Cingal Pre-filled Syringe

Cingal Pre-filled Syringe

Cingal is a whitish, opaque, sterile, single-use suspension of a cross-linked hyaluronic acid (HA) gel with the addition of a corticosteroid (triamcinolone hexacetonide).

Presentation
L&rsquo ;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 path.
The HA is property manager 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 proven well tolerated in synovial joints affected by osteoarthritis and act to reduce pain and improve function. via lubrication and mechanical support.
The added corticosteroid triamcinolone hexacetonide provides 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 drying).

Validity
36 months (from the date of manufacturing).

Classification
Class III Medical Device (Directive 93-42-EEC).

Regulatory status
CE mark (Designated 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 relieving the symptoms of joint diseases such as osteoarthritis.
Cingal acts in the long term by relieving symptoms through lubrication and mechanical support, also guaranteeing short-term pain relief thanks to triamcinolone hexacetonide.< br />
Contraindications
Cingal is composed of cross-linked hyaluronic acid, triamcinolone hexacetonide and inactive ingredients. The following pre-existing pathologies could lead to relative or absolute contraindications to the use of Cingal:
• hypersensitivity to the active ingredient or to one 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 ancillary medicinal substance, is contraindicated in cases of:
• active tuberculosis;
• herpes simplex keratitis;
• acute psychosis;
• systemic mycoses and parasitoses (strongyloid infections).

Instructions for use
Cingal is injected directly into the chosen joint space using a sterile hypodermic needle and disposable of suitable thickness.
Healthcare personnel must insert the sterile needle into the Cingal syringe with an aseptic technique approved by the health center.
The recommended needle size for knee injections is 18-21 gauge.
The final choice of needle for any procedure is within the competence of the doctor.
The doctor must ensure that the needle has correctly penetrated the synovial space of the joint before injecting Cingal.

Presentations
Cingal is a sterile preparation supplied in a 4.0 ml disposable glass syringe

Mode 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 approximately 20 to 45 minutes).