Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Inclusion Criteria:

• In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
• Written consent from the subject

Exclusion Criteria:

• Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
• Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
• Severe liver insufficiency
• Severe blood coagulation disorders
• Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
• Unstable conditions
• Unstable angina pectoris
• Acute shock
• Chemotherapy within 4 weeks before start of the trial
• Chemotherapy during the trial
• Subjects for whom the trial treatment is not appropriate
• Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.
• Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
• Prior inclusion in the present study
• Any other feature that in the opinion of the investigator should preclude study participation