Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

Inclusion Criteria:

- Male or female patients 2 to 16 years of age

- Patients who require at least 80% of their caloric intake as PN at study start, and in
whom an indication for PN is expected for at least 5 days

- Patients who require a central venous line to receive PN or already have a central
venous line in place for other reasons

- Written informed consent from legal representative(s)

Exclusion Criteria:

- Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn
products, or to any of the active substances or excipients

- Severe hyperlipidemia or severe disorders of lipid metabolism characterized by
hypertriglyceridemia (serum triglyceride concentration >1,000 g/dL).

- Inborn errors of amino acid metabolism

- Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency,
myocardial infarction, acidosis and hemodynamic instability requiring significant
vasopressor support)

- Hemophagocytic syndrome.

- PN in the last 7 days prior to study enrollment.

- Need for chronic PN before study start

- Liver enzymes (either AST, ALT, GGPT), or direct bilirubin exceeding 2 x upper limit
of normal range

- Pathologically altered level of any serum electrolyte (sodium, potassium, magnesium,
calcium, chloride, phosphate) unless corrected prior to the start of study treatment

- Pathologically altered blood pH, or oxygen saturation, or carbon dioxide unless
corrected prior to the start of study treatment

- Pregnancy or lactation

- Participation in another clinical study