Sodium hyaluronate from fermentation 1.0%. Viscoelastic solution for injection into small joints. Sterile by moist heat.
Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluronate as well as sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, and water for injection purposes.
Indications:
Pain and restricted mobility in degenerative and traumatic changes of small synovial joints, such as the facet joints of the lumbar spine, the thumb saddle joint, the interphalangeal joints of fingers and toes, the big toe metatarsophalangeal joint, and the temporomandibular joint. For the treatment of large joints such as knee, hip, or shoulder joints, HYA-JECT® pre-filled syringes with 20 mg/2.0 ml should be used.
Contraindications:
Do not use HYA-JECT® MINI in case of known hypersensitivity to any of the ingredients.
Interactions:
No incompatibility (intolerance) of HYA-JECT® MINI with other intra-articularly applicable solutions has been reported so far. Concurrent use of orally administered analgesic and anti-inflammatory drugs during the first treatment days may be helpful for the patient.
Side effects:
During or after injection of HYA-JECT® MINI, very rare local and general accompanying symptoms such as pain, sensation of heat, redness, swelling/joint effusion, and palpitations may occur.
Dosage instructions and method of administration:
Inject HYA-JECT® MINI 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 effect of one treatment can last more than six months. Repeated treatment cycles are possible if needed. In case of joint effusion, puncture of the effusion, immobilization of the joint, and application of an ice pack and/or intra-articular administration of corticosteroids are recommended. Treatment with HYA-JECT® MINI is started two to three days later. As long as the sterile packaging is unopened, the content and surface of the pre-filled syringe remain sterile. Remove the pre-filled syringe from the sterile packaging, unscrew the cap from the Luer-Lock connection, attach a suitable cannula (e.g., 19 to 25 G), and lock it with a slight twist. Before injection, remove any air bubble present in the syringe.
Precautions:
Use caution when applying HYA-JECT® MINI in patients with known hypersensitivity to drugs. As with all invasive joint treatments, infection can occur in very rare cases. Therefore, general precautions for intra-articular injections should be observed, including measures to prevent joint infection. HYA-JECT® MINI should be correctly injected into the joint space, if necessary under fluoroscopic control. Avoid injections into blood vessels and surrounding tissue! Since there is insufficient experience with the use of hyaluronic acid in children, pregnant and breastfeeding women, or patients with inflammatory joint diseases such as rheumatoid arthritis and ankylosing spondylitis, the use of HYA-JECT® MINI is not recommended in these cases. Do not use if the pre-filled syringe or sterile packaging is damaged. Any solution not used immediately after opening must be discarded. Otherwise, sterility is no longer guaranteed, which can lead to an infection risk. Store between 2 °C and 25 °C! Observe expiration date. Keep out of reach of children!
Properties and mode of action:
Joint lubricant, which behaves viscoelastically due to its hyaluronic acid content, is present in all synovial joints, where it ensures normal, pain-free movement due to its lubricating and shock-absorbing properties. It is also responsible for supplying nutrients to the joint cartilage. In degenerative joint diseases, such as osteoarthritis, the viscoelasticity of the joint lubricant is significantly impaired, reducing its lubricating and shock-absorbing effect. This increases the mechanical load on the joint and the breakdown of joint cartilage to such an extent that pain and restricted mobility occur in the affected joint. A qualitative improvement of the joint lubricant by intra-articular administration of highly pure hyaluronic acid can improve the viscoelastic properties of the joint lubricant. This enhances its lubricating and shock-absorbing effect and reduces mechanical overload of the joint. The result is usually a reduction in pain and an improvement in joint mobility, which can last several months after one treatment cycle.
HYA-JECT® MINI is a clear solution of natural, highly pure sodium hyaluronate obtained by fermentation and therefore free of animal proteins. In biocompatibility studies, HYA-JECT® MINI has proven to be particularly well tolerated.
Package size:
One pre-filled syringe HYA-JECT® MINI with 10 mg/1.0 ml in sterile packaging.
For use by a physician only.
Information status: 2017-07