openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Remove all air from the syringe and associated tubing prior to injection. ( 5.1 ) May cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. ( 5.3 ) Establish intravascular catheter patency prior to administration. ( 5.4 ) 5.1 Air Embolism Remove all air from the syringe and associated tubing prior to injection to avoid air embolus with the associated risk of stroke, organ ischemia and/or infarction, and death. 5.2 Infectious Complications Use of a damaged syringe or failure to maintain aseptic technique may result in infection, sepsis and death [ see Dosage and Administration (2) ]. 5.3 Fluid Overload Sodium Chloride Injection USP 0.9% may cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. Consider each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure to determine if use of Sodium Chloride Injection USP 0.9% is appropriate. 5.4 Extravasation Extravasation of the Sodium Chloride Injection USP 0.9% may cause mechanical compression of neurovascular structures. Extravasation of contrast agent may result in tissue injury by osmolar and direct cytotoxicity (see package inserts of specific contrast agents). Establish intravascular catheter patency prior to the administration of Sodium Chloride Injection USP 0.9%.
6 ADVERSE REACTIONS Reported adverse reactions include: air embolization with stroke, chest pain, and dyspnea arrhythmia hypotension myocardial infarction sepsis febrile response local tenderness infection at the site of injection venous thrombosis or phlebitis extending from injection site extravasation fluid overload hypervolemia Adverse reactions due to solution or administration technique may include: air embolism with stroke, chest pain, and dyspnea, arrhythmia, hypotension, myocardial infarction, sepsis, febrile response, local tenderness, infection at the site of injection, venous thrombosis or phlebitis extending from injection site, extravasation, fluid overload and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liebel-Flarsheim Company LLC at 1-855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.