Sinovial HL 64mg/2ml - Joint Viscosupplementation

<p>Sinovial HL 64mg/2ml is an innovative medical device developed by Fidia Farmaceutici, specifically designed for intra-articular viscosupplementation. This product is primarily aimed at patients suffering from joint pain and stiffness, particularly related to osteoarthritis or other degenerative joint conditions. Its formula is based on an optimized combination of high and low molecular weight hyaluronic acid, aimed at restoring the viscosity and elasticity of synovial fluid, improving joint lubrication, and promoting symptomatic relief of joint discomfort. Sinovial HL is presented in a sterile pre-filled syringe of 2 ml, convenient for direct administration by a trained healthcare professional.</p><p>The hyaluronic acid used is of non-animal origin, highly purified, and perfectly biocompatible, ensuring optimal tolerance as well as a high safety profile for use in viscosupplementation sessions. This product is indicated for joints affected by mild to moderate osteoarthritis or presenting functional limitations, with the aim of restoring mobility and reducing local inflammation.</p><p>The pack includes a single, ready-to-use, sterile syringe that is easy to handle in sterile conditions. Each sterile syringe contains 64 mg of hyaluronic acid dissolved in 2 ml of solution, allowing for effective treatment with a minimum of passes for the user. The preservation and integrity of the product are ensured by the airtight packaging, preventing any alteration before use.</p><ul><li>Joint viscosupplementation with hyaluronic acid</li><li>Relief of pain related to osteoarthritis and joint degeneration</li><li>Restored lubricating and cushioning properties of synovial fluid</li><li>Contains 64 mg of hyaluronic acid of two molecular weights</li><li>Non-animal origin, high purity</li><li>Ready-to-use syringe, single use</li><li>Optimal tolerance and high safety profile</li><li>Injection exclusively by authorized healthcare professional</li><li>Secure and sterile packaging</li><li>Indicated for peripheral joints</li><li>Does not contain preservatives</li><li>Transparent and viscous solution</li></ul><p>Sinovial HL offers a non-surgical management option suitable for various joints (knees, shoulders, hips, etc.), allowing for an improvement in the quality of life of patients suffering from moderate joint disorders. It thus fits into a comprehensive approach to managing osteoarthritis and mechanical joint pain, in addition to or as an alternative to other therapeutic approaches after medical advice.</p>

<p>Sinovial HL is intended for intra-articular administration by a healthcare professional trained in this type of procedure. The use of the product requires adherence to aseptic standards to avoid any risk of infection. Before any administration, it is imperative to check the integrity of the primary packaging and the absence of turbidity in the solution. The injection site must be carefully disinfected.</p><p>The injection is generally performed in a consultation, without systematic anesthesia, under sterile conditions. The practitioner introduces the syringe into the targeted joint cavity (usually the knee, shoulder, hip, or other peripheral joints), after precise anatomical localization. The dose of 2 ml, corresponding to 64 mg of hyaluronic acid, is injected in a single instance.<br>The number of sessions will depend on the medical diagnosis, but often one to three injections spaced several weeks apart are sufficient. After the injection, it is advised for the patient to limit major efforts on the infiltrated joint for 24 to 48 hours.</p><ul><li>Injection only by trained physician</li><li>Strict adherence to the asepsis of the equipment and site</li><li>Verification of the integrity of the device and the solution</li><li>Intra-articular injection, single dose of 2 ml</li><li>Possibility of renewal according to the therapeutic scheme</li><li>Advice to avoid major efforts 24-48 hours after the procedure</li><li>Clinical follow-up recommended to assess effectiveness</li><li>In case of pain or abnormal swelling, consult a physician</li></ul><p>Sinovial HL should not be used in subjects with a local infection, a wound in the area to be treated, or a known hypersensitivity to any of its components. Handling and administration are exclusively the responsibility of the medical staff.</p>

<p>The composition of Sinovial HL is specifically designed to ensure optimal efficacy in viscosupplementation while maintaining excellent local tolerance. Each pre-filled syringe of 2 ml contains 64 mg of hyaluronic acid, evenly distributed between high molecular weight (HMW) and low molecular weight (LMW) molecules. This combination aims to best replicate the natural properties of human synovial fluid, being both viscous for cushioning and fluid for lubrication.</p><p>The hyaluronic acid used in Sinovial HL is of non-animal origin, obtained through bacterial fermentation, and then highly purified to eliminate any protein or pyrogen residues that could trigger undesirable reactions. Its high concentration (32 mg/ml) allows for a significant amount of active ingredient to be delivered in a single injection, contributing to a rapid restoration of the biomechanical properties of synovial fluid. The solution is clear, viscous, isotonic, free of dyes and preservatives, ensuring perfect biocompatibility with sensitive joint tissues.</p><ul><li>HMW hyaluronic acid: viscoelastic and cushioning properties</li><li>LMW hyaluronic acid: promotes rapid diffusion and lubrication</li><li>Non-animal origin, obtained through bacterial fermentation</li><li>Thorough purification eliminating any protein and endotoxin</li><li>Water for injectable preparation (excipients)</li><li>Absence of preservatives or other additives</li><li>Sterile and apyrogenic solution</li><li>Sterile syringe packaging ready for use</li></ul><p>The synergy of the two forms of hyaluronic acid gives the product a mechanical and biological action closely resembling that of healthy synovial fluid, thus allowing for a notable and lasting improvement in joint functionality while limiting the risks of intolerance or undesirable side effects.</p>

