Olive Oil: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 17, 2026🚩 Report this page

Olive Oil

Active ingredient

Sold as OLIMEL 7.6% · CLINOLEIC 20% · OLIMEL 5.7% E · OLIMEL 7.6% E · PERIOLIMEL 2.5% E

CA Health CanadaGB MHRA

Drug class: -
Availability: See label
Routes: Intravenous
Markets covered: 2
Products on record: 6

Overview

Olive Oil is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	5	March 22, 2025
GB United Kingdom	MHRA	1	April 17, 2026

CACanada· Health Canada

5 products

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20% is indicated for: • parenteral nutrition in adults when oral or enteral nutrition is not possible, insufficient, or contraindicated. • As a lipid emulsion, CLINOLEIC 20% provides a source of fat (or lipids) for adult patients requiring parenteral nutrition.
1 Pediatrics Clinical data on the use of CLINOLEIC 20% in the pediatric population are not provided. 2 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.

How to take

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised April 17, 2026[2]

Parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

How to take

Sources & citations

[1]Health Canada (DPD) · 02344327 · revised March 22, 2025
[2]MHRA (UK) · PL001160362 · revised April 17, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

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.
These reactions are listed by MedDRA System Order Class (SOC), then by Preferred Term in order of severity.
BLOOD AND LYMPHATIC SYSTEM DISORDERS:
Thrombocytopenia IMMUNE SYSTEM DISORDERS: Hypersensitivity GASTROINTESTINAL DISORDERS: Diarrhea SKIN AND SUBCUTANEOUS DISORDERS: Urticaria, Pruritus GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Chills INVESTIGATIONS: International normalized ratio decreased Class / Other Reactions Other adverse reactions associated with similar products include: • Fat overload syndrome, Thrombocytopenia • Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Cholecystitis, Cholelithiasis

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

, 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 .......................................................................................
17 13 PHARMACEUTICAL INFORMATION ............................................................................ 17 14 CLINICAL TRIALS ........................................................................................................

This is not medical advice. Consult a qualified healthcare professional.

Posology The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolize the constituents of OLICLINOMEL, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.
The administration may be continued for as long as is required by the patient’s clinical conditions.
Maximum daily dose:
The maximum daily dose should not be exceeded in adult and paediatric patients. Due to the static composition of the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag.
35 g/kg/day (approximately 1 to 2 g amino acids/kg/day). Energy requirements vary depending on the patient's nutritional state and level of catabolism. On average these are 20 to 40 kcal/kg/day.
Maximum daily dose:
The maximum daily dose is defined by the energy component. e. 2310 ml of the emulsion for infusion for a patient weighing 70 kg. In adolescent and children greater than two years of age There have been no studies performed in the pediatric population.
Posology:
The dosage is based on fluid intake and daily nitrogen requirements. These intakes should be adjusted to take account of the child's hydration status. Daily fluid, nitrogen, and energy requirements continuously decrease with age. 06 a: Recommended values from 2018 ESPGHAN/ESPEN/ESPR Guidelines b: Glucose concentration is the limiting factor for maximum hourly rate in both age groups Method and duration of administration For single use only.
It is recommended that after opening the bag, the contents should be used immediately and not stored for subsequent infusion.
Appearance after reconstitution:
Homogeneous liquid with a milky appearance. 6. BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL VEIN ONLY (Due to high osmolarity of OLICLINOMEL) The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours.
4). Normally, the flow rate should be increased gradually during the first hour. e. 06 g lipids/kg body weight /hour. 15 g/kg/hour lipids, except in particular cases.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[2]

