Manual compounding has been associated with the underreporting of errors by a magnitude of 14x1. Approximately 4% of all doses experience a compounding error, meaning that the average hospital facility can encounter ~2,800 potential errors2. Despite the prevalence of compounding errors, only 33% of hospital facilities in the U.S. have adopted pharmacy workflow technology3. The DoseEdge System helps protect patients, pharmacy technicians, and pharmacists through its robust error-catching algorithms that intercepts a compounding error every 22 seconds.
The DoseEdge Pharmacy Workflow Manager is an enterprise solution that interfaces with your Pharmacy Information System (PIS) to automate the process of routing, preparing, inspecting, tracking and reporting on IV and oral liquid doses. The DoseEdge System enables remote verification, allowing pharmacists to verify compounded doses remotely (outside of the cleanroom or hospital facility, where permitted), and to verify doses of sister facilities.
The DoseEdge System helps pharmacies:
- Increase safety from preparation to delivery by intercepting compounding errors before they reach the patient
- Drive efficiency and optimization through automated label sorting and routing to the correct preparation area, and through remote verification of prepared doses
- Reduce waste and drive savings by allowing pharmacists to recycle doses to use for other patients and tracking volume remaining for multi-dose vials
- Achieve regulatory compliance by automating documentation necessary to meet USP 797 standards
- Stephen F Eckel, Jordyn P Higgins, Elizabeth Hess, Thomas Cerbone, Jennifer B Civiello, Christian Conley, Nilofar Jafari, Shailly Shah, Stephen L Speth, Lynn Thornton, Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety, American Journal of Health-System Pharmacy, Volume 76, Issue 12, 15 June 2019, Pages 895–901, https://doi.org/10.1093/ajhp/zxz067
- Baxter Internal Data on File. DoseEdge System 2019 Safety Statistics.
- Pharmacy Purchasing & Products. IV Safety. Volume 12. March 2020.
- Trusted: #1 choice for over 1,000 pharmacies nationwide
- Proven PN performance, with over 100,000,000 bags compounded
- Accurate: Transfer volumes as low as 0.2 mL
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Rx Only: For safe and proper use of this device, please refer to Operator’s Manual
Proven Leadership for automated workflow in the pharmacy.
- The Repeater Pump is a versatile peristaltic pump designed to reduce the workload of pharmacy technicians through automated fluid transfers.
- Quick set up helps streamline pharmacy operations.
- Used for multiple applications – reconstitution of drugs, IV admixing and transfer and filling of IV bags, syringes, elastomeric devices and oral syringes.
Rx Only: For safe and proper use of this device, refer to the Instructions for Use of Appropriate Manual.
- Only 20% Soybean Oil
- Rich in Immune Neutral Omega-9
- Stable and well tolerated
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IMPORTANT RISK INFORMATION FOR CLINOLIPID
Clinolipid (Lipid Injectable Emulsion) for Intravenous Use 20% Indication
Clinolipid injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
Clinolipid injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid injection provides sufficient amounts of essential fatty acids in this population.
The omega-3: omega-6 fatty acid ratio in Clinolipid injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
Important Risk Information
WARNING: DEATH IN PRETERM INFANTS
● Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
● Autopsy findings included intravascular fat accumulation in the lungs.
● Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increase free fatty acid plasma levels following lipid emulsion infusion.
The use of Clinolipid injection is contraindicated in patients with the following:
- Known hypersensitivity to egg or soybean proteins, the lipid emulsion and/or excipients.
- Severe hyperlipidemia or severe disorders of lipid metabolism
Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.
Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.
Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.
Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.
Content of vitamin K may counteract anticoagulant activity.
Clinolipid injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.
Reduce dose of Clinolipid injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL.
The most common (5%) adverse drug reactions reported during Clinolipid injection clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
Clinimix sulfite-free (amino acid in dextrose) Injections
Clinimix E sulfite-free (amino acid with electrolytes in dextrose and calcium) Injections
- Clinimix is a ready-to-use amino acids in dextrose parenteral nutrition (PN) solution NOW AVAILABLE with higher protein (amino acid) and with and without electrolytes.
- Choose from formulations as distinct as your patients
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INDICATIONS AND IMPORTANT RISK INFORMATION FOR CLINIMIX
CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E (amino acids with electrolytes in dextrose with calcium) Injections are indicated as a source of calories and protein (and electrolytes for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E may be used to treat negative nitrogen balance in patients.
