TAUROLIN Solution for intraperitoneal lavage after dilution or solution for instillation Ref.[10990] Active ingredients: Taurolidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Elara Pharmaservices Europe Limited, 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, Dublin, D15KV21, Ireland

4.1. Therapeutic indications

For use in the local treatment of peritonitis.

4.2. Posology and method of administration

Following standard supportive, surgical and peritoneal toilet procedures, Taurolin may be used as a supplementary peritoneal lavage for either single or repeated instillation depending upon the degree of severity of the presenting condition and the infecting agents.

Adult

Lavage. Up to 1 litre of 0.5% Taurolin pre-warmed to 37°C. Taurolin solution (2% w/v) should be diluted with recommended diluents (see 6.6) to a final concentration of 0.5% w/v.

Single instillation (eg, perforated appendix or local peritonitis). 200 ml Taurolin pre-warmed to 37°C should be instilled at the site of maximum contamination before closure. If a drain is left in situ it should be clamped for 2 hours to prevent drainage of Taurolin.

Repeated instillation (eg, generalised (diffuse or faecal) peritonitis). At laparotomy a subumbilical or suprapubic peritoneal dialysis catheter should be inserted through a stab wound in the upper abdomen to lie in relation to the right lobe of the liver. A tube drain down to the site of maximum contamination is brought through a stab wound in the lower abdomen. 300 ml Taurolin, pre-warmed to 37°C is instilled before closure. Thereafter, 100 ml Taurolin pre-warmed to 37°C is instilled daily through the catheter for up to 5 days postoperatively if indicated bacteriologically or clinically. The lower drain should be clamped for 2 hours after each instillation.

Elderly

Taurolin should be used with caution in patients with impaired renal function.

Children

There is limited clinical experience of use in young children, and Taurolin should not be administered to neonates, infants and children under 10 years of age.

Pre-, peri- and post-operative administration of antibiotics is possible.

4.9. Overdose

There have been no reported cases of overdosage. Taurolin appears to be devoid of pharmacodynamic activity on major body systems, and has produced no adverse or toxic reactions on either local or systemic haematological, biochemical or metabolic parameters following intraperitoneal doses considerably in excess of those recommended.

6.3. Shelf life

Three years if bottle unopened. Product should be used immediately after first opening/dilution.

6.4. Special precautions for storage

Store at room temperature (15-25°C). Do not refrigerate or freeze.

6.5. Nature and contents of container

Clear, Type II Ph.Eur. glass bottles (100ml and 250ml) with rubber closures and aluminium snap caps.

6.6. Special precautions for disposal and other handling

Preparation of dilute lavage solution. Taurolin 2% w/v should be diluted 1:3 with one of the following recommended diluents: Water for Injections BP; Sodium Chloride Intravenous Infusion BP, or Compound Sodium Chloride Injection BPC (Ringer’s solution) to a concentration of 0.5% w/v. No other diluents should be used. Product is for single use only. Any remaining solution should be discarded. Product should be pre-warmed to 37ºC and inspected for visible particles before use.

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