TauroLock™-HEP500 is indicated for those patients who use a port or a silicone or polyurethane catheter-based device for their vascular access. TauroLock ™-HEP500 is intended to be used as a catheter lock solution. It is to be instilled into the device at the end of dialysis and withdrawn prior to initiating subsequent treatments.
Actions and Uses:
TauroLock™-HEP500 is instilled into the device lumen between treatments to reduce clot formation within the internal flow passages and to create a hostile environment to bacterial and fungal growth. The solution must be aspirated from the lumen prior to initiating the next treatment. Its ingredients include taurolidine, citrate 4% and heparin 500units/ml. Taurolidine is a broad spectrum antibiotic and antiendotoxin, which provides cover against gram-positive and gramnegative organisms, anaerobes and fungi. Citrate is used as an anticoagulant but can also help improve antimicrobial activity. Heparin is included to further improve patency of the line.
TauroLock ™-HEP500 is supplied from Raigmore Pharmacy department as 10x5ml ampoules (single use). [100 x 10 mL TauroLock™-HEP500 vials (multi dose container-must be used within 48 hours of puncturing) are also available but are not currently stocked by Raigmore Pharmacy department].
- TauroLock ™-HEP500 is not for systemic injection. TauroLock ™-HEP500 must be used as a catheter lock solution as described in the access device’s instructions 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 ampoule is for single dose only due to potential risk of contamination.
- Some patient populations even when using TauroLock ™-HEP500 antimicrobial solution may experience blood clots in the catheter lumen. In the event that access device patency is compromised follow local policy for restoring flow.
- In access devices which were blocked regularly with non –antimicrobial lock solutions (e.g. with heparin, low concentrated citrate or saline) prior to application of TauroLock ™-HEP500, viable organisms and endotoxins may be released from the biofilm. The lock solution must be aspirated before the next treatment to prevent very rare anaphylaxis reactions to these organisms or endotoxins.
- Concentration of the antimicrobial compound is near to saturation. If not stored or transported according to the storage instruction, precipitation may occur in the product. The product is supplied as a clear solution-Do not use if product looks precipitated.
To date, there are no known adverse effects in humans due to the active ingredient concentrations in TauroLock ™-HEP500 when used as directed. There are no known risks associated with concomitant systemic antibiotic therapy or exposure to magnetic fields. TauroLock ™-HEP500 may cause mild hypocalcaemic symptoms if instillation is not done slowly as directed.
TauroLock ™-HEP500 is contraindicated for patients with a known allergy to (cyclo)-taurolidine, citrate or heparin (mucosa) or when a patient is currently taking medication with known adverse interaction to citrate, heparin or (cyclo)-taurolidine. TauroLock ™-HEP500 is also contraindicated for patients with heparin-induced thrombocytopenia or increased bleeding risk. Due to a lack of data, TauroLock ™-HEP500 should not be used during pregnancy or breastfeeding.
TauroLock ™-HEP500 must be stored at a temperature of 15 to 30°C. Do not freeze.