Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
The veterinary medicinal product has been demonstrated to be efficacious in horses with first time overstrain lesions in the superficial digital flexor tendon of the front leg, or the suspensory ligament in the back or front leg. Efficacy data are not available regarding treatment of other tendons and ligaments. Treatment of traumatic injuries with lacerations or completely ruptured tendons has not been evaluated. This veterinary medicinal product is not intended for treatment of such injuries.
The efficacy of the veterinary medicinal product was demonstrated in a pivotal field trial with horses working at training level or competition level within the disciplines dressage or show jumping, before tendon or ligament injury occurred.
A standard program of box rest and slowly increasing exercise regimen under veterinary guidance is required as part of the rehabilitation of tendon and ligament injuries. The program should be adapted based on serial ultrasonographic monitoring and clinical signs such as lameness, heat and swelling.
The efficacy and safety of the veterinary medicinal product were demonstrated in a pivotal field trial after single administration of the veterinary medicinal product and concurrent single systemic administration of an NSAID (ketoprofen or meloxicam). According to the benefit-risk assessment of the responsible veterinarian of the individual case, a single dose systemic NSAID may be administered on the day of intralesional injection.
Special precautions for use
Special precautions for safe use in the target species
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
When the veterinary medicinal product is stored in liquid nitrogen, direct exposure to liquid nitrogen or cold nitrogen vapours can cause extensive tissue damage or burns. When liquid nitrogen vaporises it can expand to 700-times its volume which may create an explosion hazard in unvented cryovials. Liquid nitrogen containers should be handled by properly trained personnel only. The handling of liquid nitrogen should take place in a well-ventilated area. Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
In case of accidental self-injection, this veterinary medicinal product can cause pain, local inflammatory reactions and swelling at the site of injection which may persist for several weeks. Transient fever may also occur. Seek medical advice immediately and provide the package leaflet or label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses:
Very common (>1 animal / 10 animals treated): | Injection site reaction (e.g. injection site warmth, injection site pain, limb swelling and increased limb circumference)1 |
1 Mild and occurred during the first 10 days after administration.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
No data available.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No data available.
Withdrawal periods
Zero days.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.