Arti-Cell Forte

1 x 2 ml

Suspension for injection

Active substance

MSC (horseblood) : 2 ml

ATC code

QM09AX90 Equine stem cells

QM09AX Other drugs for disorders of the musculo-skeletal system

QM09A Other drugs for disorders of the musculo-skeletal system

QM09 Other drugs for disorders of the musculo-skeletal system

QM Musculo-skeletal system

Species

Horses

Indications

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

Dose to be administered and administration route

Intra-articular use.

Recommended dosage:

A single intra-articular injection of 1 dose (2 ml) per animal.

Preparation of the suspension for injection:

The veterinary product must be administered intra-articularly 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 (1 ml)) 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 solvent).

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.

Adverse reactions

Horses:

Very common

(>1 animal / 10 animals treated):

Lameness^1,2

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.