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TauroLock-Hep为4％的柠檬酸抗凝剂-首个获批的中心静脉接入系统低浓度的肝素封管液的新药
Anbieter: Tauro-Implant GmbH
Inhalt: 10 x 5Milliliter 10X3Milliliter 100X10ml/vial 5X5ml/vial
TauroLock-HEP导管溶液：含有牛磺罗定，作为血液透析导管的抗微生物剂的封管溶液可以显著降低导管相关的脓毒症的发病率
贮存条件：
商店在15-30*℃的温度
不要冻结。
该产品是供一次性使用;
资料来源附件：http://www.taurolock.com/de
TauroLock™-Hep 100 500
What is the nature of TauroLock™?
TauroLock™ is a catheter lock solution for tunneled and non-tunneled central venous access systems. It has to be instilled in the device lumens between treatments in order to make the internal flow passages resistant to clot formation and hostile to bacterial and fungal growth.
What are the ingredients of TauroLock™?
Active ingredients of TauroLock™ are the antimicrobial compound (cyclo)-taurolidine and citrate (4%) as an anticoagulant.
Are there different formulations (products) available for patients with recurrent flow problems?
For enhancing the flow TauroLock™-Hep100 additionally contains 100 IU/mL of heparin as an anticoagulant and TauroLock™- Hep500 contains 500 IU/mL. Ampoules have a filling volume of 3mL (TauroLock™-Hep100, 10 ampoules per box) and 5mL (TauroLock™-Hep500, 10 ampoules per box).
The most intensive prophylaxis against catheter occlusions is achieved with TauroLock™- U25.000 (contains 25.000 IU of urokinase). Flow problems are reduced significantly.
The decision which locking solution is most adequate depends on the individual patient situation. The alternative use of different locking solutions in the same catheter (e.g. TauroLock™-HEP500, TauroLock™-U25.000) is possible.
Why should I use TauroLock™?
For preventing infections and clot formation in catheters and port systems. Citrate (4%) alone acts only as an anticoagulant and has no bactericidal activity. Therefore a contamination with microbes may cause bacteraemia and catheter sepsis. The use of TauroLock™ prevents of the development of a biofilm and improves the patency of the catheter or port system.
What are the side effects of TauroLock™?
No topical or systemic side effects are known. If TauroLock™ is quickly instilled into the access device mild hypocalcaemic symptoms (e. g. metallic taste) might occur caused by the contents of 4% citrate.
How to use TauroLock™?
1.Flush the device with a minimum of 10 mL of saline.
2.Withdraw TauroLock™ from the container using an appropriate syringe
3.Instill TauroLock™ slowly (not more than 1 mL per second, infants and children less than two years of age not more than 1 mL per 5 seconds) into the access device in a quantity sufficient to fill the lumen completely. The filling volume has to be strictly respected. Consult the manufacturer’s instructions for the specific fill volume. TauroLock™ will remain inside the access device until the next treatment.
4.If aspiration of TauroLock™ is needed and possible it should be withdrawn from the access device and discarded prior to initiation of the next treatment. TauroLock™-Hep100 or Hep500 has to be aspirated before the next dialysis or treatment and discarded.
5.Flush the device with a minimum of 10 mL of saline.
What happens if TauroLock™ enters the bloodstream?
The antimicrobial ingredient has an extremely short half-life within the blood. It is metabolised into the naturally occurring amino acid taurine. No toxic effects are expected or reported after accidental instillation.
Is TauroLock™ approved?
TauroLock™ was approved as a CE marked medical device in 2004 and can be sold all over Europe.
How can I order TauroLock™?
The exclusive distributor of TauroLock™ in Germany is Tauro-Implant GmbH in Winsen. For distributors in other countries please visit www.TauroLock.com or send a message to infos@tauropharm.de.
What is the minimum order quantity of TauroLock™?
TauroLock™ catheter lock solutions are available in different packaging sizes.
Does TauroLock™ interact with the catheter surface?
The activity of TauroLock™ on different catheter materials and surfaces were studied (polyurethane, silikon). All types of catheter showed no damage after long term interaction with TauroLock™.
Why is the concentration of citrate only 4%?
A concentration of 4% citrate is recommended by the FDA (USA). FDA stopped a product with a higher concentrated citrate solution (46.7%) in the year 2000. An over-instillation of less than 1 mL per lumen of a 30% citrate solution caused temporary cardiac arrest. (Punt CD, Boer WE, Cardiac arrest following injection of concentrated trisodium citrate, Clinical Nephrology 2008, 69 (4), 317-318). Also highly concentrated citrate solutions (46.7%) may cause embolic complications (Davenport A , Willicombe MK, Vernon K, Embolic complications from central venous hemodialysis catheters used with hypertonic citrate solution, American Journal of Kidney Diseases, 2010, 55, 348-351/ Schilcher G, Scharnagl H, Horina JH, Ribitsch W, Rosenkranz AR, Stojakovic T and Polaschegg H-D, Trisodium citrate induced protein precipitation in haemodialysis catheters might cause pulmonary embolism, Nephrol Dial Transplant (2012) 0: 1–5).
Currently I use heparin as a lock solution - can I change to TauroLock™ without problems?
Patency problems have been reported occasionally after the instillation of TauroLock™ into catheters which had been locked with heparin before. The manufacturer therefore recommends the addition of 0.5 mL of heparin (5000 IU/mL) to TauroLock™ or the use of TauroLock™-Hep500 .
When should I use TauroLock™-Hep500 or TauroLock™-Hep100?
In general the doctor decides which product should be used instead of heparin as a lock solution. Current experiences with TauroLock™ products containing heparin show that in dialysis catheters a solution containing heparin 5000 IU/mL can be replaced without problems by TauroLock™- Hep500. It turned out that TauroLock™- Hep500 is the gold standard in catheters of dialysis patients. TauroLock™-Hep100 is used in central venous access systems used in hematology/oncology patients. TauroLock™-Hep100 or Hep500 has to be aspirated before the next dialysis or treatment.
Can I use aspirated blood from catheters locked with TauroLock™ for coagulation tests?
Yes you can. After aspirating TauroLock™ catheter lock solution (without heparin) the catheter is flushed with 10 mL of saline solution. Then blood is withdrawn in a sufficient amount. Traces of citrate do not influence the coagulation test. The test tube contains also 3,13 % of citrate solution. When TauroLock™-Hep500 or TauroLock™-Hep100 was used as a lock solution blood has to be withdrawn peripherally.
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