intravenous injection.

PIGS: Metritis-mastitis-agalactia: 2mg/kg (1 mL per 20kg bw) as a single

intramuscular injection into the rump.

WITHHOLDING PERIODS

MEAT:

Cattle by intramuscular administration: DO NOT USE less than 10 days

before slaughter for human consumption.

Cattle by intravenous administration: DO NOT USE less than 4 days

before slaughter for human consumption.

Pigs by intramuscular administration: DO NOT USE less than 6 days

before slaughter for human consumption.

MILK:

Cattle by Intramuscular or Intravenous Administration:

Milk collected from cows within 12 hours (1 milking) following treatment MUST

NOT BE USED for human consumption or processing, or fed to bobby calves.

TRADE ADVICE

EXPORT SLAUGHTER INTERVAL

(

ESI

):

DO NOT USE

less than 21days (pigs) or 28 days (cattle) before slaughter for

export. The ESI on this label was correct at the time of label approval. Before

using this product, confirm the current ESI from the registrant on 02 9517 1166 or

the APVMA website (www.apvma.gov.au/residues/ESI.shtml)

DRAFT TEXT LABEL – Tolfedine CS Injection

LEAFLET

Text appearing above the Header and below the Footer lines is not included in the label

May 2015

Page 9 of 9

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre.

Phone Australia 131 126.

Store below 30

C (Room temperature) away from direct sunlight.

Dispose of empty containers by wrapping with paper and putting in garbage.

Presentation:

Tolfedine CS is available in vials containing 50mL, 100mL or 250mL.

APVMA Approval No 52850/49084

Manufactured By:

VETOQUINOL S.A., 70204 LURE Cedex (France).

Distributed By:

Vetoquinol Australia Pty Ltd

ABN 64 006 949 480

Unit 302/2, 6-12 Boronia Road,

DaVinci Business Park, Brisbane Airport, QLD, 4008

Phone: 1800 032 355

sales.australia@vetoquinol.com

www.vetoquinol.com

Product Name: TOLFEDINE CS INJECTION

Page: 1 of 5

This version issued: January, 2016

SAFETY DATA SHEET

Issued by: Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

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

Section 1 - Identification of The Material and Supplier

Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

Unit 302/2, 6-12 Boronia Road, Da Vinci Business Park,

Fax: 1800 648 460

Brisbane Airport, Qld 4008

Chemical nature:

Tolfedine is a highly effective and safe Non Steroidal Anti-Inflammatory, COX-2

preferential inhibitor.

Trade Name:

TOLFEDINE CS INJECTION

APVMA Code:

52850

Product Use:

Nonsteroidal anti-inflammatory, analgesic, antipyretic for cattle and pigs.

Creation Date:

October, 2015

This version issued:

January, 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:

Xi, Irritating. N, Dangerous to the environment. 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: NONE. Not hazardous.

PREVENTION

P102: Keep out of reach of children.

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

P281: Use personal protective equipment as required.

RESPONSE

P353: Rinse skin or shower with water.

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

P370+P378: Not combustible. Use extinguishing media suited to burning materials.

STORAGE

P410: Protect from sunlight.

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

P403+P235: Store in a well-ventilated place. Keep cool, below 30°C.

DISPOSAL

P501: 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.

Emergency Overview

Physical Description & Colour

: Colourless, slightly viscous liquid.

Odour:

No data re odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Tolfenamic acid

13710-19-5

40mg/mL

not set

not set

Benzyl alcohol

100-51-6

10.4mg/mL

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.

Product Name: TOLFEDINE CS INJECTION

Page: 2 of 5

This version issued: January, 2016

SAFETY DATA SHEET

Issued by: Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

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

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.

Self Injection: Accidental self injection may lead to an inflammatory response. Medical advice should be sought on

the management of deep injections, particularly those near a joint or associated with bruising. If possible the

application of gentle squeezing pressure with absorbent material (e.g. facial tissues) at the injection site will swab up

unabsorbed vaccine. Strong squeezing of the site should be avoided. The damaged area should be thoroughly

cleansed and a topical antiseptic applied. Check your tetanus immunisation status.

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:

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:

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. 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 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.

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

a fire. This will only occur after heating to dryness.

Fire decomposition products from this product are likely to be harmful if inhaled. Take suitable 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

:

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.

Section 6 - Accidental Release Measures

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, refer to product label for specific instructions. No special protective

clothing is normally necessary because of this product. However it is good practice to wear latex gloves when

handling injectables. In the event of a major spill, prevent spillage from entering drains or water courses and call

emergency services.

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 (below

30°C), 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. 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.

Product Name: TOLFEDINE CS INJECTION

Page: 3 of 5

This version issued: January, 2016

SAFETY DATA SHEET

Issued by: Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

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

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.

The ADI for Tolfenamic acid is set at 0.005mg/kg/day. The corresponding NOEL is set at 0.5mg/kg/day. ADI means

Acceptable Daily Intake; NOEL means No-observable-effect-level. Data from Australian ADI List, June 2014.

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:

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

used.

Skin Protection:

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: butyl

rubber.

Respirator:

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

the Australian Standard mentioned above. Otherwise, not normally necessary.

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

Colourless, slightly viscous liquid.

Odour:

No data re odour.

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Approximately 0°C.

Volatiles:

Water component.

Vapour Pressure:

2.37 kPa at 20°C (water vapour pressure).

Vapour Density:

As for water.

Specific Gravity:

No data.

Water Solubility:

Completely soluble in water.

pH:

7.5-9.5 (as supplied)

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

As for water.

Coeff Oil/water Distribution

No data

Autoignition temp:

Not applicable - does not burn.

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:

strong oxidising agents.

Fire Decomposition:

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

temperatures normally achieved in a fire. This will only occur after heating to dryness. Combustion forms carbon

dioxide, and if incomplete, carbon monoxide and possibly smoke. Water is also formed. May form nitrogen and its

compounds, and under some circumstances, oxides of nitrogen. Occasionally hydrogen cyanide gas in reducing

atmospheres. 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.

Product Name: TOLFEDINE CS INJECTION

Page: 4 of 5

This version issued: January, 2016

SAFETY DATA SHEET

Issued by: Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

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

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.

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.

Eye Contact:

Short Term Exposure

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

mild discomfort which should disappear once product is removed.

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.

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

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

Tolfenamic Acid:

Oral, Rat 225-246mg/kg

Benzyl Alcohol:

Oral, Rat 1200-3100mg/kg

Section 12 - Ecological Information

Harmful to aquatic organisms, may cause long-term adverse effects to the aquatic environment.

Section 13 - Disposal Considerations

Disposal:

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

Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. For

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

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: Tolfenamic acid, 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

Product Name: TOLFEDINE CS INJECTION

Page: 5 of 5

This version issued: January, 2016

SAFETY DATA SHEET

Issued by: Vetoquinol Australia Pty Ltd

Phone: 1800 032 355

(business hours)

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

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

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” (December 2011)

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

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

Phone (02)9251 4532

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