Descrizione Clinica
Medical devices - medical devices Cingal syringe preriemp 4ml Abiogen
C+NGAL
CROSS-LINKED SODIUM HYALURONATE 88 sqm
With TRIAMCINOLONE HEXACETONIDE 18 sqm
FOR INTRA-ARTICULAR INJECTION
CROSS-LINKED SODIUM HYALURONATE 88 sqm
With TRIAMCINOLONE HEXACETONIDE 18 sqm
FOR INTRA-ARTICULAR INJECTION
Materials
Cingal is a whitish, opaque, sterile suspension, disposable hyaluronic acid gel (HA) reticulated with addition of a corticosteroid (triamcinolone esacetonide).
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 the synovial liquid.
The synovial fluid of the joints with osteoarthritis has a lower concentration of HA and a reduced molecular weight of HA compared to that of healthy joints. Integrators based on sodium hyaluronate (viscosupplements) have been well tolerated in the synovial joints with osteoarthritis and act to reduce pain and improve functionality through lubrication and mechanical support.
The added corticosteroid triamcinolone esacetonide carries out an anti-inflammatory action to offer a short-term relief of pain when used in an intrarticular injection of a joint with osteoarthritis.
Sterile
Sterile product (steam sterilization).
Validity
36 months (from the date of manufacture).
Classification
Medical device of Class III (Directive 93-42-EEC).
Regulatory status
CE mark ( Designated Organization 0120).
Indications
Cingal is indicated as a viscoelastic supplement or as a substitute for the synovial fluid in human joints.
Cingal is suitable for quick and long-term relief of symptoms of joint pathologies such as osteoarthritis.
Cingal acts in the long term by alleviating the symptoms by means of lubrication and mechanical support, also ensuring short-term pain relief thanks to hexatonide triamcinolone.
Contraindications
Cingal is composed of reticulated hyaluronic acid, hexatonide triamcinolone and inactive ingredients. The following pre-existing pathologies may result in relative or absolute contraindications for the use of Cingal:
• hypersensitivity to the active ingredient or one of the excipients contained in Cingal;
• pre-existing infections in the skin area of the intended injection site;
• infection known in the reference articulation;
• systemic disorders of known clotting.
Hexacetonide triamcinolone, the medicinal substance, is contraindicated in the cases of:
• active tuberculosis;
• keratite by herpes simplex;
• acute psychosis;
• systemic and parasite mycosis (infections of strongiloids).
Instructions for use
Cingal is directly injected into the chosen joint space by means of a sterile hypodermic needle and disposable of suitable thickness.
Health care personnel must enter the sterile needle in the Cingal syringe with an aseptic technique approved by the health centre.
The recommended needle size for knee injections are 18-21 gauge.
The final choice of the needle for any procedure is the responsibility of the doctor.
The doctor must ensure that the needle is properly penetrated into the synovial space of the joint before injecting Cingal.
Presentations
Cingal is a sterile preparation provided in a 4.0 ml disposable glass syringe
Storage mode
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).
Cod. VRCN1
Cingal is a whitish, opaque, sterile suspension, disposable hyaluronic acid gel (HA) reticulated with addition of a corticosteroid (triamcinolone esacetonide).
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 the synovial liquid.
The synovial fluid of the joints with osteoarthritis has a lower concentration of HA and a reduced molecular weight of HA compared to that of healthy joints. Integrators based on sodium hyaluronate (viscosupplements) have been well tolerated in the synovial joints with osteoarthritis and act to reduce pain and improve functionality through lubrication and mechanical support.
The added corticosteroid triamcinolone esacetonide carries out an anti-inflammatory action to offer a short-term relief of pain when used in an intrarticular injection of a joint with osteoarthritis.
Sterile
Sterile product (steam sterilization).
Validity
36 months (from the date of manufacture).
Classification
Medical device of Class III (Directive 93-42-EEC).
Regulatory status
CE mark ( Designated Organization 0120).
Indications
Cingal is indicated as a viscoelastic supplement or as a substitute for the synovial fluid in human joints.
Cingal is suitable for quick and long-term relief of symptoms of joint pathologies such as osteoarthritis.
Cingal acts in the long term by alleviating the symptoms by means of lubrication and mechanical support, also ensuring short-term pain relief thanks to hexatonide triamcinolone.
Contraindications
Cingal is composed of reticulated hyaluronic acid, hexatonide triamcinolone and inactive ingredients. The following pre-existing pathologies may result in relative or absolute contraindications for the use of Cingal:
• hypersensitivity to the active ingredient or one of the excipients contained in Cingal;
• pre-existing infections in the skin area of the intended injection site;
• infection known in the reference articulation;
• systemic disorders of known clotting.
Hexacetonide triamcinolone, the medicinal substance, is contraindicated in the cases of:
• active tuberculosis;
• keratite by herpes simplex;
• acute psychosis;
• systemic and parasite mycosis (infections of strongiloids).
Instructions for use
Cingal is directly injected into the chosen joint space by means of a sterile hypodermic needle and disposable of suitable thickness.
Health care personnel must enter the sterile needle in the Cingal syringe with an aseptic technique approved by the health centre.
The recommended needle size for knee injections are 18-21 gauge.
The final choice of the needle for any procedure is the responsibility of the doctor.
The doctor must ensure that the needle is properly penetrated into the synovial space of the joint before injecting Cingal.
Presentations
Cingal is a sterile preparation provided in a 4.0 ml disposable glass syringe
Storage mode
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).
Cod. VRCN1
