1 ml isotonic solution contains 5.0 mg sodium hyaluronate from fermentation, sodium chloride, disodium phosphate, sodium dihydrogen phosphate and water for injections.
Sterile by moist heat.
Characteristics and mode of action: Arthroscopy is a common procedure to visualise, diagnose and treat problems inside a joint. The joint is normally irrigated with solutions such as saline or Ringer lactate before and during arthroscopy in order to allow a clear view of the operation site and to rinse out debris. There is evidence that the presence of these solutions in the joint after irrigation may be detrimental to the cartilage. Furthermore, during the procedure the synovial fluid, which has particular viscoelastic and protective properties due to its hyaluronic acid content, is washed from the joint. Therefore, although the intervention may result in a long-term improvement of joint function, in the short-term patients may suffer from post-arthroscopy complaints like pain, swelling and impaired mobility of the joint.
VISCOSEAL SYRINGE has been developed to relieve these symptoms and promote joint recovery. It contains a highly purified specific fraction of hyaluronic acid produced by fermentation and is devoid of animal protein. Flushing VISCOSEAL SYRINGE solution through the joint cavity will help remove the remaining irrigating solution and efficiently coat all surfaces of the joint. The VISCOSEAL SYRINGE solution left in the joint will act as a lubricant and a shock absorber and its macromolecular meshwork will prevent the free passage of inflammatory cells and molecules through the joint cavity.
To relieve pain, improve mobility and promote joint recovery by flushing out irrigating solution and substituting the synovial fluid following arthroscopic procedures or joint lavage of the shoulder or knee joint.
The contents and the outer surface of the VISCOSEAL SYRINGE pre-filled syringe are sterile as long as the sterile pack remains intact. VISCOSEAL SYRINGE should be used at the end of the arthroscopy after completion of the normal irrigating procedure. Take the pre-filled syringe out of the sterile pack. Remove the cap, attach a suitable needle and secure it by turning slightly. Remove any air bubble, if present, before injection. Introduce VISCOSEAL SYRINGE into the joint cavity. Alternatively, the pre-filled syringe may be placed directly into a portal in the joint. The introduction of VISCOSEAL SYRINGE into the joint cavity will help to wash out the remaining irrigation solution.
Known hypersensitivity to any of the constituents of the product.
The general precautions for arthroscopic procedures should be observed. VISCOSEAL SYRINGE should be instilled accurately into the joint cavity.
Any solution not used immediately after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not use if the pre-filled syringe or the sterile pack are damaged.
Use in pregnancy & lactation: As no clinical evidence is available on the use of sodium hyaluronate in pregnant and lactating women, treatment with VISCOSEAL SYRINGE is not recommended in these cases.
Use in children: As no clinical evidence is available on the use of sodium hyaluronate in children, treatment with VISCOSEAL SYRINGE is not recommended in this case.
As no clinical evidence is available on the use of sodium hyaluronate in pregnant and lactating women, treatment with VISCOSEAL SYRINGE is not recommended in these cases.
No undesirable effects are expected with VISCOSEAL SYRINGE when used in the approved indication and at the dosage prescribed. To date, no cases of infections and allergic reactions causally associated with the use of VISCOSEAL SYRINGE have been reported. However, both risks cannot be completely excluded. The contra-indications must be considered.
Avoid using VISCOSEAL SYRINGE with materials disinfected with quaternary ammonium salt solutions.
Store between 2 °C and 25 °C.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Viscoseal pre-filled syringe 50 mg/10 mL
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