CLINIMIX and CLINIMIX E Injections can align with AAP and ASPEN pediatric parenteral nutrition guidelines to provide pediatric patients with appropriate protein and caloric nutrition therapy.

Indications

CLINIMIX sulfite-free (Amino Acid in Dextrose) and 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 the 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.

Pediatric Use

• Use of CLINIMIX and CLINIMIX E sulfite-free 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.

• Solution administration by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Pediatric Precautions

• Dextrose is safe and effective for the stated indications in pediatric patients.

  • As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of increased risk of hyperglycemia/hypoglycemia.

  • Frequent monitoring of serum glucose concentrations is required in these patient populations.

• Safety and effectiveness of CLINIMIX and CLINIMIX E Injections in pediatric patients have not been established by adequate and well-controlled studies.

  • However, use of amino acid injections in pediatric patients to help offset nitrogen loss or treat negative nitrogen balance is referenced in the medical literature.

Important Risk Information

• It is essential that a carefully prepared protocol based on current medical practices be followed, preferably by an experienced team. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.

• CLINIMIX and CLINIMIX E 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.

• Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.

• Use with caution when administering to patients with anuria or renal insufficiency, pulmonary insufficiency, or heart disease. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema.

• Metabolic complications have been reported, such as acid-base, electrolyte, and blood glucose imbalances, elevated liver enzymes, and osmotic diuresis and dehydration.

• Other adverse reactions that may occur include febrile response, infection at the site of injection, extravasation, and hypervolemia. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis.

• This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired.

• CLINIMIX and CLINIMIX E Injections must be admixed prior to infusion.