INJECTION AquaMEPHYTON® (PHYTONADIONE) Aqueous Colloidal Solution of Vitamin K1

http://web.archive.org/web/20070213093306/http://www.fda.gov/medwatch/SAFETY/2003/03Feb_PI/AquaMEPHYTON_PI.pdf

INJECTION

AquaMEPHYTON®

(PHYTONADIONE)

Aqueous Colloidal Solution of Vitamin K1

WARNING – INTRAVENOUS USE

Severe reactions, including fatalities, have occurred during and immediately after the parenteral administration of AquaMEPHYTON* (Phytonadione). Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving AquaMEPHYTON for the first time. The majority of these reported events occurred following intravenous administration, even when precautions have been taken to dilute the AquaMEPHYTON and to avoid rapid infusion. Therefore, the INTRAVENOUS route should be restricted to those situations where another route is not feasible and the increased risk involved is considered justified.

 

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