{"product_id":"recosyn-20-1-x-2-ml","title":"Recosyn 20 1x 2.0 ml","description":"\u003cdiv class=\"page\" title=\"Page 1\"\u003e\n\u003cdiv class=\"section\"\u003e\n\u003cdiv class=\"layoutArea\"\u003e\n\u003cdiv class=\"column\"\u003e\n\u003cp\u003e\u003ca href=\"https:\/\/stakonmed.de\/collections\/recosyn\" title=\"Recosyn | Joint Injections | StakonMed\"\u003e\u003cspan\u003eRECOSYN\u003c\/span\u003e\u003c\/a\u003e\u003cspan\u003e®\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e1. Intended Use\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThis product is a medical device for use in humans and is injected intra-articularly into the knee joint. The medical device is intended to reduce functional limitations, relieve pain, and consequently improve quality of life.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e2. Indications\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIndicated for patients with symptomatic femorotibial knee osteoarthritis.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e3. Description\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe product consists of a sterile, isotonic, viscoelastic solution for intra-articular use and is supplied in a prefilled syringe. Each prefilled syringe contains 2 ml of the viscoelastic solution. 1 ml of the product contains: 10 mg (1%) sodium hyaluronate as well as sodium chloride, sodium monohydrogen phosphate, citric acid, and water for injection purposes. The product is supplied sterile and is intended for single use only. The product is steam sterilized in its blister packaging. No ingredients or raw materials of animal origin are used in the manufacture of the product. The product contains no medicinal active substances.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e4. Method of Administration and Dosage\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eRemove the prefilled syringe from the blister and carefully unscrew the rubber cap from the Luer-Lock connector. For intra-articular injections, a 21G cannula is recommended. Attach the cannula to the Luer-Lock connector and lock it with a slight twist. Hold the syringe during administration as shown in Figure 1. It is recommended to administer three injections of 2 ml of the product per knee at weekly intervals. Both knee joints can be treated simultaneously, and treatment cycles of up to 3 injections can be repeated. To avoid intra-articular infections, the injection must be performed under strict aseptic conditions. It is recommended to apply an ice pack to the treated joint for 5–10 minutes after application to prevent pain, swelling, and bleeding.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e5. Properties and Mode of Action\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn patients with degenerative joint disease (osteoarthritis), the viscoelasticity of the synovial fluid is significantly impaired. Mechanical \u003c\/span\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003estress on the joint leads to the breakdown of joint cartilage, which in turn causes restricted joint mobility and pain. The lubricating properties of this product contribute to pain reduction and improved joint mobility. The effect of the product lasts up to 6 months after a treatment cycle of 3 intra-articular injections.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"page\" title=\"Page 1\"\u003e\n\u003cdiv class=\"section\"\u003e\n\u003cdiv class=\"layoutArea\"\u003e\n\u003cdiv class=\"column\"\u003e\n\u003cp\u003e\u003cspan\u003e6. Contraindications and Possible Interactions\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe product must not be used in the following patients:\u003cbr\u003ePatients with hemochromatosis, ochronosis, or hemophilia \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with Paget's disease of bone, chondromatosis, or pigmented villonodular synovitis \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with inflammatory, infectious, or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, soft tissue rheumatism...) \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with a history of coagulation disorders or on anticoagulant therapy \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with known allergy to the product or any of its components \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients requiring permanent or intermittent steroid therapy \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with immunodeficiency or with severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic, or infectious disease) \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with venous stasis or lymphostasis in the target limb \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with skin diseases or infections at the injection site \u003c\/span\u003e\u003cspan\u003e| \u003c\/span\u003e\u003cspan\u003ePatients with a severe acute or chronic illness for which the use of the product is contraindicated or poses an additional risk according to the physician's assessment\u003cbr\u003eCurrently, no information is available on undesirable interactions with other intra-articularly administered therapies.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e7. Side Effects and Adverse Events\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe physician must inform the patient about potential side effects and\/or incompatibilities related to the use of this product, which may occur immediately or some time after the injection. After application, local symptoms may occur in the treated joint (pain, warmth, redness, and swelling). In connection with comparable products, the following adverse events have been reported: mild to moderate joint pain, rarely skin rash, pseudo-septic joint effusions, pruritus, and muscle cramps. In very rare cases, the following adverse events have also been observed: allergic reactions, anaphylactic shock, hemarthrosis, phlebitis, severe acute inflammatory reactions (SAIR), nasopharyngitis, joint stiffness, tendinitis, bursitis, fever, myalgia, and septic arthritis.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe physician must advise the patient to seek medical advice promptly in the event of such an adverse event. Such side effects must be treated appropriately. Adverse reactions related to the injection of the product must be reported to the marketing authorization holder and\/or the manufacturer.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"page\" title=\"Page 1\"\u003e\n\u003cdiv class=\"section\"\u003e\n\u003cdiv class=\"layoutArea\"\u003e\n\u003cdiv class=\"column\"\u003e\n\u003cp\u003e\u003cspan\u003e8. Warnings\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe product must only be administered by physicians trained in intra-articular injection techniques. They should also be familiar with all immunological and other risks that may be associated with the use of biological materials. The product must not be used in pregnant or breastfeeding women or in patients under 18 years of age, as no clinical data are available for these groups.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eKeep the product out of sight and reach of children. The product is intended for single use only; the syringe must never be resterilized. Reuse of the product carries a potential infection risk for patients and users. Do not use if the blister packaging is opened and\/or damaged. Do not use any syringe whose protective cap in the blister pack is opened or displaced. Do not use after the expiration date. Patients should be advised to rest the treated joints for 24 hours after each injection (but not immobilize completely) to avoid overuse. Dispose of the syringe, product residues, and cannula after use in a designated container. A 21G cannula is recommended for injection of the product. Compatibility of other needles\/cannulas with the product and syringe has not been tested.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e9. Storage\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eStore the product at room temperature (2–25 °C\/36–77 °F) and protect from frost and moisture.\u003cbr\u003eAvailable pack sizes: 1 or 5 prefilled syringes\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"page\" title=\"Page 1\"\u003e\n\u003cdiv class=\"section\"\u003e\n\u003cdiv class=\"layoutArea\"\u003e\n\u003cdiv class=\"column\"\u003e\n\u003cp\u003e\u003cspan\u003e10. Last Revision\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e2020-01 Version number: Z07\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Recordati Pharma GmbH","offers":[{"title":"Default Title","offer_id":47355880571220,"sku":"131","price":22.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/recosyn-20-recordati-pharma-gmbh-gelenkspritzen-stakonmed-263726.jpg?v=1772215288","url":"https:\/\/stakonmed.com\/products\/recosyn-20-1-x-2-ml","provider":"StakonMed","version":"1.0","type":"link"}