RIMADYL INJECTION

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(50mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
CARPROFEN ANTI-INFLAMMATORY-NONSTEROIDAL Active 50.0 mg/ml
Units in package:
20mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
ANALGESIC+MUSCULOSKELETAL
Therapeutic indications:
ANALGESIC | ANTI-INFLAMMATORY AGENT | NON STEROIDAL | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | COLIC | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE RELAXANT | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SEDATIVE | SPASMOLYTIC | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: 28 days.; Host/pest details: CAT: [ANALGESIC, ANTI-INFLAMMATORY AGENT, NON STEROIDAL]; DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT, NON STEROIDAL]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, NON STEROIDAL]; Non-steroidal, anti-inflammatory and analgesic for use in dogs, cats and horses.Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not administer other NSAID’s concurrently or within 24 hours of each other.
Authorization status:
Registered
Authorization number:
51605
Authorization date:
2020-07-01

LAB0140a

Copy in the header and footer

will

not appear on the

final

printed

label

Prepared:

22/01102

IMMEDIATE CONTAINER (Vial)

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Rimadyl* Injection

CARPROFEN

50mg/mL

Non-steroidal,

anti-inflammatory and analgesic for use in dogs,

cats and horses.

20mL

READ ATTACHED LEAFLET BEFORE USING THIS PRODUCT

DOSE:

- DOGS:

1mL/12.5 kg IV or SC

- CATS:

0.24 mL/3.0 kg IV or SC (single dose)

MEAT WITHHOLDING PERIOD:

28 days.

Made in UK

Pfizer Animal

Health Group

A division of Pfizer Pty.

Limited

Wharf Road,

West Ryde.

2114.

Pfizer trademark

2002

NRA:

516051

D"'5>

STORE

between 2° C and 8° C (Refrigerate Do not freeze).

Protect from light.

Exp:

PM 63861

N.R.A.

~:~~~:~~:~~~~

Date:

....

.I..

Q11..Qd.

Signature:

~Si:

.

S:\Clinical\REGUL

IAUSnl

NUNy

.LABEL\Lab0140a.doc

Page 1

of7

LAB0140a

LEAFLET

Copy in the header and footer will

not appear on the final

printed label

Prepared:

22/01102

PRESCRIPTION

ANIMAL

REMEDY

KEEP OUT OF REACH OF CHILDREN

ANIMAL

TREATMENT

ONLY

Rimadyl* Injection

Carprofen 50

mg/mL

Presentation:

Rimadyl

injection is a clear,

sterile,

mixed micelle solution for injection,

containing

50mg carprofen per mL.

Indications:

Rimadyl

Injection is a non-steroidal,

anti-inflammatory formulation with analgesic

action.

It is indicated as an aid in the alleviation of pain and inflammation associated

with musculoskeletal

disorders and for anti-inflammatory treatment after surgery in

the horse.

In the dog and cat,

it is indicated for the control

of post-operative pain

and inflammation following orthopaedic and soft

tissue (including intra-ocular)

surgery.

DIRECTIONS FOR USE:

Restraints

administer

intramuscular

injection.

exceed

recommended

dose

duration

treatment.

administer

other

NSAID's

concurrently

within

hours

each

other.

Some

NSAID's

highly

bound

plasma

proteins

compete

with

other

highly

bound

drugs,

which

lead

toxic

effects.

animal

less

than

weeks

age,

aged

animals,

Contraindications

Contraindicated in animals suffering from cardiac,

hepatic or renal

disease,

or where

there is evidence

a blood dyscrasia or hypersensitivity to the product.

Avoid use in

any dehydrated,

hypovolaemic or hypotensive animal,

as there is a potential

risk of

increased renal

toxicity.

Precautions

Where there is a possibility of gastro-intestinal

ulceration or bleeding,

use may

involve additional

risk.

If such a use cannot be avoided,

animals may require a

reduced dosage and careful

clinical

management.

Concurrent administration

potential

nephrotoxic drugs should be avoided.

In the absence

any specific studies in pregnant target animals,

such use is not

indicated.

