DESCRIPTION

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.
 
CLINICAL PHARMACOLOGY

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections administered intravenously provide biologically utilizable source material for protein synthesis and have value as a source of calories and water.
 
INDICATIONS AND USAGE

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:

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 Administration: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.

Peripheral Vein Administration: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.

CONTRAINDICATIONS

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients hypersensitive to one or more amino acids, and in patients with severe liver disease or hepatic coma.

Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

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 i