Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.
• Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with TRAVASOL.
Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Metabolic acidosis • Alkalosis • Osmotic diuresis and dehydration, • Rebound hypoglycemia • Hypo- and hyper-vitaminosis Adverse reactions include pulmonary vascular emboli, hypersensitivity reactions infection, refeeding syndrome, hyperglycemia and hyperosmolar hyperglycemic state, vein thrombosis, elevated liver function tests, hyperammonemia, electrolyte imbalances, and hypervolemia.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
(5.1) • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur.
(5.2) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State : monitor for signs and symptoms;
monitor laboratory parameters.
(5.3 , 5.4 , 5.5) • Vein Damage and Thrombosis: solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter.
Like all medications, Travasol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: