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

4.3. Contraindications

Taurolin should not be used if an allergy against the active ingredient or the excipients is known or suspected.

Taurolin should not be co-administered with oxidising agents such as Dakin’s Solution, povidone iodine or hydrogen peroxide.

4.4. Special warnings and precautions for use

Long-term effects of use, particularly of repeated instillation beyond 5 days postoperatively have not yet been established.

During intra-operative application of Taurolin an increase or decrease in blood pressure or variation of the heart rate might be seen, particularly with light anaesthaesia.

Taurolin should not be co-administrated with oxidising agents, such as Dakin’s Solution, povidone iodine or hydrogen peroxide. This can cause a metabolic acidosis.

As indicated in Section 4.2, Taurolin should be used with caution in patients with renal impairment.

4.5. Interaction with other medicinal products and other forms of interaction

When co-administered with systemic antibiotics, the product has an additive (or indifferent) antimicrobial interaction with cephalosporins, ureidopenicillins and metronidazole, and synergism with aminoglycosides, in addition to neutralizing their induced bacterial endotoxin release.

4.6. Fertility, pregnancy and lactation

Taurolidine has shown no evidence of teratogenicity in animal studies, but administration to pregnant or lactating women should only be undertaken if the clinician considers it essential.

4.7. Effects on ability to drive and use machines

None stated.

4.8. Undesirable effects

Taurolin is generally well-tolerated. Occasional local pain or irritation may occur in conscious, sensitive patient following the initial instillation, and can be abolished for subsequent Taurolin instillations by the pre-installation of 10 ml 0.1% lignocaine.

Reporting of suspected adverse events

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlesfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; Email: medsafety@hpra.ie.

6.2. Incompatibilities

Taurolin should not be co-administered with oxidising agents such as Dakin’s Solution, povidone iodine or hydrogen peroxide.

This can cause metabolic acidosis.

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