Geistlich TauroSept®

Instruction for use

Geistlich TauroSept® can be used with any vascular access device. Follow the manufacturer's instructions for the particular catheter utilized. Specific catheter volumes are associated with each device and must be strictly followed. Use of the device by patients requires proper training by authorized health care personnel. If legally required, the training must be documented.

  • Before each use, Geistlich TauroSept® should be inspected for the presence of visible particles. Do not use Geistlich TauroSept® if particles are visible.
  • Flush the catheter with 10 ml sterile physiological saline solution before instillation of TauroSept®.
  • Disinfect the surface of the septum with a non-iodine based disinfectant immediately before using Geistlich TauroSept®. Transfer the required volume of Geistlich TauroSept® from the vial with a sterile syringe and fill the lumen of the catheter with Geistlich TauroSept®. Remove the needle from the vial cap.
  • Allow Geistlich TauroSept® to remain inside the catheter for at least 30 minutes but no longer than 4 weeks. Geistlich TauroSept® can be used as adjuvant treatment in infected catheters. If treating an infected catheter allow Geistlich TauroSept® to remain inside the catheter for 12 hours and replace the product every 12 hours until the desired effect is achieved.
  • Geistlich TauroSept® is not to be used for systemic injection. The solution should be withdrawn from the catheter before next use. If withdrawal of Geistlich TauroSept® is not possible for technical reasons, e.g. with totally implantable venous access systems (portacaths), or clinically not wanted, e.g. in parenteral nutrition, the flushing of Geistlich TauroSept® can be done without systemic effect.

 

Precautions

Patients

  • Geistlich TauroSept® should be handled with caution in patients with known allergic predisposition and when patients are concomitantly treated with products which are known to interact with taurolidine.

Interactions

  • Geistlich TauroSept® must not be mixed with oxidizing agents such as Dakin's solution (sodium hypochlorite), povidone iodine, or hydrogen peroxide because of oxidation to formic acid. The risk can be considered to be very low as these agents are not used in the catheter but only on the surrounding skin.

Device handling

  • Geistlich TauroSept® must be instilled into the access device as described in the product's user manual. Failure to comply with these instructions may result in inadvertent systemic injection of the taurolidine solution.
  • Geistlich TauroSept® solution must only be instilled once and the withdrawn residue must be disposed of. Reuse may result in decreased effectiveness of the device.
  • Do not use Geistlich TauroSept® if the vial is damaged.
  • Geistlich TauroSept® must be stored in a horizontal position at a controlled temperature of 15 to 25 °C. Do not refrigerate.
  • Do not use if the package is damaged. If the package is opened and no date and time indicating first opening are legible on the vial, the product must not be used.

 

Presentation and package sizes

Each original pack contains 5 glass vials containing 6 ml or 10 ml of Geistlich TauroSept®. The product is sterile. Opened Geistlich TauroSept® vials can be stored for 48 hours and multiple withdrawal is possible. The content of a vial is for a single patient only and must be used within 48 hours after the first puncture. Write time and date when the vial was opened on the vial label. Re-sterilisation is not possible! Do not use if the packaging is damaged. If the packaging is opened and no date and time indicating first opening are legible on the vial, the product must not be used.