When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4.2 To include information relating to administration (previously given in section 6.6). Additionally the statement relating to paediatric patients has been updated.
4.4 Warning relating to latex has been added.
4.6 Inclusion of statement on fertility.
4.8 The side effect section has been updated and revised.
10 The revision date has been updated to 27 July 2011.
In addition a number or editorial changes have been made throughout the document.
The majority of changes are formatting changes.
Section 4.4 Special warnings and special precautions for use
The following information has been added to section 4.4
Combinations with cardiotoxic substances (e.g. anthracyclines) should be avoided because it is possible that tasonermin could enhance cardiotoxicity, as has been observed in preclinical 13-week toxicological investigations. Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.5).
A number of therapeutic measures are routinely used during the ILP and in the immediate post operative period. These include standard anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulants and vasopressor agents. There is no evidence that any of these agents counteracts the pharmacodynamic effects of tasonermin. No significant interactions have so far been noted, but caution should be exercised (see section 4.5).
This medicinal product contains up to 77 mg (3.3 mmol) sodium per recommended dose. To be taken into consideration by patients on a controlled sodium diet.