Instructions for use now include use in
neonates, infants and children as well as adults.
For Healthcare Professionals only
Instructions for use
now include use in
neonates, infants and children as well as adults.
HOW TAUROSEPT® WORKS
Find out how TauroSept® works to battle the intraluminal pathology associated with catheter-related bloodstream infections.
TauroSept® Frequently Asked Questions
What is TauroSept<sup>®</sup> ?
TauroSept® is a medical device for the treatment and prevention of catheter infections.1 TauroSept® contains taurolidine 2%, an antimicrobial chemotherapeutic agent that exhibits activity against a wide-range of pathogenic microorganisms, including aerobic and anaerobic, gram-negative and gram-positive bacteria, yeasts and moulds.1 Taurolidine also inhibits staphylococcal coagulase and reduces microbial adherence to cells and surfaces of biomaterials.1
2% taurolidine – the strongest concentration of taurolidine available in the UK as a catheter lock solution
TauroSept® is manufactured by Geistlich Pharma AG and distributed in the UK by Calea and Fresenius Kabi.
For an overview, click this link to download the TauroSept brochure.
What is TauroSept<sup>®</sup> used for?
TauroSept® is intended for instillation in intravascular catheters between treatments in order to lock the catheter, to prevent bacterial and fungal growth leading to microbial infection in the catheter lumen as well as to maintain device patency and to avoid staphylocoagulase induced clotting of blood. TauroSept® can also be used as adjuvant treatment in infected catheters.1
TauroSept can be used in adults, children, infants and newborns.1
How long has TauroSept<sup>®</sup> been in clinical use?
Taurolidine was synthesised from taurine by Geistlich Pharma AG in Switzerland in 1972. The compound was first used in clinical trials in 1975 for severe peritonitis. The successful antimicrobial activity led to product developments and TauroSept® was first available for use as a catheter lock solution in Europe in 2006.
There is over 10 years’ experience of using TauroSept® in the real-world
What is the evidence for the effectiveness of TauroSept<sup>®</sup>
The effects of TauroSept® have been investigated in a number of different studies.2,4-6 An in vitro study demonstrated that TauroSept® was more effective at inhibiting microbial growth, as determined by measurements of optical density, than 1.34% taurolidine + 4% citrate and 1.34% taurolidine + 4% citrate + 500IU/ml heparin.6
A multi-centre double-blinded trial (published 2018) comparing TauroSept® to 0.9% saline for effect on the rate of catheter related bloodstream infections (CRBSIs) per 1000 catheter days showed a significant reduction in the rate of CRBSIs/ 1000 catheter (0.29 versus 1.49, relative risk 0.20; 95% CI 0.04-0.71, p=0.009) in patients who had a new catheter and were treated with TauroSept®.5
In an open label, prospective randomised trial in 30 home parenteral nutrition (HPN) patients who had developed an episode of CRBSI, TauroSept® was compared to heparin (control) catheter lock solution. In the TauroSept® group, over 5370 catheter days only one re-infection occurred, whereas in the heparin group, 10 re-infections were observed over 4939 catheter days.2 A retrospective investigation assessing data of catheter-related complications in 212 HPN patients following a protocol change from the use of heparin (150IU/ml) to TauroSept® catheter lock also showed a reduction in bloodstream infection incidence rates (1.1/year for heparin and 0.2/year for TauroSept) following the protocol change to TauroSept®.4
Are there any guidelines regarding the use of taurolidine to prevent CRBSIs?
ESPEN (the European Society for Clinical Nutrition and Metabolism) published guidelines on home parenteral nutrition in 2020.7 Taurolidine locking is recommended as an additional strategy to prevent CRBSIs due to its favourable adverse event and cost profile.
BIFA (British Intestinal Failure Alliance) also published guidelines in 2019 for the management of catheter related bloodstream infections.8 These guidelines recommend consideration of the use of a prophylactic antimicrobial lock (e.g. taurolidine) for recurrent CRBSIs.
