Sodium hyaluronate 2.0%. Viscous-elastic solution for injection into the joint space to improve mobility and for pain relief in osteoarthritis. Transparent solution made from natural, highly purified, fermentation-derived sodium hyaluronate. Free from animal proteins. Sterilized with moist heat. The contents and the outer surface of the HYA-JECT® PLUS prefilled syringe are sterile as long as the sterile barrier is intact. For single use only.
Composition:
1 ml isotonic solution (pH 7) contains 20.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol, and water for injection.
Indications:
Pain and restricted mobility of the knee and other large synovial joints such as hip and shoulder.
Contraindications:
HYA-JECT® PLUS must not be administered to patients with known hypersensitivity to any of the components of the product.
Precautions:
Treatment with HYA-JECT® PLUS is not recommended for children, pregnant or breastfeeding women, or in inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis. If a joint effusion is present, it should be reduced first. National guidelines for intra-articular injections must be observed, including thorough disinfection of the injection site and other measures to prevent joint infections. HYA-JECT® PLUS should be injected precisely into the joint space, if necessary under imaging guidance. Avoid injections into blood vessels or surrounding tissue. Do not use if the prefilled syringe or sterile packaging is damaged. Any solution not used immediately after opening must be discarded. Otherwise, sterility cannot be guaranteed, which may pose an infection risk. Do not re-sterilize as this may damage the product. There is currently no information on interference with diagnostic procedures such as magnetic resonance imaging, clinical assessments, or therapeutic treatments by HYA-JECT® PLUS.
Interactions:
There is currently no information on incompatibility of HYA-JECT® PLUS with other medical devices and drugs for intra-articular use or with oral analgesics or anti-inflammatory drugs.
Side effects:
In very rare cases (less than 1 in 10,000 patients), local side effects such as pain, warmth, redness, swelling/joint effusion, itching, and other local intolerance reactions may occur during or after injection of HYA-JECT® PLUS. As with all invasive joint treatments, infection may occur in very rare cases. It cannot be completely excluded that in very rare cases the intra-articular injection itself causes systemic side effects such as tachycardia, hypotension, hypertension, palpitations, nausea, and shortness of breath. These reactions may occur independently of the applied solution. Patients should be informed about contraindications and side effects before injection of HYA-JECT® PLUS.
Reporting side effects:
Any serious incident related to the medical device must be reported to the manufacturer TRB CHEMEDICA AG and the responsible local authority of the user.
Dosage and administration:
Inject HYA-JECT® PLUS a total of 1–3 times at weekly intervals into the affected joint. Multiple joints can be treated simultaneously. Depending on the severity of the joint disease, the positive effect can last at least six months. Sodium hyaluronate itself is broken down within a few days. If necessary, the treatment cycle can be repeated. Remove the prefilled syringe from the sterile packaging, remove the Luer Lock cap from the syringe, attach a suitable needle with Luer connection (e.g., 18 to 25 G) and lock it by slight rotation. Remove any air bubbles from the syringe before injection.
Disposal:
Dispose of the syringe immediately after use in an appropriate safety container. Do not throw the HYA-JECT® PLUS prefilled syringe into household waste. Follow local regulations for proper disposal of the safety container.
Properties and mode of action:
Synovial fluid, which behaves viscoelastically due to the presence of hyaluronic acid, is found in all synovial joints, where it ensures normal, pain-free movement because of its lubricating and cushioning properties. In degenerative joint diseases such as osteoarthritis, the viscoelasticity of synovial fluid is significantly reduced, impairing its lubricating and cushioning properties. This increases mechanical stress on the joint and cartilage destruction, ultimately leading to pain and restricted mobility of the affected joint. Supplementing this synovial fluid by intra-articular injections with highly purified hyaluronic acid can improve the viscoelastic properties of the synovial fluid. Lubricating and cushioning properties are enhanced, and mechanical overload of the joint is reduced. Clinical studies have shown pain relief and improved joint mobility for up to six months.
HYA-JECT® PLUS additionally contains mannitol, a radical scavenger that helps stabilize the sodium hyaluronate chains.
Storage:
Store in a dry, light-protected place at 2°C to 25°C! Do not use after the expiration date indicated on the packaging. Keep out of reach of children.
Dosage form:
1 prefilled syringe containing 40 mg/2.0 ml, HYA-JECT® PLUS in sterile packaging.
As long as the EUDAMED database is not fully operational, the Safety and Clinical Performance Report (SSCP) is available to the public on the company website www.trbchemedica.de.
HYA-JECT® PLUS is a medical device. It may only be used by a physician experienced and trained in intra-articular injections.
Date of last revision: 2022-05
Joint injections
Dermafiller
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