<p>Sinovial HL benefits from an excellent tolerance profile due to its non-animal sourced hyaluronic acid and its high purity obtained through bacterial fermentation. Nevertheless, as with any injectable medical device, some adverse effects or risks of local reactions remain possible. It is important to inform the physician of any known allergies or history of reactions to a similar product prior to administration.</p><ul><li>Exclusive presence of purified hyaluronic acid (absence of animal proteins)</li><li>Absence of preservatives, colorants, or allergenic agents</li><li>Possible risks of transient local reactions (redness, swelling, pain at the injection site)</li><li>Rare cases of documented inflammatory reactions or hypersensitivity</li><li>Do not use if there is a known allergy to hyaluronic acid or any of the excipients</li><li>Strict adherence to aseptic conditions to limit the risk of infection</li><li>Not recommended for patients with an evolving or joint infection</li><li>Do not use in case of a wound or lesion at the injection site</li></ul><p>In the event of an allergic reaction or severe side effect, it is advisable to consult a healthcare professional immediately. Safety parameters are evaluated during clinical trials and post-marketing, and cases of severe allergy remain rare with this type of sterile, pyrogen-free, and biocompatible preparation.</p>

<p><strong>1. What is the mechanism of action of Sinovial HL?</strong><br>It restores the viscosity of synovial fluid thanks to its double molecular weight hyaluronic acid, promoting lubrication and pain reduction.</p><p><strong>2. Who is Sinovial HL intended for?</strong><br>The product is primarily indicated for adults suffering from joint pain related to osteoarthritis, but its use in other joint pathologies can be evaluated by a physician.</p><p><strong>3. How is the injection performed?</strong><br>The injection must be carried out in a sterile medical environment by a trained healthcare professional, directly into the targeted joint.</p><p><strong>4. How many injections are generally needed?</strong><br>Depending on the severity and medical advice, one to three spaced sessions may be considered for optimal therapeutic impact.</p><p><strong>5. Are there any contraindications?</strong><br>Yes, particularly an ongoing infection, a known allergy to hyaluronic acid, or a skin lesion at the injection site.</p><p><strong>6. What precautions should be taken after the injection?</strong><br>It is advised not to excessively strain the joint in the 24 to 48 hours following the infiltration and to report any unusual pain.</p><p><strong>7. Does Sinovial HL contain any medications or allergenic substances?</strong><br>No, this device contains only highly purified hyaluronic acid and no recognized additives or allergens.</p><p><strong>8. Can these injections replace surgery?</strong><br>Sinovial HL can delay or limit the need for surgery in cases of moderate osteoarthritis, subject to the advice of a specialist.</p>

<p>Sinovial HL is designed to offer numerous benefits in the medical management of osteoarthritis and joint pain of degenerative or mechanical origin. Its use significantly improves the mobility and comfort of patients, limiting the need for more invasive medication or surgical solutions. The dual molecular weight of its hyaluronic acid ensures both rapid and prolonged action in the joint.</p><p>Thanks to its high level of biocompatibility and absence of preservatives, Sinovial HL demonstrates exceptional tolerance, minimizing the risk of side effects for the majority of patients. Its presentation in a ready-to-use syringe simplifies the medical procedure and reduces the possibilities of contamination or handling errors.</p><ul><li>Effective restoration of synovial fluid properties</li><li>Supports the regeneration of the articular matrix</li><li>Improves internal lubrication and cushioning</li><li>Rapid reduction of joint pain</li><li>Promotes increased mobility and flexibility</li><li>Limits micro-inflammatory phenomena</li><li>Allows for a slowdown in arthritic progression</li><li>Reduces the need for analgesics or anti-inflammatories</li><li>Suitable for various types of peripheral joints</li><li>Ease of injection, sterile presentation suitable for medical practice</li><li>Single-use device, ensuring safety of use</li><li>Optimized for lasting effectiveness after a single injection</li></ul><p>Sinovial HL thus contributes to improving the quality of life for individuals suffering from chronic joint pain, integrating an advanced, reliable therapeutic approach validated by multiple clinical studies published in the medical literature.</p>