PRE-FILLED INTRA ARTICULAR SYRINGE CINGAL 4 ML 22MG/ML RETICULATED ACID WITH 4.5 MG/ML TRIAMCINOLONE HEXACETONIDE

Materials
Cingal is an off-white, opaque, 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 the joints.
Hyaluronic acid is biocompatible by nature and its degradation process follows a normal physiological path.
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 than that of healthy joints. Sodium hyaluronate supplements (viscosupplements) have been shown 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 has 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 squeezing).

Validity
36 months (from date of manufacture).

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

Regulatory status
CE mark (Designated Body 0120).

Directions
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 the symptoms of joint diseases such as osteoarthritis.
Cingal acts in the long term by relieving 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 could lead to relative or absolute contraindications for the use of Cingal:
• hypersensitivity to the active substance 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 parasitosis (strongyloid infections).

Instructions for Use
Cingal is injected directly into the chosen joint space by means of a sterile and disposable hypodermic needle of suitable thickness.
Healthcare personnel must insert the sterile needle into the Cingal syringe using aseptic technique approved by the healthcare institution.
The recommended needle size for knee injections is 18-21 gauge.
The final choice of needle for any procedure rests with the physician.
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 4.0ml 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 requires approximately 20 to 45 minutes).

Code VRCN1