Each dose of 1 ml contains:

Tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells (tpMSCs): 2.0–3.5×106

Clear, colourless suspension.

Horses

To improve healing of injuries of tendons and suspensory ligaments in horses.

Intralesional use.

A single intra-lesional injection of 1 ml per animal on one occasion.

The veterinary medicinal product must be administered intralesionally by a veterinary surgeon taking special precautions to ensure sterility of the injection process. The veterinary medicinal product should be handled and injected using sterile techniques and in a clean environment.

The veterinary medicinal product is required to be administered immediately after thawing in order to maintain cell viability.

Using appropriate gloves, remove the vial from the freezer/liquid nitrogen and thaw immediately at 25 °C–37 °C, e.g. in a water bath, until the content is completely thawed (approximately 5 minutes).

If any cell clusters are visible after thawing, gently invert the vial until the suspension is clear and colourless.

Remove the cap of the vial and aspirate the suspension into a sterile syringe for injection.

Administer using a needle with a diameter greater than or equal to 22G in order to prevent cell damage.

Administer intralesionally under ultrasound guidance with chemical or physical restraint as needed according to good veterinary practice to facilitate a safe intralesional injection. After insertion of the needle into the tendon or ligament, redirect the needle, if necessary, until the lesion is reached. Slowly inject the suspension. In case of a larger lesion the needle can be slowly retracted during injection to facilitate dispersion of the cells throughout the lesion.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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.

Not applicable.

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.

Not applicable.

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.

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.

No data available.

No data available.

Zero days.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after thawing according to directions: Use immediately.

Store and transport frozen (-90 °C to -70 °C) or in liquid nitrogen.

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap containing a single dose of stem cell suspension.

Each pack (polycarbonate container or cardboard box) contains a single dose of the veterinary medicinal product: one vial (1 ml) of stem cell suspension.

Boehringer Ingelheim Vetmedica GmbH

QM09AX90

This veterinary medicinal product contains tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells (tpMSCs). The tenogenic priming of the mesenchymal stem cells aims to promote tissue restoring and healing mechanisms in tendons, such as improving extracellular matrix production. The effects were reflected after tpMSC administration in an experimental tendon injury model in horses through improved ultrasound echogenicity and fibre scoring, higher percentages of intact and fully aligned tendon fascicles reflected by a higher collagen type I content and a lower collagen type III and smooth muscle actin presence.

In the pivotal clinical trial, efficacy of treatment compared to a placebo group was evaluated under conditions of a standard program of box rest and slowly increasing exercise regimen under veterinary guidance. A significant improvement in fibre alignment score in the tendon lesion was demonstrated which coincided with an improvement of echogenicity and size of the cross sectional area on ultrasound examinations.

After injection of the veterinary medicinal product, the tpMSCs do not migrate or distribute from the treated tendon to surrounding tissues or the draining lymph node.

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

UK(NI): EU/2/22/282/001