Selenium

4 CONTRAINDICATIONS None. None. 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. Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central venous catheter. ( 2.1 , 5.2 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. ( 5.3, 5.4 ) 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. ( 5.4 , 2.4 ) 5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition.

The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops. 5.3 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. Patients with impaired kidney function, including preterm neonates, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration. Exposure to aluminum from Selenious Acid Injection is not more than 0.6 mcg/kg/day. When prescribing Selenious Acid Injection for use in parenteral nutrition containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use in Specific Populations] . 5.4 Monitoring and Laboratory Tests Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters during treatment [see Dosage and Administration] .

Important Administration Information Selenious Acid Injection is supplied as a pharmacy bulk package or single-dose vial for admixing use only. It is not for direct intravenous infusion . Prior to administration, Selenious Acid Injection must be transferred to a separate parenteral nutrition container, prepared and used as an admixture in parenteral nutrition solutions.

The Pharmacy Bulk Package vial of Selenious Acid Injection is intended for dispensing of single doses to multiple patients in a pharmacy admixture program. The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.

Solutions with osmolarity of 900 mOsmol/L or greater must be infused through a central venous catheter [see Warnings and Precautions] .

Preparation and Administration Instructions

Selenious Acid Injection is not for direct intravenous infusion . Prior to administration, Selenious Acid Injection must be prepared and used as an admixture inparenteral nutrition solutions.

Selenious Acid Injection is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.

Visually inspect the prepared parenteral nutrition solution containing Selenious Acid Injection for particulate matter before admixing, after admixing, and prior to administration.

Preparation Instructions for Admixing Using a Parenteral Nutrition Container Inspect Selenious Acid Injection vials for particulate matter. Transfer Selenious Acid Injection to the parenteral nutrition solution following the admixture of amino acids, dextrose, lipid (if added), and electrolytes solutions. Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation.

Consult with pharmacist, if available. Questions about compatibility may be directed to America Regent. If it is deemed advisable to introduce additives to the parenteral nutrition container, use aseptic technique. Inspect the final parenteral nutrition containing Selenious Acid Injection to ensure that: Precipitates have not formed during mixing or addition of additives.

The admixed emulsion has not separated, if a lipid emulsion has been added. Separation of the admixed emulsion can be visibly identified by a yellowish streaking of the accumulation of yellowish droplets. Discard if any precipitates are observed. Stability and Storage Single-dose vial (2 mL): Discard unused portion. Pharmacy Bulk Package vial (10 mL): Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the content.

Use Selenious Acid Injection for admixing promptly once the sterile transfer set has been inserted into the Pharmacy Bulk Package container or not more than 4 hours at room temperature (25ºC/77ºF) after the container closure has been penetrated. Discard any remaining drug. Use parenteral nutrition solutions containing Selenious Acid Injection promptly after mixing.

Any storage of the admixture should be under refrigeration from 2°C to 8°C (36°F to 46°F) and limited to a period of time no longer than 9 days. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Discard any remaining admixture. Protect the admixed parenteral nutrition solution from light.