RIMADYL 20MG TABLETS FOR DOGS

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

Buy It Now

Active ingredient:
CARPROFEN
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
carprofen(20mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
CARPROFEN ANTI-INFLAMMATORY-NONSTEROIDAL Active 20.0 mg/Tb
Units in package:
100 Tabs
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
ANALGESIC | INFLAMMATORY JOINT DISEASE | ANTIPYRETIC | COLIC | MUSCLE RELAXANT | NON-INFECTIOUS JOINT DISEASE | SEDATIVE | SPASMOLYTIC
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ANALGESIC, INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANALGESIC, INFLAMMATORY JOINT DISEASE]; A non-steroidal anti-inflammatory drug for the relief of pain and inflammation in dogs.Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is evidence of blood dyscrasia or hypersensitivity to product. Avoid use in dehydrated, hypovolaemic or hypotensive animals, due to risk of increased renal toxicity.
Authorization status:
Registered
Authorization number:
51747
Authorization date:
2020-07-01

READ THE ENCLOSED LEAFLET BEFORE USING THIS

PRODUCT.

DIRECTIONS FOR USE

Dosage: 2-4 mg/kg bodyweight per day. Dose,

frequency and duration of treatment will be

dependent upon clinical response. See leaflet for full

details.

Storage: Store below 30°C (Room Temperature) in a

dry place out of direct sunlight.

PM63922

Pfizer Animal Health

A division of Pfizer Australia Pty Ltd

Wharf Rd, West Ryde. 2114

®Pfizer trademark ©2008

APVMA No.: 51747100/0508

Made in U.K.

Exp.

CODE NR

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Each tablet contains

20 mg CARPROFEN

A non-steroidal anti-inflammatory

drug for the relief of pain and

inflammation in dogs.

100 tablets

®

106 mm

32 mm

File Name: 51747_44709_100 tabs_Primary_MPL_V01.pdf

Dimension: 32mm x 106mm

Date: V01, 0508

Scale: 100% A4

APPROVED

LABEL

Info

pest

Verified

FRONT

BACK

65 mm

405 mm

Rimadyl tablets are white and scored down the middle,

containing either 20 mg or 50 mg carprofen.

Description:

Rimadyl contains carprofen, a non-steroidal anti-inflammatory

drug (NSAID) of the propionic acid class. The chemical

name for carprofen, a substituted carbazole, is (±)-6-chloro-

α-methylcarbazole-2-acetic acid. The structural formula is:

Carprofen

white,

crystalline

compound

with

empirical formula of C

ClNO

and a molecular weight of

273.72.

freely

soluble

ethanol,

practically

insoluble in water at 25°C.

Clinical Pharmacology:

Carprofen is a non-narcotic, non-steroidal, anti-inflammatory

drug with characteristic analgesic and antipyretic activity,

approximately

equipotent

indomethacin

animal

models.

with

other

NSAIDs,

exact

mode

action

carprofen has not been established; however, inhibition of

prostaglandin synthesis accounts for at least part of its

mechanism of action.

Carprofen is a moderately potent inhibitor of phospholipase

and a reversible inhibitor of cyclooxygenase.

unique

cyclooxygenases

have

been

described

mammals.

constitutive

cyclooxygenase,

COX-1,

synthesises

prostaglandins

necessary

normal

gastrointestinal

renal

function.

inducible

cyclooxygenase, COX-2, generates prostaglandins involved

inflammation.

Inhibition

COX-1

thought

associated with gastrointestinal and renal toxicity while

inhibition of COX-2 provides anti-inflammatory activity. The

specificity of a particular NSAID for either COX-2 or COX-1

may vary from species to species. In an in vitro study using

canine cell cultures, carprofen demonstrated a greater than

100-fold

selective

inhibition

COX-2

compared

with

COX-1.

Carprofen has also been shown to inhibit the release of

several prostaglandins in two inflammatory cell systems: rat

polymorphonuclear

leukocytes

(PMN)

human

rheumatoid

synovial

cells,

indicating

inhibition

acute

(PMN

system)

chronic

(synovial

cell

system)

inflammatory reactions.

