ℹ️ Compiled from public regulatory records · Last regulator revision: January 9, 2026🚩 Report this page
Histidine
Active ingredient
Sold asSMOFKABIVEN · PRIMENE 10% · NUTRINEAL PD4 WITH 1.1%…
GB MHRACA Health Canada
Drug class
-
Availability
See label
Routes
Intravenous
Markets covered
2
Products on record
4
Overview
Histidine 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.
GBOfficial regulatory label· revised November 14, 2025[1]
Supply of energy, essential fatty acids, amino acids and fluids for parenteral nutrition of patients in states of moderate to severe catabolism, when oral or enteral nutrition is impossible, insufficient or contraindicated. Lipoflex special without electrolytes is indicated in adults, adolescents and children older than two years.
How to take
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE 3 CONTRAINDICATIONS ........................................................................................................ 3 WARNINGS AND PRECAUTIONS ......................................................................................
4 ADVERSE REACTIONS......................................................................................................... 9 DRUG INTERACTIONS .......................................................................................................
11 DOSAGE AND ADMINISTRATION .................................................................................. 11 OVERDOSAGE ......................................................................................................................
15 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 16 STORAGE AND STABILITY .............................................................................................. 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................
Sources & citations
[1]MHRA (UK) · PL035510141 · revised November 14, 2025
[2]Health Canada (DPD) · 02236875 · revised March 22, 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.
Posology The dosage should be adapted to the patients’ individual requirements. It is recommended that this medicinal product be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications.
4 g lipid /kg body weight per day. 07 g lipid /kg body weight per hour. For a patient weighing 70 kg this corresponds to a maximum infusion rate of 119 ml per hour. 8 g of lipids per hour. 3). Children from 2-18years of age No clinical studies were performed in the paediatric population.
This medicinal product without electrolytes can provide only a basic nutrient and energy supply to the paediatric patients. Depending on the individual need Carnitine supplementation may be considered in paediatric patients expected to receive PN for more than 4 weeks.
The exact dosage depends on the patient's energy expenditure and the ability to metabolize the active ingredients of this medicinal product and therefore, should be individually adapted according to age, body weight, clinical condition and underlying disease.
Since Lipoflex special without electrolytes does not contain electrolytes, these nutrients have to be administered separately as appropriate. Due to the individual needs of paediatric patients, this medicinal product may not cover sufficiently the total energy, nutrient, electrolyte and fluid requirements.
In such cases additional amino acids, carbohydrates and/or lipids, minerals and/or fluids must be provided in addition, as appropriate. For calculation of dosage account must be taken of the hydration status of the paediatric patient.
The bag size should be chosen accordingly. In addition, the daily fluid, glucose and energy requirements decrease with age. Thus, two age groups, from 2 to 12 years and 12 to 18 years, are considered. Maximum daily dose According to the paediatric guidelines the dose depends not only on the age but also on the medical condition (acute, stable and recovery phase) of the paediatric patient.
For Lipoflex special without electrolytes in the paediatric age group 2 to 12 years the glucose concentration is the limiting nutrient in the acute phase, and the amino acid concentration in the stable and recovery phase. For the age group 12 to 18 years the maximum daily dose is limited by the glucose concentration in all medical conditions.
The resulting maximum daily doses are given in the table below. 3 - -
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised November 14, 2025[1]
Under conditions of correct use, in terms of dosing monitoring, observation of safety restrictions and instructions, undesirable effects may still occur. The following listing includes a number of systemic reactions that may be associated with the use of Lipoflex special without electrolytes.
g. anaphylactic reactions,dermal eruptions, laryngeal, oral and facial oedema) Metabolism and nutrition disorders Uncommon: Loss of appetite Very rare: Hyperlipidaemia, hyperglycaemia, metabolic acidosis The frequency of these undesirable effects is dose- dependent and may be higher under the condition of absolute or relative lipid overdose.
Nervous system disorders Rare:
Headache, drowsiness Vascular disorders Rare: Hypertension or hypotension, flush Respiratory, thoracic and mediastinal disorders Rare: Dyspnoea, cyanosis Gastrointestinal disorders Uncommon: Nausea, vomiting Hepatobiliary disorders Not known: Cholestasis Skin and subcutaneous tissue disorders Rare: Erythema, sweating Musculoskeletal and connective tissue disorders Rare: Pain in the back, bones, chest and lumbar region General disorders and administration site conditions Rare: Elevated body temperature, feeling cold, chills Very rare: Fat overload syndrome (details see below) Should adverse reactions occur, the infusion must be stopped.
