CARTROPHEN VET

Main information

  • Trade name:
  • CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 10mL, 12x10mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • BIOPHARM AUSTRALIA

Documents

Localization

  • Available in:
  • CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
  • Therapeutic area:
  • NSAID
  • Therapeutic indications:
  • INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE
  • Product summary:
  • 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.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36037/100762
  • Authorization date:
  • 02-12-2015
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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:

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 should be sought.

Dosage and

Administration:

Dog: Give by subcutaneous or intramuscular injection.

Horse: Give ONLY by intramuscular injection and use alternate sides of the neck for repeat

injections.

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

Dog: 3 mg/kg (1.0mL per 33 kg) on four occasions with an interval of 5-7 days between

each injection, or as recommended by the Veterinary Surgeon.

Horse: 2-2.5 mg/kg (10-12.5mL per 500kg horse) on four occasions, with an interval of 5-7

days between each injection, or as recommended by the Veterinary Surgeon.

General Directions:

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 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.

Withholding

Periods:

MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before

slaughter for human consumption.

Trade Advice:

Safety Directions:

First Aid

Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11

First Aid Warnings:

Additional User

Safety:

Environmental

Statements:

Disposal:

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

Storage:

Store below 25°C (Air conditioning). Protect from light.

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

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