Presentation
HA is an essential component of the extracellular matrix and is found in high concentrations in the synovial fluid of 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 a lower concentration of HA and a reduced molecular weight of HA compared to that of healthy joints. Supplements based on sodium hyaluronate (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 provides an anti-inflammatory action to offer short-term pain relief when used in an intra-articular injection of an osteoarthritic joint.

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).

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 symptoms of joint diseases such as osteoarthritis.
Cingal acts long-term by alleviating symptoms through lubrication and mechanical support, also providing 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.
The triamcinolone hexacetonide, the auxiliary medicinal substance, is contraindicated in cases of:
• active tuberculosis;
• herpes simplex keratitis;
• acute psychosis;
• systemic mycoses and parasitic infections (strongyloid infections).

Instructions for use
Cingal is injected directly into the chosen joint space using a suitable sterile single-use hypodermic needle.
Healthcare personnel must insert the sterile needle into the Cingal syringe using an aseptic technique approved by the healthcare center.
The recommended needle sizes for injections in the knee 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 correctly penetrated the synovial space of the joint before injecting Cingal.

Presentations
Cingal is a sterile preparation provided in a single-use glass syringe of 4.0 ml

Storage conditions
Store at a 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).

Code VRCN1