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    Intralipid and other Lipid Emulsions
    Intralipid and other Lipid Emulsions
    Intralipid and other Lipid Emulsions
    Ebook270 pages2 hours

    Intralipid and other Lipid Emulsions

    By Joseph Eldor

    ()

    Read preview

    About this ebook

    Contents

    1. CELEPID
    2. ClinOleic
    3. Deltalipid
    4. ELOLIPID
    5. LÍPIDOS
    6. INTRALIPID
    7. IVELIP
    8. Lipidem
    9. Lipofundin
    10. Liposyn
    11. Lipovenös
    12. Nutriflex
    13. SMOFLIPID
    14. Omegaven
    15. Kombilipid
    16. Lipoplus
    17. Optilipid
    18. Salvilipid
    19. STRUCTOLIPID

    LanguageEnglish
    PublisherJoseph Eldor
    Release dateMar 2, 2018
    ISBN9781370743292
    Intralipid and other Lipid Emulsions

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      Book preview

      Intralipid and other Lipid Emulsions - Joseph Eldor

      INTRALIPID

      and other Lipid Emulsions (LE)

      Joseph Eldor, MD

      Joseph Eldor, MD

      Theoretical Medicine Institute, Jerusalem, Israel

      [email protected]

      Copyright ©2018 by Joseph Eldor, MD

      Smashwords Edition

      All rights reserved. No part of this book may be used or reproduced in any manner whatsoever without written permission, except in the case of brief quotations embodied in critical articles or reviews. Please do not participate in or encourage the piracy of copyrighted materials in violation of the author’s rights. Purchase only authorized editions.

      Contents

      1. CELEPID

      2. ClinOleic

      3. Deltalipid

      4. ELOLIPID

      5. LÍPIDOS

      6. INTRALIPID

      7. IVELIP

      8. Lipidem

      9. Lipofundin

      10. Liposyn

      11. Lipovenös

      12. Nutriflex

      13. SMOFLIPID

      14. Omegaven

      15. Kombilipid

      16. Lipoplus

      17. Optilipid

      18. Salvilipid

      19. STRUCTOLIPID

      1. CELEPID

      Description
CELEPID - the parenteral fat emulsion - is a milky-white emulsion of soybean oil-in-water, and is used as a source of concentrated energy as well as to counter essential fatty acid deficiencies in critically ill patients. World-class quality of raw material, emulsion manufacturing technology, and above all our commitment to nutrition makes CELEPID one of the safest lipid emulsion products in the world.

      Indications
- Parenteral nutrition for pre, peri, and post operative support
- Inadequate or impossible oral feeding, e.g., malabsorption, G.I. bleeding, chronic diarrhoea and vomiting
- G.I. Tract disease / disorders : short gut syndrome, inflammatory bowel disease, tumors, pancreatitis, peritonitis, fistula, ulcerative colitis, etc.
- Cancer and related cachexia
- Burns
- Hypermetabolism during stress
- Sepsis
- Prolonged unconsciousness, head injury, poisoning
- Prophylaxis & therapy for Essential Fatty Acids Deficiency (EFAD)

      Product Variants & Features

      2. ClinOleic

      ClinOleic 20%

      Baxter Healthcare Ltdcontact details

      Active ingredient

      • olive oil, refined

      • soya bean oil, refined

      Legal Category

      POM: Prescription only medicine

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      • SmPC

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      Last updated on eMC: 01 Apr 2015

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      • 1. Name of the medicinal product

      • 2. Qualitative and quantitative composition

      • 3. Pharmaceutical form

      • 4. Clinical particulars

      • 4.1 Therapeutic indications

      • 4.2 Posology and method of administration

      • 4.3 Contraindications

      • 4.4 Special warnings and precautions for use

      • 4.5 Interaction with other medicinal products and other forms of interaction

      • 4.6 Pregnancy and lactation

      • 4.7 Effects on ability to drive and use machines

      • 4.8 Undesirable effects

      • 4.9 Overdose

      • 5. Pharmacological properties

      • 5.1 Pharmacodynamic properties

      • 5.2 Pharmacokinetic properties

      • 5.3 Preclinical safety data

      • 6. Pharmaceutical particulars

      • 6.1 List of excipients

      • 6.2 Incompatibilities

      • 6.3 Shelf life

      • 6.4 Special precautions for storage

      • 6.5 Nature and contents of container

      • 6.6 Special precautions for disposal and other handling

      • 7. Marketing authorisation holder

      • 8. Marketing authorisation number(s)

      • 9. Date of first authorisation/renewal of the authorisation

      • 10. Date of revision of the text

      This information is intended for use by health professionals

      1. Name of the medicinal product

      ClinOleic 20%

      2. Qualitative and quantitative composition

      Composition per 100 ml

      Refined olive oil and refined soybean oil*: 20.00g

      corresponding to a content of essential fatty acids: 4.00g

      *Mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%)

      Energy content: 2000 kcal/l (8.36 MJ/l)

      Lipid content (olive and soybean oil): 200 g/l

      Osmolarity: 270 mOsm/l

      pH: 6-8

      Density: 0.986

      ClinOleic contains 47 milligrams or 1.5 mmol of phosphorus per 100 ml

      3. Pharmaceutical form

      Emulsion for infusion.