Calea have recently collaborated with the British Journal of Nursing to develop a guide to catheter lock solutions for the prevention of CRBSI.9 A copy can be downloaded for self print here.
Does TauroSept<sup>®</sup> contain Heparin or Citrate?
No. TauroSept® does not contain Heparin or Citrate
Heparin has not been shown to be of benefit in preventing CRBSIs, and there is evidence that heparin can promote the growth of biofilm.7 Furthermore, heparin is not compatible with lipid-containing parenteral nutrition solutions, and systemic exposure can cause adverse reactions (including heparin-induced thrombocytopenia).
Citrate is believed to have some antimicrobial and anti-biofilm properties, but when evaluated alone, citrate has not been shown to be any better than heparin at concentrations of up to 4%.9 Additionally, there is only one study demonstrating antimicrobial effects, but this was with a citrate concentration of 30%.10 There are also concerns regarding systemic exposure to citrate, and overspill from the catheter may be why patients report sensations such as taste disturbances associated with its use.
How is TauroSept<sup>®</sup> administered?
TauroSept® can be used with any vascular access device.1 Follow the manufacturer’s instructions for the particular catheter used. Specific catheter volumes are associated with each device and must be strictly followed.
- Before each use, TauroSept® should be inspected for the presence of visible particles.
Do not use TauroSept® if particles are visible.
- Flush the catheter with 10ml sterile physiological saline solution before installation of TauroSept®.
- Newborns, infants and children: adjust the flushing volume according to the volume of the catheter as this is typically smaller than in adults. Flush slowly (not more than 1ml per 2 seconds).
- Adults: 10ml sterile physiological saline
- Disinfect the surface of the septum of opened vials with a non-iodine based disinfectant immediately before using TauroSept®. Transfer the required volume of TauroSept® from the vial with a sterile syringe and slowly (not more than 1ml per 2 seconds) fill the lumen of the catheter with TauroSept.® In newborns, infants and children adjust the volume of TauroSept® according to the volume of the catheter. Overfilling of the catheter must be avoided. Remove the needle from the vial cap.
- Allow TauroSept® to remain inside the catheter for at least 30 minutes, but no longer than 4 weeks. If treating an infected catheter allow TauroSept® to remain inside the catheter for 12 hours and replace the product every 12 hours until the desired effect is achieved.
- TauroSept® is not to be used for systemic injection. The solution should be withdrawn from the catheter before the next use.
- Newborns, infants and children: TauroSept® must be duly withdrawn from the catheter before next use. Do not flush.
- Adults: If withdrawal of TauroSept® is not possible for technical reasons e.g. with totally implantable venous systems or clinically not wanted, e.g. in parenteral nutrition, the flushing of TauroSept® can be done without systemic effect
For more information about the use of TauroSept®, please refer to the TauroSept® Instructions for Use1 that are provided with the product.
Are there any contraindications, or side effects associated with the use of TauroSept<sup>®</sup>?
Allergic reactions have been observed in rare cases.1 TauroSept® has no contraindications to date but its use should be handled with caution in patients with a known allergic predisposition and when patients are concomitantly treated with products known to interact with taurolidine (see TauroSept® Instructions for Use for more information).1
How do I order TauroSept<sup>®</sup>?
Order codes are as follows:
TauroSept 6 x 5ml – CHEP2520
TauroSept 6 x 10ml – CHEP2519
TauroSept® is available in packs of 5 vials of 6ml or 10ml.
In the UK, TauroSept® is distributed by Calea Homecare Limited.
If you would like to order TauroSept®, you can either contact your local Calea Business Development Manager (01928 533500), or you can email taurosept@calea-online.com and a team member will be in touch to advise.
Calea is a registered UK pharmacy with licensed sterile production unit.
Who do I contact for more information?
To find out more about TauroSept® :
Phone – get in touch with your local Calea Business Development Manager via 01928 533500.
Email – there’s a contact form at the end of this site. Simply fill it in and we’ll be in touch.
Alternatively email direct to taurosept@calea-online.com.
TauroSept® Frequently Asked Questions
What is TauroSept® ?
