Cingal Pre-filled Syringe 4ml

Injection combination of hyaluronic acid and steroids

Materials
Cingal is an off-white, opaque, sterile, single-use suspension of a cross-linked hyaluronic acid (HA) gel with the addition of a corticosteroid (triamcinolonehexacetonide).

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 path.
The HA is responsible for the viscoelastic properties of the synovial liquid.
Synovial fluid from joints affected by osteoarthritis has a lower concentration of HA and a lower molecular weight of HA than that of healthy joints. Sodium hyaluronate supplements (viscosupplements) have proven to be well tolerated in synovial joints affected by osteoarthritis and act to reduce pain and improve function through lubrication and mechanical support.
The added corticosteroid triamcinolone hexacetonide performs 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 squeezing).

Validity
36 months (from the date of manufacture).

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

Regulatory status
CE mark (Designated Body 0120).

Cingal is indicated as a viscoelastic supplement or as a substitute for synovial fluid in human joints.
Cingal is suitable for the rapid and long-term relief of the symptoms of joint hepatic 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 other diamcinolone hexacetonide.

Cingal is composed of cross-linked hyaluronic acid, triamcinolone hexacetonide and inactive ingredients. The following pre-existing conditions could lead to relative or absolute contraindications to the use of Cingal:
• hypersensitivity to the active substance or to one of the excipients contained inCingal;
• pre-existing infections in the skin area of the intended injection site;
• known infection in the reference joint;
• known systemic bleeding disorders.
Triamcinolone hexacetonide, the ancillary drug substance, is contraindicated in cases of:
• active tuberculosis;
• herpes simplex keratitis;
• acute psychosis;
• systemic mycoses and parasites (strongyloid infections).

Instructions for Use
Cingal is injected directly into the selected joint space by means of a sterile and disposable hypodermic needle of suitable thickness.
Healthcare professionals 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 the responsibility of the physician.
The physician must ensure that the needle has entered the synovial space of the joint correctly before injecting Cingal.

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

Method of conservation

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).