Clinimix

Dosage Modifications in Patients with Kidney Disease Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of CLINIMIX administered as required [see Warnings and Precautions ] . Chronic kidney disease patients with less than nephrotic range proteinuria require 0.8 g of protein/kg/day.

Chronic kidney disease patients with nephrotic range proteinuria require 0.8g of protein/kg/day plus 1g of protein for each gram of proteinuria. Patients needing dialysis should receive from 1.2 of protein/kg/day up to a maximum of 2.5 g of protein/kg/day depending on the nutritional status and the dialysis modality. Serum electrolyte levels should be closely monitored.

The CLINIMIX dosage can be adjusted based on the severity of kidney disease, supplementing protein as indicated. If required, additional amino acids may be added to the CLINIMIX container or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Baxter.

Preparation Prior to Administration

CLINIMIX is available in a three port container configuration and a two port container configuration. o Three Port Container : the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. o Two Port Container : the ports consist of one medication port and one outlet port.

Additives, including lipids, can be introduced to the container through the medication port on the two port container.

Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.

Inspect the container prior to activation. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow.

Discard if the seal is broken or if the solution is bright yellow or yellowish brown. o Check for minute leaks by separately squeezing each chamber. If external leaks or leakage between the chambers are found, discard solution as sterility or stability may be impaired.

Lipids and/or additives can be introduced to the container after opening seal between chambers. Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced. Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.

Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions ] .

Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product. If lipid has been added, ensure the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion.

Discard the admixture if any of the above are observed.

Important Administration Instructions

Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.

Use a dedicated line without any connections to avoid air embolism.

CLINIMIX is for intravenous infusion only 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 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions ] . o For central vein infusion only: CLINIMIX 4.25/10, 5/15, 5/20, 8/10, 8/14 o For central or peripheral vein infusion: CLINIMIX 4.25/5, 6/5

The solution should be inspected for precipitates before admixing, after admixing, and again before administration.

Use a 0.22 micron filter for administration of CLINIMIX. If a lipid is also administered, use a 1.2 micron filter.

If lipid emulsion is added, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.

Preparation and Addition of Lipid Emulsion Three Port Container 1. Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3. 2. Prepare lipid emulsion transfer set following instructions provided. 3. Attach transfer set to lipid emulsion container using aseptic technique. 4. Twist off protector on the additive port of the container. 5.

Attach the transfer set to the exposed additive port. 6. Open clamp on transfer set. 7. After completing transfer, use appropriate plastic clamp or metal ferrule to seal off additive port tube. 8. Remove transfer set. 9. Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter.

Check for leaks. Two Port Container 1. Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3 . 2. Prepare lipid emulsion transfer set following instructions provided. 3. Attach transfer set to lipid emulsion container using aseptic technique. 4. Prepare medication port. 5. Using a 19 to 22 gauge needle, puncture resealable medication port. 6.

Open clamp on transfer set and transfer lipid emulsion. 7. Remove needle. 8. Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks . Storage Once Lipids are Added: Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, no longer than 24 hours.

After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any mixture remaining must be discarded.

Recommended Dosage in Pediatric Patients The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia [see Use in Specific Populations ] . Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

The infusion rate and volume should be determined by the consulting physician experienced in pediatric intravenous fluid therapy. In pediatric patients, CLINIMIX is dosed on the basis of protein provided as amino acids. The recommended dosage, by age group is provided in Tables 3 - 6 . Infusion rates are based on protein and do not take carbohydrates, fluid or electrolytes into consideration.

This product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants. If possible, these amino acids should be added to this product if used in this pediatric population. [See table below.] [See table below.] [See table below.] [See table below.]