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Go-On 1 pre-filled syringe 2,5ml GOON
Per syringe: 2.5 ml of sodium hyaluronate solution at 1 %, sodium chloride, disodium phosphate, monosodium phosphate, ppi water.
Sodium hyaluronate is a high molecular weight polysaccharide, composed of a linear chain of disaccharide units made of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is widely distributed in the tissues of the human body and is present in high concentrations in synovial fluid, of which it is the main component. Sodium hyaluronate acts as a tissue lubricant and plays an important role in modulating the physical and mechanical interaction between adjacent tissues and maintains tissue separation as a viscoelastic substance. While the molecular weight varies between sodium hyaluronate preparations, the chemical structure is always the same. Go-On is a 1 % sodium hyaluronate solution obtained from the bacterium Streptococcus equi through fermentation and purification processes.
Synovial fluid, which owes its viscoelastic properties to its hyaluronic acid content, is present in all synovial joints, especially in weight-bearing joints, where its lubricating and shock-absorbing characteristics allow normal, pain-free movement. It also provides nutrients to the articular cartilage. Degenerative joint diseases such as osteoarthritis are associated with a significant decrease in the viscosity of synovial fluid, which loses its lubricating and shock-absorbing functions. The mechanical stress on the joints increases and the articular cartilage becomes thinner, causing pain and impairing the function of the affected joints.
An improvement in the quality of the synovial fluid due to an intra-articular injection of sodium hyaluronate preparations has been shown to enhance the viscoelastic properties of the synovial fluid. The lubricating and shock-absorbing actions increase, while the mechanical stress on the joints decreases. The pain subsided and joint mobility was restored. After a single treatment of five intra-articular injections, this improvement lasts for at least six months.
Viscosupplementation of synovial fluid in knee and shoulder joints.
Viscosupplementation of other synovial joints.
Suitable for the treatment of osteoarthritis symptoms due to its lubricating and mechanical action.
Go-On is contraindicated in patients with a history of hypersensitivity to any of the components of the product, and in inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis.
Instructions for use, dosage
Go-On should be injected into the affected joint a total of five times, one week apart. It is possible to treat several joints simultaneously. Depending on the severity of the joint disease, the effects of a treatment of five injections may last for more than six months. Treatment cycles can be repeated if necessary. If joint effusion occurs, it is advisable to perform a puncture, immobilize the joint, apply an ice pack and/or administer corticosteroids by intra-articular injection. Treatment with Go-On can be restarted two to three days later. As long as the sterile blister is closed, the contents and surface of the pre-filled syringe are sterile.
Remove the syringe from the sterile blister, remove the rubber stopper, fit a suitable sterilized needle (e.g. 19 or 21 G) and secure it by turning it slightly. Do not tighten or apply excessive pressure to secure the needle or remove the needle sheath. If necessary, remove any air bubbles from the syringe before injection. GO-ON should be administered alone and not mixed with any other substance before injection.
Precautions for use
Long-term viscosupplementation with GO-ON in synovial joints other than the knee and shoulder is permitted only in patients eligible for joint replacement surgery.
Handling of this product is restricted to persons familiar with its use. General precautions for intra-articular injections should be observed and the injection site should be disinfected. The preparation should be discarded if the pre-filled syringe or the sterile blister pack is damaged. The product should not be used after the expiry date indicated on the packaging. The product should be kept out of the reach of children.
This product may aggravate local inflammation in patients with osteoarthritis and joint inflammation. It is therefore advisable to wait until the local symptom has disappeared before administering the product.
On rare occasions, the administration of the product may cause local pain. In order to prevent such pain, it is advisable to keep the affected area still after the injection. The product must be injected into the joint space; failure to do so may result in pain. Injection into a blood vessel or adjacent tissue is not recommended. Go-On should be administered with caution in patients with a history of drug hypersensitivity and in those with liver failure or liver disorders.
The product should be administered with caution in these patients, whose physiological functions are often impaired.
The safety of this product has not been established in children and it should be administered with caution in these patients.
Pregnant or Nursing Women:
Although no teratogenic effects have been detected in animals, the safety of the product has not been established in pregnant women. Therefore, caution should be exercised when administering this product to pregnant women or in case of suspected pregnancy. Sodium hyaluronate is excreted in the milk of treated animals; it is therefore advisable to discontinue breastfeeding during treatment.
Some patients may, on rare occasions, develop a skin rash, such as urticaria or pruritus. If this occurs, the product should be discontinued and the patient provided with appropriate treatment. Pain (mainly transient pain following administration), swelling and effusions, and infection at the injection site have been reported on rare occasions. Patients may occasionally complain of redness, warmth and heaviness at the injection site. Shock has been reported very rarely. Anaphylactic reactions may occur. If this occurs, the product should be discontinued and the patient should be closely monitored and given appropriate treatment.
Local side effects in the treated joint, such as pain, warmth, redness and/or swelling, effusion or infection, may occur after Go-On injection. These adverse events may be relieved by applying an ice pack to the treated joint for 5 to 10 minutes.
Interactions with other agents:
Do not use concomitantly with disinfectants containing quaternary ammonium salts such as benzalkonium chloride as there is a known incompatibility with hyaluronic acid. GO-ON should therefore not come into contact with such products, nor with medical-surgical equipment treated with such products, as sodium hyaluronate may precipitate in their presence.
To date, no incompatibilities (interactions) of Go-On with other intra-articular solutions have been reported. Concomitant administration of analgesics and oral anti-inflammatory drugs may be beneficial to the patient during the first days of treatment.
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