Cingal Pre-filled Intra-Articular Syringe 4 ml 22mg/ml Cross-linked Hyaluronic Acid with 4.5 mg/ml Triamcinolone Hexacetonide

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

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 naturally biocompatible, 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 healthy joints. Sodium hyaluronate supplements (viscosupplements) have been shown to be well-tolerated in synovial joints affected by osteoarthritis and work to reduce pain and improve function through lubrication and mechanical support.
The added corticosteroid triamcinolone hexacetonide has an anti-inflammatory action to provide short-term pain relief when used in an intra-articular injection of an osteoarthritis-affected joint.

Sterility
Sterile product (steam sterilization).

Validity
36 months (from 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 replacement for synovial fluid in human joints.
Cingal is suitable for rapid and long-term relief of symptoms of joint diseases such as osteoarthritis.
Cingal provides long-term symptom relief through lubrication and mechanical support, and also 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 lead to relative or absolute contraindications to the use of Cingal:
• hypersensitivity to the active substance 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 target joint;
• known systemic coagulation disorders.
Triamcinolone hexacetonide, the accessory medicinal substance, is contraindicated in cases of:
• active tuberculosis;
• herpes simplex keratitis;
• acute psychosis;
• systemic mycoses and parasitoses (strongyloides infections).

Instructions for use
Cingal is injected directly into the chosen joint space by means of a sterile, single-use hypodermic needle of appropriate gauge.
Healthcare personnel must attach the sterile needle to the Cingal syringe using an aseptic technique approved by the healthcare facility.
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 a sterile preparation supplied in a 4.0 ml single-use glass syringe.

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).

Code VRCN1