TauroSept® is a medical device for the treatment and prevention of catheter infections.1 TauroSept® contains taurolidine 2%, an antimicrobial chemotherapeutic agent that exhibits activity against a wide-range of pathogenic microorganisms, including aerobic and anaerobic, gram-negative and gram-positive bacteria, yeasts and moulds.1 Taurolidine also inhibits staphylococcal coagulase and reduces microbial adherence to cells and surfaces of biomaterials.1
2% taurolidine – the strongest concentration of taurolidine available in the UK as a catheter lock solution
TauroSept® is manufactured by Geistlich Pharma AG and distributed in the UK by Calea and Fresenius Kabi.
For an overview, click this link to download the TauroSept brochure.
What is TauroSept® used for?
TauroSept® is intended for instillation in intravascular catheters between treatments in order to lock the catheter, to prevent bacterial and fungal growth leading to microbial infection in the catheter lumen as well as to maintain device patency and to avoid staphylocoagulase induced clotting of blood. TauroSept® can also be used as adjuvant treatment in infected catheters.1
TauroSept can be used in adults, children, infants and newborns.1
How long has TauroSept<sup>®</sup> been in clinical use?
Taurolidine was synthesised from taurine by Geistlich Pharma AG in Switzerland in 1972. The compound was first used in clinical trials in 1975 for severe peritonitis. The successful antimicrobial activity led to product developments and TauroSept® was first available for use as a catheter lock solution in Europe in 2006.
There is over 10 years’ experience of using TauroSept® in the real-world.
What is the evidence for the effectiveness of TauroSept<sup>®</sup>
The effects of TauroSept® have been investigated in a number of different studies.2,4-6 An in vitro study demonstrated that TauroSept® was more effective at inhibiting microbial growth, as determined by measurements of optical density, than 1.34% taurolidine + 4% citrate and 1.34% taurolidine + 4% citrate + 500IU/ml heparin.6
A multi-centre double-blinded trial (published 2018) comparing TauroSept® to 0.9% saline for effect on the rate of catheter related bloodstream infections (CRBSIs) per 1000 catheter days showed a significant reduction in the rate of CRBSIs/ 1000 catheter (0.29 versus 1.49, relative risk 0.20; 95% CI 0.04-0.71, p=0.009) in patients who had a new catheter and were treated with TauroSept®.5
In an open label, prospective randomised trial in 30 home parenteral nutrition (HPN) patients who had developed an episode of CRBSI, TauroSept® was compared to heparin (control) catheter lock solution. In the TauroSept® group, over 5370 catheter days only one re-infection occurred, whereas in the heparin group, 10 re-infections were observed over 4939 catheter days.2 A retrospective investigation assessing data of catheter-related complications in 212 HPN patients following a protocol change from the use of heparin (150IU/ml) to TauroSept® catheter lock also showed a reduction in bloodstream infection incidence rates (1.1/year for heparin and 0.2/year for TauroSept) following the protocol change to TauroSept®.4
Are there any guidelines regarding the use of taurolidine to prevent CRBSIs?
ESPEN (the European Society for Clinical Nutrition and Metabolism) published guidelines on home parenteral nutrition in 2020.7 Taurolidine locking is recommended as an additional strategy to prevent CRBSIs due to its favourable adverse event and cost profile.
BIFA (British Intestinal Failure Alliance) also published guidelines in 2019 for the management of catheter related bloodstream infections.8 These guidelines recommend consideration of the use of a prophylactic antimicrobial lock (e.g. taurolidine) for recurrent CRBSIs.
Calea have recently collaborated with the British Journal of Nursing to develop a guide to catheter lock solutions for the prevention of CRBSI.9 A copy can be downloaded for self print here.
Does TauroSept<sup>®</sup> contain Heparin or Citrate?
No. TauroSept® does not contain Heparin or Citrate
Heparin has not been shown to be of benefit in preventing CRBSIs, and there is evidence that heparin can promote the growth of biofilm.7 Furthermore, heparin is not compatible with lipid-containing parenteral nutrition solutions, and systemic exposure can cause adverse reactions (including heparin-induced thrombocytopenia).
