The product must be injected strictly into the intra-articular area, as otherwise it may cause pain. Avoid injections into blood vessels or surrounding tissue! The preparation should be administered with caution to patients who have frequently shown hypersensitivity to medications, and the patient should remain under clinical observation for at least 1 hour after the injection.
SIDE EFFECTS:
In rare cases, some patients develop a skin rash, such as urticaria and pruritus. In such cases, administration should be discontinued and the patient treated accordingly. Pain (mainly transient pain after administration), swelling and effusions, as well as infections at the injection site, have been reported only rarely. Patients rarely complain of redness, warmth, and a feeling of heaviness at the injection site. Shock has been reported only in rare cases. Anaphylactic reactions may occur. In this case, administration should be stopped, the patient closely monitored, and appropriate treatment carried out. Other reported incidents include reactive arthritis, necrosis of the M. vastus medialis and skin, pulmonary embolism, lesions, torn meninges with injections into facet joints, skin rash, deep vein inflammation, general fatigue, high blood pressure, cardiac arrhythmias, knee inflammations, knee cysts, allergic reactions, and surgical interventions. After injection of GO-ON®, local side effects may occur in the treated joint, such as pain, warmth, redness, and/or swelling and effusion. These side effects can be alleviated by applying an ice pack to the treated joint for can be reduced by 5 to 10 minutes.
INTERACTIONS WITH OTHER MEDICATIONS:
There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts, such as benzalkonium chloride, which can be used as skin disinfectants. Therefore, GO-ON® must never come into contact with such products or with medical or surgical devices treated with these types of products, as hyaluronic acid may precipitate in their presence. No incompatibilities (interactions) with other solutions for intra-articular administration have been observed with GO-ON® so far. During the first days of treatment, the simultaneous administration of oral analgesics or anti-inflammatory drugs may prove beneficial.
DOSAGE AND ADMINISTRATION:
GO-ON should be injected into the affected joint a total of 5 times at weekly intervals. Depending on the severity of the joint disease, the effect of a course of five treatments can last up to 6 months.
Treatment cycles can be repeated if necessary. In the case of effusion in a joint, it is recommended to puncture it, immobilize the joint, apply an ice pack, and/or administer corticosteroids by intra-articular injection. Treatment with GO-ON® can be repeated 2-3 days later. Remove the syringe from the blister, take off the rubber stopper, attach a suitable sterilized needle (e.g., 19 or 21 G), and secure it with a slight twist. When attaching the needle and removing the needle cover, be careful not to tighten it too much or lever it excessively. Before injection, press out excess air from the syringe. GO-ON should be administered separately and not mixed with other substances before injection.
FEATURES AND MODE OF ACTION:
The viscoelastic synovial fluid, due to its hyaluronic acid content, is found in all synovial joints, especially in the large joints, which are subjected to considerable stress due to body weight. Here, synovial fluid serves as joint lubricant and shock absorber, ensuring normal, pain-free joint movements. Furthermore, synovial fluid supplies nutrients to the joint cartilage. Degenerative joint diseases such as osteoarthritis are associated with a significant reduction in the viscosity of synovial fluid, which impairs its lubricating and shock-absorbing function. As a result, mechanical joint stress and the loss of joint cartilage tissue increase so significantly that pain and functional limitations occur in the affected joints It has been proven that the quality improvement of synovial fluid caused by intra-articular injection of sodium hyaluronate preparations also improves its viscoelastic properties. This promotes its function as a lubricant and shock absorber, which reduces mechanical joint stress. This leads to pain relief and improved joint mobility. This effect can last more than six months after a treatment cycle of five intra-articular injections.
PACKAGING:
GO-ON® is supplied as a prefilled syringe with 2.5 ml (25 mg) sodium hyaluronate solution. The product was sterilized by steam inside the blister. One package contains
1 syringe.
SHELF LIFE:
3 years
STORAGE:
Store at 2°C to 25°C.
SYMBOLS ON THE PACKAGING: 1: Batch number | 2: Use by |
3: Single use only | 4: Observe instructions for use. | 5: Sterile by moist heat | 6: Storage temperature 2-25°C | 7: Manufacturer | 8: Do not use if the packaging is damaged! | 9: Keep dry | 10: Do not re-sterilize
USE OF GO-ON®:
❶ Remove the syringe from the container. If the product is stored in the refrigerator (see storage conditions), take it out twenty or thirty minutes before use. | ❷ Turn and remove the rubber stopper. | ❸ Attach a 19- or 21-gauge injection needle. When attaching the needle and removing the needle cap, be careful not to tighten too much or lever too hard, as this could break the syringe tip. | ❹ The syringe is ready for use. *Before administration, thoroughly disinfect the injection site. Do not use a disinfectant containing quaternary ammonium salts at the same time.
Reusing single-use products carries a potential infection risk for patients or users. Contamination of the unit can lead to injury, illness, or death of the patient.
Please dispose of GO-ON® according to local regulations.
NOTE: The GO-ON® implant is considered safe in the magnetic resonance (MR) environment.
MANUFACTURER ACCORDING TO MEDICAL DEVICE REGULATIONS:
Rottapharm Ltd., Damastown Industrial Park, Mulhuddart-Dublin 15, Ireland;
+353 1 8852 700
DISTRIBUTION FOR BELGIUM: See folding box
DISTRIBUTION FOR GERMANY: See folding box
DISTRIBUTION FOR AUSTRIASee folding box
This instruction manual was last revised in 03/2021 M1161A
Joint injections
Dermafiller
Supplements
