Aptissen Swiss Technology

Synolis VA 80/160

Mono Injection Hyaluronic Acid 80mg + Sorbitol 160mg

Description

Synolis VA 80/160 is a viscoelastic, sterile, apyrogenic, isotonic, 2% sodium hyaluronate buffer solution. The sodium hyaluronate contained in Synolis VA 80/160 is obtained from bacterial fermentation and has a medium-high molecular weight of 2 MDalton. Synolis VA 80/160 has a neutral pH of 6.8 - 7.4 similar to that of synovial fluid. The high concentration and molecular weight of sodium hyaluronate, combined with a polyol (sorbitol) which limits its degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties, similar to those of synovial fluid. healthy. Synolis VA 80/160 works by restoring the physiological and viscoelastic properties of the synovial fluid which has gradually been depleted during the development of osteoarthritis. Synolis VA 80/160 therefore reduces the local pain and discomfort caused by symptomatic osteoarthritis and improves the mobility of the synovial joints.
Synolis VA 80/160 is indicated for the treatment of symptomatic osteoarthritis, to reduce pain and improve mobility following degenerative changes in the synovial joints of the knee and hip. This treatment responds to the patient in whom conservative non-drug therapy and simple analgesics have failed.
Sterilization method: moist heat.

How to use

When treating osteoarthritis of the knee or hip, Synolis VA 80/160 is given as a single intra-articular injection. An additional injection of Synolis VA 80/160 may be given upon resumption of osteoarthritis symptoms to maintain local pain management and joint function. However, treatment benefits are expected to last at least 6 months for responsive patients. The length of time before repeating the treatment regimen also depends on the doctor's experience and / or the severity of the condition. Synolis VA 80/160 must be injected into the synovial cavity by a doctor who specializes in intra-articular injections. Before injecting Synolis VA 80/160, do the following:
- aspirate any joint effusion before injecting the viscoelastic gel;
- at the time of intra-articular injection, Synolis VA 80/160 must be at room temperature;
- thoroughly disinfect the injection site;
- use an appropriately sized needle (recommendation: 18G to 21G);
- firmly attach the needle to the luer lock port of the syringe;
- inject exclusively into the joint cavity.

Components

Sodium hyaluronate, sorbitol, phosphate buffer.

Warnings

Synolis VA 80/160 should not be injected in patients with known hypersensitivity to sodium hyaluronate and / or sorbitol preparations, in pregnant or lactating 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 available data on intolerance to Synolis VA 80/160 injection in patients with autoimmune pregressive or active disease, the physician should decide whether to inject Synolis VA 80/160 depending on the case, based on the nature of the concomitant diseases and treatments. associated concomitants. It is recommended to offer these patients a preliminary test and not to perform the injection if the disease is evolving. It is also recommended that these patients be closely monitored after the injection. Check the integrity of the inner packaging before use and check the expiration date. Do not use the product beyond the expiration date or if the package has been opened or damaged. Do not transfer Synolis VA 80/160 to another container and do not add other ingredients to the product. Intra-articular injection should be done carefully to avoid injecting into the joint of a limb with venous or lymphatic stasis, injecting into the infected and inflamed joint, injecting in the presence of severe joint effusion, injecting outside the cavity intra-articular or in the synovial membrane; viscoelastic gels injected into the perisynovial area can be painful due to compression on other surrounding tissues. Synolis VA 80/160 solution must be administered following strict aseptic procedures. Synolis VA 80/160 is a single use product, which should not be used for different patients and / or sessions. It must not be re-sterilized. Reuse of single-use products can cause infections, as it would no longer be sterile. Only the gel is sterile, not the outside of the syringe. Advise patients to avoid any strenuous physical activity for at least 48 hours after intra-articular injection. Dispose of the syringe in accordance with accepted medical practice and applicable national, local and institutional requirements. There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Avoid contact of Synolis VA 80/160 with products (eg some disinfectants) or with medical or surgical instruments treated with this type of products. To date, there is no data available on the compatibility of Synolis VA 80/160 with other products for use as an intra-articular injection. There is a possibility of side effects occurring which must be described to the patient prior to treatment. A slight bleeding may occur during the injection, but it will stop spontaneously upon 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 effusion. These reactions usually resolve within a few days. If symptoms persist for more than a week or if other side effects occur, the patient should inform the physician. Your doctor can 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.

storage

Store at a temperature between 2 ° C and 25 ° C. Protect from light and frost. Do not freeze the product.
Validity for intact packaging: 24 months

Format

Synolis VA 80/160 is available as a 5 ml pre-filled glass syringe containing 4 ml of viscoantalgic gel. Synolis VA 80/160 is available in packs of 1 syringe. Each box includes labels for traceability and 1 sheet of instructions for use.

Code SYN400