Hyruan One solution for injection 3ml x 1 syringe
The Hyruan ONE medical device is in the form of a pre-filled syringe containing 2% cross-linked sodium hyaluronate. The preparation is indicated for intra-articular administration as part of the symptomatic treatment of osteoarthritis of the knee joint.
Composition of Hyruan ONE:
Sodium hyaluronan cross-linked with 1,4-butanediol diglycidyl ether (BDDE2) 60mg (2% cross-linked hyaluronic acid).
How Hyruan ONE works:
Preparation in the form of a pre-filled syringe for intra-articular administration. The medical device Hyruan ONE is intended for the symptomatic treatment of knee osteoarthritis. It contains 2% cross-linked sodium hyaluronate (3 ml in one pre-filled syringe). Hyaluronic acid occurs naturally in the body - in large amounts in the joints. He is responsible, inter alia, for protecting cartilage against shock, it also has the ability to relieve the pain associated with osteoarthritis. Sodium hyaluronate reduces friction and also replenishes the synovial fluid content in the knee joint cavity.
Application:
The Hyruan ONE medical device is intended for the symptomatic treatment of osteoarthritis of the knee joint.
Additional Hyruan One solution for injection 3ml x 1 syringe information:
Store the product out of reach of children, at room temperature. It is recommended to protect against moisture and light. Use in children and adolescents: clinical safety and efficacy have not been established. Caution should be exercised when treating the elderly. Injecting the preparation into joints that are strongly inflamed by osteoarthritis may exacerbate local inflammatory symptoms. It should be used after the inflammatory symptoms have subsided. Occasionally, local pain or swelling may occur after administration of the preparation, therefore patients should be advised to avoid vigorous exercise or activities leading to pain in the knee joint for up to 48 hours after administration of the solution, and should be advised to perform local relaxation.
The leakage of the preparation outside the joint cavity can cause pain, so it must be carefully injected into the joint cavity. Intravascular, extra-articular and synovial injection should be avoided. Administer using the attached needle. Caution should be exercised when using a quaternary ammonium salt disinfectant (e.g. benzalkonium chloride and chlorhexidine) as it may contribute to the precipitation of hyaluronic acid. Single-use preparation. Do not re-use and re-sterilize. After treatment, dispose of the syringe, needle, and any unused solution. If the preparation is to be administered to both knee joints, a different preparation should be used for each administration.
Contraindications:
Do not use in case of hypersensitivity to any component of the preparation. Do not use in the case of infection or severe arthritis, disease or skin infection in the area of the application site.
Side effects:
Administration of the preparation may cause serious adverse events: frequency unknown - shock; adverse events reported in clinical trials (local injection site reactions) - pain, heat, redness, swelling; adverse events excluding those occurring at the injection site (mild to moderate severity) - nasopharyngitis, pain, heat increase, upper respiratory tract infection, pain in extremity, cystitis, dyspepsia, paraesthesia, redness, joint swelling, musculoskeletal pain, plantar fascia.
How to use Hyruan ONE solution:
For use by a physician trained in treatment only. Serve intraarticularly. Disinfect the application site with alcohol or another disinfectant. The solution should be injected directly into the joints, and the procedure should be performed under sterile conditions. If there is fluid in the joint cavity, it must first be removed by puncturing the joint. Each pre-filled syringe contains a single dose for one injection, to be administered once during the treatment cycle. Recommended dose: 3 ml into the knee joint.