Descrizione Clinica
Medical devices - medical devices Synolis v-a 80/160 mono 4ml
SYNOLIS VA 80/160
Description
Synolis VA 80/160 is a viscoelastic, sterile, apirogenous, isotonic, 2% sodium pad. The hyaluronate sodium contained in Synolis VA 80/160 is obtained from bacterial fermentation and has an average high molecular weight of 2 MDalton. Synolis VA 80/160 has a neutral pH of 6.8 - 7.4 similar to that of the synovial liquid. The high concentration and molecular weight of hyaluronate sodium, combined with a polyol (sorbitol) that limits its degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties, similar to those of healthy synovial fluid. Synolis VA 80/160 acts by restoring the physiological and viscoelastic properties of the synovial fluid that gradually became exhausted during the development of osteoarthritis. Synolis VA 80/160 therefore reduces local pain and discomfort caused by symptomatic osteoarthritis and improves the mobility of synovial joints.
Synolis VA 80/160 is indicated for the treatment of symptomatic osteoarthritis, to reduce pain and improve mobility due to degenerative alterations to the joints of the knee and hip. This treatment responds to the patient in which non-preservative drug therapy and simple analgesics have failed.
Sterilization Method: wet heat.
Mode of use
During the treatment of knee or hip osteoarthritis, Synolis VA 80/160 is administered as a single intra-articular injection. A further injection of Synolis VA 80/160 can be carried out at the recovery of osteoarthritis symptoms or for the maintenance of local pain management and joint function. However, the benefits of treatment are expected to last at least 6 months for respondents. The time period before repeating the treatment regime also depends on the experience of the doctor and/or the severity of the affection. Synolis VA 80/160 must be injected into the synovial cavity by a doctor specializing in intra-articocular injections. Before injecting Synolis VA 80/160, do as follows:
- aspire the possible joint deposit before injecting viscoelastic gel;
- at the time of intra-articular injection, Synolis VA 80/160 must be at room temperature;
- disinfect the injection site carefully;
- use an appropriate size needle (recommendation: from 18G to 21G);
- securely attach the needle to the luer lock attack of the syringe;
- inject only within the joint cavity.
Components
Hyaluronate sodium, sorbitol, phosphate buffer.
Warnings
Synolis VA 80/160 should not be injected in patients with known hypersensitivity to hyaluronate sodium and/or sorbitol preparations, pregnant or breastfeeding women, in patients under 18 years of age, intravascularly, in patients with a skin disorder or infection at the injection site.
Before treatment, inform patients about the device, its contraindications and possible side effects. Do not use Synolis VA 80/160 for any indication other than symptomatic osteoarthritis. In the absence of clinical data available on the injection intolerance of Synolis VA 80/160 in patients with early or active autoimmune diseases, the doctor must decide whether to inject Synolis VA 80/160, depending on the nature of the associated concomitant diseases and concomitant treatments. It is recommended to propose to these patients a preliminary test and not to injection if the disease is evolving. It is also recommended to carefully monitor these patients after injection. Check the integrity of the internal packaging before use and check the expiration date. Do not use the product beyond the expiration date or if the packaging has been opened or damaged. Do not transfer Synolis VA 80/160 to another container and do not add other ingredients to the product. The intra-articular injection must be carried out carefully to avoid injecting in the articulation of a limb presenting venous or lymphatic stasis, injecting in the infected and inflamed joint joint joint, injecting outside the intra-articular cavity or in the synovial membrane; viscoelastic gels injected into the perisinovial area can be painful due to compression on other surrounding tissues. The Synolis VA 80/160 solution must be administered by strict aseptic procedures. Synolis VA 80/160 is a disposable product, which should not be used for different patients and/or sessions. It must not be resterilized. Reuse of disposable products can cause infections, as it would no longer be sterile. Only the gel is sterile, not the outside of the syringe. Recommend patients to avoid any intense physical activity for at least 48 hours after intra-articular injection. Dispose of syringe in accordance with accepted medical practice and national, local and institutional requirements in force. There is an incompatibility between hyaluronate sodium and quaternary ammonium salts such as benzalconio chloride. Avoid contact with Synolis VA 80/160 with such products (e.g. some disinfectants) or with medical or surgical instruments treated with this type of products. To date, there is no data available on Synolis VA 80/160 compatibility with other products for use as an intra-articular injection. There is a possibility that secondary effects should be described to the patient before treatment. During the injection, a slight hemorrhage may occur, but it will spontaneously stop at the completion of the injection. Occasionally one or more of the following reactions may occur immediately or as a delayed reaction. This is temporary local pain, edema and/or joint deposit. Usually such reactions resolve in a few days. If symptoms persist for more than a week or if other side effects occur, the patient must inform the doctor. Your doctor may prescribe appropriate treatment for these side effects. Other typical possible side effects of viscosupplement injections include inflammation, redness, swelling, skin irritation, allergic and tissue reaction.
Conservation
Store at a temperature between 22°C and 25°C. Protect from light and frost. Do not freeze the product.
Validity of whole packaging: 24 months
Format
Synolis VA 80/160 is available as a 5 ml pre-filled glass syringe containing 4 ml viscoantalgic gel. Synolis VA 80/160 is available in 1 syringe pack. Each box includes labels for traceability and 1 instruction sheet for use.