9). g. sweating, fever, shivering, headache, skin rashes, dyspnoea, bronchospasm) should be cause for immediate discontinuation of the infusion. OLICLINOMEL N4-550E, N7-1000E, and N8-800 have been used in 286 patients in four (4) clinical trials.
Three (3) studies evaluated the ease of use, the safety, and the nutritional efficiency of the product. Two of the 3 studies were open-label, non-comparative studies in patients undergoing gastrointestinal surgery for gastric cancer.
In these trials, a total of 36 patients received up to 40 mL/kg/d over 5 days in OLICLINOMEL N4-550E study (N = 20), and up to 36 mL/kg/d over 5 days in OLICLINOMEL N7-1000E study (N = 16). , postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) associated with cardiac, respiratory, gastrointestinal, metabolic, nervous system, infectious, renal, and neoplastic diseases.
The last study was a randomized, open-label, active controlled trial, to assess the safety and efficacy of OLICLINOMEL N4-550E in 226 patients admitted to a surgical service. 3% underwent surgery (most were abdominal surgery for gastrointestinal disease).
The study treatments were intended to provide 25 kcal/kg/day over 5 to 14 days. The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to OLICLINOMEL: System Organ Class (SOC) Preferred MedDRA Term Frequencya Hypersensitivity Uncommonb IMMUNE SYSTEM DISORDERS Bronchospasm (as manifestation of hypersensitivity) Not knownc INJURY, POISONING AND PROCEDURAL COMPLICATIONS Fat overload syndrome Not knownc NERVOUS SYSTEM DISORDERS Tremor Not knownc GASTROINTESTINAL DISORDERS Diarrhoea Vomiting Nausea Not knownc Not knownc Not knownc SKIN AND SUBCUTANEOUS TISSUE DISORDERS Erythema* Hyperhidrosis Not knownc Not knownc MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS Pain in extremity Muscle spasm Not knownc Not knownc GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Infusion site oedema / swellingd Infusion site paind Infusion site extravasation Infusion site reaction Pyrexia Infusion site vesiclesd Malaise Chills Catheter site phlebitisd Localized oedemad Peripheral oedemad Feeling hotd Inflammation Infusion site necrosis/ ulcer* Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc Not knownc a: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100): rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
b: ADR reported during clinical trials.
These studies included only 286 patients c:
ADR reported during postmarketing experience with OLICLINOMEL. 4) • Blood and lymphatic system disorders (frequency not known): thrombocytopenia • Hepatobiliary disorders (frequency not known): cholestasis, hepatomegaly, jaundice • Immune system disorders (frequency not known): hypersensitivity • Investigations (frequency not known): gamma-glutamyltransferase increased, hepatic enzyme increased (including aspartate aminotransferase increased, alanine aminotransferase increased, transaminases increased), blood triglycerides increased, blood alkaline phosphatase increased, blood bilirubin increased • Renal and urinary disorders (frequency not known): azotemia Description of selected adverse reactions • Fat Overload Syndrome Fat overload syndrome has been reported with the administration of OLICLINOMEL and/or similar products.
g. overdose and/or infusion rate higher than recommended; however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions. The reduced or limited ability to metabolize the lipids contained in OLICLINOMEL, accompanied by prolonged plasma clearance may result in a "fat overload syndrome".
g. coma), requiring hospitalization. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. Paediatric population Thrombocytopenia has been reported in children receiving lipid infusions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[2]

Do not administer through a peripheral vein An excessively fast administration of total parenteral nutrition (TPN) solutions, including OLICLINOMEL, may result in severe or fatal consequences. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes, dyspnoea or bronchospasm) develop.
This medicinal product contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed. 3). Specific clinical monitoring is required when an intravenous infusion is started.
Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion. Ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions even via different infusion lines or different infusion sites.
Cefriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt solution to avoid precipitation.
In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites.
2). Pulmonary vascular precipitates causing pulmonary vascular embolism and respiratory distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. 2). Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, the stability of the lipid emulsion).
6). Vascular-access infection and sepsis are complications that may occur in patients receiving parenteral nutrition, particularly in case of poor maintenance of catheters, immunosuppressive effects of illness or drugs. Careful monitoring of signs, symptoms, and laboratory tests results for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognize early infections.

This is not medical advice. Consult a qualified healthcare professional.