BioportCrosslink synovial fluid prosthesis in a disposable syringe, 2%

Description

General description: "BioportCrosslink Synovial fluid Prosthesis" is a sterile non-pyrogenic product for restoring the viscosity of synovial fluid. The product is made on the basis of a viscous aqueous solution of cross-linked sodium hyaluronate with a high degree of purification. Each pre-filled syringe contains 20 mg/ml (2.0%) of sodium hyaluronate dissolved in buffered saline solution. The viscoelastic solution has a pH of 6.8-7.5, an osmolality of 270 - 330mosmol/kg, a viscosity of 126.83±16.19 Pa, a degree of reticulation of 3.67 ± 1.15%, a molecular weight of hyaluronic acid of 30 MDa, and the amount of bacterial endotoxins < 0.05 EE/mg. Appointment. Indications for use: It is intended for the treatment of pain in osteoarthritis of the knee for patients who have not shown an adequate response to conservative non-pharmacological treatment, as well as to mild analgesics such as acetaminophen. The effect of BioportCrosslink is to increase the viscoelasticity of synovial fluid, reduce the inflammatory response, protect joint tissues, and reduce pain in osteoarthritis when administered by intra-articular injection. Method of application: Bioport Crosslink is administered by intraarticular injection using the standard one-time method. The maximum possible volume of injection per procedure is 3.0 ml. The depth of injection into the joint cavity is determined by the doctor individually. The duration of the clinical effect is 6 months. It requires compliance with all the rules of asepsis. Before the Bioport Crosslink is administered, the articular effusion must be removed (if present). Information about potential consumers and the scope of the medical product: The product is intended for use only by qualified traumatologists and surgeons. Scope of application: traumatology and surgery. The BioportCrosslink Synovial Fluid prosthesis is a sterile medical device. Work with the product is allowed only with the use of personal protective equipment (gloves). Contraindications: Do not prescribe to patients with identified hypersensitivity to hyaluronate-based drugs. Intra-articular injections are contraindicated in cases of infection or skin diseases in the injection area. To date, no other contraindications to the use of Bioport Crosslink synovial fluid prosthesis have been identified when using the product for its intended purpose. Warning and precautions: The Bioport Crosslink product is intended for intra-articular insertion only. Do not use in conjunction with disinfectants containing quaternary ammonium salts, as the reaction with them may lead to the precipitation of hyaluronate. Do not use Bioport Crosslink if the package is opened or damaged. The contents of the product are sterile if the package is not opened or damaged. Bioport Crosslink should be used immediately after opening the blister pack. The contents of the syringe were made using the aseptic filling method. Do not sterilize again. The syringe is intended for one-time use only. Any unused Bioport Crosslink products must be disposed of. Do not reuse it. Strictly follow the method of aseptic administration. Use Bioport Crosslink with caution in patients with severe allergies. Use Bioport Crosslink with caution if there are signs of venostasis or stagnation of lymph in the injected leg. After intraarticular injection of Bioport Crosslink, passing pain and swelling of the corresponding joint may occur. The attending physician may prescribe appropriate medication. Joint effusion should be removed (if present) before Bioport Crosslink is administered. To insert the Bioport Crosslink into the joint using a sterile 20 gauge (20G) needle. Do not use the same syringe to remove joint effusion and administer Bioport Crosslink. Carefully remove the syringe plug and needle cap in an aseptic manner. As with any other invasive procedure performed on a joint, it is recommended not to overload the joint immediately after intra-articular injection. It is also recommended not to perform the procedure if the patient cannot be under medical supervision for the next 48 hours. The use of Bioport Crosslink during pregnancy, nursing mothers, and children is prohibited. Be sure to follow the procedures for maintaining sterility at the injection site and use the appropriate injection method. In vitro laboratory studies have shown the opalescence of sodium hyaluronate when mixed with other solutions containing quaternary ammonium compounds. Therefore, sodium hyaluronate should not be administered through a product that was previously used to administer these solutions. An undesirable reaction: Sodium hyaluronate is a natural component found in the tissues of the human body. It is usually well tolerated by humans. There are reports of temporary postoperative inflammatory reactions. There are also reports of adverse reactions in some patients, such as pain at the injection site, swelling of the knee joint and/or joint effusion, local skin reactions (rash, ecchymosis) and itching. There have been reports of a temporary increase in the inflammatory response in the corresponding knee joint in some patients after injection with inflammatory arthritis, such as rheumatoid or gouty arthritis. Transportation conditions: Transportation temperature: from 15°C to 25°C Relative humidity: no more than 65 % Atmospheric pressure: 70 – 106 kPa Storage conditions: Storage temperature: from 15°C to 25°C Relative humidity: no more than 65 % Atmospheric pressure: 70 – 106 kPa Store in a cool, dry place protected from light. Application conditions: The product is intended for indoor use at ambient temperatures from 15 °C to 25°C Relative humidity: no more than 65%. Atmospheric pressure: 86-106 kPa Completeness of delivery: Bioport Crosslink synovial fluid prosthesis, consisting of: - one disposable syringe without a needle containing a 2% solution of sodium hyaluronate, volume 3.0 ml – 1 pc.; - instructions for use – 1 pc.; - patient's stickers – 2 pcs. Compatible products: To insert the Bioport Crosslink into the joint, connect any sterile 20 gauge (20G) needle to the syringe. Accessories information: "Bioport Crosslink Synovial fluid Prosthesis" is supplied without accessories. The insertion needle is purchased separately by the user. The shelf life for Bioport Crosslink Synovial Fluid Prosthesis is 3 years. The warranty period of storage is equal to the expiration date. Service life: Not applicable, as the Bioport Crosslink is a disposable product. The product is intended for use only by qualified doctors in hospital settings. Procedure and conditions for the disposal or destruction of a medical device: "Bioport Crosslink synovial fluid prosthesis" must be used immediately after opening the package. Disposal is carried out in a safe and permitted manner in compliance with the requirements of local regulations regarding the treatment of medical waste. Disposal is carried out in accordance with the legislation in force on the territory of the Russian Federation. Waste class according to SanPiN 2.1.3684-21 "B". Unpolluted cardboard packaging is disposed of as household waste. Warranty: This warranty is provided to replace and cancel any other warranties that are not explicitly stated in this document, whether express or implied warranties under the law or other warranties, including any implied warranties of merchantability or fitness for a particular purpose. Maxigin Biotech Inc. assumes no responsibility with respect to recycled, recycled, or sterilized products and makes no warranties, express or implied, with respect to such products, including warranties of merchantability or fitness for a particular purpose. All questions about the warranty on the territory of the Russian Federation should be directed to an authorized representative appointed by Maxigin Biotech Inc.