PROLET 20MG TABLETS FOR SMALL DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CARPROFEN

Available from:

JUROX PTY LIMITED

INN (International Name):

carprofen(20mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

CARPROFEN ANTI-INFLAMMATORY-NONSTEROIDAL Active 20.0 mg/Tb

Units in package:

100Tablets; 42Tablets; 500Tablets

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; A non-steroidal anti-inflammatory drug for the relief of pain and inflammation in dogs (small dogs).Contraindicated in dogs exhibiting previous hypersensitivity to carprofen. Use in cats is contraindicated. Use in dogs suffering from cardiac, hepatic or renal disease, …NOT RECOMMENDED. Other Contraindications, Precautions etc: SEE LABEL.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

B
Exp:
A non-steroidal anti-inflammatory drug
for the relief of pain and
inflammation in dogs.
100 TABLETS
Each Tablet Contains:
20MG CARPROFEN
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TABLETS FOR SMALL DOGS
PROLET
20MG
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.
STORE below 30ºC (Room Temperature) in a dry place out of direct
sunlight.
Jurox Pty Ltd
85 Gardiners Road, Rutherford
NSW 2320 AUSTRALIA
Infoline 1800 023 312
APVMA Approval No.61915/100Tab/0109
408003
DIE LINE
BLACK
PMS 294
PMS 186
w/t: 78427
date: 28/07/09
artist: James
file name: 408003 PROLET 20mg 100T Label
size: 27 X 90mm
notes
date
ok
C L
I
E N T
U S E
LABELCRAFT
phone [phone]
fax [phone]
please
proof
art
carefully,
any
errors
overlooked
become
the
client’s
l i a b i l i t y
Alter existing artwork: 01/04/08
Alts artwork: 28/07/09
90
27
APVMA file: 61915_46405_100 tablet _ immediate _ MPL_VO1.PDF
Dimensions: Immediate pack 27mm (high) X 90mm (wide)
Scale: 100% of A4 size
Date: 08/07/09
•
Varnish free area
APPROVED
LABEL
Info
PEST


Verified
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.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131126.
Jurox Pty Ltd
85 Gardiner Road, Rutherford
NSW 2320 AUSTRALIA
Infoline 1800 023 312
APVMA Approval No. 61915/500Tab/0109
STORE below 30ºC (Room Temperature) in a dry place out of direct
sunlight.
B
Exp:
407999
A non-steroidal
anti-inflammatory drug
for the relief of pain and
inflammation in dogs.
500 TABLETS
Each Tablet Contains:
20MG CARPROFEN
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TABLETS FOR SMALL DOGS
PROLET
20MG

Summary of Product characteristics

PROLET TABLETS FOR DOGS
Page 1 of 5
continued
ISSUED:
5 NOVEMBER 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
PROLET 20 MG TABLETS FOR SMALL DOGS
PROLET 50 MG TABLETS FOR DOGS
PRODUCT CODE:
502680 (100 x 20 mg); 502675 (500 x 20 mg); 502485 (100 x 50 mg);
502490 (500 x 50 mg)
RECOMMENDED USE:
A non-steroidal anti-inflammatory drug for the relief of pain and
inflammation in dogs.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
ACUTE AQUATIC HAZARD CATEGORY 2
ACUTE TOXICITY (ORAL) CATEGORY 3
CHRONIC AQUATIC HAZARD CATEGORY 2
REPRODUCTIVE TOXICITY CATEGORY 1B
SKIN SENSITIZER CATEGORY 1
GHS PICTOGRAMS*:
SKULL AND
HEALTH HAZARD
AQUATIC POLLUTANT
CROSSBONES
SIGNAL WORD*:
DANGER
HAZARD STATEMENTS*:
Toxic if swallowed.
May cause an allergic skin reaction.
May damage fertility or the unborn child.
Toxic to aquatic life with long lasting effects.
PRECAUTIONARY STATEMENTS*: PREVENTION
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read label before use.
Obtain special instructions before use.
Do not handle until all safety precautions have been read and
understood.
Avoid breathing dust.
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Contaminated work clothing should not be allowed out of the workplace.
Avoid release to the environment.
Wear protective gloves.
Use personal protective equipment as required.
RESPONSE
IF SWALLOWED: Immediately call a POISON CENTER or doctor.
IF ON SKIN: Wash with plenty of soap and water.
IF exposed or concerned: Get medical advice.
Rinse mouth.
PROLET TABLETS FOR DOGS
Page 2 of 5
continued
If skin irritation or rash occurs: Get medical advice.
Wash contaminated clothing before reuse.
Collec

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Carprofen 20 mg/tablet, 50 mg/tablet.
DESCRIPTION
White, half scored.
ACTIONS
Carprofen is a non-narcotic, non-steroidal anti-inflammatory drug
(NSAID) with characteristic analgesic and antipyretic activity. As
with other NSAIDs, the exact mode of action of 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 A2 and a reversible
inhibitor of cyclooxygenase.
Carprofen is rapidly and nearly completely absorbed when administered
orally. Peak blood plasma concentrations are achieved in one
to three hours after oral administration to dogs. The mean terminal
half-life is approximately eight hours after single oral doses. After
a
single intravenous bolus dose of 100 mg, the mean elimination
half-life was approximately 11.7 hours in the dog.
Carprofen is more than 99% bound to plasma protein and exhibits a very
small volume of distribution. It is eliminated in the dog
primarily by biotransformation in the liver, followed by rapid
excretion of the resulting metabolites in the faeces (70 to 80%) and
urine
(10 to 20%).
PRECAUTIONS
All dogs should undergo a thorough clinical examination and
appropriate laboratory tests to establish haematological and serum
biochemical baseline data before introduction of NSAID therapy. During
extended administration, appropriate re-evaluation and
laboratory tests should be undertaken periodically.
Use in animals less than 6 weeks of age, or in aged animals, may
involve additional risk. If such use cannot be avoided, these animals
may require a reduced dosage and careful clinical management.
PROLET
Tablets
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
NSAIDs can cause inhibition of phagocytosis. Hence, in the treatment
of inflammatory conditions associated with bacterial