4 mmol/l (1000 mg/dl) during infusion, the infusion must be stopped. 4). If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Information on particular undesirable effects Nausea, vomiting and lack of appetite are symptoms often related to conditions for which parenteral nutrition is indicated, and may be associated with parenteral nutrition at the same time.
Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to ‘fat overload syndrome’, which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses.
This syndrome may also appear during severe hypertriglyceridaemia, even at the recommended infusion rate, and in association with a sudden change in the patient’s clinical condition such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma.
The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of this medicinal product should be discontinued immediately. 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.
GBOfficial regulatory label· Warnings and precautions· revised November 14, 2025[1]
Caution should be exercised in cases of increased serum osmolarity. Disturbances of the fluid, electrolyte or acid-base balance must be corrected before the start of infusion. Too rapid infusion can lead to fluid overload with pathological serum electrolyte concentrations, hyperhydration and pulmonary oedema.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion. The serum triglyceride concentration should be monitored when infusing this medicinal product.
Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia may occur. 6 mmol/l (400 mg/dl) during administration of lipids it is recommended to reduce the infusion rate. 4 mmol/l (1000 mg/dl), as these levels have been associated with acute pancreatitis.
g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), sepsis, and metabolic syndrome. 4 mmol/l (1000 mg/dl). In combined hyperlipidaemias and in metabolic syndrome, triglyceride levels react to glucose, lipids and overnutrition.
Adjust dose accordingly. Assess and monitor other lipid and glucose sources, and drugs interfering with their metabolism. The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.
Like all solutions containing carbohydrates the administration of this medicinal product can lead to hyperglycaemia. The blood glucose level should be monitored. If there is hyperglycaemia, the rate of infusion should be reduced or insulin should be administered.
If the patient is receiving other intravenous glucose solutions concurrently, the amount of additionally administered glucose has to be taken into account. An interruption of administration of the emulsion may be indicated if the blood glucose concentration rises to above 14 mmol/l (250 mg/dl) during administration.
Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Adequate supplementation of electrolytes according to deviations from normal values is necessary. Controls of the serum electrolytes, the water balance, the acid-base balance and of blood cell counts, coagulation status, hepatic and renal function are necessary.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised November 14, 2025[1]
4 Acute phase = resuscitation phase when the patient requires vital organ support (sedation, mechanical ventilation, vasopressors, fluid resuscitation); Stable phase = patient is stable on, or can be weaned, from this vital support; Recovery phase = patient who is mobilizing.
1 g/kg/day can be given, which also provides an adequate intake of linolenic acid (ALA) with all 20% lipid emulsions currently registered for pediatric use (Lapillonne et al. 2018). For children, it might be necessary to start the nutritional therapy with half of the target dosage.
The dosage should be increased stepwise according to the individual metabolic capacity up the maximum dosage. Maximum infusion rate According to the paediatric guidelines the maximum hourly infusion rate depends not only on age but also on the medical condition (acute, stable and recovery phase) of the paediatric patient.
For Lipoflex special without electrolytes the glucose infusion rate is the limiting factor for both paediatric age groups in all medical conditions. The resulting maximum hourly infusions rates are given in the table below. 4). Duration of treatment The duration of treatment for the indications stated is not limited.
During the administration of Lipoflex special without electrolytes it is necessary to provide an appropriate amount of electrolytes, trace elements and vitamins. Duration of infusion of one single bag The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h.
Method of administration Intravenous use. For central venous infusion only. 4 mmol/l) ● severe coagulopathy ● hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour ● acidosis ● intrahepatic cholestasis ● severe hepatic insufficiency ● severe renal insufficiency in absence of renal replacement therapy ● aggravating haemorrhagic diatheses ● acute thrombo-embolic events, lipid embolism.
On account of its composition, this medicinal product must not be used in newborn infants, infants and toddlers under 2 years of age. g. severe postaggression syndrome, coma of unknown origin) ● inadequate cellular oxygen supply ● disturbances of the electrolyte and fluid balance ● acute pulmonary oedema ● decompensated cardiac insufficiency
This is not medical advice. Consult a qualified healthcare professional.
25 PRIMENE 10% (Amino Acid Injection) Page 3 of 26 PRIMENE 10% (Amino Acid Injection) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous 10% Solution for Infusion For a complete listing see Dosage Forms, Composition and Packaging section.
