HYA-JECT®
Sodium hyaluronate 1.0%. Viscous-elastic solution for injection into the joint space to improve mobility and relieve pain in osteoarthritis. Transparent solution made from natural, highly purified sodium hyaluronate obtained by fermentation. Free of animal proteins. Sterilized with moist heat. The contents and the outer surface of the HYA-JECT® prefilled syringe are sterile as long as the sterile barrier is intact. For single use only.
Composition:
1 ml isotonic solution (pH 7) contains 10.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, and water for injection purposes.
Indications:
Pain and restricted mobility of the knee and other large synovial joints such as hip and shoulder.
Contraindications:
HYA-JECT® must not be administered to patients with known hypersensitivity to any of the components of the product.
Precautions:
Treatment with HYA-JECT® 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 followed, including thorough disinfection of the injection site and other measures to prevent joint infections. HYA-JECT® 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 impairment of diagnostic procedures such as magnetic resonance imaging, clinical assessments, or therapeutic treatments by HYA-JECT®.
Interactions:
There is currently no information on incompatibility of HYA-JECT® 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 reactions such as pain, warmth, redness, swelling/joint effusion, itching, and other local intolerance reactions may occur during or after injection of HYA-JECT®. 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 solution administered. Patients should be informed about contraindications and side effects before injection of HYA-JECT®.
Reporting of 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® 3–5 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 of a treatment cycle of five intra-articular injections 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.
Joint injections
Dermafiller
Supplements
