1. Description and Specifications
TauroLock™ contains anticoagulant and antimicrobial substances. It is to be used with a port or a catheter-based vascular access device.
It is 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. The solution must be withdrawn prior to initiating the next treatment.
Active ingredients in TauroLock™ are (cyclo)-taurolidine and citrate (4%). Other components include water for injection, PVP. The pH is adjusted with citrate and/or sodium hydroxide. The product is sterile filter processed and supplied as a clear, sterile, non-pyrogenic solution.
- For complete details of catheter-based vascular access products, consult the manufacturer’s instructions or clinician’s manual.
- If aspiration of TauroLock™ is not needed or not possible, e. g. in parenteral nutrition, slow flushing of TauroLock™ (not more than 1mL per 3 seconds) prior to the next treatment does not cause any systemic effect.
- With respect to infants and children less than two years of age clinical experiences are insufficient. The solution must therefore be aspirated.
- Access devices which were used without antimicrobial lock solutions (e.g. Heparin, low concentrated citrate, saline) most likely contain a bacterial biofilm. In these cases TauroLock™ should be withdrawn prior to initiating the next treatment.
TauroLock™ is indicated for those patients who are using a port or a silicone or polyurethane catheter-based device for their vascular access. TauroLock™ is intended to be used as a catheter lock solution. It is to be instilled into the device at the termination of a treatment and should be withdrawn prior to initiating subsequent treatments (see F4).
TauroLock™ is contraindicated for patients with a known allergy to citrate or (cyclo) taurolidine, or when a patient is currently taking medication with known adverse interaction to citrate or (cyclo)-taurolidine.
- TauroLock™ is for single use.
- TauroLock™ is not for systemic injection. TauroLock™ must be used as a catheter lock solution as described in the access device’s instruction for use. Failure to adhere to these instructions may result in inadvertent systemic injection of the solution. Once instilled into the catheter the solution must not be used again after aspiration.
- The vial is a multidose container. Once punctured it must be used within 48 hours. The ampoule is for single use only. Multi use is contraindicated due to potential risk of contamination.
- Some patient populations using TauroLock™ antimicrobial lock solution may experience a higher frequency of occlusion problems.
In the event that access device patency is compromised, follow institutional protocol for restoring flow. In addition, heparin may be used as an accessory to TauroLock™ in these patient populations to decrease the incidence of thrombosis. If heparin is used as an additive do not add more than 1,0 (2,0) mL volume of heparin to 5 mL (10 mL) volume of TauroLock™. The maximum concentration of heparin used is 25.000 IU/mL. If heparin is added the combined solution should not be flushed into the bloodstream due to the systemic effect of heparin.
- If aspirating of TauroLock™ is not needed or not wanted (e. g. in parenteral nutrition) the flushing of TauroLock™ can be done slowly without systemic effect.
- The concentration of the antimicrobial compound is near to saturation. If not stored or transported according to the instructions under section H, precipitation can occur in the product. Do not use such a precipitated product.
4. Adverse Effects
To date, there are no known adverse effects in humans due to the active ingredient concentrations in TauroLock™ when used as directed.
There are no known risks associated with concomitant systemic antibiotic therapy or exposure to magnetic fields. TauroLock™ may cause mild hypocalcaemic symptoms if instillation is not done slowly as directed.
5. Instillation of TauroLock™
Follow the manufacturer’s instructions that accompany the particular vascular access product utilized. Specific catheter lock volumes are associated with each device.
- Flush the device with 10 mL of saline.
- Withdraw TauroLock™ from the container using an appropriate syringe.
- 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 second) into the access device in a quantity sufficient to fill the lumen completely.
Consult the manufacturer’s instructions for the specific fill volume or specify fill volume during implantation. The volume has to be strictly respected. TauroLock™ will remain inside the access device until the next treatment.
- If aspiration of TauroLock™ is needed and possible, it should be withdrawn from the port/catheter and discarded prior to initiation of next treatment.
- Flush the device with 10 mL of saline.
- Pregnancy and Breastfeeding
No data is available for pregnant and breastfeeding women. For safety reasons TauroLock™ should not be used during pregnancy and breastfeeding.
6. Storage and shipment
TauroLock™ must be stored at a temperature of 15 to 30°C and must not be shipped at freezing temperature. Do not freeze.
Sterile, aseptic fill
Read instruction for use
Ampoule is for single use only. (Vial is for multi use)
Don’t use when package is damaged
Manufactured by: TauroPharm GmbH.
Add: Jägerstraße 5a · D-97297 Waldbüttelbrunn, Germany
Tel: +49 931 404 805 11 · Fax: +49 931 405 878