CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PENTOSAN POLYSULFATE SODIUM

Available from:

BIOPHARM AUSTRALIA PTY LTD

INN (International Name):

sodium pentosan polysulfate(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

PENTOSAN POLYSULFATE SODIUM MINERAL-SODIUM Active 100.0 mg/ml

Units in package:

10mL; 12 x 10mL

Class:

VM - Veterinary Medicine

Manufactured by:

BIOPHARM AUSTRALIA

Therapeutic group:

DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES) DO NOT USE less that 28 days before s laughter for human consumption.; Host/pest details: DOG: [INFLAMMATORY JOINT DISEASE]; HORSE: [INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [INFLAMMATORY JOINT DISEASE]; HORSE: [INFLAMMATORY JOINT DISEASE]; For the relief of pain associated with non-infectious inflammatory joint disease in dogs and as an aid in the treatment of non-infectious inflammatory joint disease in horses.Do not use in dogs or horses with clotting defects, traumatic haemorrhage, infection, liver or kidney failure, or within 1 day of surgery. Use alternate sides of horse's neck for repeat injections.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
BIOPHARM AUSTRALIA PTY LTD
PRODUCT NAME:
CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE
ELABEL APPLICATION NO:
DC14-2239249E16
APVMA APPROVAL NO:
36037/100762
PRODUCT NO:
36037
VERSION NO:
8.0
APPLICATION STARTED:
2014-Oct-22 12:41:14
VERSION CREATED:
2015-Nov-30 11:02:15
STARTED BY:
David Cullis-Hill
PRINTED:
2015-Dec-01 12:12:52
LABEL NAME:
CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
100 mg/mL PENTOSAN POLYSULFATE SODIUM
CLAIMS:
Cartrophen Vet is a pale yellow sterile solution formulated as an aid
in the treatment of non-
infectious joint disease in the dog and horse.
For the relief of pain associated with non-infectious inflammatory
joint disease in dogs and
as an aid in the treatment of non-infectious, inflammatory joint
disease in horses:
(1) Osteoarthritis, especially in conditions affecting multiple
joints;
(2) Osteochondrosis dissecans;
(3) Traumatic joint and peri-articular inflammation in working and
racing dogs and for
the relief of lameness and pain in horses associated with
osteoarthritis or traumatic joint
disease
(4) As treatment following intra-articular surgery but not within the
first 24 hours
NET CONTENTS:
10mL
12 x 10mL
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
This product is contraindicated for use in dogs and horses with
clotting defects, traumatic
haemorrhage, infection, liver or kidney failure, or within 1 day of
surgery.
PRECAUTIONS:
Cartrophen Vet should not be administered to horses within 24 hours of
high stress
activities or where physical injury may occur and avoid concurrent
treatment with
anticoagulant drugs. RLP APPROVED
For Official Use Only
SIDE EFFECTS:
Depression and vomiting have been associated in a small number of
patients receiving
Cartrophen Vet. In horses, some discolouration of the hair at the site
of injection may occur.
If clinical signs arise veterinary advice shoul

Summary of Product characteristics

Cartrophen Vet Injection MSDS Issued October 2011      

        Page 1 of 4 
Issued by Biopharm Australia Pty Ltd 

                MATERIAL SAFETY DATA SHEET       

           CARTROPHEN VET INJECTION 

                       Issue Date: October 2011    

            Issued By Biopharm Australia Pty Ltd 

SECTION 1 – IDENTIFICATION OF THE MATERIAL AND SUPPLIER 

_COMPANY DETAILS: _

COMPANY:   
  Biopharm Australia Pty Ltd 
ADDRESS:       

                       111
Bronte Road, Bondi Junction, NSW, 2022. 
TELEPHONE NUMBER:                                 
            [phone] 
FAX NUMBER:                                      
                  [phone] 
EMERGENCY TELEPHONE NUMBER:                     
    [phone]               

  (Available Monday – Friday between 9am and 5pm) 
                             _ _
_IDENTIFICATION: _

PRODUCT NAME:                                   
                 CARTROPHEN VET Injection 
OTHER NAMES:                                   
                   Pentosan Polysulfate Sodium, NaPPS,
Sodium Pentosan         

 Polysulfate, ANARTHRON, ELMIRON, CARTROPHEN  

EQUINE, CARTROPHEN EQUINE FORTE. 
UN NUMBER:            

Safety Data Sheet

VET
INJECTION OF PENTOSAN POLYSULFATE
ACTIVE CONSTITUENT: 100mg/mL PENTOSAN POLYSULFATE SODIUM
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DESCRIPTION
CARTROPHEN VET is a pale yellow sterile solution formulated as an aid
in the treatment of non-infectious joint disease
in the dog and horse.
PHARMACOLOGY
Pentosan polysulfate is a semi-synthetic polysaccharide polymer, which
possesses anti-inflammatory, anti-arthritic and
chondroprotective properties. These beneficial effects arise from:
a)
Direct anti-inflammatory activity;
b)
Inhibition of neutrophil migration into joints;
c)
Stimulation of hyaluronic acid synthesis by synovial fibroblasts which
results in marked increase in synovial
fluid volume and viscosity;
d)
Stimulation of chondrocytes and the biosynthesis of proteoglycans;
e)
Strong fibrinolytic activity which improves the circulation of
subchondral bone and peri-articular structures.
INDICATIONS
For the relief of pain associated with non-infectious inflammatory
joint disease in dogs and as an aid in the treatment of
non-infectious inflammatory joint disease in horses:
(i)
Osteoarthritis, especially in conditions affecting multiple joints;
(ii)
Osteochondrosis dissecans;
(iii)
Traumatic joint and peri-articular inflammation in working and racing
dogs and for the relief of lameness and pain
in horses associated with osteoarthritis or traumatic joint disease;
(iv)
As treatment following intra-articular surgery but not within the
first 24 hours.
Dog: Give by subcutaneous or intramuscular injection.
Horse: Give ONLY by intramuscular injection and use alternate sides of
the neck for repeat injections.
CONTRA-INDICATIONS
This product is contraindicated for use in dogs and horses with
clotting defects, traumatic haemorrhage, infection, liver
or kidney failure, or within 1 day of surgery.
Cartrophen Vet should not be administered to horses within 24 hours of
high stress activities or where physical injury
may occur and avoid concurrent treatment with anticoagulant drugs.
SIDE