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Orhovisc Intra-articular Syringe 2ml 15mg/ml
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Description Orhovisc Intra-articular Syringe 2ml 15mg/ml
Orhovisc Intra-articular Syringe
CE class III medical devices.
Sterile, non-pyrogenic solutions of sodium hyaluronate (15 mg/ml) dissolved in a saline solution. They are indicated as viscoelastic supplements or substitutes for synovial fluid in human joints; are suitable for the treatment of symptoms of human synovial joint dysfunction such as osteoarthritis. The actions of both products are lubrication and mechanical support.
Mode; of use
Keep at a temperature between 2° and 25°C. Let them reach room temperature approximately 20-45 minutes before use. Not for intravenous injection. The amount of required is slowly infused into the selected joint space via a non-rigid, ISO/ANSI compliant hypodermic fulcrum needle of suitable diameter. The diameters used for knee injections are 18-21 gauges. The final selection for any procedure must be determined by the physician. The volume varies according to the size of the joint space, but should not exceed 2 mL for the knee and other large joints or 1 mL for small joints. It is up to the doctor to determine the appropriate volume to ensure that the joint is not overfilled. The recommended treatment regimen is of 3 injections at intervals of one week for each treatment cycle, with a maximum treatment cycle for an individual joint in any 6 month period. Remove any joint effusion before injecting the product. Do not overfill the joint space.
Contraindications
The following pre-existing conditions may constitute relative or absolute contraindications for the use of the products:
– known sensitivity; to any of the ingredients contained in the two products;
– pre-existing infections of the skin region of the intended injection site;
– known infections of the joint;
– known systemic bleeding abnormalities.
Products may contain trace amounts of gram-positive bacterial proteins and are contraindicated in patients with a history of similar allergies.
Warnings
It is recommended to adopt the normal precautions for injections of substances into the joints. Only medical personnel skilled in accepted injection techniques for administering agents into joint spaces should inject sodium hyaluronate for this application. Do not use an amount excessive sodium hyaluronate and keep the patient under close supervision. Don't overfill the space. If pain increases during the injection, stop the injection and withdraw the needle. In case of any abnormal consequences to the administration of the products, patients should contact the doctor immediately. Do not use if the inner packaging (bag) is sealed. opened or damaged. By intra-articular injection. Not for intravenous injection. The sale and use of this medical device is restricted to or under the supervision of a physician. Disposable product. Do not resterilize.
Format
Orthosivisc: pack of 1 and 3 syringes of 2 ml.
Orthosivisc mini (quantity for small joints): pack of 1 and 3 syringes of 1 ml.
Sterile, non-pyrogenic solutions of sodium hyaluronate (15 mg/ml) dissolved in a saline solution. They are indicated as viscoelastic supplements or substitutes for synovial fluid in human joints; are suitable for the treatment of symptoms of human synovial joint dysfunction such as osteoarthritis. The actions of both products are lubrication and mechanical support.
Mode; of use
Keep at a temperature between 2° and 25°C. Let them reach room temperature approximately 20-45 minutes before use. Not for intravenous injection. The amount of required is slowly infused into the selected joint space via a non-rigid, ISO/ANSI compliant hypodermic fulcrum needle of suitable diameter. The diameters used for knee injections are 18-21 gauges. The final selection for any procedure must be determined by the physician. The volume varies according to the size of the joint space, but should not exceed 2 mL for the knee and other large joints or 1 mL for small joints. It is up to the doctor to determine the appropriate volume to ensure that the joint is not overfilled. The recommended treatment regimen is of 3 injections at intervals of one week for each treatment cycle, with a maximum treatment cycle for an individual joint in any 6 month period. Remove any joint effusion before injecting the product. Do not overfill the joint space.
Contraindications
The following pre-existing conditions may constitute relative or absolute contraindications for the use of the products:
– known sensitivity; to any of the ingredients contained in the two products;
– pre-existing infections of the skin region of the intended injection site;
– known infections of the joint;
– known systemic bleeding abnormalities.
Products may contain trace amounts of gram-positive bacterial proteins and are contraindicated in patients with a history of similar allergies.
Warnings
It is recommended to adopt the normal precautions for injections of substances into the joints. Only medical personnel skilled in accepted injection techniques for administering agents into joint spaces should inject sodium hyaluronate for this application. Do not use an amount excessive sodium hyaluronate and keep the patient under close supervision. Don't overfill the space. If pain increases during the injection, stop the injection and withdraw the needle. In case of any abnormal consequences to the administration of the products, patients should contact the doctor immediately. Do not use if the inner packaging (bag) is sealed. opened or damaged. By intra-articular injection. Not for intravenous injection. The sale and use of this medical device is restricted to or under the supervision of a physician. Disposable product. Do not resterilize.
Format
Orthosivisc: pack of 1 and 3 syringes of 2 ml.
Orthosivisc mini (quantity for small joints): pack of 1 and 3 syringes of 1 ml.
