to straightforward [30:5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension. Non-serious adverse events and serious events thought to be due to underlying disease or concurrent illness were not recorded. Patients were observed for serious adverse events until catheter function was deemed to be restored or for a maximum of 4 or 6 hours depending on study. For most patients the observation period was 30 minutes to 2 hours. Spontaneously reported deaths and serious adverse events that were not thought to be related to the patient's underlying disease were also recorded during the 30 days following treatment. Four catheter-related sepsis events occurred from 15 minutes to 1 day after treatment with Alteplase, and a fifth sepsis event occurred on Day 3 after Alteplase treatment. All 5 patients had positive catheter or peripheral blood cultures within 24 hours after symptom onset. Three patients had a major hemorrhage from a gastrointestinal source from 2 to 3 days after Alteplase treatment. One case of injection site hemorrhage was observed at 4 hours after treatment in a patient with pre-existing thrombocytopenia. These events may have been related to underlying disease and treatments for malignancy, but a contribution to occurrence of the events from Alteplase cannot be ruled out. There were no reports of intracranial hemorrhage. Three cases of subclavian and upper extremity deep venous thrombosis were reported 3 to 7 days after treatment. These events may have been related to underlying disease or to the long-term presence of an indwelling catheter, but a contribution to occurrence of the events from Alteplase treatment cannot be ruled out. There were no reports of pulmonary emboli. There were no gender-related differences observed in the rates of adverse reactions. Adverse reactions profiles were similar across age subgroups, but there was insufficient enrollment of pediatric patients to draw any conclusions regarding relative adverse event rates (see PRECAUTIONS , Pediatric Use ). Allergic Reactions No allergic-type reactions were observed in the trials in patients treated with Alteplase. If an anaphylactic reaction occurs, appropriate therapy should be administered. Dosage and Administration Cathflo Activase (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. Patients weighing >/=30 kg: 2 mg in 2 mL Patients weighing >/=10 to] FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates abruptly
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