Cingal Pre-filled Syringe 4ml Abiogen - Medical Device Cingal is una whitish, opaque, sterile, single-use gel of cross-linked hyaluronic acid (HA) with the addition of a corticosteroid (triamcinolone hexacetonide).| Presentation HA is an essential component of the extracellular matrix and is found in high concentrations in the synovial fluid of the joints.| Hyaluronic acid is biocompatible by nature and its degradation process follows a normal physiological pathway.| HA is responsible for the viscoelastic properties of synovial fluid.| The synovial fluid of joints affected by osteoarthritis has una lower concentration of HA and a reduced molecular weight of HA compared to that of healthy joints. Sodium hyaluronate-based supplements (viscosupplements) have been shown to be well tolerated in synovial joints affected by osteoarthritis and act to reduce pain and improve functionality through lubrication and mechanical support.| The added corticosteroid triamcinolone hexacetonide exerts an anti-inflammatory action to provide short-term pain relief when used in an intra-articular injection of a joint affected by osteoarthritis.| Sterility Sterile product (steam sterilization).| Validity 36 months (from the date of manufacture).| Classification Class III Medical Device (Directive 93-42-EEC).| Regulatory status CE Mark (Notified Body 0120).| Indications Cingal is indicated as a viscoelastic supplement or as a substitute for synovial fluid in human joints.| Cingal is suitable for quickly and long-term alleviating the symptoms of joint disorders such as osteoarthritis.| Cingal acts long-term by alleviating symptoms through lubrication and mechanical support, also ensuring short-term pain relief thanks to triamcinolone hexacetonide.| Contraindications Cingal is composed of cross-linked hyaluronic acid, triamcinolone hexacetonide, and inactive ingredients. The following pre-existing conditions may pose relative or absolute contraindications to the use of Cingal:| hypersensitivity to the active ingredient or to any of the excipients contained in Cingal;| pre-existing infections in the skin area of the intended injection site;| known infection in the reference joint;| known systemic coagulation disorders.| Triamcinolone hexacetonide, the auxiliary medicinal substance, is contraindicated in cases of:| active tuberculosis;| herpes simplex keratitis;| acute psychosis;| systemic mycoses and parasitosis (strongyloid infections).| Instructions for use Cingal is injected directly into the chosen joint space using a sterile, single-use hypodermic needle of suitable gauge.| Healthcare personnel must insert the sterile needle into the Cingal syringe using una aseptic technique approved by the healthcare center.| The recommended needle sizes for knee injections are 18-21 gauge.| The final choice of needle for any procedure is the responsibility of the physician.| The physician must ensure that the needle has properly penetrated the synovial space of the joint before injecting Cingal.| Presentations Cingal is una sterile preparation provided in una single-use glass syringe of 4.0 ml.| Storage conditions Store at una temperature between 2 and 25°C.| Avoid freezing.| Before using Cingal, the refrigerated product must be brought to room temperature (this process takes about 20 to 45 minutes).| Format Pre-filled syringe 4 ml.