Dogs

Improvement in function, reduction of pain and lameness associated with mild to severe osteoarthritis in hips and elbow joint.

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

The veterinary medicinal product has been demonstrated to be efficacious in dogs with mild to severe osteoarthritis in elbow and hip joints diagnosed using a combination of local heat, effusion, joint mobility, pain on palpation, lameness and radiological image. Efficacy data are not available regarding treatment of other joints.

Efficacy of the veterinary medicinal product demonstrated that by day 56, 51.4% of dogs treated with the product had achieved more then 7% improvement in functional outcome (measured by Peak Vertical Force, normalised for bodyweight) with associated improvement in lameness, pain on palpation, local heat and effusion and improved quality of life.

The onset of efficacy may be gradual. Clinical improvement may be seen by 4 weeks after treatment, but more likely by 8-12 weeks after treatment.

Reduced pain and increased mobility of the treated joint may last from 3 months to more than a year (in 27.5% of dogs treated with the product in clinical study; results from an owner questionnaire). There may be improvements in temperament, in playing with other dogs, in stiffness, ability to run and climb stairs.

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. 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-articular injection.

No efficacy and safety data are available regarding the treatment in more than one arthritic joint at the same time. (see adverse reactions).

Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an associated risk of thrombosis.

The safety of the veterinary medicinal product has only been investigated in dogs of at least one year old.

there are only limited data available to support 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 time whilst handling and administering the product. Wash any spills off exposed skin, eyes or mucous membranes immediately.The product contains Dextran-40, which may cause hypersensitivity (allergic) type reactions in some people. Avoid contact with the product if you know you are sensitised to this substance.

Take care not to accidentally self-administer this product. 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. Transient fever may also occur. Seek medical advice immediately and provide the package leaflet or label to the physician.

Lameness and pain (mild to severe) was reported very commonly within 24 hours after product administration. Lameness and pain with a delayed onset (≤ 1 week post-treatment) was also observed commonly. Resolution of lameness and pain depended on the severity. Mild lameness and pain resolved completely within a few days without the need for anti-inflammatory treatment. Severe lameness and pain required symptomatic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)and complete remission took a period of weeks.

The frequency of adverse reactions is defined using the following convention:

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.

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

Intra articular use.

A single intra articular injection of 1ml (6.5x106- 9x106 equine umbilical cord mesenchymal stem cells) into the affected joint.

The veterinary product must be administered intra articularly , only by a veterinary surgeon, taking special precautions to ensure the sterility of the injection process. The product must be handled and injected following sterile techniques and in a clean environment. Swirl gently before use in order to ensure the contents are well mixed. Use 23G needle. Intra articular placement should be confirmed by the appearance of synovial fluid in hub of the needle. The use of a single dose of systemic NSAIDs is recommended on the day of product administration.

No data available

Not applicable.