In mice, carprofen has been shown to be a much weaker

blocker of castor oil induced diarrhoea and arachidonic

acid-induced toxicity than indomethacin.

This

decreased

effect

carprofen

prostaglandin

synthesis

gastrointestinal

tract

explain

relatively low ulcerogenic activity compared to other drugs

in its class.

Several

studies

have

demonstrated

that

carprofen

modulatory effects on both humoral and cellular immune

responses.

7,8,9,10

Data also indicate that carprofen inhibits the production of

osteoclast-activating factor (OAF), PGE

, and PGE

by its

inhibitory effects on prostaglandin biosynthesis.

Whole blood clotting times were evaluated in dogs given

carprofen at a dose rate of 9mg/kg once daily for 14 days. At

all observations both prior to and during treatment, the

mean clotting times remained within the range of normal

values.

Based

upon

comparison

with

data

obtained

from

intravenous administration, carprofen is rapidly and nearly

completely absorbed (more than 90% bioavailable) when

administered orally.

11,12

Peak blood plasma concentrations are achieved in 1–3

hours

after

oral

administration

mg/kg

bodyweight to dogs.

The mean terminal half-life of carprofen is approximately 8

hours (range 4.5–9.8 hours) after single oral doses varying

from 1–25 mg/kg of body weight.

After

single

intravenous

bolus

dose,

mean

elimination half-life was approximately 11.7 hours in the dog.

Rimadyl is more than 99% bound to plasma protein and

exhibits a very small volume of distribution.

Carprofen

eliminated

primarily

biotransformation in the liver followed by rapid excretion of

resulting

metabolites

(the

ester

glucuronide

carprofen

ether

glucuronides

phenolic

metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen)

in the faeces (70–80%) and urine (10–20%).

Some

enterohepatic

circulation

drug

been

observed. Studies have not revealed any evidence of chiral

inversion of carprofen enantiomers.

15,16

Following repeated therapeutic dosing periods up to and

greater than one month, a preliminary study has indicated

that carprofen does not have a detrimental effect on canine

arthritic cartilage.

18,19

Preliminary

data

using

therapeutic

concentrations

carprofen

have

been

shown

in

vitro

increase

glycosaminoglycan

(GAG)

synthesis

chondrocytes

derived from healthy canine cartilage, suggesting some

chondroprotective properties; however these did not totally

negate

effects

inflammatory

mediators

degenerative enzymes.

17,20, 21

Stimulation of GAG synthesis would be expected to narrow

difference

between

rate

degeneration

regeneration of cartilage matrix, resulting in a slowing of

the process of cartilage loss.

Indications:

A non-steroidal anti-inflammatory drug for the relief of pain

and inflammation in dogs

DIRECTIONS FOR USE:

For oral administration only.

Dosage: 2 to 4 mg/kg bodyweight per day. Dose, frequency

and duration of treatment will

be dependent upon clinical

response of the condition under treatment. Initial therapy at

4 mg/kg bodyweight per day given in 2 equally divided doses

is generally recommended.

Subject to clinical response, the dose may be reduced to

2mg/kg bodyweight per day administered as a once daily

dose.

All dogs should undergo a thorough clinical examination

appropriate

laboratory

tests

before

introduction

NSAID

therapy.

During

extended

administration,

appropriate re-evaluation and laboratory tests should be

undertaken periodically.

Contraindications

Rimadyl should not be used in dogs exhibiting previous

hypersensitivity to carprofen

The elimination time of NSAIDs, including carprofen, in the

cat is longer than in the dog, and the therapeutic index is

narrower. In the absence of specific data, the use of

Rimadyl Tablets in the cat is contraindicated.

Precautions

class,

cyclooxygenase

inhibitory

NSAIDs

associated with gastrointestinal and renal toxicity. Effects

may result from decreased prostaglandin production and

inhibition

enzyme

cyclooxygenase,

which

responsible

formation

prostaglandins

from

arachidonic acid. When NSAIDs inhibit prostaglandins that

cause

inflammation

they

also

inhibit

those

prostaglandins

which

maintain

homeostatic

function.

