Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not administer simultaneously with any other intra-lesional veterinary medicinal product
Special warnings for each target species
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. By day 112 post-treatment, 65% of horses treated with this product during the pivotal field trial had achieved greater than 75% fibre alignment within the affected soft tissues.
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 intra-lesional injection.
Special precautions for use
Special precautions for use in animals
A correct foot balance is critical in the management of superficial digital flexor tendon or suspensory ligament lesions.
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.
There is only limited data available to support the human safety of this product. In particular, women of childbearing age and people with compromised immune systems should take care to avoid contact with the product. It is recommended to wear impermeable gloves at all times whilst handling and administering the product. Wash any spills off exposed skin, eyes, or mucous membranes immediately.
Take care not to accidentally self-administer this product. 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.
Adverse reactions (frequency and seriousness)
Mild injection site reactions, such as increased heat, pain at palpation, limb swelling and increased limb circumference occurred very commonly during the first 10 days after administration.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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
Do not administer simultaneously with any other intra-lesional veterinary medicinal product.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No data available.
Withdrawal period(s)
Meat and Offal: zero days
Milk: zero hours
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.