{"product_id":"sinovial-hl-64","title":"Sinovial HL 64 1x 2.0 ml","description":"\u003ch2\u003eSINOVIAL® HL 64 2 ml – Instructions for use\u003c\/h2\u003e\n\u003ch3\u003eDescription\u003c\/h3\u003e\n\u003cp\u003eHyaluronic acid sodium salt is formed from repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and is an essential component of synovial fluid, giving it its special viscoelastic properties.\u003c\/p\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml consists of a buffered saline solution with high-molecular-weight (H-HA) and low-molecular-weight (L-HA) hyaluronic acid.\u003c\/p\u003e\n\u003cp\u003eThe high- and low-molecular-weight hyaluronic acid used in the medical device is obtained by fermentation and has not been chemically modified. This results in excellent tolerability.\u003c\/p\u003e\n\u003cp\u003eFurthermore, the HA chains with different molecular weights contained in SINOVIAL® HL 64 2 ml interact with each other thanks to a specific and patented treatment of the solution, giving SINOVIAL® HL 64 2 ml unique rheological properties that allow higher concentrations of hyaluronic acid to be administered at the same solution viscosity.\u003c\/p\u003e\n\u003cp\u003eThe HA chains with different molecular weights offer greater resistance to hyaluronidase, as this enzyme cannot recognize the conformation of these high-molecular complexes. Therefore, SINOVIAL® HL 64 2 ml is better suited for in vivo applications in tissues.\u003c\/p\u003e\n\u003ch3\u003ePurpose of use\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml with its special formula belongs to the latest generation of intra-articular treatments. SINOVIAL® HL 64 2 ml is a medical device designed to restore the physiological and rheological properties of synovial fluid in joints affected by osteoarthritis. SINOVIAL® HL 64 2 ml reduces joint pain and promotes the restoration of associated joint mobility. Clinical data have shown that SINOVIAL® HL 64 2 ml combined with laser therapy can improve symptoms associated with tendinopathy.\u003c\/p\u003e\n\u003ch3\u003eAreas of application\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml is indicated for pain or limited mobility due to degenerative diseases (e.g., osteoarthritis), post-traumatic disorders associated with acute and chronic joint complaints in large and small joints.\u003c\/p\u003e\n\u003ch3\u003eTarget groups and users\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml is indicated for adult men and women and should only be administered by qualified personnel via intra-articular injection.\u003c\/p\u003e\n\u003ch3\u003eComposition\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL consists of a prefilled syringe with 1 or 2 ml solution containing the following ingredients:\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003eComponent\u003c\/th\u003e\n\u003cth\u003eSyringe volume 1 ml\u003c\/th\u003e\n\u003cth\u003eSyringe volume 2 ml\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium hyaluronate\u003c\/td\u003e\n\u003ctd\u003e16 mg (H-HA) + 16 mg (L-HA)\u003c\/td\u003e\n\u003ctd\u003e32 mg (H-HA) + 32 mg (L-HA)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium chloride\u003c\/td\u003e\n\u003ctd\u003e8.000 mg\u003c\/td\u003e\n\u003ctd\u003e16.000 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium phosphate\u003c\/td\u003e\n\u003ctd\u003e0.205 mg\u003c\/td\u003e\n\u003ctd\u003e0.410 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWater for injection purposes\u003c\/td\u003e\n\u003ctd\u003eq.s. 1.0 ml\u003c\/td\u003e\n\u003ctd\u003eq.s. 2.0 ml\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ch3\u003eDosage\u003c\/h3\u003e\n\u003cp\u003eIt is recommended to perform 1 infiltration per week, with a maximum of 3 infiltrations per treatment cycle. The appropriateness and frequency with which the treatment cycle can be repeated must be individually assessed by the physician considering the risk-benefit ratio for each patient.