For Patients
For Patients
Arthrosamid® is a hydrogel consisting of 97.5 % sterile water and 2.5 % polyacrylamide. The hydrogel is supplied in a sterile pre-filled 1 mL syringe. Recommended dosage is 6 mL.
Arthrosamid® is an injectable, non-absorbable and biocompatible hydrogel intended to be used for symptomatic treatment of adult patients with knee osteoarthritis. The hydrogel will remain in the knee for the entire lifetime as an integral part of the synovial tissue of the inner joint capsule of the knee.
Arthrosamid® should not be injected:
Do not subsequently have an injection with a different non-absorbable implant in the injected knee.
No serious side effects related to the hydrogel were reported in the clinical trials performed with Arthrosamid®. The most reported side effects were associated with the injection. These side effects were mild to moderate injection site pain and swelling during the first weeks to months following the injection and were generally transient in nature. Formation or swelling of Baker’s cysts may also occur.
A rare side effect may be infection at the injection site. Contact the injecting physician if you experience any sign of infection. The infection must be treated immediately with antibiotics. Do not use corticosteroids, as this may complicate treatment of the infection.
Arthrosamid® should be used with caution in patients: with acute or chronic infections in other parts of the body, with autoimmune disorders, in immunosuppressive therapy, with a compromised immune system, suffering from uncontrolled diabetes, undergoing major dental work or an invasive medical procedure.
Safety and effectiveness have not been established for: patients under 18 years of age, pregnant or lactating women, patients with BMI ≥ 35 kg/m2, single doses higher than 6 mL.
If you need surgery or dental work after the Arthrosamid treatment, inform the treating physician that you have a permanent implant, and you should discuss the possible need for prophylactic antibiotic therapy.