|Product Description:||Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.|
|Voluntary/Mandated:||Voluntary: Firm Initiated|
|Initial Firm Notification:||Letter|
|Distribution Pattern:||US Nationwide|
|Product Quantity:||7,068 bags|
|Reason For Recall:||Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.|
|Recall Initiation Date:||20131118|
Clinimix E Recall
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Questions & Answers
Side Effects & Adverse Reactions
Additives may be incompatible including fat emulsions. Consult with pharmacist, if available.
When introducing additives, use aseptic techniques. Mix thoroughly.
Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
These CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections, must be admixed prior to infusion. For admixing instructions see DIRECTIONS FOR USE OF PLASTIC CONTAINER.
The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis. After mixing, strongly hypertonic nutrient injections should only be administered through an indwelling intravenous catheter with the tip located in a large central vein, such as the superior vena cava.
Proper administration of these admixed amino acid with electrolytes/dextrose with calcium injections requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, complete blood count with differential, carbon dioxide combining power or content, serum osmolarities, blood cultures, and blood ammonia levels.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor, and coma.
Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
Conservative doses of these admixed amino acid with electrolytes/dextrose with calcium injections should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient’s clinical status be reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
These admixed injections should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels 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.
Research indicates that patients with impaired kidney function, including premature neonates, 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.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are indicated as a caloric component in a parenteral nutrition regimen and as the protein (nitrogen) source for offsetting nitrogen loss or for 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.
Central vein infusion should be used when amino acid solutions are admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.
For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein.
There is currently no drug history available for this drug.
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.
The sulfite-free Amino Acid Injections with Electrolytes in the outlet port chamber are solutions of essential and nonessential amino acids provided with electrolytes.
The Dextrose Injections with Calcium in the injection port chamber are solutions for fluid replenishment and caloric supply.
After opening the seal between the chambers and mixing thoroughly, the admixed product is intended for intravenous use. See Table 1 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product.
The CLARITY Dual Chamber Container is a lipid-compatible plastic container (PL 2401 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.