      ClinOleic 20% contains 200 g/l of lipids corresponding to 200 mg/ml.

      4. Clinical particulars

      4.1 Therapeutic indications

      ClinOleic 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition.

      4.2 Posology and method of administration

      The emulsion is for administration by intravenous infusion as part of a parenteral nutrition regimen.

      Posology

      The posology depends on energy expenditure, the patient's clinical status, 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.

      Adult patients

      Up to 60% of the energy requirements of the patient can be provided by ClinOleic 20%.

      The infusion should be started at a rate of 0.5ml per minute for the first 15-30 minutes. The rate can then be increased to allow 500ml of ClinOleic 20% to be administered on the first day. On subsequent days the dose may be increased to a maximum of 2.5g lipids/kg of body weight with a maximum infusion rate of 0.25g lipids/kg/hour.

      Paediatric patients

      Up to 60% of the energy requirements of the patient can be provided by ClinOleic 20%.

      The infusion should be started at a rate of 0.05ml per minute for the first 10-30 minutes. Never exceed an infusion rate of 0.25g lipids/kg/hour. The daily dosage should not exceed 4g lipids/kg of body weight.

      In small for gestational age or premature infants with impaired capacity to metabolise fat, initial dosage should be 0.5g lipids/kg/day. This dosage can be increased daily by 0.25g lipids/kg/day up to a maximum dose of 3g lipids/kg/day.

      Intravenous fat clearance must be monitored closely every day. In the absence of monitoring of serum triglycerides, the dosage should not exceed 2g lipids per kg body weight in 24 hours.

      Method of administration

      Intravenous infusion:

      When administered as part of a complete nutrition admixture (with glucose and amino acids) the central or peripheral venous route should be chosen depending on the osmolarity of the final admixture.

      In rare cases, when infused alone as a complementary support to oral or enteral nutrition, ClinOleic 20% can be administered via central or peripheral vein.

      It is recommended that after opening the bag, the contents should be used immediately, and should not be stored for a subsequent infusion.

      The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation.

      The administration flow rate must be adjusted taking into account the dose being administrated, the daily volume intake, and the duration of the infusion (see Section 4.9).

      Treatment with parenteral nutrition may be continued for as long as it is justified by the clinical situation of the patient.

      Usage in nutritive admixtures (with glucose and amino acids)

      Before administration to the patient, the compatibility of the components and stability of the admixture must be checked. Admixing should be accompanied by gentle agitation during preparation under strict aseptic conditions.

      4.3 Contraindications

      The use of ClinOleic is contra-indicated in the following situations:

      hypersensitivity to egg protein, soya protein or peanut protein or to any of the active substances or excipients.

      - severe hyperlipidaemia and severe disorders of lipid metabolism characterised by hypertriglyceridemia. Lipoid nephrosis and acute pancreatitis if accompanied by hyperlipaemia.

      4.4 Special warnings and precautions for use

      WARNINGS

      The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction (such as sweating, fever, shivering, headache, skin rashes or dyspnoea) develop. This medicinal product contains soya-bean oil and egg phospholipids. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.

      Infection and sepsis complications

      Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state. Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral formulations, or poor maintenance of catheters and contaminated solutions. Immunosuppression and hyperglycemia may predispose patients to infectious complications.

      The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation of the nutritional formula. Careful monitoring of signs, symptoms, and laboratory test results (including fever, chills, leukocytosis, and hyperglycaemia), and frequent checks of the access device for technical complications can help recognize early infections.

      Hepatic Insufficiency

      Use with caution in patients with hepatic insufficiency. Regular clinical and laboratory tests are required, particularly blood glucose, electrolytes and triglycerides (not exceeding 3 mmol/L during infusion).

      Haematologic and thrombophlebitis

      Use with caution in patients with coagulation disorders and anaemia. Blood count and coagulation parameters should be closely monitored

      Thrombophlebitis may develop, particularly if peripheral veins are used. The catheter insertion site must be monitored daily for local signs of thrombophlebitis.

      Fat overload syndrome may be caused by overdose and/or infusion rate higher than recommended. However, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions, e.g. in patients with reduced or limited ability to metabolize the lipids contained in CLINOLEIC 20%. This syndrome is associated with a sudden deterioration in the patient's clinical condition and is characterized by findings such as fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.

      ClinOleic 20% is administered as part of a parenteral nutrition regimen. Refeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome. The syndrome is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes, while avoiding overfeeding, can prevent these complications.

      Patients at risk of refeeding syndrome include those with anorexia nervosa, chronic malnutrition (due to age or carcinoma), chronic alcoholism, prolonged fasting, or postoperative patients.

      Baxter has not performed any compatibility studies of additions made directly to the Clinoleic 20% emulsion container. Destabilization of the lipid emulsion may result from such additions. If admixture into the Clinoleic 20% emulsion container is deemed necessary, insure that additives are compatible with the emulsion. Any additions to the container should be performed under strict aseptic conditions.

      If ClinOleic 20% is mixed with glucose and/or amino acid solutions, the compatibility should be checked before administration (see Sections 6.2 and 6.6). Formation of precipitates could result in microvascular pulmonary emboli.

      PRECAUTIONS

      As for any parenteral infusion, particular attention should be given on monitoring fluid status, especially in

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