Cingal - viscoelastic supplement 4 ml syringe

Product Description

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

Indications

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 diseases such as osteoarthritis.
Cingal acts by relieving symptoms in the long term through lubrication and mechanical support, while also providing short-term pain relief thanks to triamcinolone hexacetonide.

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).

HA is an essential component of the extracellular matrix and is found in high concentrations in the fluid. Synovial fluid in 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.
The synovial fluid of 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 of an osteoarthritic joint.

Sterile product (steam sterilization).

Ingredients

Chaste tree (Vitex agnus-castus) fruit extract, motherwort (Leonorus cardiaca) flowering herb extract, parsley (Petroselinum crispum) fruit extract, microcrystalline cellulose, gum arabic, Chinese angelica (Angelica sinensis) root extract, common wormwood (Artemisia pontica) flowering herb extract, common wormwood (Artemisia vallesiaca) flowering herb E.S., climbing ivy (Hedera helix) leaves E.S., papyrus (Cyperus rotundus) roots E.S., marigold (Calendula officinalis) flower heads E.S., Roman chamomile (Anthemis nobilis) flower heads E.S., verbena (Verbena officinalis) flowering herb E.S., silicon dioxide, magnesium stearate of vegetable origin.
Bulking agent. Anti-caking agent.
E.S. = Dry extract.

Lactose and gluten free.

Directions for use and Dosage

Cingal is injected directly into the chosen joint space using a sterile, disposable hypodermic needle of appropriate thickness.
Healthcare personnel must insert the sterile needle into the Cingal syringe using 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 properly penetrated the synovial space of the joint before injecting Cingal.

Contraindications

Cingal is composed of cross-linked hyaluronic acid, triamcinolone hexacetonide, and inactive ingredients. The following pre-existing conditions may result in relative or absolute contraindications to the use of Cingal:

• hypersensitivity to the active substance or to any of the excipients contained in Cingal;
• pre-existing infections in the skin area of ​​the intended injection site;
• known infection in the target joint;
• known systemic coagulation disorders.

Triamcinolone hexacetonide, the ancillary medicinal product, is contraindicated in cases of:

• active tuberculosis;
• herpes simplex keratitis;
• acute psychosis;
• systemic mycoses and parasitoses (strongyloides infections).

Storage

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).
36 months (from the date of manufacture).

Format

Cingal is a sterile preparation supplied in a 4.0 ml disposable glass syringe.