Cod. SYN400
Synolis VA 80/160 is a viscoelastic, sterile, apirogenous, isotonic, 2% sodium pad. The hyaluronate sodium contained in Synolis VA 80/160 is obtained from bacterial fermentation and has an average high molecular weight of 2 MDalton. Synolis VA 80/160 has a neutral pH of 6.8 - 7.4 similar to that of the synovial liquid. The high concentration and molecular weight of hyaluronate sodium, combined with a polyol (sorbitol) that limits its degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties, similar to those of healthy synovial fluid. Synolis VA 80/160 acts by restoring the physiological and viscoelastic properties of the synovial fluid that gradually became exhausted during the development of osteoarthritis. Synolis VA 80/160 therefore reduces local pain and discomfort caused by symptomatic osteoarthritis and improves the mobility of synovial joints.
Synolis VA 80/160 is indicated for the treatment of symptomatic osteoarthritis, to reduce pain and improve mobility due to degenerative alterations to the joints of the knee and hip. This treatment responds to the patient in which non-preservative drug therapy and simple analgesics have failed.
Sterilization Method: wet heat.
Mode of use
During the treatment of knee or hip osteoarthritis, Synolis VA 80/160 is administered as a single intra-articular injection. A further injection of Synolis VA 80/160 can be carried out at the recovery of osteoarthritis symptoms or for the maintenance of local pain management and joint function. However, the benefits of treatment are expected to last at least 6 months for respondents. The time period before repeating the treatment regime also depends on the experience of the doctor and/or the severity of the affection. Synolis VA 80/160 must be injected into the synovial cavity by a doctor specializing in intra-articocular injections. Before injecting Synolis VA 80/160, do as follows:
- aspire the possible joint deposit before injecting viscoelastic gel;
- at the time of intra-articular injection, Synolis VA 80/160 must be at room temperature;
- disinfect the injection site carefully;
- use an appropriate size needle (recommendation: from 18G to 21G);
- securely attach the needle to the luer lock attack of the syringe;
- inject only within the joint cavity.
Components
Hyaluronate sodium, sorbitol, phosphate buffer.
Warnings
Synolis VA 80/160 should not be injected in patients with known hypersensitivity to hyaluronate sodium and/or sorbitol preparations, pregnant or breastfeeding women, in patients under 18 years of age, intravascularly, in patients with a skin disorder or infection at the injection site.
Before treatment, inform patients about the device, its contraindications and possible side effects. Do not use Synolis VA 80/160 for any indication other than symptomatic osteoarthritis. In the absence of clinical data available on the injection intolerance of Synolis VA 80/160 in patients with early or active autoimmune diseases, the doctor must decide whether to inject Synolis VA 80/160, depending on the nature of the associated concomitant diseases and concomitant treatments. It is recommended to propose to these patients a preliminary test and not to injection if the disease is evolving. It is also recommended to carefully monitor these patients after injection. Check the integrity of the internal packaging before use and check the expiration date. Do not use the product beyond the expiration date or if the packaging has been opened or damaged. Do not transfer Synolis VA 80/160 to another container and do not add other ingredients to the product. The intra-articular injection must be carried out carefully to avoid injecting in the articulation of a limb presenting venous or lymphatic stasis, injecting in the infected and inflamed joint joint joint, injecting outside the intra-articular cavity or in the synovial membrane; viscoelastic gels injected into the perisinovial area can be painful due to compression on other surrounding tissues. The Synolis VA 80/160 solution must be administered by strict aseptic procedures. Synolis VA 80/160 is a disposable product, which should not be used for different patients and/or sessions. It must not be resterilized. Reuse of disposable products can cause infections, as it would no longer be sterile. Only the gel is sterile, not the outside of the syringe. Recommend patients to avoid any intense physical activity for at least 48 hours after intra-articular injection. Dispose of syringe in accordance with accepted medical practice and national, local and institutional requirements in force. There is an incompatibility between hyaluronate sodium and quaternary ammonium salts such as benzalconio chloride. Avoid contact with Synolis VA 80/160 with such products (e.g. some disinfectants) or with medical or surgical instruments treated with this type of products. To date, there is no data available on Synolis VA 80/160 compatibility with other products for use as an intra-articular injection. There is a possibility that secondary effects should be described to the patient before treatment. During the injection, a slight hemorrhage may occur, but it will spontaneously stop at the completion of the injection. Occasionally one or more of the following reactions may occur immediately or as a delayed reaction. This is temporary local pain, edema and/or joint deposit. Usually such reactions resolve in a few days. If symptoms persist for more than a week or if other side effects occur, the patient must inform the doctor. Your doctor may prescribe appropriate treatment for these side effects. Other typical possible side effects of viscosupplement injections include inflammation, redness, swelling, skin irritation, allergic and tissue reaction.
Conservation
Store at a temperature between 22°C and 25°C. Protect from light and frost. Do not freeze the product.
Validity of whole packaging: 24 months
Format
Synolis VA 80/160 is available as a 5 ml pre-filled glass syringe containing 4 ml viscoantalgic gel. Synolis VA 80/160 is available in 1 syringe pack. Each box includes labels for traceability and 1 instruction sheet for use.
Cod. SYN400
