Instructions for Use
Sodium hyaluronate from fermentation 0.5%. Synovial fluid substitute. 10 ml pre-filled syringe in a sterile pack for single use. Sterile by moist heat.
1 ml isotonic solution contains 5.0 mg sodium hyaluronate from
fermentation, sodium chloride, disodium phosphate, sodium dihydrogen
phosphate and water for injections.
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.
Known hypersensitivity to any of the constituents of the product.
Avoid using VISCOSEAL® SYRINGE with materials disinfected with quarternary ammonium salt solutions.
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.
Dosage and administration:
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 introduction. 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 displace any remaining irrigation solution.
The general precautions for arthroscopic procedures should be observed. VISCOSEAL® SYRINGE should be instilled accurately into the joint cavity. As no clinical evidence is available on the use of sodium hyaluronate in children, pregnant and lactating women, treatment with VISCOSEAL® SYRINGE is not recommended in these cases. 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. Store between 2 °C and 25 °C! Do not use after the expiry date indicated on the box. Keep out of the reach of children.
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 postarthroscopy 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. Instilling VISCOSEAL® SYRINGE into the joint cavity will help displace any remaining irrigating solution and efficiently coat all surfaces of the joint. The VISCOSEAL® SYRINGE solution 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.
1 pre-filled syringe of 50 mg/10 ml VISCOSEAL® in a sterile pack for single use.
To be used by a physician only.
Last revision date: 2019-10.
TRB CHEMEDICA AG
85622 Feldkirchen/Munich, Germany