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PERIOLIMEL is a brand name for Olive Oil, supplied as a emulsion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OLIMEL E / PeriOLIMEL E (amino acids WITH electrolytes, dextrose, lipids) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated. 1.1 Pediatrics Pediatrics (<18 years of age): There have been no studies performed in the pediatric population. 1.2…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosing of OLIMEL E / PeriOLIMEL E (amino acids WITH electrolytes, dextrose, lipids) is based upon protein, energy, and electrolyte requirements of the individual patient. Some patients with renal and hepatic disease may benefit from reduced protein intakes.
Some patients with diabetes mellitus or glucose intolerance may benefit from reduced carbohydrate intake. Patients with parenteral nutrition induced liver disease may benefit from reduction in lipid intake. Patients with renal disease have decreased capacity to excrete potassium, magnesium, and phosphorus.
Levels of these electrolytes should be carefully monitored in these patients. 2 Recommended Dose and Dosage Adjustment Adults Due to its high osmolarity (1120-1360 mOsmol/L), OLIMEL E must only be administered through a central vein.
Due to its low osmolarity (760 mOsmol/L), PeriOLIMEL E can be administered through a peripheral or central vein. The dosage depends on the patient’s energy expenditure, clinical status, body weight, and ability to metabolize the constituents of OLIMEL E / PeriOLIMEL E, as well as additional energy or proteins/amino acids given orally/enterally; therefore, the bag size should be chosen accordingly.
35 g nitrogen /kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress. 5 g of amino acids/kg). 5 mL per expended kcal. *This is dependent on not over feeding the patient calories or protein.
The maximum daily dose should not be exceeded. 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.
In this situation the impact of any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of OLIMEL E / PeriOLIMEL E products. 2 mmol/kg/day of phosphate.
In those situations, healthcare professionals may consider adjusting the volume (dose) of OLIMEL E / PeriOLIMEL E in order to meet these increased requirements. 5 g Energy: Total calories approx. 700 kcal 1050 kcal 1400 kcal 1750 kcal Non-amino acid calories approx.
1 Adverse Reaction Overview See WARNINGS AND PRECAUTIONS. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) was assessed in a double-blind randomized controlled study over five days.
Fifty-six (56) patients requiring parenteral nutrition were enrolled, of whom twenty-eight (28) were treated with OliClinomel (a triple-chamber parenteral nutrition product similar to OLIMEL, that contains the same olive oil/soybean oil lipid, a similar amino acid profile, and dextrose) and twenty-eight (28) were treated with OLIMEL.
The goal of the study was to provide information on the safety and nutritional efficacy of OLIMEL in a clinical setting. A total of fifty-three (53) adverse events occurred during treatment; twenty-nine (29) adverse events were observed in fourteen (14) patients in the OLIMEL group versus twenty-four (24) adverse events observed in eleven (11) patients in the OliClinomel (control) group.
Of the twenty-nine (29) adverse events observed in the OLIMEL group, seven (7) adverse events were designated as related to treatment. Of the twenty-four (24) adverse events observed in the OliClinomel (control) group, seven (7) patients presented with adverse events that were reported as related to treatment.
3 Post-Market Adverse Reactions In addition, the following adverse reactions have been reported in the postmarketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term (PT) in order of severity.
1 Pregnant Women ................................................................................................. 2 Breast-feeding .....................................................................................................
3 Pediatrics ............................................................................................................. 45 4 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OLIMEL E / PeriOLIMEL E (amino acids WITH electrolytes, dextrose, lipids) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
1 Pediatrics Pediatrics (<18 years of age): There have been no studies performed in the pediatric population. 2 Geriatrics Geriatrics (> 65 years of age): There are no known differences in safety and effectiveness of parenteral nutrition formulations in the adult population based upon age.
2 CONTRAINDICATIONS The use of OLIMEL E / PeriOLIMEL E (amino acids WITH electrolytes, dextrose, lipids) is contraindicated in the following populations/situations: • Known hypersensitivity to egg, soybean or peanut products, olive products or any of the active substances, excipients, or components of the container.
For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. • Known allergy to corn or corn products since the products contain corn- derived dextrose • Patients with acute renal failure and without undergoing renal […]
The use of OLIMEL E / PeriOLIMEL E (amino acids WITH electrolytes, dextrose, lipids) is contraindicated in the following populations/situations: • Known hypersensitivity to egg, soybean or peanut products, olive products or any of the active substances, excipients, or components of the container.
For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. • Known allergy to corn or corn products since the products contain corn- derived dextrose • Patients with acute renal failure and without undergoing renal replacement therapy.
• Patients with severe liver failure or hepatic coma. • Congenital abnormalities of amino acid metabolism • Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia • Hypertriglyceridemia-associated acute pancreatitis • Severe hyperglycemia • Hyperkalemia (see General in WARNINGS AND PRECAUTIONS).
• Hypercalcaemia (see General in WARNINGS AND PRECAUTIONS). • Hyperphosphatemia (see General in WARNINGS AND PRECAUTIONS) • Hypernatremia. • Hypermagnesemia. g. via Y-site) because of the risk of precipitation of ceftriaxone-calcium salt.
If the same infusion line is used for sequential administration, the line must be thoroughly flushed with a compatible fluid between infusions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Olive Oil in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 mmol Acetate 27 mmol 41 mmol 55 mmol 69 mmol Chloride 24 mmol 37 mmol 49 mmol 61 mmol pH approx. 4 Osmolarity approx. 5 g Energy: Total calories approx. 1490 kcal 1980 kcal 2480 kcal Non-amino acid calories approx. 5 mmol Acetate 55 mmol 73 mmol 91 mmol Chloride 68 mmol 90 mmol 113 mmol pH approx.
4 Osmolarity approx. 0 g Energy: Total calories approx. 1140 kcal 1710 kcal 2270 kcal Non-amino acid calories approx. 0 mmol Acetate 45 mmol 67 mmol 89 mmol Chloride 45 mmol 68 mmol 90 mmol pH approx. 4 Osmolarity approx. 0 g Energy: Total calories approx.
1070 kcal 1600 kcal 2140 kcal Non-amino acid calories approx. 840 kcal 1260 kcal 1680 kcal Glucose calories 440 kcal 660 kcal 880 kcal […]
GASTROINTESTINAL DISORDERS:
Vomiting SKIN AND SUBCUTANEOUS SKIN DISORDERS: Rash 26 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Injection site extravasation, Pyrexia, Chills Class Reactions The following adverse reactions have been reported with similar products: Pruritus, Fat overload syndrome, Cholestasis, Elevated liver enzymes and Azotemia Pulmonary vascular precipitates (pulmonary vascular emboli and pulmonary distress) (see WARNINGS AND PRECAUTIONS)