These anti-prostaglandin effects may result in clinically

significant

disease

patients

with

underlying

pre-existing disease more often than in healthy patients.

Sensitivity to drug-associated adverse effects varies with

the individual patient. NSAID therapy could unmask occult

disease, which

has previously been undiagnosed due to the

absence of clinical signs.

Therefore use with caution in dogs that are:

less than 6 weeks of age,

debilitated and aged or with existing cardiac, hepatic or

renal disease.

dehydrated, hypovolaemic or hypotensive.

Rimadyl should be used with caution in dogs with bleeding

disorders (e.g. Von Willebrand’s disease), as safety has not

been established in dogs with these disorders. The safe use

of Rimadyl in pregnant and lactating bitches and dogs used

for breeding purposes has not been established.

Studies

determine

activity

Rimadyl

when

administered concurrently with other protein-bound drugs

have not been conducted. Drug compatibility should be

monitored closely in patients requiring additional therapy.

Concurrent use of Rimadyl with other anti-inflammatory

drugs such as corticosteroids and other NSAIDs, should be

avoided. If changing anti-inflammatory products, take into

account the pharmacokinetic properties of the drugs used

previously when considering the delay period between the

individual drugs.

Side effects

Carprofen is an NSAID, and as with others in the class,

adverse reactions may occur with its use. Typical adverse

reactions of NSAIDs include loss of appetite, vomiting,

diarrhoea, melaena or faecal occult blood, and lethargy.

Events

involving

suspected

renal,

haematological,

neurological, dermatological and hepatic effects have also

been reported. Symptomatic treatment may be necessary.

In rare cases death has been reported. In most cases, side

effects are transient and disappear following termination of

treatment.

Owners

should

advised

discontinue

therapy and contact their

veterinary surgeon immediately if

signs of intolerance are observed.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information

Centre. Phone Australia 131126

Disposal:

Dispose

empty

containers

expired

product

wrapping with paper and putting in garbage.

Presentation:

Packs of 100 tablets.

APVMA Approval Numbers:

Rimadyl 50 mg Tablets For Dogs 51746/0508

Rimadyl 20 mg Tablets For Dogs 51747/0508

Storage:

Store below 30°C (Room Temperature) in a dry place out of

direct sunlight.

Pfizer Animal Health

A division of Pfizer Australia Pty Ltd

Wharf Road, West Ryde. 2114

®Pfizer trademark ©2008

For further technical information call the Pfizer Veterinary

Hotline at 1 800 814 883

REFERENCES

Baruth H, Berger L, Bradshaw D, Cashin CH, Coffey JW, Gupta N,

Konikoff J, Roberts NA and Wyler-Plaut R (1986)

Carprofen In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II,

Newer Anti-Inflammatory Drugs, Rainsford KD, ed. CRC Press,

Boca Raton, p. 33-47

Ricketts AP, Lundy KM and Seibel SB (1998)

Evaluation of selective inhibition of canine cyclooxygenase 1 and 2

by carprofen and other nonsteroidal anti-inflammatory drugs.

Am J Vet Res 59(11):1441-6

Hope WC and Welton AF(1983)

Comparison of nonsteroidal anti-inflammatory drugs as inhibitors

of phospholipase A

(Abstract)

Fed Proc Am Soc Exp Biol 42: 875

Masferrer JL, Isakson PC and Seibert K (1996)

Cylcooxygenase-2 Inhibitors. A new class of anti-inflammatory

agents that spare the gastrointestinal tract

Gastroenterology Clin North Am 25: 363 – 372

Strub KM and Muller RKM (1979)

Relation between ulcerogenic activity of various NSAIDs and their

potency as inhibitors of prostaglandin synthesis in vivo.

In Arachidonic Acid Metabolism in Inflammation and Thrombosis.