Important Risk Information
- CLINIMIX and CLINIMIX E Injections are contraindicated in patients with known hypersensitivity to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications; and in patients with pulmonary edema or acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated in neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
- Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. Excess addition of calcium and phopshate increases the risk of the formation of calcium phosphate precipitates. The solution should be inspected for precipitates before admixing, after admixing, and again before administration. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
- Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.
- Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop.
- Monitor for signs and symptoms of early infections.
- Refeeding severely undernourished patients may result in refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely undernourished patients and slowly increase nutrient intakes.
- CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused through a central catheter.
- CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum which may reach toxic levels with prolonged administration in patients with renal impairment. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
- Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. If CLINIMIX and CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.
- Use CLINIMIX and CLINIMIX E with caution in patients with cardiac insufficiency or renal impairment due to increased risk of electrolyte and fluid volume imbalance.
- Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have been corrected.
- Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma.
- A comprehensive range of amino acids, with 10%, 15% and the only 20% concentration
- Premasol, pediatric amino acid in a plastic-container, backed by calcium-phosphate solubility data
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6% and 10% Premasol sulfite-free (Amino Acid) Injections are indicated for the nutrition support of Infants (including those of very low birth weight) and young children requiring TPN via central or peripheral infusion routes. Please read the accompanying Full Indication(s) and Important Risk Information and the Package Insert for Full Prescribing Information for Premasol.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications and Important Risk Information for CLINISOL
Indications for 15% CLINISOL sulfite-free (Amino Acid) Injection
15% CLINISOL sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.
Important Risk Information
- Contraindicated in patients with hypersensitivity to one or more amino acids, severe liver disease or hepatic coma, Anuria and Metabolic disorders involving impaired nitrogen utilization.
- Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition admixture.
- This injection is for compounding only, not for direct infusion.
- Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. If hyperammonemia develops, discontinue the amino acid administration and reevaluate the patient’s clinical status.
- This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amount of calcium and phosphate solutions, which contain aluminum.
- The administration of 15% Clinisol Injection as part of the total parenteral nutrition with large volumes of hyperosmotic fluids requires periodic monitoring for signs of hyperosmolarity, hyperglycemia, glycosuria, hypertriglyceridemia and volume overload. Initiation and termination of TPN infusion must be gradual to permit adjustment of endogenous insulin release.
- During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop and therefore plasma lipids should be monitored. This syndrome may be prevented or corrected by treatment with intravenous fat emulsions.
- Frequent clinical evaluations and laboratory determinations are necessary for proper monitoring during administration.
- Total parenteral nutrition therapy may include multiple vitamins, trace elements and additional electrolytes. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
- Local adverse reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. Generalized flushing, fever and nausea have been reported during peripheral infusions of amino acid solutions.
- The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.
Please click here for full prescribing information for CLINISOL.
Indications and Important Risk Information for PREMASOL
Indications for 6% and 10% PREMASOL sulfite-free (Amino Acid) Injections
6% and 10% PREMASOL sulfite-free (Amino Acid) Injections are indicated for the nutrition support of Infants (including those of very low birth weight) and young children requiring TPN via central or peripheral infusion routes. Parenteral nutrition with PREMASOL injections is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired, or (3) protein requirements are substantially increased, as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance.
Important Risk Information
- PREMASOL Injections are contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids in the solution.
- This injection is for compounding only, not for direct infusion.
- Safe, effective use of parenteral nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur.
- Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Depending on the patient’s conditions or disease state, additional electrolyte supplementation may be required.
- Fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema can occur with IV administration.
- Administration of amino acids in patients with impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Do not inf use amino acids in patients with azotemia.
- Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
- It is essential that blood ammonia be measured frequently in infants. Hyperammonemia in the syndrome is caused by genetic metabolic defects and is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy.
- This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
- Strongly hypertonic nutrient solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior vena cava.
- Special care must be taken when giving hypertonic dextrose to patients with diabetes or impaired glucose tolerance. To prevent hyperglycemia in such patients, insulin may be required.
- The final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
- Adverse reactions reported in clinical studies were: water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypovolemia. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorous intake can precipitate hypocalcemia with cramps, tetany, and muscular hyperexcitability. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination, if deemed necessary.
Please click here for full prescribing information for PREMASOL.
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