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

Product name and form

Taurolin 2% w/v solution for intraperitoneal lavage after dilution or solution for instillation.

Pharmaceutical Form

Solution for intraperitoneal lavage after dilution or solution for instillation.

Clear, colourless to very faintly reddish solution with a pH of 7.0 to 7.6.

Qualitative and quantitative composition

Active ingredient: Taurolidine 2% w/v, 2.0 g/100 ml.

For full list of excipients, see section 6.1.

Active Ingredient Description
Taurolidine

Taurolidine inhibits the formation of postoperative peritoneal adhesions, and in vitro has been shown to reduce the adherence of micro-organisms to mucosal epithelium. The chemical mode of action of taurolidine via its reactive methylol groups confers greater potency in vivo than indicated by in vitro MIC values, and also appears to preclude susceptibility to resistance mechanisms.

List of Excipients

Povidone
Sodium hydroxide (pH adjuster)
Water for injections

Pack sizes and marketing

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

Marketing authorization holder

Elara Pharmaservices Europe Limited, 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, Dublin, D15KV21, Ireland

Marketing authorization dates and numbers

PA22637/005/001

Date of authorisation: 13 March 1987

Date of last renewal: 13 March 2007

Drugs

Drug Countries
TAUROLIN Austria, Ireland

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