What is TauroSept®?
TauroSept® is an antimicrobial catheter lock solution for the prevention and treatment of catheter associated infections and is suitable for use for all tunnelled and non-tunnelled vascular access and port systems.
What does TauroSept® contain?
TauroSept® contains 2% taurolidine solution (0.2 g /10 ml), sterile water for injections, 5% polyvinylpyrrolidone (PVP) and traces of HCl or NaOH to adjust the pH to 7.3. TauroSept® is a class III medical device. TauroSept® contains no added anticoagulant substances and no preservatives.
Why should TauroSept® be used?
TauroSept® is effective against a broad range of bacteria and fungi, including antibiotic-resistant micro-organisms such as methicillin-and vancomycin-resistant bacteria. The particular mechanism of action prevents development of resistance. TauroSept® inhibits the adherence of bacteria to human epithelial tissue and biomaterials. In catheter and port systems, TauroSept® prevents biofilm formation and possible colonisation of the system by micro-organisms.
Are there any known side effects with the use of TauroSept®?
No. When TauroSept® is used as indicated in the instructions for use, neither local nor systemic side effects are known.
How should TauroSept® be used?
After flushing the vascular access system with 10 ml of normal saline, TauroSept® is drawn up using a syringe and instilled into the vascular access system. The required filling volume is found in the respective catheter manufacturer's instructions for use. Filling should be done according to these instructions. It must always be ensured that the entire cavity of the catheter is filled. Underfilling should be avoided. TauroSept® remains in the access system until the next treatment (but for at least 30 minutes). Before the catheter is used the next time, TauroSept® must be aspirated from the catheter and disposed of.
Is there a risk if TauroSept® is accidentally injected into the bloodstream?
No. Taurolidine is metabolised rapidly in the body via the metabolites taurultam and methylol taurinamide, which are also bactericidal, to taurine, an endogenous aminosulphonic acid, CO2 and H2O. Therefore, no toxic effects are known or to be expected in the event of accidental injection. Clinically relevant adverse effects are also very unlikely because of the low concentration and the low volume in the catheter in relation to the total volume of the circulation.
What precautions should be observed when TauroSept® is used?
TauroSept® must not be mixed with oxidising agents such as sodiumhypochlorite (Dakin solution), iodine or povidone iodine, hydrogen peroxide or other substances with an oxidising action as otherwise formic acid is formed. Normal skin disinfection is not affected by this restriction.
Can unneeded leftover TauroSept® be stored or sterilised? No. Leftover TauroSept® must always be discarded and cannot be resterilised. Damaged packs must be regarded as unsterile and accordingly be disposed of.
Can TauroSept® cause damage to the catheter?
No. TauroSept® does not lead to any damage to the catheter material,regardless of what type of catheter is used.
Can heparin or plasminogen activators (r-tPA) be added directly to a TauroSept® solution if necessary?
Yes. If necessary, TauroSept® can be mixed directly with heparin or plasminogen activators (r-tPA) and administered together. The activity of these substances is not influenced by TauroSept®. TauroSept® has not exhibited any influence on heparin activity in in vitro studies, animal studies and clinical studies.
Can prefilled TauroSept® syringes be stored for a longer period?
No. The most important rule in dealing with a catheter and port system is observation of strict hygiene regulations. These rules are infringed with advance mixing or stocking up with prefilled syringes. The requirements for optimally sterile work are no longer met as a result.
Are laboratory parameters altered or influenced when TauroSept® is used?
No. TauroSept® is a bactericidal and antiadhesive catheter / port lock solution and does not contain any anticoagulants such as heparin or citrate. Even if there should be small traces of TauroSept® in the catheter, this does not influence the result of a blood test.
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