INFORMATION FOR USE
VISCOSEAL® SYRINGE
Sodium hyaluronate from fermentation 0.5%. For substitution of joint lubricant. Pre-filled syringe with 10 ml solution (in sterile packaging) for single use. Sterile by moist heat.
Composition:
1 ml isotonic solution contains 5.0 mg sodium hyaluronate from fermentation as well as sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, and water for injection purposes.
Indications:
For pain relief, improved joint mobility, and faster restoration of joint function after arthroscopy or joint lavage in the shoulder or knee joint by removing the rinse fluid and substituting the joint lubricant.
Contraindications:
Known hypersensitivity to any of the ingredients.
Interactions:
Do not bring VISCOSEAL® SYRINGE into contact with objects disinfected with solutions of quaternary ammonium salts.
Side effects:
No adverse effects are expected when VISCOSEAL® SYRINGE is used according to the indication and prescribed dosage guidelines. There have been no reports of infections or allergic reactions causally related to the use of VISCOSEAL® SYRINGE so far. However, both risks cannot be completely excluded. Contraindications must be observed.
Dosage instructions and method of application:
As long as the sterile packaging is unopened, the contents and surface of the pre-filled syringe are sterile. VISCOSEAL® SYRINGE should be used after completion of arthroscopy and normal joint lavage. Remove the pre-filled syringe from the sterile packaging and remove the cap. Attach a suitable cannula and lock it with a slight twist, or connect the pre-filled syringe to an access already in the joint. Before use, any air bubble present in the pre-filled syringe should be removed. Inject VISCOSEAL® SYRINGE into the joint space. This promotes the removal of remaining rinse fluid.
Precautions:
Observe general precautions for arthroscopic procedures. VISCOSEAL® SYRINGE should be correctly instilled into the joint space. Since there is insufficient experience with the use of sodium hyaluronate in children as well as in pregnant and breastfeeding women, the use of VISCOSEAL® SYRINGE is not recommended in these cases. Any solution not used immediately after opening must be discarded. Otherwise, sterility is no longer guaranteed, which can lead to an infection risk. Do not use if the pre-filled syringe or sterile packaging is damaged. Store between 2 °C and 25 °C! Observe expiration date. Keep out of reach of children!
Properties and mode of action:
Arthroscopy is a common procedure for visualization, diagnosis, and treatment of joint problems. To create clear visibility and to remove cartilage debris, the joint is rinsed during arthroscopy with solutions such as physiological saline or Ringer's lactate solution. There is evidence that the rinse fluid remaining in the joint can impair cartilage metabolism. Furthermore, during the procedure, the synovial fluid, which has special viscoelastic and protective properties due to its hyaluronic acid content, is rinsed out of the joint. Therefore, patients who experience long-term improvement in joint function through the procedure may have complaints such as pain, swelling, and impaired joint mobility immediately after the procedure. VISCOSEAL® SYRINGE was developed to relieve such complaints and to enable faster recovery of joint function. VISCOSEAL® SYRINGE contains a highly pure specific fraction of hyaluronic acid produced by a fermentation process and contains no animal proteins. Instillation of VISCOSEAL® SYRINGE into the joint space helps remove remaining rinse fluid and efficiently coats all surfaces within the joint. The VISCOSEAL® SYRINGE remaining in the joint acts as a lubricant and shock absorber, and its network of macromolecules prevents free passage of inflammatory cells and molecules through the joint space.
Package size:
1 pre-filled syringe of 50 mg/10 ml (in sterile packaging) for single use.
For use by a physician only.
Information status: 2019-10
Joint injections
Dermafiller
Supplements
