Alanine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: June 20, 2025🚩 Report this page

Alanine

Active ingredient

Sold as ESSEPNA · OLIMEL 5.7%

CA Health CanadaGB MHRA

Drug class: -
Availability: See label
Routes: Intravenous
Markets covered: 2
Products on record: 8

Overview

Alanine is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	6	March 22, 2025
GB United Kingdom	MHRA	2	June 20, 2025

CACanada· Health Canada

6 products

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

OLIMEL (amino acids, 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.

How to take

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised June 20, 2025[2]

TRIOMEL PERIPHERAL is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

How to take

Sources & citations

[1]Health Canada (DPD) · 02352540 · revised March 22, 2025
[2]MHRA (UK) · PL001160645 · revised June 20, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

CAOfficial regulatory label· revised March 22, 2025[1]

1 Dosing Considerations Dosing of OLIMEL (amino acids, 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 phosphorus.
Levels of this electrolyte should be carefully monitored in these patients. 2 Recommended Dose and Dosage Adjustment Adults Due to its high osmolarity (1120-1360 mOsmol/L), OLIMEL must only be administered through a central vein. The dosage depends on the patient’s energy expenditure, clinical status, body weight, and ability to metabolize the constituents of OLIMEL, 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 6 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 products. 2 mmol/kg/day of phosphate. In those situations, healthcare professionals may consider adjusting the volume (dose) of OLIMEL in order to meet these increased requirements.
0 g Energy: Total calories approx. 1140 kcal 1710 kcal 2270 kcal Non-amino acid calories approx. 0 mmol Acetate 31 mmol 46 mmol 62 mmol pH approx. 4 Osmolarity approx. 0 g Energy: Total calories approx. 1070 kcal 1600 kcal 2140 kcal Non-amino acid calories approx.
0 mmol Acetate 40 mmol 60 mmol 80 mmol pH approx. 4 Osmolarity approx. 7 g Energy: Total calories approx. 620 kcal 950 kcal 1420 kcal 1900 kcal Non-amino acid calories approx. 2 mmol Acetate 35 mmol 54 mmol 80 mmol 107 mmol pH approx. 4 Osmolarity approx.
(1130 mosm/L (1130 mosm/L (1130 mosm/L (1130 mosm/L 1 Includes calories from purified egg phosphatides 2 Phosphate provided by the lipid emulsion As a general rule, daily doses of 2 g/kg of amino acids and/or 7 g/kg of dextrose and/or 2 g/kg of lipids and/or 40 kcal/kg and/or 40 mL fluid/kg should not be exceeded, except in particular cases when specific demands exceed the usual recommendations.
The first of these doses to be reached sets the maximum daily dose. The OLIMEL formulations may be limited by fluid (40 ml/kg/day), energy (40 kcal/kg/day total calories) or amino acids intakes (2g/kg/day). In Continuous Renal Replacement (CRRT) and patients with morbid obesity, the maximal daily dose is defined by amino acids intake.
2 * In Continuous Renal Replacement (CRRT) and patients with morbid obesity ** In patients with morbid obesity, dosing is based on ideal body weight (IBW) The maximal infusion rates for the average patient receiving OLIMEL formulations over a 24 hour administration […]

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

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, 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.
GASTROINTESTINAL DISORDERS:
Vomiting SKIN AND SUBCUTANEOUS SKIN DISORDERS: Rash 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)

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

1 Pregnant Women ................................................................................................. 2 Breast-feeding .....................................................................................................
3 Pediatrics ............................................................................................................. 37 4 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OLIMEL (amino acids, 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 (amino acids, 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, STRENGTHS, 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 […]

This is not medical advice. Consult a qualified healthcare professional.

2). The maximum daily dose mentioned below 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 any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of TRIOMEL. In adults The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise the constituents of TRIOMEL, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.
5 mL per expended kcal. 1 mmol/kg potassium. , 2,058 non-protein kcal and 2,622 total kcal). Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
07 g/kg/hour lipids. In children greater than 2 years of age and adolescents There have been no studies performed in the paediatric population. The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise constituents of TRIOMEL, as well as additional energy or proteins given orally/enterally; therefore, the bag size should be chosen accordingly.
In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered. For TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes in the 2 to 11 year age group, the magnesium concentration is the limiting factor for daily dose.
In this age group, the glucose concentration is the limiting factor for hourly rate. In the 12 to 18 year age group, amino acid and magnesium concentrations are the limiting factors for daily dose. In this age group, the amino acid concentration is the limiting factor for hourly rate.
08 a: Recommended values from 2018 ESPGHAN/ESPEN/ESPR Guidelines Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
In general, it is recommended to start the infusion for small children with low daily dose and gradually increase it up to the maximal dosage (see above). Method and duration of administration For single use only. It is recommended that, after opening the bag, the contents are used immediately and not stored for subsequent infusion.
After reconstitution, the mixture is homogenous with a milky appearance. 6. Due to its high osmolarity, TRIOMEL can only be administered through a central vein. The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.
Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical conditions.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised June 20, 2025[2]

9). At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion: The following adverse drug reactions (ADRs) were reported with TRIOMEL 9 g/l nitrogen 1070 kcal/l in a randomized, double-blind, active-controlled, efficacy and safety study.
, postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) were included and treated; patients in the TRIOMEL group received drug product up to 40 mL/kg/d over 5 days. The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to TRIOMEL.
System Organ Class MedDRA Preferred Term Frequencya Immune System Disorders Hypersensitivity reactions including hyperhidrosis, pyrexia, chills, headache, skin rash (erythematous, papular, pustular, macular, generalised rash), pruritus, hot flush, dyspnoea Not knownb Cardiac Disorders Tachycardia Commona Decreased appetite Commona Metabolism and Nutrition Disorders Hypertriglyceridemia Commona Abdominal pain Commona Diarrhoea Commona Nausea Commona Gastrointestinal Disorders Vomiting Not knownb Vascular Disorders Hypertension Commona General disorders and administration site conditions Extravasation which may result at infusion site level in: pain, irritation, swelling/oedema, erythema/warmth, skin necrosis, blisters/vesicles, inflammation, induration, skin tightness Not knownb a: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from the available data).
b: ADRs reported during post-marketing experience with TRIOMEL The following class-like-adverse drug reactions (ADRs) have been described in other sources in relation to similar parenteral nutrition products; the frequency of these events is not known.
4) Fat overload syndrome (very rare) Fat overload syndrome has been reported with similar products. g. 9); 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 TRIOMEL accompanied by prolonged plasma clearance may result in a “fat overload syndrome”. g. coma). The syndrome is usually reversible when infusion of the lipid emulsion is stopped.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised June 20, 2025[2]

An excessively fast administration of total parenteral nutrition (TPN) solutions 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, or dyspnea develop.
This medicinal product contains soya-bean oil, and egg phospholipids. Soya-bean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soya-bean and peanut proteins have been observed. 3). Ceftriaxone must not be mixed or administered simultaneously with any calcium- containing IV solutions even via different infusion lines or different infusion sites.
Ceftriaxone 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). Suspected precipitate formation in the blood stream has also been reported.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. If signs of respiratory distress occur, the infusion should be stopped and medical evaluation initiated. 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).
6). Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion. Specific clinical monitoring is required when an intravenous infusion is started.

This is not medical advice. Consult a qualified healthcare professional.