INDICATIONS AND CLINICAL USE PRIMENE 10% (Amino Acid Injection 10% w/v) is indicated for: The nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes.
The purpose of the solution is to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.
CONTRAINDICATIONS The use of PRIMENE 10% (Amino Acid Injection 10% w/v) is contraindicated in the following populations/situations: Known hypersensitivity to any of the active substances or excipients, or to components of the container.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. Patients with untreated anuria Hepatic coma Congenital abnormality of amino acid metabolism , including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia.
PRIMENE 10% (Amino Acid Injection) Page 4 of 26 WARNINGS AND PRECAUTIONS General This solution is for compounding only, not for direct infusion. Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
The IV administration of these solutions can lead to fluid or solute overload resulting in hyper or hypoosmolal states. The risk of hypoosmolal states is especially present in conditions associated with ADH secretion and is proportional to the infusion rate.
Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion. Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle enzymes of genetic or product origin.
It is essential that blood ammonia be measured frequently in infants. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.
Concentrated dextrose solutions are an effective source of such calories. With the administration of PRIMENE 10% (Amino Acid Injection 10% w/v) in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result.
Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy Special care must be taken when giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava. Solutions ideally should be prepared in the hospital pharmacy under a laminar flow hood.
The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. Infection and sepsis may occur as a result of intravenous catheters used to administer parenteral formulations, poor maintenance of catheters or contaminated solutions.
Immunosuppression and other factors such as hyperglycemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications. PRIMENE 10% (Amino Acid Injection) Page 5 of 26 Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, […]
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
Adverse Drug Reaction Overview Adverse reaction information is based on postmarketing experiences. Post-Market Adverse Drug Reactions The adverse reactions listed below have been identified from post-marketing reports of PRIMENE 10% (Amino Acid Injection) administered as a component of parenteral nutrition.
They are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
IMMUNE SYSTEM DISORDERS:
Hypersensitivity reaction: Face edema Eyelid edema Rash Other adverse reactions reported with parenteral amino acid products include: RENAL AND URINARY DISORDERS: Azotemia METABOLISM AND NUTRITION DISORDERS: Hyperammonemia Adverse reactions reported with parenteral nutrition to which the amino acid component may play a causal or contributory role include: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Chills Infusion site discolouration Injection site erythema Infusion site extravasation Infusion site induration Infusion site phlebitis Infusion site swelling Infusion site thrombosis Infusion site warmth Necrosis Pyrexia Swelling PRIMENE 10% (Amino Acid Injection) Page 10 of 26 IMMUNE SYSTEM DISORDER: Anaphylactic / anaphylactoid reactions, including skin, gastrointestinal and respiratory manifestations Hypersensitivity reaction INJURY, POISONING AND PROCEDURAL COMPLICATIONS: Infusion related reaction Scar INVESTIGATIONS: Blood bilirubin increased Hepatic enzyme increased HEPATOBILIARY DISORDERS: Cholecystitis Cholelithiasis Cholestasis Hepatic cirrhosis Hepatic failure Hepatic fibrosis Hepatic steatosis METABOLISM AND NUTRITION DISORDERS: Metabolic acidosis MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia Myalgia NERVOUS SYSTEM DISORDERS: Headache PRIMENE 10% (Amino Acid Injection) Page 11 of 26 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Pulmonary Vascular disorder SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Blister Erythema Pruritus Urticaria VASCULAR DISORDER: Hypertension Hypotension Infusion site pain Shock Vein disorder DRUG INTERACTIONS Overview No interaction studies have been performed by Baxter Healthcare Corporation with PRIMENE 10% (Amino Acid Injection 10% w/v).
Drug-Drug Interactions Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids. Drug-Food Interactions No drug-food interaction studies have been evaluated.
Drug-Laboratory Interactions No drug-laboratory interaction studies have been evaluated. Drug-Lifestyle Interactions Interactions with lifestyle have not been evaluated. DOSAGE AND ADMINISTRATION PRIMENE 10% (Amino Acid Injection 10% w/v) is intended for intravenous use.
The product PRIMENE 10% (Amino Acid Injection) Page 12 of 26 is in Pharmacy Bulk Package and not for direct infusion. PRIMENE 10% (Amino Acid Injection 10% w/v) is not intended for fluid or volume replacement. Dosing Considerations The total daily dose of PRIMENE10% (Amino Acid Injection 10% w/v) depends on daily protein requirements and on the patient's metabolic and clinical response.
