Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Contraindications

4 CONTRAINDICATIONS The use of CLINIMIX E is contraindicated in: 1. Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 2. Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3) ] . 3. Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. 4. Patients with pulmonary edema or acidosis due to low cardiac output. • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Known hypersensitivity to one or more amino acids or dextrose. ( 4 ) • Inborn errors of amino acid metabolism. ( 4 ) • Patients with pulmonary edema or acidosis due to low cardiac output. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.