Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
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
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.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
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.
Use during pregnancy, lactation or lay
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.
Interaction with other medicinal products and other forms of interaction
No data available.
Do not administer simultaneously with any other intra-articular veterinary medicinal product.
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.