New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Over or under infusion of fluids to the patient has the potential to cause patient injury or death.
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.
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