NSAID's can cause inhibition of phagocytosis and hence,

in the treatment of

inflammatory conditions associated with bacterial

infection,

appropriate concurrent

antimicrobial

therapy should be instigated.

S:IClinicaIIREGULIAUSnINLlNijlLABELILab0140a.doc

Page 2 of

LAB0140a

LEAFLET (cont)

Copy

in the header and footer will

appear on the final

printed label

Prepared:

25/03/02

Side

Effects

As with other NSAIDs,

there is a risk of

renal

or rare idiosyncratic hepatic adverse

events.

HORSES:

For intravenous use only.

Dose rate is 0.7mg per kg (1

mU70Kg)

bodyweight.

should be given by intravenous injection as a single dose.

The dose may be

repeated after 24 hours and then daily for a total

treatment period of

up to 5 days.

clinical

re-evaluation should be conducted before continuing treatment beyond 5

days.

DOGS:

For intravenous and subcutaneous use.

Dose rate is 4.0mg/kg (1mL/12.5kg)

bodyweight.

Rimadyl

Injection is best

given pre-operatively,

either at the time of pre-

medication or induction

anaesthesia.

CATS:

For intravenous and subcutaneous use as a single dose.

Dose rate is 4.0 mglkg

(0.24mL/3.0kg).

Rimadyl

Injection is best

given pre-operatively,

either at the time of

pre-medication or induction of anaesthesia.

Due to the longer half-life in cats and

narrower therapeutic index,

particular care should be taken not

to exceed the

recommended dose and the use of a 1 mL graduated syringe is recommended to

measure the dose accurately.

MEAT WITHHOLDING PERIOD:

28 DAYS.

DISPOSAL:

Disposal

of empty containers,

outer packaging or expired product by wrapping with

paper and putting in garbage.

Additional

information is in the Material

Safety Data Sheet.

NRA Approval

Number:

516051

C>!.o

";L

STORAGE:

Store between 2°C and 8°C (Refrigerate.

Do not

freeze).

Protect from light.

Once

broached,

the product

is stable for use at temperatures up to 25°C for 28 days.

PRESENTATION:

20 mL multi

dose amber glass vial.

S :\Clinical\REGUL

\AUSnIN

NE\LABEL

\LabO

140a.doc

Page 3 of

LAB0140a

LEAFLET (cant)

Copy in the header and

footer

will

not appear on the

final

printed

label

Prepared:

22/01102

Pfizer Animal

Health Group

A division of Pfizer Pty. Limited

Wharf Road, West

Ryde NSW.

2114

Pfizer trademark

2002

PM72481

S:\Clinical\REGU L

\AUSnINLlNF-\LABEL

\Lab0140a.doc

Page 4 of7

LAB0140a

CARTON

FRONT PANEL

Copy

in the

header

and

footer

will

notappearon the

final

printed

label

Prepared:

22/01102

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Rimadyl* Injection

CARPROFEN

50mg/mL

Non-steroidal,

anti-inflammatory and analgesic for use in dogs,

cats and horses.

the control

of post-operative pain and inflammation following surgery and the

alleviation of pain and inflammation associated with musculo-skeletal

disorders in

horses.

20mL

CARTON

TOP LID

Rimadyl* Injection

CARTON

BOnOM

S:IClinicaIIREGULIAUSTlINLI!'iEILABELILab0140a.doc

Page 5 of?

LAB0140a

CARTON

BACK PANEL

Copy inthe headerand footer

will

notappear on the

final

printed

label

Prepared:

22/01102

Rimadyl* Injection

Carprofen 50mg/mL

READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT for detailed

product indications,

directions for use,

restraints and disposal

instructions.

Directions for use:

DOGS:

For intravenous and subcutaneous use.

Dose rate is 4.0mg/kg (1mU12.5kg)

bodyweight.

Rimadyl

Injection is best given pre-operatively,

either at the time

premedication or induction

anaesthesia.

CATS

For intravenous and subcutaneous use as a single dose.

Dose rate is 4.0mg/kg

(0.24mU3.0kg) Rimadyl

Injection is best given pre-operatively,

either at the time

premedication or induction of anaesthesia.