Brune K, Baggiolini M, eds. Birkhauser Verlag, Basel, pp 245-253

Randall LO and Baruth H (1976)

Analgesic

Anti-Inflammatory

Activity

6-Chloro-Alpha-Methyl-Carbazole-2-Acetic Acid (C-5720)

Arch Int Pharmacodyn 220: 94–114

Ceuppens JL, Rodriguez MA and Goodwin JS (1982)

Non-steroidal anti-inflammatory agents inhibit the synthesis of

IgM rheumatoid factor in vitro.

Lancet 1(8271): 528-530

Ceuppens JL and Goodwin JS (1982)

Endogenous prostaglandin E

enhances polyclonal immunoglobulin

production by tonically inhibiting T suppressor cell activity.

Cellular Immunology 70:41-54

Schleimer RP and Benjamini E (1981)

Effects

prostaglandin

synthesis

inhibition

immune

response.

Immunopharmacology 3: 205-219

Veit BC (1982)

Immunoregulatory

activity

cultured-induced

suppressor

macrophages.

Cellular Immunology 72: 14-27

McKellar QA.,Pearson T, Bogan JA, Galbraith EA, Lees P, Ludwig B

and Tiberghien MP (1990)

Pharmacokinetics, tolerance and serum thromboxane inhibition of

carprofen in the dog.

Journal of Small Animal Practice 31, 443-448

Schmitt M and Guentert W (1990)

Biopharmaceutical

evaluation

carprofen

following

single

intravenous, oral, and rectal doses in dogs.

Biopharm Drug Dispos 11(7): 585-594

Tateishi M and Shimizu H (1975)

Blood

level

profile

20-5720

following

single

oral

administration to the dog

Data on file

Rubio F, Seawall S, Pocelinko R, DeBarbieri B, Benz W, Berger L,

Morgan L, Pao J, Williams TH and Koechlin B (1980)

Metabolism of carprofen, a nonsteroidal anti-inflammatory agent,

in rats, dogs, and humans

J Pharmaceutical Sciences 69: 1245-1253

Priymenko N, Garnier F, Ferre JP, Delatour P and Toutain PL (1998)

Enantioselectivity of the enterohepatic recycling of carprofen in the

dog.

Drug Metab Dispos 26(2):170-6

McKellar QA, Delatour P and Lees P (1994)

Stereospecific

pharmacodynamics

pharmacokinetics

carprofen in the dog.

J Vet Pharmacol Therap 17(6):447-54

Benton, HP et al., 1997, Effect of carprofen on sulphated

glycosaminoglycan

metabolism,

protein

synthesis

prostaglandin release by

cultured

osteoarthritic

canine

chondrocytes. American Journal of Veterinary

Research; 58: 286-292.

Pelletier, J.P. et al., 2000, Carprofen simultaneously reduces the

progression of morphological changes in cartilage and subchondral

bone in experimental dog osteoarthritis. Journal of Rheumatology;

27: 2893 - 2902.

Dassler,

Griffey,

Vasseur,

2003.

Histological

features of osteoarthritic

canine

cartilage

after

prolonged

administration

carprofen.

Veterinary

Comparative

Orthopaedics and Traumatology; 16:32-37.

Schneider

Budsberg

2001.

Plasma

synovial

concentrations of carprofen in dogs with chronic osteoarthritis.

Veterinary and Comparative Orthopaedics

Traumatology,

19:19-24

Dvorak, L.D. et al., 2002, Effect of carprofen and dexamethasone

on canine

chondrocytes in a three-demensional culture model of

osteoarthritis.

American

Journal

Veterinary

Research

10:1363-1369.

PM72542

CODE NR

CODE NR

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Tablets for Dogs

®

®

File Name: 51746_44708_Leaflet_MPL_V01.pdf

Dimension: 64mm x 405mm

Date: V01, 0508

Scale: 65% A4

APPROVED

LABEL

Product Name: Rimadyl

Tablets 20/50mg

Page: 1 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Section 1 - Identification of Chemical Product and Company

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

Tel: (02) 9850 3333

Fax: (02) 9850 3399

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Substance:

Non-steroidal anti-inflammatory compound.