The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.
When used in neonates and children below 2 years, the solution (in containers and administration sets) should be protected from light exposure after admixture through administration. Any unused portion of PRIMENE 10% (Amino Acid Injection 10% w/v) should be discarded and should not be used for subsequent admixing.
Recommended Dose and Dosage Adjustment Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient’s age, weight, clinical condition, nitrogen requirements, ability to metabolize the constituents of PRIMENE 10% (Amino Acid Injection 10% w/v), additional nutrition that may be provided parenterally and/or enterally.
5 grams of amino acids per kilogram of body weight per day. Typically, PRIMENE10% (Amino Acid Injection 10% w/v) is admixed with 50% dextrose and supplemented with electrolytes and administered continuously over a 24 hour period. 2 g/kg of protein and 120 Kcal/kg/day.
For premature infants, especially those in catabolic state, these requirements could be even higher. Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN.
Provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance. In addition, the provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids, and sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given.
Therefore, if oral feeding is not possible or advisable and TPN is necessary, the volume restrictions dictate how to administer Primene, dextrose and most electrolytes in the same hypertonic solution through intravenous lines. Even such hypertonic solutions will not provide the required daily calories.
If prolonged TPN is required (5 days or more), intravenous lipid emulsions will also have to be administered. The following scenario can serve as an example. 5 g/kg of amino acid per day and 125 cc/kg/day fluid volume. 5 g 10 20 Dextrose 50% 42 mL 21 g 71 110 Water for Injection […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
General This solution is for compounding only, not for direct infusion. Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
The IV administration of these solutions can lead to fluid or solute overload resulting in hyper or hypoosmolal states. The risk of hypoosmolal states is especially present in conditions associated with ADH secretion and is proportional to the infusion rate.
Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion. Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle enzymes of genetic or product origin.
It is essential that blood ammonia be measured frequently in infants. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.
Concentrated dextrose solutions are an effective source of such calories. With the administration of PRIMENE 10% (Amino Acid Injection 10% w/v) in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result.
Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy Special care must be taken when giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava. Solutions ideally should be prepared in the hospital pharmacy under a laminar flow hood.
The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. Infection and sepsis may occur as a result of intravenous catheters used to administer parenteral formulations, poor maintenance of catheters or contaminated solutions.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
and ADVERSE REACTIONS). The infusion must be stopped immediately if any signs or symptoms of a reaction develop. , uremia). Nitrogen tolerance may be altered and dosage may have to be adjusted. Fluid and electrolyte status should be closely monitored in these patients.
Azotemia has been reported with parenteral administration of solutions containing amino acids, and may occur in particular in the presence of renal impairment. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
Respiratory Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates.
Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation distal to the in‐line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
Special Populations Pregnant Women:
There are no adequate data on the use of PRIMENE 10% (Amino Acid Injection 10% w/v) in pregnant women. Healthcare professionals should carefully consider the potential risks and benefits for each specific patient before prescribing the product.
Nursing Women:
There are no adequate data on the use of PRIMENE 10% (Amino Acid Injection 10% w/v) in nursing women. Healthcare professionals should carefully consider the potential risks and benefits for each specific patient before administering the product.
Pediatrics:
The product is specifically indicated for the pediatric population. Monitoring and Laboratory Tests Monitoring should be appropriate to the patient’s clinical situation and condition, and may include determinations of fluid balance, water and electrolyte balance, serum osmolarity, and acid / base balance, blood glucose, serum proteins, blood ammonia levels, kidney and liver function tests, electrolytes, hemogram, arterial blood gases, and blood cultures.
PRIMENE 10% (Amino Acid Injection) Page 9 of 26 ADVERSE REACTIONS Adverse Drug Reaction Overview Adverse reaction information is based on postmarketing experiences. Post-Market Adverse Drug Reactions The adverse reactions listed below have been identified from post-marketing reports of PRIMENE 10% (Amino Acid Injection) administered as a component of parenteral nutrition.
