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ESSEPNA is a brand name for Alanine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EssepnaTM (Amino acids injection 10% w/v) is indicated for supply of amino acids as part of a parenteral nutrition regimen. Amino acid solutions should be administered as intravenous infusion into a central vein when oral or enteral nutrition is impossible, insufficient or contraindicated. Generally, it is consumed in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Essepna is for use as part of total parenteral nutrition in combination with adequate amounts of energy supplements (carbohydrate solutions, lipid emulsions), electrolytes, vitamins, and trace elements. Only compatible components should be mixed, and sterile techniques should be used while compounding.
The daily requirement of amino acids depends on the body weight and the metabolic conditions of the patient. The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.
ESSEPNATM - Product Monograph Template date:
June 2017 Page 5 of 30 Continuous infusion over 14 to 24 hours is recommended, depending on the clinical situation. Bolus administration is not recommended. , nutritional state and degree of catabolic stress or anabolism). 21 g nitrogen/kg bw/d) in the normal nutritional state or in conditions with mild catabolic stress.
32 g nitrogen/kg bw/d). 32 g nitrogen/kg body weight/d). 32 g nitrogen/kg body weight/d). 016 g nitrogen/kg body weight/h). Pediatric population Health Canada has not authorized an indication for pediatric use. 3 Administration Method of administration: For continuous infusion via central vein.
4 Missed Dose Do not attempt to make up any missed doses. Proceed with the regular administration of Essepna and continue treatment at regular intervals as required. 4. OVERDOSAGE As with other amino acid solutions, shivering, vomiting, nausea, dyspnoea, and increased renal amino acid losses may occur if a dose higher than the recommended maximum daily dose is given or the recommended maximum infusion rate is exceeded.
Overdose might cause fluid overload, electrolyte imbalances, and serum hyperosmolarity. In this case of overdose, infusion should be stopped immediately. It may be possible to continue at a reduced dose. There is no specific antidote for overdose of amino acid solutions.
Emergency procedures should be supportive general measures, with particular attention to respiratory and EssepnaTM 10% w/v - Product Monograph Template date: June 2017 Page 6 of 30 cardiovascular systems. Close biochemical monitoring is essential and specific abnormalities should be treated appropriately.
For management of a suspected drug overdose, contact your regional Poison Control Centre. 5. 3 Theoretical osmolarity: 1100 mOsmol/l Pack sizes: 500 mL in bag: Box of 12 units 1000 mL in bag: Box of 6 units 6 WARNINGS AND PRECAUTIONS General Essepna is for use as part of total parenteral nutrition in combination with adequate amounts of energy supplements (carbohydrate solutions, lipid emulsions), electrolytes, vitamins and trace ESSEPNATM - Product Monograph Template date: June 2017 Page 7 of 30 elements.
General Essepna is for use as part of total parenteral nutrition in combination with adequate amounts of energy supplements (carbohydrate solutions, lipid emulsions), electrolytes, vitamins and trace ESSEPNATM - Product Monograph Template date: June 2017 Page 7 of 30 elements.
The intravenous infusion of amino acids is accompanied by an increased excretion of trace elements, such as copper and zinc. Therefore, it is important to supply adequate amounts of trace elements to all patients who receive prolonged PN longer than 5 days.
The amount of individually added electrolytes is determined by the clinical condition of the patient and by frequent monitoring of serum levels. Routine laboratory tests such as renal and liver function, fluid and acid/base balance, serum electrolytes, blood glucose, serum proteins, blood count, and coagulation should be performed.
In cases of hypokalemia and/or hyponatremia adequate amounts of potassium and/or sodium should be supplied simultaneously. Amino acid solutions may induce acute folate deficiency. Therefore, folic acid should be given daily. Parenteral nutrition should be given with caution in metabolic acidosis, cellular hypoxia, and increased serum osmolarity.
In severely malnourished patients, initiation of parenteral nutrition can induce fluid shifts resulting in pulmonary edema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphate, magnesium, and water-soluble vitamins (refeeding syndrome).
These changes can occur within 24 to 48 hours. Therefore, careful and slow initiation of parenteral nutrition is recommended in these patients, with close monitoring and appropriate adjustments of fluids, electrolytes, trace elements, and vitamins.