\u003c\/p\u003e\n\u003ch3\u003eAvailable packages\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml is available in packages with 1 prefilled syringe in the following volumes:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e1 ml prefilled syringe (16 mg (H-HA) + 16 mg (L-HA) hyaluronic acid sodium salt in 1 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle\u003c\/li\u003e\n\u003cli\u003e1 ml prefilled syringe (16 mg (H-HA) + 16 mg (L-HA) hyaluronic acid sodium salt in 1 ml sodium chloride buffered saline) and two needles: 1 needle 22 G x 1½” (0.7 x 40 mm); 1 needle 29 G x ½ TW (0.3 x 12 mm)\u003c\/li\u003e\n\u003cli\u003e2 ml prefilled syringe (32 mg (H-HA) + 32 mg (L-HA) hyaluronic acid sodium salt in 2 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe contents of the syringe are sterile and pyrogen-free.\u003c\/p\u003e\n\u003cp\u003ePrefilled syringe steam sterilized.\u003c\/p\u003e\n\u003cp\u003eNeedles sterilized with ethylene oxide.\u003c\/p\u003e\n\u003cp\u003eManufacturer: Terumo Europe N. V. – Interleuvenlaan 40 – 3001 Leuven, Belgium\u003c\/p\u003e\n\u003ch3\u003eInstructions for use\u003c\/h3\u003e\n\u003cp\u003eJoint effusions must be aspirated before injecting SINOVIAL® HL 64 2 ml.\u003c\/p\u003e\n\u003cp\u003eCarefully unscrew the syringe cap, holding the Luer-Lock collar between your fingers and taking special care not to touch the opening.\u003c\/p\u003e\n\u003cp\u003eScrew the 21G needle (included in the kit) firmly onto the Luer-Lock collar of the syringe until you feel slight resistance to ensure an airtight seal and prevent fluid leakage during administration.\u003c\/p\u003e\n\u003cp\u003eInject SINOVIAL® HL 64 2 ml at room temperature and under strictly aseptic conditions.\u003c\/p\u003e\n\u003cp\u003eInject SINOVIAL® HL 64 2 ml into the synovial cavity of the joint or into the tendon sheath\/peritendinous area according to medical need.\u003c\/p\u003e\n\u003ch3\u003eAfter use\u003c\/h3\u003e\n\u003cp\u003eFill out the implant card and hand it over to the patient.\u003c\/p\u003e\n\u003cp\u003eNote: Fill out one implant card for each prefilled syringe used for treatment (i.e., 1 prefilled syringe = 1 completed implant card).\u003c\/p\u003e\n\u003cp\u003eThe implant card is inside the box; to remove it, proceed as follows:\u003c\/p\u003e\n\u003col\u003e\n\u003cli\u003eOpen the SINOVIAL® HL 64 2 ml box.\u003c\/li\u003e\n\u003cli\u003eRemove all blister packs with prefilled syringes from the box.\u003c\/li\u003e\n\u003cli\u003eRemove the implant card from the box. Gently press down the blue-bordered area of the outer packaging (back side) without breaking it.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch3\u003eInstructions for filling out the implant card\u003c\/h3\u003e\n\u003cp\u003eFill in the fields marked with the following symbols with the specified information:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003ePatient name or patient ID\u003c\/li\u003e\n\u003cli\u003eDate of treatment\u003c\/li\u003e\n\u003cli\u003eName and address of the implanting healthcare facility\u003c\/li\u003e\n\u003cli\u003eDoctor's name\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003eWarnings\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eThe contents of the prefilled syringe are sterile. The syringe and needles are packaged in a sealed blister pack.\u003c\/li\u003e\n\u003cli\u003eThe outer surface of the syringe is not sterile.\u003c\/li\u003e\n\u003cli\u003eDo not use SINOVIAL® HL 64 2 ml after the expiration date printed on the package.\u003c\/li\u003e\n\u003cli\u003eDo not use SINOVIAL® HL 64 2 ml if the packaging is opened or damaged, as the product's sterility may be compromised.\u003c\/li\u003e\n\u003cli\u003eInjection must be performed on healthy skin.\u003c\/li\u003e\n\u003cli\u003eDo not use in pregnant or breastfeeding women.\u003c\/li\u003e\n\u003cli\u003eDo not use in patients with autoimmune diseases.\u003c\/li\u003e\n\u003cli\u003eDo not inject intravascularly. Do not inject outside the joint cavity, into synovial tissue, or the joint capsule.\u003c\/li\u003e\n\u003cli\u003eDo not administer SINOVIAL® HL 64 2 ml if there is a severe joint effusion.