CLINOLEIC

1 Dosing Considerations Dosing of CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20% is based on the energy requirements of the individual patient. Lipids present only one component in parenteral nutrition. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary.

Lipid content:

CLINOLEIC 20% contains 200 g/L of lipids (200 mg/mL), corresponding to a content of 40 g/L essential fatty acids.

Product Monograph Template Date:

September 2020 CLINOLEIC 20% (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) Page 5 of 30 Care must be taken in co-administering the components of parenteral nutrition. If CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20% is to be used as a component of parenteral nutrition, compatibility of the resulting infusion should be evaluated and ensured prior to administration to the patient.

2 Recommended Dose and Dosage Adjustment The dosage depends on energy expenditure, and the patient’s clinical status (degree of stress and daily fatty acid needs), body weight, and ability to metabolize CLINOLEIC 20%, as well as additional energy given orally/enterally.

Therefore, the dosage should be individualized and the bag size chosen accordingly. The maximum daily dose of CLINOLEIC 20% should be based on individual total nutritional requirements and patient tolerance. Adults The usual dosage is 1 to 2 g lipids/kg/day.

5 mL (10 drops) per minute for 10 minutes then gradually increased until reaching the required rate after half an hour. The administration flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion (see

1 Adverse Reaction Overview Adverse drug reactions occurred with similar frequencies and in similar proportions of patients treated with CLINOLEIC 20% or refined soybean oil lipid emulsion as evidenced by data obtained from 261 adult patients treated with CLINOLEIC 20% in 14 completed clinical efficacy and safety studies.

The most frequent adverse drug reactions noted for CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20% in clinical trials were nausea/vomiting and muscle spasm. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Table 1 reflects adverse reactions from exposure to CLINOLEIC 20% in 261 adult patients in 14 active-controlled studies with refined soybean oil lipid emulsions. None of the adverse drug reactions were considered serious reactions. 2%) *N = Number of patients reporting this ADR.

** Includes Bilirubin Conjugated Increased ***includes reports of Hepatic Function Abnormal, Hepatic Enzyme Increased, Blood Alkaline Phosphatase Increased, Gamma Glutamyl Transferase Increased, Blood Alkaline Phosphatase Abnormal, Gamma Glutamyl Transferase Abnormal In an open-label, non-comparative study of patients with chronic intestinal failure treated with CLINOLEIC 20% for at least six months, two of 13 patients experienced a reaction considered possibly related to the study treatment (fever suspected to be linked to line infection, and severe pneumonia resulting in death).

All patients in this study had severe digestive diseases and were dependent on supplemental parenteral nutrition (to meet their required fat/lipids needs) for 1 to 9 years prior to entry into the clinical trial. 5 Post-Market Adverse Reactions In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience.

, Immune 08/2023 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING 08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................

6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................

13 9 DRUG INTERACTIONS ................................................................................................ 14 10 CLINICAL PHARMACOLOGY .......................................................................................

15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 15 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 16 PART II: SCIENTIFIC INFORMATION .......................................................................................

The use of CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20% is contraindicated in the following populations/situations: • Known hypersensitivity to egg, soybean or peanuts proteins, or to any active ingredient (olive or soybean oil), excipients, or components of the container.

For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia • Hypertriglyceridemia-associated acute pancreatitis