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SMOFKABIVEN LOW OSMO PERIPHERAL is a brand name for Lysine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
Verbatim from this product's MHRA label. Tap a section to expand.
61 MJ 1 Contribution from both the lipid emulsion and the amino acid solution. 1. 3 PHARMACEUTICAL FORM Emulsion for infusion. Glucose and amino acid solutions are clear and colourless to slightly yellow and free from particles. The lipid emulsion is white and homogenous.
Osmolality: approx. 870 mosmol/kg water Osmolarity: approx. 750 mosmol/l pH (after mixing): approx. 1 Therapeutic indications Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
2 Posology and method of administration Posology The appearance of the product after mixing the 3 chambers is a white emulsion. The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section
8. SmofKabiven Low Osmo Peripheral should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.
This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reactions has been observed between soya-bean and peanut. To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.
g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion. SmofKabiven Low Osmo Peripheral should be given with caution to patients with a tendency towards electrolyte retention. Special clinical monitoring is required at the beginning of any intravenous infusion.
Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any peripheral vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests should be monitored. Blood cell count and coagulation should be monitored when lipids are given for a longer period. In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphataemia and hyperkalaemia.
The amount of individual electrolytes to be provided in addition is governed by the clinical condition of the patient and by frequent monitoring of serum levels. Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
4. The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake. g. nutritional state and degree of catabolic stress or anabolism).
9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. 6 g amino acids/kg bw/day). g. burns or marked anabolism) the nitrogen need may be even higher. 0 g amino acids/kg bw/day) and 14-29 kcal/kg bw/day of total energy (12-25 kcal/kg bw/day of non-protein energy).
This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight. 15 g/kg bw/h. 13 g lipids/kg bw/h). The recommended infusion period is 12-24 hours.
Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 40 ml/kg bw/day. 4 g lipids/kg bw/day and a total energy of 29 kcal/kg bw/day (corresponding to 25 kcal/kg bw/day of non-protein energy).
Paediatric population Children (2-11 years) Dosage:
The dose up to 40 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients. 14 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 10 hours, except in exceptional cases and with careful monitoring.
The recommended infusion period is 12-24 hours.
Maximum daily dose:
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 40 ml/kg bw/day. 4 g lipids/kg bw/day and a total energy content of 29 kcal/kg bw/day (corresponding to 25 kcal/kg bw/day of non-protein energy).
g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma) - Neonates and infants under 2 years of age
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion. , bilirubin, lactate dehydrogenase, oxygen saturation, haemoglobin) if blood is sampled before lipids have been adequately cleared from the bloodstream.
Lipids are cleared after a lipid-free interval of 5-6 hours in most patients. Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-term intravenous nutrition.
Amounts of zinc administered with SmofKabiven Low Osmo Peripheral should be taken into account. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins.
These changes can occur within 24 to 48 hours, therefore careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, trace elements and vitamins.
SmofKabiven Low Osmo Peripheral should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination. In patients with hyperglycaemia, administration of exogenous insulin might be necessary. Thrombophlebitis may occur if peripheral veins are used for infusions.
The catheter insertion site should be evaluated daily for local signs of thrombophlebitis. SmofKabiven Low Osmo Peripheral is a preparation of complex composition. 2). Paediatric population Due to composition of the amino acid solution in SmofKabiven Low Osmo Peripheral it is not suitable for the use in new-borns or infants below 2 years of age.
There is no clinical experience of the use of SmofKabiven Low Osmo Peripheral in children and adolescents (age 2 to 16/18 years). 5 Interaction with other medicinal products and other forms of interaction Some medicinal products, like insulin, may interfere with the body’s lipase system.
This kind of interaction seems, however, to be of limited clinical importance. Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.
Soya-bean oil has a natural content of vitamin K1. However, the concentration in SmofKabiven Low Osmo Peripheral is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.
6 Fertility, pregnancy and lactation Pregnancy There are no data on exposure of SmofKabiven Low Osmo Peripheral in pregnant women. 3). Parenteral nutrition may become necessary during pregnancy. SmofKabiven Low Osmo Peripheral should only be given to pregnant women after careful consideration.
Breastfeeding There are no data available on exposure of SmofKabiven Low Osmo Peripheral in breast-feeding women. Components and metabolites of parenteral nutrition like SmofKabiven Low Osmo Peripheral are excreted in human milk. Parenteral nutrition may become necessary during lactation.
SmofKabiven Low Osmo Peripheral should only be given to breast-feeding women after consideration of the potential risks and benefits. Fertility There are no data on fertility available. 7 Effects on ability to drive and use machines Not relevant.
8 Undesirable effects Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Cardiac disorders Tachycardia Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal […]
Adolescents (12-18 years) In adolescents, SmofKabiven Low Osmo Peripheral can be used as in adults. Method of administration Intravenous use, infusion into a peripheral or central vein. SmofKabiven Low Osmo Peripheral is available in four pack sizes intended for patients with moderately increased or basal nutritional requirements.
To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven Low Osmo Peripheral) should be provided in addition to SmofKabiven Low Osmo Peripheral according to the patient’s need.
6. g. 4 Special warnings and precautions for use The capacity to eliminate lipids is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels.
The concentration of triglycerides in serum should not exceed 4 mmol/l during infusion. 8. SmofKabiven Low Osmo Peripheral should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.
This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reactions has been observed between soya-bean and peanut. To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.
g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion. SmofKabiven Low Osmo Peripheral should be given with caution to patients with a tendency towards electrolyte retention. Special clinical monitoring is required at the beginning of any intravenous infusion.
Should any […]