•Do not use in the treatment of septic arthritis. In this case, appropriate antimicrobial therapy should be instigated.
•Do not use in dogs with advanced liver or kidney impairment, or evidence of infection.
•Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
•Do not use in the skeletally immature dog (i.e. dogs whose long bone growth plates have not closed).
•Do not use in dogs with blood disorders, coagulation disorders, bleeding, trauma or malignancy (especially haemangiosarcoma) or during the peri-operative period within 6 – 8 hours of surgery as pentosan polysulphate has an anticoagulant effect.
•Do not use in arthritides of immunological origin (e.g. rheumatoid arthritis).
Special warnings for each target species
A clinical effect may not be observed until after the second injection of the course of treatment.
Special precautions for use in animals
Do not exceed the standard dose. Increasing the recommended dose may result in exacerbation of stiffness and discomfort.
Because of the fibrinolytic action of pentosan polysulphate sodium, the possibility of internal bleeding from a tumour or vascular abnormality should be considered and appropriate therapeutic action taken.
It has been reported that a dog which had suffered pulmonary lacerations twelve months previously had severe pulmonary bleeding after an injection of pentosan polysulphate sodium. Use with caution in dogs with a history of pulmonary lacerations.
Caution is also recommended in cases of hepatic impairment.
Pentosan polysulphate sodium has an anticoagulant effect.
It is recommended that the Packed Cell Volume (PVC) and capillary filling time should be monitored, when the veterinary medicinal product is used.
Avoid intramuscular injection because of the risk of haematoma at the injection site.
No more than three courses of four injections should be administered in a twelve month period.
It is recommended that the animal should be monitored for signs of blood loss and treated appropriately. Interrupt the treatment if signs of increased bleeding occur.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The preservative, benzyl alcohol, can cause hypersensitivity (allergic) reactions in sensitised people. If you know that you are sensitised, care should be taken when handling this veterinary medicinal product. If accidental skin or eye contact occurs, rinse affected area immediately with water.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Dogs:
Rare
(1 to 10 animals / 10 000 animals treated):
Injection site reaction1
Very rare
(1 animal / 10 000 animals treated, including isolated reports):
Vomiting2
Depression3 and lethargy4,6
Undetermined frequency
(cannot be estimated from the available data)
Prolonged activated partial thrombin time (APTT) and thrombin time (TT)5
Emesis6, diarrhoea6, anorexia6
Bleeding disorders (such as nasal bleeding, haemorrhagic diarrhoea and haematomas)
Local reactions (e.g. swelling7)
1 May occur within 24 hours in an apparently healthy animal. Treatment should be discontinued and symptomatic relief given.
2 Occurs immediately after injection. Such dogs generally require no medical treatment and make an uneventful recovery. Further treatment with pentosan polysulphate is not recommended.
3 Apparently mild.
4 Lasts up to 24 hours.
5 may persist for up to 24 hours after administration in healthy dogs. This very rarely results in clinical effects, but because of the fibrinolytic action of pentosan polysulphate sodium, the possibility of internal bleeding from a tumour or vascular abnormality should be considered if signs develop. It is recommended that the animal should be monitored for signs of blood loss and treated appropriately.
6 These signs may be the result of a hypersensitivity reaction and may require appropriate symptomatic treatment including antihistamine administration.
7 Transient
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laboratory studies in rabbits showed embryotoxic effects associated with a primary effect on the parent at repeated daily doses 2.5 times the recommended dose.
The safety of the veterinary medicinal product in the pregnant or lactating animal has not been studied, therefore use is not recommended in pregnant or lactating animals.
The veterinary medicinal product should not be used at the time of parturition due to its anticoagulant effects.
Interaction with other medicinal products and other forms of interaction
NSAIDs and in particular aspirin should not be used in combination with pentosan polysulphate sodium as they may affect thrombocyte adhesion and potentiate the anticoagulant activity of the veterinary medicinal product. Corticosteroids have been shown to be antagonistic to a number of actions of pentosan polysulphate sodium. Furthermore, use of anti-inflammatory drugs may result in a premature increase in the dog’s activity, which may interfere with the analgesic and regenerative effects of the veterinary medicinal product.
Do not use concurrently with steroids or non-steroidal anti-inflammatory drugs, including aspirin and phenylbutazone or within 24 hours of such administration. Do not use in conjunction with heparin and other anti-clotting agents.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
At overdose there may be hepatocellular damage and an associated, dose-dependent, elevation in ALT.
Increases in aPTT and TT are dose-dependent. At repeated doses greater than five times that recommended, these increases may persist beyond 1 week after administration in healthy dogs. Signs associated with these defects may include bleeding into the gastro-intestinal tract, body cavities and ecchymoses. At repeated doses greater than ten times that recommended there may be fatality as a result of gastro-intestinal haemorrhage.
If overdose occurs dogs should be hospitalised and observed and supportive therapy provided as deemed necessary by the veterinarian.
Withdrawal period
Not applicable.