Olimel N12E

Olimel N12E

Manufacturer:

Baxter Healthcare

Distributor:

Zuellig Pharma

Marketer:

Baxter Healthcare
Concise Prescribing Info
Contents
Per 650 mL Lipid emulsion 22.8 g, glucose 47.7 g, amino acids 49.4 g, nitrogen 7.8 g, electrolytes. Energy: 620 kCal. Per 1,000 mL Lipid emulsion 35 g, glucose 73.3 g, amino acids 75.9 g, nitrogen 12 g, electrolytes. Energy: 950 kCal. Per 1,500 mL Lipid emulsion 52.5 g, glucose 110 g, amino acids 113.9 g, nitrogen 18 g, electrolytes. Energy: 1,420 kCal. Per 2,000 mL Lipid emulsion 70 g, glucose 146.7 g, amino acids 151.9 g, nitrogen 24 g, electrolytes. Energy: 1,900 kCal
Indications/Uses
Parenteral nutrition for adults & childn >2 yr when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage/Direction for Use
Parenteral Administer through central vein. Recommended duration of infusion: Between 12 & 24 hr. Adult Individualised dosage. Ave daily requirements: 0.16-0.35 g nitrogen/kg (1-2 g of amino acids/kg) up to 0.4 g nitrogen/kg, (2.5 g of amino acids/kg), 20-40 kCal/kg, 20-40 mL fluid/kg, or 1-1.5 mL/expended kCal. Max daily dose (by amino acid intake): 26 mL/kg corresponding to 2 g/kg amino acids, 1.9 g/kg glucose, 0.9 g/kg lipids. Continuous renal replacement therapy, morbid obesity (using ideal body wt) Max daily dose (by amino acids intake): 33 mL/kg corresponding to 2.5 g/kg amino acids, 2.4 g/kg glucose, 1.2 g/kg lipids. 70 kg patient 175 g amino acids, 169 g glucose, 81 g lipids. Max infusion rate: 1.3 mL/kg/hr corresponding to 0.1 g/kg/hr amino acids, 0.1 g/kg/hr glucose & 0.05 g/kg/hr lipids. Childn 12-18 yr Max daily dose: 50-80 mL/kg fluid, 1-2 g/kg amino acids, 0.7-5.8 g/kg glucose, 0.5-2 (up to 3) g/kg lipids. Max infusion rate: 1.6 mL/kg/hr. Childn 2-11 yr Max daily dose: 60-120 mL/kg fluid, 1-2 (up to 2.5) g/kg amino acids, 1.4-8.6 g/kg glucose, 0.5-3 g/kg lipids. Max infusion rate: 2.6 mL/kg/hr.
Contraindications
Hypersensitivity to egg, soya bean, peanut proteins, or corn/corn products; to active substances or excipients. Congenital abnormalities of amino acid metabolism. Severe hyperlipidaemia, disorders of lipid metabolism characterised by hypertriglyceridaemia & hyperglycaemia. Pathologically-elevated Na, K, Mg, Ca, &/or P plasma conc. Premature neonates, infants, & childn <2 yr.
Special Precautions
Not to be administered through a peripheral vein. Not to be mixed or administered simultaneously w/ ceftriaxone. Not to be restarted in same central vein. Not to exceed 3 mmol/L of serum triglyceride conc during infusion. Not to connect bags in series to avoid possibility of air embolism. Discontinue treatment if allergic reaction eg, sweating, fever, chills, headache, skin rashes or dyspnea; signs of resp distress; if extravasation occurs. Cross-allergic reactions between soya bean & peanut proteins. Pulmonary vascular embolism & resp distress; vascular access infection & sepsis; elevated liver enzymes & cholestasis; metabolic complications; fat overload syndrome. Formation of precipitates or destabilization of lipid emulsion resulting to vascular occlusion. Increased risk of Ca phosphate precipitate formation w/ excessive addition of Ca & phosphate. May precipitate acute folate deficiency. Risk of developing or worsening neurological disorders associated w/ hyperammonaemia in patients w/ hepatic insufficiency; metabolic acidosis & hyperazotaemia if extra-renal waste removal is not being performed in patients w/ renal insufficiency. Increased urinary excretion of trace elements eg, Cu & Zn during long-term IV nutrition. Patients who are predisposed to infectious complications due to malnutrition &/or underlying disease state; w/ coagulation disorders & anaemia; metabolic acidosis; DM; hyperlipidaemia due to presence of lipids; amino acid metabolism disorders; increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction; tendency towards electrolyte retention. Malnourished patients. Periodically check infusion & catheter for precipitates. Carefully monitor signs, symptoms & lab test results for fever/chills, leukocytosis, technical complications w/ access device & hyperglycaemia; water & electrolyte, & acid/base balance, serum osmolarity & triglycerides, blood glucose & count including platelets throughout treatment; serum ammon if hepatic insufficiency is suspected; extravasation site at least every 4 hr during 1st 24 hr, then once daily; coagulation tests. Correct severe water & electrolyte equilibration, & metabolic disorders, & fluid overload states before starting infusion. Assess patients developing abnormal lab parameters or other signs of hepatobiliary disorders. Regularly check serum triglyceride conc & ability of body to remove lipids. Measure daily serum triglyceride levels after 5-6 hr period w/o administering lipids. Interference w/ lab tests by lipids. Hepatic steatosis, fibrosis & cirrhosis leading to hepatic failure; cholecystitis & cholelithiasis. Pregnancy & lactation. Not suitable in childn <2 yr due to low Ca, glucose/lipid ratio, & absence of cysteine. Elderly.
Adverse Reactions
Tachycardia; decreased appetite, hypertriglyceridemia; abdominal pain, diarrhoea, nausea; HTN. Parenteral nutrition-associated liver disease; pulmonary vascular embolism, resp distress.
Drug Interactions
Interference w/ lab tests by lipids. Precipitation of ceftriaxone-Ca in the same IV line. Risk of hyperkalemia w/ K-sparing diuretics (eg, amiloride, spironolactone, triamterene), ACE inhibitors, AIIA, or immunosuppressants tacrolimus or cyclosporine. Increased plasma lipolysis followed by transient decrease in triglyceride clearance w/ heparin.
MIMS Class
Parenteral Nutritional Products
ATC Classification
B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Form
Olimel N12E emulsion for infusion 1000 mL
Packing/Price
1's
Form
Olimel N12E emulsion for infusion 1500 mL
Packing/Price
1's
Form
Olimel N12E emulsion for infusion 2000 mL
Packing/Price
1's
Form
Olimel N12E emulsion for infusion 650 mL
Packing/Price
1's
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