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American Regent, Inc.
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SELENIOUS ACID INJECTION
For intravenous use
INDICATIONS AND USAGE
Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Important Administration Information
Selenious Acid Injection is supplied as a pharmacy bulk package for admixing use only. It is not for direct intravenous infusion.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
Vein Damage and Thrombosis: Selenious Acid Injection has a low pH and must be prepared and used as an admixture in PN solutions. Solutions with osmolarity of 900 mOsm/L or more must be infused through a central venous catheter.
Aluminum Toxicity: Selenious Acid Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which also contain aluminum.
Monitoring and Laboratory Tests: Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.
No selenium-related adverse reactions have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered PN solutions containing selenious acid within the recommended dosage range.
USE IN SPECIFIC POPULATIONS
Pregnancy: Risk Summary: Administration of the recommended dose of Selenious Acid Injection in PN is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Lactation: Risk Summary: Selenium is present in human milk. There is no information on the effects of selenious acid on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Selenious Acid Injection and any potential adverse effects on the breastfed infant from Selenious Acid Injection or from the underlying maternal condition.
Pediatric Use: Safety and dosing recommendations in pediatric patients are based on clinical experience.
Geriatric Use: Dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at
1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.