They are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
IMMUNE SYSTEM DISORDERS:
Hypersensitivity reaction: Face edema Eyelid edema Rash Other adverse reactions reported with parenteral amino acid products include: RENAL AND URINARY DISORDERS: Azotemia METABOLISM AND NUTRITION DISORDERS: Hyperammonemia Adverse reactions reported with parenteral nutrition to which the amino acid component may play a causal or contributory role include: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Chills Infusion site discolouration Injection site erythema Infusion site extravasation Infusion site induration Infusion site phlebitis Infusion site swelling Infusion site thrombosis Infusion site warmth Necrosis Pyrexia Swelling PRIMENE 10% (Amino Acid Injection) Page 10 of 26 IMMUNE SYSTEM DISORDER: Anaphylactic / anaphylactoid reactions, including skin, gastrointestinal and respiratory manifestations Hypersensitivity reaction INJURY, POISONING AND PROCEDURAL COMPLICATIONS: Infusion related reaction Scar INVESTIGATIONS: Blood bilirubin increased Hepatic enzyme increased HEPATOBILIARY DISORDERS: Cholecystitis Cholelithiasis Cholestasis Hepatic cirrhosis Hepatic failure Hepatic fibrosis Hepatic steatosis METABOLISM AND NUTRITION DISORDERS: Metabolic acidosis MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia Myalgia NERVOUS SYSTEM DISORDERS: Headache PRIMENE 10% (Amino Acid Injection) Page 11 of 26 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Pulmonary Vascular disorder SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Blister Erythema Pruritus Urticaria VASCULAR DISORDER: Hypertension Hypotension Infusion site pain Shock Vein disorder DRUG INTERACTIONS Overview No interaction studies have been performed by Baxter Healthcare Corporation with PRIMENE 10% (Amino Acid Injection 10% w/v).
Drug-Drug Interactions Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids. Drug-Food Interactions No drug-food interaction studies have been evaluated.
Drug-Laboratory Interactions No drug-laboratory interaction studies have been evaluated. Drug-Lifestyle Interactions Interactions with lifestyle have not been evaluated. DOSAGE AND ADMINISTRATION PRIMENE 10% (Amino Acid Injection 10% w/v) is intended for intravenous use.
The product PRIMENE 10% (Amino Acid Injection) Page 12 of 26 is in Pharmacy Bulk Package and not for direct infusion. PRIMENE 10% (Amino Acid Injection 10% w/v) is not intended for fluid or volume replacement. Dosing Considerations The total daily dose of PRIMENE10% (Amino Acid Injection 10% w/v) depends on daily protein requirements and on the patient's metabolic and clinical response.
The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.
When used in neonates and children below 2 years, the solution (in containers and administration sets) should be […]
This is not medical advice. Consult a qualified healthcare professional.
This product does not contain electrolytes. Therefore sufficient amounts of electrolytes must be administered together with Lipoflex special without electrolytes according to the patient’s requirements. A sufficient potassium substitution has to be ensured.
It may be necessary to supply also trace elements and vitamins. Close monitoring of serum electrolytes is mandatory. This applies especially for re- feeding or repletion of malnourished or depleted patients who are at special risk to develop hypokalaemia, hypophosphataemia and hypomagnesaemia.
5). This medicinal product is a preparation of complex composition. 2). As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of this medicinal product. Elderly patients Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.
Patients with diabetes mellitus, impaired cardiac or renal function Like all large-volume infusion solutions, this medicinal product should be administered with caution to patients with impaired cardiac or renal function. There is only limited experience of its use in patients with diabetes mellitus or renal failure.
e. it is essentially ‘sodium-free’. g. bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been adequately cleared from the blood stream.
Immunosuppression and other factors such as hyperglycemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications. PRIMENE 10% (Amino Acid Injection) Page 5 of 26 Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycemia can help recognize early infections.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula preparation. Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic.
Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. During administration of amino acids in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs.
Correction of ketonemia usually can be accomplished by administering some carbohydrates. Peripheral administration of PRIMENE10% (Amino Acid Injection 10% w/v) requires appropriate dilution and provision of adequate calories. Hypertonic infusion solutions may cause irritation of the vein, vein damage, and thrombosis when administered into a peripheral vein (see ADVERSE REACTIONS).
Care should be taken to assure proper placement of the needle within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate treatment.
Infusion site reactions have occurred with the use of parenteral nutrition. , necrosis and blistering) when associated with extravasation. See Other Reactions. Patients should be monitored accordingly. PRIMENE 10% (Amino Acid Injection 10% w/v) contains no added electrolytes.
Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.
Unit must be used with a vented set or a non vented set with a vented spike adapter. Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure.
This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team. Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature: PRIMENE 10% (Amino Acid Injection) Page 6 of 26 Technical: The placement of a central venous catheter should be regarded as a surgical procedure.
The physician should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement.
Complications known to occur from the placement of central venous catheters are […]