| Product Description: | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. |
|---|---|
| Status: | Ongoing |
| City: | Deerfield |
| State: | IL |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | US Nationwide |
| Classification: | Class I |
| Product Quantity: | 7,388 bags |
| Reason For Recall: | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. |
| Recall Initiation Date: | 20131118 |
| Report Date: | 20140326 |
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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 sulfite-free (Amino Acid in Dextrose) 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/dextrose 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/dextrose 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.
Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
CLINIMIX sulfite-free (Amino Acid in Dextrose) 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:
- the alimentary tract cannot or should not be used,
- gastrointestinal absorption of protein is impaired, or
- 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.
History
There is currently no drug history available for this drug.
Other Information
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.
The sulfite-free Amino Acid Injections in the outlet port chamber are solutions of essential and nonessential amino acids.
The Dextrose Injections, USP 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.
Sources
Clinimix Manufacturers
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Baxter Healthcare Corporation
![Clinimix (Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose) Injection [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clinimix | Baxter Healthcare Corporation
If a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition should be considered.
The total daily dose of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.
Recommended Dietary Allowances 1 of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants up to three months of age. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.
For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.
Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to these admixed injections, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.
Patients receiving CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections without electrolytes should be monitored frequently and their electrolyte requirements individualized.
Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.
Maintenance vitamins, additional electrolytes, and trace elements should be administered as required.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
Fat emulsion administration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.
Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid/dextrose injections in the CLARITY Container to supplement caloric intake.
Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.
Do not administer unless seal between chambers is opened, other seals are intact, and solution is clear and thoroughly mixed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
A slight yellow color does not alter the quality and efficacy of this product.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.
Do not store solutions containing additives. These amino acid with electrolytes/dextrose with calcium injections should be used promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours.
1Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989).
Pediatric Use:Use of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solution administrations by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Central Vein Administration:Hypertonic mixtures of amino acid/dextrose injections may be administered safely by continuous infusion through a central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient’s tolerance to dextrose, as indicated by frequent determinations of urine and blood sugar levels. Daily intake of amino acids in dextrose should be increased gradually to the maximum required dose.
Sudden cessation in administration of these admixed injections may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.
Peripheral Vein Administration:For patients requiring parenteral nutrition in whom the central vein route is not indicated, low concentration amino acid/dextrose injections may be administered by peripheral vein. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
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