ALTAPRO 3 Description Sterile prefilled syringe for intra-articular infiltration. It is a medical device consisting of: gelatinous material for cartilage support, high-purity sodium hyaluronate and L-proline. Hyaluronic acid is distributed throughout the body and is present in high concentrations in tissues such as vitreous humor, synovial fluid, umbilical cord, and dermis. Hyaluronic acid acts as a tissue lubricant and is thought to play an important role in regulating interactions between adjacent tissues. It also acts as a viscoelastic support to keep tissues separate. Different preparations of hyaluronic acid may have different molecular weights, but are considered to have the same chemical structure. AltaPro 3 is intended to treat the symptoms of joint conditions, such as osteoarthritis. AltaPro 3 is indicated for viscoelastic reconstitution or replacement of synovial fluid in human joints. It is also indicated for pain treatment, joint protection, anti-inflammatory treatment, inhibition of cartilage degeneration and activation of cartilage regeneration in osteoarthritis, gonarthrosis grade I-II-III, degenerative meniscus disease and degenerative knee diseases. AltaPro 3 is recommended for use in patients with osteoarthritis or other joint conditions. Since there is no clinical evidence available on the use of hyaluronic acid for joint injections in children, pregnant and lactating women, or in inflammatory joint conditions such as rheumatoid arthritis or Bechterews disease, treatment with AltaPro 3 in these cases is at the discretion of the specialist. How to use Intra-articular infiltration must be administered by a doctor. AltaPro 3 should be administered only once every 6 months. Depending on the severity of the disease, the effects of intra-articular infiltration may decrease after 6 months. If necessary, a second administration may be performed. In case of joint effusion, arthrocentesis, rest, ice packs and/or intra-articular cortisone administration are recommended to reduce symptoms. The product can be administered after 2 or 3 days. The product and pre-filled syringe are sterile until the package is opened. Remove any air bubbles before injection. Remove the syringe from the packaging. Remove the Luer Lock cap. Insert a suitable needle (18-22G) by carefully rotating it. components 40 mg/2 ml sodium hyaluronate, 30 mg/2 ml L-proline. warnings Known sensitivity to any of the ingredients contained in the product. Pre-existing skin infections in the area indicated for infiltration. Notice the joint infection. Note systemic bleeding abnormalities. Do not use on inflamed or infected joints. Infection, arthralgia (joint pain), swelling, joint effusion, stiffness, pain in the limb, paraesthesia, phlebitis, itching, erythema or pain or reaction at the injection site, bursitis, immune response. Single-use device. Do not reuse. The product is intended for single use only. It should not be reused. Reuse or reprocessing (e.g., cleaning and sterilization) could compromise the structural integrity of the device and/or could lead to device ineffectiveness, resulting in patient injury, illness, or death. In addition, the reuse or reprocessing of single-use devices could create contamination risks, such as the transmission of infectious materials from one patient to another, potentially hazardous to the health of patients and healthcare workers. Contaminated devices should not be reprocessed. Any product contaminated with blood, tissue and/or body fluids should never be reused and should be handled according to sanitary protocols. All precautions normally taken when performing joint infiltrations are recommended. Only medical professionals specifically trained in generally accepted infiltration techniques for administering agents into synovial joint spaces may infiltrate sodium hyaluronate for this application. Do not use excessive amounts of sodium hyaluronate; the patient should be monitored carefully. The joint space should not be overfilled. If the perceived pain increases during the infiltration procedure, the infiltration should be discontinued and the needle removed. Patients who experience any abnormal side effects after taking the product should consult a doctor immediately. Conservation Products should be stored below 25°C and at low humidity (40-60% RH) before shipping to the customer. Extreme storage conditions, such as exposure to direct sunlight and/or proximity to heat sources, could damage the product. Do not freeze. Shelf life in unopened packaging: 24 months. Format 2 ml pre-filled syringe. Code ALAPR3