DogStem Suspension for Injection for Dogs

The veterinary medicinal product has been demonstrated to be efficacious in dogs
with mild to severe osteoarthritis in elbow or hip joints diagnosed using a combination
of local heat, effusion, joint mobility, 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 than 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.

Issued: September 2022
AN: 00764/2021
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 a 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 section 4.6.

Special precautions for use in animals
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 at
least one year old.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
There are only limited data available to support the 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 times 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