Incompatibilities Essepna may only be mixed with other nutritional products for which compatibility has been shown. Cardiovascular Care should be given if large volumes are infused in patients with cardiac insufficiency or fluid restrictions.
Essepna is contraindicated in patients who are hypersensitive to this product or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
As for all amino acid solutions the administration of Essepna is contraindicated in the following conditions: - Abnormalities of amino acid metabolism - Metabolic acidosis - Renal insufficiency without hemodialysis or hemofiltration - Advanced liver insufficiency - Fluid overload - Shock - Hypoxia - Decompensated heart failure
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alanine in Canada.
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The intravenous infusion of amino acids is accompanied by an increased excretion of trace elements, such as copper and zinc. Therefore, it is important to supply adequate amounts of trace elements to all patients who receive prolonged PN longer than 5 days.
The amount of individually added electrolytes is determined by the clinical condition of the patient and by frequent monitoring of serum levels. Routine laboratory tests such as renal and liver function, fluid and acid/base balance, serum electrolytes, blood glucose, serum proteins, blood count, and coagulation should be performed.
In cases of hypokalemia and/or hyponatremia adequate amounts of potassium and/or sodium should be supplied simultaneously. Amino acid solutions may induce acute folate deficiency. Therefore, folic acid should be given daily. Parenteral nutrition should be given with caution in metabolic acidosis, cellular hypoxia, and increased serum osmolarity.
In severely malnourished patients, initiation of parenteral nutrition can induce fluid shifts resulting in pulmonary edema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphate, magnesium, and water-soluble vitamins (refeeding syndrome).
These changes can occur within 24 to 48 hours. Therefore, careful and slow initiation of parenteral nutrition is recommended in these patients, with close monitoring and appropriate adjustments of fluids, electrolytes, trace elements, and vitamins.
Incompatibilities Essepna may only be mixed with other nutritional products for which compatibility has been shown. Cardiovascular Care should be given if large volumes are infused in patients with cardiac insufficiency or fluid restrictions.
Fluid status should be closely monitored. Endocrine and Metabolism Essepna should be given with caution in conditions of impaired […]
Fluid status should be closely monitored. , in patients with hyperammonemia, renal failure, impaired liver function, diabetes mellitus, hypothyroidism, and sepsis. Immune system If a hypersensitivity reaction occurs (signs or symptoms of anaphylactic reaction such as fever, shivering, sweating, headache, skin rash, or dyspnea) infusion of the solution must be stopped immediately and the appropriate treatment and supportive measures should be undertaken until the conditions have been resolved.
EssepnaTM 10% w/v - Product Monograph Template date:
June 2017 Page 8 of 30 Renal Serum electrolytes, fluid balance, and renal function should be monitored in any patient receiving amino acids solution. Care should be given, if large volumes are infused in renal impaired patients with fluid restrictions.
Special Populations Pregnant Women There are no data available on exposure of Essepna in pregnant women. There are no studies available on reproductive toxicity in animals. An embryo-foetal development study was performed with an amino acid solution for parenteral nutrition that has a similar composition as Essepna.
No embryotoxic or teratogenic effects were detected. Parenteral nutrition may become necessary during pregnancy. Essepna should only be given to pregnant women after physicians have carefully considered the potential risks and benefits.
Breast-Feeding There is no adequate data on use of Essepna in lactating women. Healthcare professionals should carefully consider the potential risks and benefits for the individual patient before prescribing the product to breastfeeding women.
Pediatrics No data are available to Health Canada; therefore, the product is not authorized for pediatric use. Geriatrics In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, and cardiac functions as well as concomitant disease and drug therapy.
7. 1 Adverse Reaction Overview Adverse reaction information is based on clinical trial adverse reactions and post-marketing experiences See also WARNINGS AND PRECAUTIONS. 2 Clinical Trial Adverse Reactions (Adults) 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 ESSEPNATM - Product Monograph Template date: June 2017 Page 9 of 30 compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In the randomized clinical study AS-CS-01-FR, Essepna 10% was compared to another amino acid solution approved in Europe.
The study in 30 patients in intensive care showed that the incidence of adverse events was comparable between the Essepna and the comparator group. An overview of the treatment emergent adverse events (TEAEs) occurring in at least one patient in the Essepna group classified as related (at least possibly related) are presented in Table 2.
3%) 0 AE = adverse events, n = number; SOC = System Organ Class; TEAEs = […]