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CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections

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CLINIMIX (Amino Acid in Dextrose) Injections and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections

PI: CLINIMIX PI: CLINIMIX E
  • Essential components of PN therapy available in a sterile, dual-chamber, clarity container
  • Variety of formulations, available in 1L and 2L bags, offer clinical flexibility to support patient specific needs
  • Up to 100 grams of protein in a 2 L bag
  • The only available manufacturer-prepared premix PN solution with and without electrolytes
  • Allows for the addition of lipids to the bag or the option to deliver lipids separately via IV piggyback
  • Appropriate for Pediatric and Adult patient populations
Indications and Important Risk Information
Indications

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. Excessive 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
Please see accompanying full Prescribing Information
CBaxter, Clinimix, Clinimix E are trademarks of Baxter International Inc.
More Information

USMP/78/14-0007a(1) 11/16