Target species
Horses.
Indications for use, specifying the target species
In horses: For treatment of lameness due to degenerative aseptic joint disease.
Contraindications
Do not administer when a pre-existent tendency to haemorrhage or increased coagulation time is known.
Do not administer within 24 hours after surgery.
Do not use for the treatment of septic arthritis; in this case appropriate treatment such as surgery and / or antimicrobial therapy should be instigated.
Treatment should not be given in cases of advanced renal or hepatic disease or in cases where there is a history of hypersensitivity to PSGAG. Reference is also made to section 4.7 |
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
This product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of the required dose should be discarded.
This product must be used with caution in horses suffering with hepatic dysfunction.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In view of possible sensitization, contact dermatitis and skin irritation any skin contact with the product should be avoided. Wear protective gloves. Avoid self-injection. Self-injection may cause delayed blood coagulation for a few hours. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the doctor.
Adverse reactions (frequency and seriousness)
On rare occasions, transient local reactions at the injection site may occur.
Use during pregnancy, lactation or lay
The safety of the product was not assessed in pregnant and lactating mares. The use of the product during pregnancy and lactation is contra-indicated.
Interaction with other medicinal products and other forms of interaction
Simultaneous use of PSGAG and anticoagulants increases the risk of haemorrhage. Simultaneous use of PSGAG and nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of bleeding in the gastro-intestinal tract. |
Amounts to be administered and administration route
The contents of a 5-ml vial are injected by deep intra-muscular injection every four days for a total of seven injections. |
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdosage, blood coagulation time, as measured by activated partial thromboplastin time, may be prolonged for 8 hours after injection. |
Withdrawal period(s)
Withdrawal period (meat): zero days.
Do not use in mares producing milk for human consumption. |