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OLICLINOMEL N7-1000E is a brand name for Olive Oil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Verbatim from this product's MHRA label. Tap a section to expand.
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.
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).
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).
The use of OLICLINOMEL is contraindicated in the following situations: - In premature neonates, infants and children less than 2 years old, as the calorie-nitrogen ratio and energy supply are inappropriate. 1. - Congenital abnormalities of amino acid metabolism.
- Severe hyperlipidaemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia. - Severe hyperglycaemia - Pathologically-elevated plasma concentration of sodium, potassium, magnesium, calcium, and/or phosphorus
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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
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.
Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state. The occurrence of septic complications can be decreased with heightened emphasis on aseptic techniques in catheter placement and maintenance, as well as aseptic techniques in the preparation of the nutritional formula.
Monitor water and electrolyte balance, serum osmolarity, serum triglycerides, acid-base balance, blood glucose, liver and kidney function tests, coagulation tests and blood count, including platelets throughout treatment. Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed.
Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs. Serum triglyceride concentrations and the ability of the body to remove lipids must be checked regularly.
Serum triglyceride concentrations must not exceed 3 mmol/l during the infusion. These concentrations should not be determined before a minimum of a 3-hour period of continuous infusion. If a lipid metabolism abnormality is suspected, it is recommended that tests be performed daily by measuring serum triglycerides after a period of 5 to 6 hours without administering lipids.
In adults, the serum must be clear in less than 6 hours after stopping the infusion containing the lipid emulsion. The next infusion should only be administered when the serum triglyceride concentrations have returned to normal values.
Fat overload syndrome has been reported with the administration of OLICLINOMEL and similar products. 8). In the event of hyperglycaemia, the infusion rate of OLICLINOMEL must be adjusted and/or insulin administered. When making additions, the final osmolarity of the mixture must be measured before administration.
The mixture obtained should be administered through a central or peripheral venous line depending on its final osmolarity. If the final mixture administered is hypertonic, it may cause irritation of the vein when administered into a peripheral vein.
Although there is a natural content of trace elements and vitamins in the product, the levels are insufficient to meet body requirements and these should be added to prevent deficiencies from developing. See instructions for making additions to this product.
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