Use an insulin syringe.

HORSES:

For intravenous use only.

Dose rate is 0.7mg per kg

mLl70kg) bodyweight.

It

should be given by intravenous injection as a single dose.

(B):

Exp:

S:\Clinical\REGULIAUSTlI NLI

N~\LABEL

\Lab0140a.doc

Page 6 of 7

LAB0140a

Copy inthe header and

footer

will

not appear on the

final

printed

label

Prepared:

22/01102

CARTON

RIGHT SIDE PANEL

MEAT WITHHOLDING PERIOD: 28 DAYS

Dispose of empty containers,

outer packaging or expired product by wrapping with

paper and putting in garbage.

Additional

information is in the Material

Safety Data Sheet.

Made in UK

Pfizer Animal

Health Group

A division of

Pfizer Pty.

Limited

Wharf Road,

West

Ryde NSW.

2114

Pfizer trademark

2002

NRAApproval

Number

516051

Cb""3-o

Store between 2°C and 8°C (Refrigerate.

Do not freeze).

Protect from light.

Once broached,

the product is stable for

use at temperatures up

to 25°C for 28 days.

EAN 9313212501649

PM 46701

S:IClinicaIIREGULIAUSTlINLlNIlLABELILab0140a.doc

Page 7 of7

Product Name: Rimadyl

Injection

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:

Water solution of ingredients (see below).

Trade Name:

Rimadyl

®

Injection

Pfizer MSDS Code:

MSDS056

Product Use:

Injectable 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:

R38. Irritating to skin.

Safety Phrases:

S24. Avoid contact with skin.

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

e

r

r

r

g

g

g

e

e

e

n

n

n

c

c

c

y

y

y

O

O

O

v

v

v

e

e

e

r

r

r

v

v

v

i

i

i

e

e

e

w

w

w

Physical Description & colour

: Clear, colourless liquid.

Odour:

Characteristic odour.

Major Health Hazards:

skin irritant.

P

P

P

o

o

o

t

t

t

e

e

e

n

n

n

t

t

t

i

i

i

a

a

a

l

l

l

H

H

H

e

e

e

a

a

a

l

l

l

t

t

t

h

h

h

E

E

E

f

f

f

f

f

f

e

e

e

c

c

c

t

t

t

s

s

s

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. However product is a skin irritant. Symptoms may include itchiness and reddening of contacted skin.

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

Long Term exposure:

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

Eye Contact:

Short term exposure

: 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 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.

Product Name: Rimadyl

Injection

Page: 2 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

not set

not set

Benzyl alcohol

100-51-6

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.

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.

Inhalation:

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

Skin Contact:

Wash gently and thoroughly with water (use non-abrasive soap if necessary) for 20 minutes or until

product is removed. Under running water, remove contaminated clothing, shoes and leather goods (e.g. watchbands

and belts). Completely decontaminate clothing, shoes and leather goods before reuse or discard. If irritation persists,

repeat flushing and obtain medical advice.

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.

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. 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

: Not Combustible. 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.

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

emergency services.

Product Name: Rimadyl

Injection

Page: 3 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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 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. 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.

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 vapours and mists are minimised.

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:

There is no specific recommendation for any particular protective material type. butyl

rubber.

Respirator:

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

the Australian Standard mentioned above.

Safety deluge showers should, if practical, be provided near to where this product is being used.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Clear, colourless liquid.

Odour:

Characteristic 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:

No data.

Specific Gravity:

No data.

Water Solubility:

Completely soluble in water.

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.

Product Name: Rimadyl

Injection

Page: 4 of 4

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

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

temperatures normally achieved in a fire. This will only occur after heating to dryness. Carbon dioxide, and if

combustion is incomplete, carbon monoxide. Nitrogen and its compounds, and under some circumstances, oxides of

nitrogen. Occasionally hydrogen cyanide gas. Water.

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:

Dispose of empty container by wrapping with paper and putting in garbage. Discarded needles should

immediately be placed in a designated and appropriately labelled sharps container.

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

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

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

Similar products

Search alerts related to this product

View documents history

Share this information