Description
C1 + NGAL
CROSS-LINKED SODIUM HYALURONATE 88 m2
WITH TRIAMCINOLONE HEXACETONIDE 18 m2
FOR INTRA-ARTICULAR INJECTION
CROSS-LINKED SODIUM HYALURONATE 88 m2
WITH TRIAMCINOLONE 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 the addition of a 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 biocompatible by nature and its degradation process follows a normal physiological path.
HA is responsible for the viscoelastic properties of synovial fluid.
Synovial fluid from joints affected by osteoarthritis has a lower concentration of HA and a reduced molecular weight of HA compared to that of 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 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).
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 diseases such as osteoarthritis.
Cingal works long-term by relieving symptoms through lubrication and mechanical support, while 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 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 ancillary drug 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 using a sterile, disposable hypodermic needle of suitable thickness.
The healthcare professional must insert the sterile needle into the Cingal syringe using an aseptic technique approved by the healthcare center.
The recommended needle size for knee injections is 18-21 gauge.
The final choice of needle for any procedure is up to the physician.
The doctor 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 4.0 ml disposable glass syringe.
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
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
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.
HA is responsible for the viscoelastic properties of synovial fluid.
Synovial fluid from joints affected by osteoarthritis has a lower concentration of HA and a reduced molecular weight of HA compared to that of 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 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).
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 diseases such as osteoarthritis.
Cingal works long-term by relieving symptoms through lubrication and mechanical support, while 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 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 ancillary drug 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 using a sterile, disposable hypodermic needle of suitable thickness.
The healthcare professional must insert the sterile needle into the Cingal syringe using an aseptic technique approved by the healthcare center.
The recommended needle size for knee injections is 18-21 gauge.
The final choice of needle for any procedure is up to the physician.
The doctor 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 4.0 ml disposable glass syringe.
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
