Cartrophen Vet (Canada)

Company: Arthropharm

PENTOSAN POLYSULPHATE SODIUM INJECTION 100 mg/mL

FOR VETERINARY USE ONLY

Description

Cartrophen Vet is a pale yellow sterile aqueous solution. Each mL contains: Pentosan Polysulphate Sodium 100 mg; Benzyl Alcohol 0.01 mL as a preservative; Disodium Hydrogen Phosphate Dodecahydrate 2.2 mg and Sodium dihydrogen Phosphate dihydrate 6.8 mg as buffers; and Water for Injection q.s.

Drug Substance Chemical Name

(1→4)-β-D-xylan 2,3-bis (hydrogen sulfate), sodium salt

Empirical Formula

(C₅H₆Na₂O₁₀S₂)n

Chemical Structure

Pentosan polysulfate is a sulfated polyxylose. (1→4) β-glycosidic connected glycan chain contains, statistically, a glucuronic group at almost every tenth unit.

Cartrophen Vet Indications

Cartrophen Vet is indicated for the treatment of osteoarthritis and allied conditions in single or multiple joints in the dog.

Cartrophen Vet Dosage And Administration

3 mg/kg (1 mL per 33 kg) body weight by subcutaneous injection for a total of 4 injections given at intervals of 5-7 days.

Contraindications

Do not use in dogs with clotting defects, thrombocytopenia, traumatic haemorrhage, abdominal cancer or infection. Any occurrence of bleeding in treated animals should prompt an investigation for the underlying cause.

Cartrophen Vet Cautions

Increasing the recommended dose may result in exacerbation of stiffness and discomfort.

Effects on fertility and reproductive function in the dog have not been studied.

Warnings

Keep out of reach of children.

Adverse Reactions

Clinical experience has not demonstrated clustering of side effects. From 70,000 animals treated, 5 drug-related reactions have been reported: 2 cases of abdominal bleeding, one of which had a splenic haemangiosarcoma and the other hepatic peliosis/telangiectasis; 2 cases of vomiting after each injection; and 1 case of diarrhoea.

Overdose

At the recommended dose and duration of treatment, no toxic effects occur. At three times the recommended dose, a transient increase in bleeding time of about 3 to 4 hours duration has been observed. Repeated daily overdoses of five times the recommended dose or more resulted in anorexia and depression which were reversible upon withdrawal of the drug.

Pharmacology

Cartrophen Vet is a semisynthetic polysulphated polysaccharide which possesses anti-inflammatory and anti-arthritic chondroprotective properties. Cartrophen Vet has the following actions:

(a) Stimulates chondrocytes to synthesize cartilage matrix;

(b) Stimulates synoviocyte biosynthesis of hyaluronic acid;

(c) Inhibits enzymes implicated in the degradation of cartilage matrix components and in the release of inflammatory mediators;

(d) Anti-inflammatory activity by inhibition of arachidonic acid metabolism;

(e) Mobilizes thrombi and fibrin deposits in synovial tissues and subchondral blood vessels, thus increasing the perfusion of the joint, with resulting improvement in cartilage nutrition;

(f) Mobilizes lipids and cholesterol in synovial and subchondral blood vessels.

Efficacy

In controlled trials and through clinical experience in countries where Cartrophen Vet is sold, a success rate has been demonstrated in 80% of dogs treated. A significant increase in spontaneous activity, mobility, weight-bearing; a significant decrease in apparent pain and discomfort; and an improvement in overall condition are often seen after the second injection. However it is important to finish the full course of treatment. The beneficial effects usually last for at least three months.

Case selection is important in maximizing the results. Failure of therapy should be expected where joint instability is present (eg lax joints in hip dysplasia, coronoid process fragmentation, ruptured cruciate ligaments, etc.), where a neurological etiology exists, and when joint mobility is mechanically restricted by gross new bone production. Cartrophen Vet will treat the secondary osteoarthritis arising from these conditions but not the primary underlying cause.

Increasing the dose will not result in a better or faster response and may produce exacerbation of stiffness and discomfort.

Storage Conditions

Store up to 25°C. Protect from light. Following withdrawal of the first dose, use the product within 3 months.

PRESENTATION

Cartrophen Vet (Pentosan Polysulphate Sodium 100 mg/mL) is supplied in 10 mL multidose vials, packaged in single units.

DIN: 02082101

Biopharm Australia Pty Ltd, 111 Bronte Road, Bondi Junction, NSW 2022, Australia

DISTRIBUTED BY

Arthropharm Pharmaceuticals Inc, 134 Main Street East, Suite 302, Hawkesbury, Ontario, K6A 1A3, Canada

TOLL FREE NUMBER

1 877 638 8607

BIO066.09

30/11/2023

CPN: 1240000.4