C1 ⁺ NGAL

CROSS-LINKED SODIUM HYALURONATE 88 m2
WITH TRIAMCINOLON HEXACETONIDE 18 m2
FOR INTRA-ARTICULAR INJECTION

Materials
Cingal is a whitish, 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 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.
Synovial fluid in 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 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 that provides short-term pain relief when used as an intra-articular injection into a joint affected by osteoarthritis.

Sterility
Sterile product (steam sterilization).

Validity
36 months (from date of manufacture).

Classification
Class III medical device (Directive 93-42-EEC).

Regulatory status
CE marking (Designated Body 0120).

Road directions
Cingal is indicated as a viscoelastic supplement or as a substitute for synovial fluid in human joints.
Cingal is suitable for rapid and long-term relief of symptoms of joint conditions, such as osteoarthritis.
Cingal provides long-term symptom relief through lubrication and mechanical support, while 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 cause relative or absolute contraindications to 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 auxiliary drug substance, is contraindicated in cases of:
• active tuberculosis;
• herpetic 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 sterile, disposable hypodermic needle of appropriate thickness.
Healthcare professionals should insert the sterile needle into the Cingal syringe using an aseptic technique approved by the medical 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 doctor must ensure that the needle has entered the synovial space of the joint correctly before injecting Cingal.

presentation
Cingal is a sterile preparation, supplied in a single-use glass syringe with a capacity of 4.0 ml.

Storage methods
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