Trade Name:

Rimadyl

®

Tablets 20/50mg

Pfizer MSDS Code:

MSDS055

Product Use:

Pain relief for musculoskeletal disorders and post-surgical treatment for large

animals.

Creation Date:

March, 2005

This version issued:

April, 2010

and is valid for 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Hazardous according to the criteria of SWA Australia.

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

Risk Phrases:

R22. Harmful if swallowed.

Safety Phrases:

S20, S45. When using, do not eat or drink. In case of accident or if you feel unwell, contact a

doctor or Poisons Information Centre immediately (show the label where possible).

SUSDP Classification:

ADG Classification:

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

UN Number:

None allocated

E

E

E

m

m

m

e

e

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r

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g

g

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c

c

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O

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v

v

v

e

e

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r

r

r

v

v

v

i

i

i

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w

w

w

Physical Description & colour

: Off-white tablets.

Odour:

Characteristic odour.

Major Health Hazards:

harmful if swallowed.

P

P

P

o

o

o

t

t

t

e

e

e

n

n

n

t

t

t

i

i

i

a

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t

t

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Inhalation

Short term exposure:

Significant inhalation exposure is considered to be unlikely. 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.

Eye Contact:

Short term exposure

: Exposure via eyes is considered to be unlikely. This product is believed to be not irritating to

eyes.

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. This product is unlikely to cause any irritation problems in the short or long

term.

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.

Product Name: Rimadyl

Tablets 20/50mg

Page: 2 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

STEL (mg/m

Carprofen

53716-49-7

<35

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:

No specific health data is available for this product. If any unusual symptoms become evident, or if in

doubt, wash skin with water and contact a Poisons Information Centre or a doctor.

Eye Contact:

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

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

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

involved in a fire.

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

:

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

: 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 rubber, PVC. 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.

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 MSDS 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 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

Product Name: Rimadyl

Tablets 20/50mg

Page: 3 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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 particular 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, 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 known significant ingredients in this product.

The ADI for Carprofen is set at 0.005mg/kg/day. The corresponding NOEL is set at 1mg/kg/day. ADI means

Acceptable Daily Intake and NOEL means No-observable-effect-level. Values taken 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 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: 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

Off-white tablets.

Odour:

Characteristic odour.

Boiling Point:

No specific data. Expected to decompose before boiling.

Freezing/Melting Point:

No specific data. Solid at normal temperatures.

Volatiles:

No data.

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

No data.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

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:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and 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,

Product Name: Rimadyl

Tablets 20/50mg

Page: 4 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

disturbance of judgment, and unconsciousness followed by coma and death. Hydrogen cyanide poisoning signs and

symptoms are weakness, dizziness, headache, nausea, vomiting, coma, convulsions, and death. Death results from

respiratory arrest. Hydrogen cyanide gas acts very rapidly; symptoms and death can both occur quickly.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

Target Organs:

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

C

C

C

l

l

l

a

a

a

s

s

s

s

s

s

i

i

i

f

f

f

i

i

i

c

c

c

a

a

a

t

t

t

i

i

i

o

o

o

n

n

n

o

o

o

f

f

f

H

H

H

a

a

a

z

z

z

a

a

a

r

r

r

d

d

d

o

o

o

u

u

u

s

s

s

I

I

I

n

n

n

g

g

g

r

r

r

e

e

e

d

d

d

i

i

i

e

e

e

n

n

n

t

t

t

s

s

s

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:

Instructions concerning the disposal of this product and its containers are given on the product label.

These should be carefully followed.

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 to be found in the public AICS Database.

The following ingredients: Carprofen, 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

Contact Points:

Pfizer

(02)9850 3333 (Business hours)

Ask for Environmental Health & Safety Manager

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(

13 1126 from anywhere in Australia)

Please read all labels carefully before using product.

This MSDS copyright © Kilford & Kilford Pty Ltd, April, 2010.

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

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