Citrate is believed to have some antimicrobial and anti-biofilm properties, but when evaluated alone, citrate has not been shown to be any better than heparin at concentrations of up to 4%.9 Additionally, there is only one study demonstrating antimicrobial effects, but this was with a citrate concentration of 30%.10 There are also concerns regarding systemic exposure to citrate, and overspill from the catheter may be why patients report sensations such as taste disturbances associated with its use.
How is TauroSept<sup>®</sup> administered?<sup>11</sup>
TauroSept® can be used with any vascular access device. 1 Follow the manufacturer’s instructions for the particular catheter used. Specific catheter volumes are associated with each device and must be strictly followed.
- Before each use, TauroSept® should be inspected for the presence of visible particles.
Do not use TauroSept® if particles are visible.
- Flush the catheter with 10ml sterile physiological saline solution before installation of TauroSept®.
- Newborns, infants and children: adjust the flushing volume according to the volume of the catheter as this is typically smaller than in adults. Flush slowly (not more than 1ml per 2 seconds).
- Adults: 10ml sterile physiological saline
- Disinfect the surface of the septum of opened vials with a non-iodine based disinfectant immediately before using TauroSept®. Transfer the required volume of TauroSept® from the vial with a sterile syringe and slowly (not more than 1ml per 2 seconds) fill the lumen of the catheter with TauroSept.® In newborns, infants and children adjust the volume of TauroSept® according to the volume of the catheter. Overfilling of the catheter must be avoided. Remove the needle from the vial cap.
- Allow TauroSept® to remain inside the catheter for at least 30 minutes, but no longer than 4 weeks. If treating an infected catheter allow TauroSept® to remain inside the catheter for 12 hours and replace the product every 12 hours until the desired effect is achieved.
- TauroSept® is not to be used for systemic injection. The solution should be withdrawn from the catheter before the next use.
- Newborns, infants and children: TauroSept® must be duly withdrawn from the catheter before next use. Do not flush.
- Adults: If withdrawal of TauroSept® is not possible for technical reasons e.g. with totally implantable venous systems or clinically not wanted, e.g. in parenteral nutrition, the flushing of TauroSept® can be done without systemic effect
For more information about the use of TauroSept®, please refer to the TauroSept® Instructions for Use1 that are provided with the product.
Are there any contraindications, or side effects associated with the use of TauroSept<sup>®</sup>?
Allergic reactions have been observed in rare cases.1 TauroSept® has no contraindications to date but its use should be handled with caution in patients with a known allergic predisposition and when patients are concomitantly treated with products known to interact with taurolidine (see TauroSept® Instructions for Use for more information).1
How do I order TauroSept®?
Order codes are as follows:
TauroSept 6 x 5ml – CHEP2520
TauroSept 6 x 10ml – CHEP2519
TauroSept® is available in packs of 5 vials of 6ml or 10ml.
In the UK, TauroSept® is distributed by Calea Homecare Limited.
If you would like to order TauroSept®, you can either contact your local Calea Business Development Manager (01928 533500), or you can email taurosept@calea-online.com and a team member will be in touch to advise.
Calea is a registered UK pharmacy with licensed sterile production unit.
Who do I contact for more information?
To find out more about TauroSept® :
Phone – get in touch with your local Calea Business Development Manager via 01928 533500.
Email – there’s a contact form at the end of this site. Simply fill it in and we’ll be in touch.
Alternatively email direct to taurosept@calea-online.com.
Contact us
Simply fill in the contact form and we’ll be in touch.
Alternatively email direct to taurosept@calea-online.com
References
Fresenius Kabi Ltd and Calea UK Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire WA7 1NT
www.fresenius-kabi.com/gb
calea.co.uk
CAL261
Date of preparation: April 2021
Fresenius Kabi Ltd and Calea UK Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire WA7 1NT
www.fresenius-kabi.com/gb
calea.co.uk
CAL261
Date of preparation: April 2021