Each dose of 2 ml contains:

Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells: 1.4 – 2.5 x 106

Stem cells: clear colourless suspension.

Solvent: clear yellow suspension.

Horses

Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.

Intra-articular use.

A single intraarticular injection of 1 dose (2ml) per animal.

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

The product needs to be administered immediately after thawing to prevent significant cell death.

Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C – 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes).

If any cell clusters are visible in either of the vials after thawing, gently shake the vial concerned until the suspension is clear and colourless (stem cell suspension) or clear and yellow (equine allogeneic plasma suspension: the diluent).

Remove the cap of the vial that thawed first and aspirate the suspension in a syringe, then remove the cap of the other (thawed) vial and aspirate the suspension in the same syringe. Then mix both the suspensions in the same syringe to produce one dose of the product (2 ml).

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

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

The product has been demonstrated to be efficacious in horses showing mild to moderate lameness in the fetlock joint. Efficacy data are not available regarding treatment of other joints.

The efficacy of the product was demonstrated in a pivotal field trial after single administration of the product and concurrent single systemic administration of an NSAID. 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 intraarticular injection.

Special precautions for use in animals:

In order to avoid thrombosis in small vessels when administering intraarticular injections the correct placement of the needle is critical.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

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 product can cause pain, local inflammatory reactions and swelling at the site of injection which may persist for several weeks and possibly cause fever, seek medical advice immediately and show the package leaflet or the label to the physician.

Not applicable.

Horses:

Very common

(>1 animal / 10 animals treated):

Lameness1,2

Injection site reaction1 (e.g. joint swelling3, injection site warmth2)

1 Occurring in the first week after use of the product.

2 Mild

3 Mild to moderate

In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.

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 accordingly to the benefit-risk assessment by the responsible veterinarian.

No data available.

Do not administer simultaneously with any other intra-articular veterinary medicinal product.

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: 3 years.

Shelf life after reconstitution 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 or household waste.

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.

Each pack (polycarbonate container) contains a single dose of the product: one vial of chondrogenic induced mesenchymal stem cell suspension and one vial of equine allogeneic plasma (EAP) suspension (solvent).

Nature of vials: cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap.

Boehringer Ingelheim Vetmedica GmbH

This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP). The addition of the EAP to the stem cells after thawing and just before injection of the product increases the viability of the stem cells.

The chondrogenic induction of the mesenchymal stem cells aims to activate chondroprotective mechanisms, such as the production of extracellular matrix. In an experimental model of osteoarthritis in horses these effects were reflected through parameters related to cartilage turnover.

After injection of the product the stem cells do not migrate or distribute from the treated joint and synovia to tissues surrounding the synovial space.

EU/2/18/228/001