\u003c\/li\u003e\n\u003cli\u003eDo not resterilize. The medical device is intended for single use only.\u003c\/li\u003e\n\u003cli\u003eDo not reuse to avoid contamination risks.\u003c\/li\u003e\n\u003cli\u003eStore at room temperature below 25 °C and away from heat sources. Do not freeze.\u003c\/li\u003e\n\u003cli\u003eAfter opening, SINOVIAL® HL 64 2 ml must be used immediately and disposed of after use.\u003c\/li\u003e\n\u003cli\u003eSINOVIAL® HL 64 2 ml is indicated for adult patients.\u003c\/li\u003e\n\u003cli\u003eKeep out of reach of children.\u003c\/li\u003e\n\u003cli\u003eAfter injection, instruct the patient to avoid any intense physical activity and to resume normal activities only after a few days.\u003c\/li\u003e\n\u003cli\u003eExisting air bubbles do not affect the product's properties.\u003c\/li\u003e\n\u003cli\u003eDo not use SINOVIAL® HL 64 2 ml in case of known hypersensitivity or allergies to any of the product's components.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003ePrecautions for use\u003c\/h3\u003e\n\u003cp\u003eDo not mix SINOVIAL® HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine, as this may cause the product to precipitate.\u003c\/p\u003e\n\u003ch3\u003eInteractions\u003c\/h3\u003e\n\u003cp\u003eBased on the available in vitro data, no chemical-physical or biological interactions are known between SINOVIAL® HL 64 2 ml and platelet-rich plasma (PRP), which is used for endoarticular infiltrative treatment of osteoarthritis.\u003c\/p\u003e\n\u003cp\u003eCurrently, no interactions between SINOVIAL® HL 64 2 ml and drugs\/other treatments are known. If you are using medications or other therapeutic measures simultaneously, ask your doctor for more information.\u003c\/p\u003e\n\u003ch3\u003eSide effects\u003c\/h3\u003e\n\u003cp\u003eExtra-articular infiltration of SINOVIAL® HL 64 2 ml can cause local adverse effects.\u003c\/p\u003e\n\u003cp\u003eDuring the use of SINOVIAL® HL 64 2 ml, symptoms such as pain, warmth, redness, or swelling at the injection site may occur. These secondary complaints can be relieved by applying ice to the treated area and usually subside. Doctors must ensure that patients are informed about all adverse effects that may occur after treatment.\u003c\/p\u003e\n\u003cp\u003eIn case of an adverse event, the manufacturer or the competent authority must be informed.\u003c\/p\u003e\n\u003ch3\u003eOverdose\u003c\/h3\u003e\n\u003cp\u003eFollow the specified dosage and contact your doctor or the nearest hospital if you notice side effects related to an overdose.\u003c\/p\u003e\n\u003ch3\u003eContraindications\u003c\/h3\u003e\n\u003cp\u003eSINOVIAL® HL 64 2 ml must not be injected if there is an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site.\u003c\/p\u003e\n\u003ch3\u003eShelf life\u003c\/h3\u003e\n\u003cp\u003eShelf life: 36 months.\u003c\/p\u003e\n\u003cp\u003eThe expiration date indicates the maximum shelf life of the medical device.\u003c\/p\u003e\n\u003ch3\u003eDisposal\u003c\/h3\u003e\n\u003cp\u003eDo not dispose of the product in the environment after use. Follow local regulations for product disposal.\u003c\/p\u003e\n\u003ch3\u003eSummary of Safety and Clinical Performance\u003c\/h3\u003e\n\u003cp\u003eYou can download the Summary of Safety and Clinical Performance (SSCP) using the following link:\u003c\/p\u003e\n\u003cp\u003ehttps:\/\/www.ibsa.it\/en\/chi-siamo\/summary-of-safety-and-clinical-performance.html\u003cbr\u003ehttps:\/\/www.ibsa.it\/en\/chi-siamo\/sscp-area-riservata.html\u003c\/p\u003e\n\u003ch3\u003eDate of last revision of the package leaflet\u003c\/h3\u003e\n\u003cp\u003eFebruary 2023\u003c\/p\u003e","brand":"IBSA","offers":[{"title":"Default Title","offer_id":51849393176916,"sku":"137","price":97.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/sinovial-hl-64-1x-20-ml-ibsa-gelenkspritzen-stakonmed-3381160.jpg?v=1772274014","url":"https:\/\/stakonmed.at\/en\/products\/sinovial-hl-64","provider":"StakonMed","version":"1.0","type":"link"}