May 2013
MedWatch May 2013 drug safety labeling changes
Italiano
MedWatch May 2013 drug safety labeling changes
L’Agenzia Italiana del Farmaco, in accordo con l’Agenzia Europea dei Medicinali (EMA), rende disponibile on line nuove ed importanti informazioni su Diane / Visofid (ciproterone acetato 2 mg + etinilestradiolo 0,035 mg).
Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.
Excessive high flow rates, presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
Testing revealed the product contains Sibutramine, which may increase blood pressure or interact, in life-threatening ways, with other medications a consumer may be taking.
The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill
patients with renal failure.
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