GO-ON is a sterile non-pyrogenic solution of Sodium Hyaluronate.
A syringe of GO-ON contains 2.5 ml of a 1% Sodium Hyaluronate solution as well as sodium chloride, sodium monohydrogen phosphate, sodium dihydrogen phosphate and water for injection.
Sodium Hyaluronate is a natural high molecular weight polysaccharide composed of a linear chain of disaccharide units made by sodium glucuronate and N-acetylglucosamine. Sodium Hyaluronate is widely distributed throughout the tissues of the human body and is present in high concentrations in the synovial fluid, of which it is the major component. Sodium Hyaluronate plays a significant role in modulating the physical and mechanical interaction between adjacent tissues functioning as a tissue lubricant; it acts also as a viscoelastic support maintaining separation between tissues.
Different Sodium Hyaluronate preparations may have different molecular weights but they have the same chemical structure.
GO-ON is a 1% Sodium Hyaluronate solution obtained from Streptococcus Equi by fermentation processes and subsequent purification.
Synovial fluid, which is due to its content of hyaluronic acid is visco-elastic, occurs in all synovial joints but especially in the large weight bearing joints, where its lubricating and shock absorbing characteristics ensure normal, painless movement. It also supplies nutrients to the articular cartilage.
Degenerative joint diseases such as osteoarthritis are associated with a substantial loss of viscosity of the synovial fluid, which impairs its lubricating and shock absorbing functions. This increases the mechanical stress on the joint, as well as the loss of articular cartilage to such an extent as to cause pain and loss of function in the affected joints. It has been established that an improvement in the quality of the synovial fluid resulting from an intra-articular injection of Sodium Hyaluronate preparations improves the visco-elastic properties of the synovial fluid. This enhances its lubricant as well as its shock-absorbing actions and reduces the mechanical stress on the joint. This results in alleviation of the pain and an improvement in joint mobility, which after a single treatment cycle of 5 intra-articular injections, last for minimum of 6 months.
GO-ON is indicated as a viscoelastic supplementation for synovial fluid in knee and shoulder joints. GO-ON is also indicated as viscoelastic supplementation in other synovial joints. The actions of the product are lubrication and mechanical support and it is suited for treatment of the symptoms of osteoarthritis.
GO-ON should be injected into the affected joint a total of 5 times, at weekly intervals. Several joints may be treated concurrently. Depending on the severity of the joint disease, the effects of a course of five treatments may last for over 6 months. Treatment cycles may be repeated if required. In the event of an effusion into a joint, it is recommended to carry out a puncture of the effusion, to immobilise the joint, apply an ice bag and/or to administer corticosteroids by intra-articular injection. The treatment with GO-ON may be repeated 2-3 days later. As long as the sterile blister remains unopened, the contents and surface of the pre-filled syringe are sterile. Remove the syringe from the sterile blister, remove the rubber stopper connection, mount a suitable sterilised needle (e.g. 19 or 21 G) and secure it by a slight turn. Do not turn over tighten or apply excessive leverage when attaching the needle or removing the needle guard. Remove the air bubble, if any, from the syringe before the injection. GO-ON should be administered on its own and not mixed with any other substances prior to injection.
GO-ON must not be used in patients with a history of hypersensitivity to any of the ingredients of the product and in the case of inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease.
Long-term viscoelastic supplementation with GO-ON in synovial joints other than the knee and shoulder can be used only in cases appropriate for joint replacement.
This product should only be used by qualified persons who are familiar with its use. The general precautions for intra-articular injections should be observed and, particularly, care should be taken to ensure that the site of injection is aseptic.
The preparation must be discarded in the event of damage to the ready-prepared syringe or sterile blister.
This product may worsen local inflammation in patients with osteoarthritis who present an inflammation of the joint. Therefore, it is advisable to administer the product after the local symptom has been alleviated.
Local pain may rarely occur after administration of the product. To avoid pain after the injection, an instruction should be given to keep the local site still after the injection has been made.
The product must be injected strictly into the intra-articular space otherwise it may cause pain. Avoid injection into a blood vessel or surrounding tissues.
GO-ON must be administered with caution to patients with a history of hypersensitivity to drugs and to patients with liver failure or impairment.
Use in Pregnancy & Lactation: although no teratogenic effects have been detected in animals, its safety in pregnant women has not been established. It is therefore recommended to administer the product with caution to pregnant women or women suspected of being pregnant. Sodium hyaluronate is excreted in milk of animals treated, so it is recommended to discontinue breast-feeding during treatment.
Use in Children: since the safety of this product has not been established in children, it must be administered with caution to these patients.
Use in Elderly: the product must be administered with caution, since physiological functions are usually reduced in these patients.
Although no teratogenic effects have been detected in animals, its safety in pregnant women has not been established. It is therefore recommended to administer the product with caution to pregnant women or women suspected of being pregnant. Sodium hyaluronate is excreted in milk of animals treated, so it is recommended to discontinue breast-feeding during treatment.
Some patients may rarely develop a skin rash, such as urticaria and pruritus. In such cases, discontinue the administration and give the patient the appropriate treatment.
Pain (mainly transient pain after administration), swelling and effusion, as well as infection, at the injection site have rarely been reported. Patients may rarely complain of redness, heat sensation and heaviness at the injection site.
Shock has been very rarely reported. Anaphylactic reactions may occur. If this occurs, discontinue administration, closely monitor the patient and provide adequate treatment.
The injection of GO-ON may be followed by local side effects in the treated joint, e.g. pain, a sensation of heat, reddening and/or swelling, effusion, infection. These adverse events can be reduced by the application of an ice-bag to the treated joint for 5 to 10 minutes.
There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride which can be used as skin disinfectants. GO-ON must therefore never come into contact with such products, nor with medical or surgical equipment treated with these types of products, since hyaluronic acid can precipitate in their presence.
To date, there are no reports of incompatibilities (interactions) of GO-ON with other solutions for intra-articular administration. The patient may benefit from the concurrent use of oral analgesic and anti-inflammatory agents during the first days of treatment.
How to use GO-ON: Take the syringe out of the container. In case the product is stored in the fridge (see Storage), take it out twenty or thirty minutes before its use.
Remove the rubber stopper by turning it.
Put on a 19 or 21 G injection needle. Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the syringe tip.
The syringe is ready for use.
*Before the administration, disinfect the injection site thoroughly.
Do not concomitantly use disinfectants containing quaternary ammonium salts.
Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
Store at a temperature lower than 25°C.
Shelf-life: Three years.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj (pre-filled syringe) 25 mg/2.5 mL (sterile, non-pyrogenic solution) x 1's.