Summary of Product Characteristics (SmPC) - Smofkabiven Nutribase emulsion for infusion
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Nutribase emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Nutribase consists of a three-chamber bag system. Each bag contains the following partial volumes depending on the four pack sizes.
1026
ml
1539 ml 2052 ml 2565 ml Per 1000 ml
Amino acid solution 10%
with electrolytes
348 ml
522 ml
696 ml
870 ml
339 ml
Glucose 19% 478 ml 717 ml 956 ml 1195 ml 466 ml
Lipid emulsion 20% 200 ml 300 ml 400 ml 500 ml 195 ml
This corresponds to the following total compositions:
| Active ingredients | 1026 ml | 1539 ml | 2052 ml | 2565 ml | Per 1000 ml |
| Alanine | 4.9 g | 7.3 g | 9.7 g | 12.2 g | 4.7 g |
| Arginine | 4.2 g | 6.3 g | 8.4 g | 10.4 g | 4.1 g |
| Glycine | 3.8 g | 5.7 g | 7.7 g | 9.6 g | 3.7 g |
| Histidine | 1.0 g | 1.6 g | 2.1 g | 2.6 g | 1.0 g |
| Isoleucine | 1.7 g | 2.6 g | 3.5 g | 4.4 g | 1.7 g |
| Leucine | 2.6 g | 3.9 g | 5.2 g | 6.4 g | 2.5 g |
| Lysine (as acetate) | 2.3 g | 3.4 g | 4.6 g | 5.7 g | 2.2 g |
| Methionine | 1.5 g | 2.2 g | 3.0 g | 3.7 g | 1.5 g |
| Phenylalanine | 1.8 g | 2.7 g | 3.5 g | 4.4 g | 1.7 g |
| Proline | 3.9 g | 5.8 g | 7.8 g | 9.7 g | 3.8 g |
| Serine | 2.3 g | 3.4 g | 4.5 g | 5.7 g | 2.2 g |
| Taurine | 0.35 g | 0.52 g | 0.70 g | 0.87 g | 0.34 g |
| Threonine | 1.5 g | 2.3 g | 3.1 g | 3.8 g | 1.5 g |
| Tryptophan | 0.70 g | 1.0 g | 1.4 g | 1.7 g | 0.68 g |
| Tyrosine | 0.14 g | 0.21 g | 0.28 g | 0.35 g | 0.14 g |
| Valine | 2.2 g | 3.2 g | 4.3 g | 5.4 g | 2.1 g |
Calcium chloride dihydrate corresponding to Calcium chloride | 0.19 g | 0.29 g | 0.39 g | 0.49 g | 0.19 g |
| Sodium glycerophosphate (hydrate) corresponding to | 1.5 g | 2.2 g | 2.9 g | 3.6 g | 1.4 g |
| Sodium glycerophosphate | |||||
Magnesium sulphate heptahydrate corresponding to Magnesium sulphate | 0.42 g | 0.63 g | 0.84 g | 1.0 g | 0.41 g |
| Potassium chloride | 1.6 g | 2.3 g | 3.1 g | 3.9 g | 1.5 g |
Sodium acetate trihydrate corresponding to Sodium acetate | 1.2 g | 1.8 g | 2.4 g | 2.9 g | 1.1 g |
Zinc sulphate heptahydrate corresponding to Zinc sulphate | 0.0045 g | 0.0067 g | 0.0090 g | 0.0112 g | 0.0044 g |
| Glucose monohydrate corresponding to Glucose | 91 g | 136 g | 182 g | 227 g | 89 g |
| Soya-bean oil, refined | 12 g | 18 g | 24 g | 30 g | 12 g |
| Medium-chain triglycerides | 12 g | 18 g | 24 g | 30 g | 12 g |
| Olive oil, refined | 10 g | 15 g | 20 g | 25 g | 9.8 g |
| Fish oil, rich in omega-3-acids | 6.0 g | 9.0 g | 12 g | 15 g | 5.9 g |
Corresponding to
| Amino acids | 34.8 g | 52.3 g | 69.7 g | 87.1 g | 33.9 g |
| Nitrogen | 5.57 g | 8.36 g | 11.1 g | 13.9 g | 5.43 g |
| Electrolytes | |||||
| 28 mmol | 42 mmol | 56 mmol | 70 mmol | 27 mmol |
| 21 mmol | 31 mmol | 42 mmol | 52 mmol | 20 mmol |
| 3.5 mmol | 5.2 mmol | 7.0 mmol | 8.7 mmol | 3.4 mmol |
| 1.8 mmol | 2.6 mmol | 3.5 mmol | 4.4 mmol | 1.7 mmol |
| 9.8 mmol | 15 mmol | 20 mmol | 24 mmol | 9.5 mmol |
| 0.028 mmol | 0.042 mmol | 0.056 mmol | 0.070 mmol | 0.027 mmol |
| 3.5 mmol | 5.3 mmol | 7.0 mmol | 8.8 mmol | 3.4 mmol |
| 24 mmol | 37 mmol | 49 mmol | 61 mmol | 24 mmol |
| 73 mmol | 109 mmol | 145 mmol | 182 mmol | 71 mmol |
| Carbohydrates | |||||
| 90.8 g | 136 g | 182 g | 227 g | 88.5 g |
| Lipids | 40.0 g | 60.0 g | 80.0 g | 100 g | 39.0 g |
| Energy content | |||||
| 904 kcal 3.78 MJ | 1356 kcal 5.67 MJ | 1808 kcal 7.56MJ | 2261 kcal 9.46 MJ | 881 kcal 3.69MJ |
| 765 kcal 3.20 MJ | 1147 kcal 4.80 MJ | 1530 kcal 6.40 MJ | 1912 kcal 8.00 MJ | 746 kcal 3.12 MJ |
1 Contribution from both the lipid emulsion and the amino acid solution.
For the full list of excipients, see section 6.1.
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. 1189 mOsmol/kg water
Osmolarity: approx. 1007 mOsmol/l
pH (after mixing): approx. 5.6
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
4.2 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 4.4.
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.
The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).
Adults
The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.
Dosage:
The dosage range of 18-40 ml SmofKabiven Nutribase /kg bw/day corresponds to 0.10-0.22 g nitrogen/kg bw/day (0.6-1.4 g amino acids/kg bw/day) and 16-35 kcal/kg bw/day of total energy (13-30 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.
Infusion rate:
The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.
The infusion rate should not exceed 2.8 ml/kg bw/h (corresponding to 0.25 g glucose, 0.09 g amino acids, and 0.11 g lipids/kg bw/h). The recommended infusion period is 6.5-24 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.
The recommended maximum daily dose of 40 ml/kg bw/day will provide 0.22 g nitrogen/kg bw/day (corresponding to 1.4 g amino acids/kg bw/day), 3.5 g glucose/kg bw/day, 1.6 g lipids/kg bw/day and a total energy of 35 kcal/kg bw/day (corresponding to 30 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.
Infusion rate:
The infusion rate should not exceed 3.4 ml/kg bw/h (corresponding to 0.30 g glucose, 0.12 g amino acids, and 0.13 g lipids/kg bw/h).
The recommended infusion period is 5-24 hours. At the recommended maximum infusion rate, do not use an infusion period longer than 11 hours 45 minutes, except in exceptional cases and with careful monitoring.
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.
The recommended maximum daily dose of 40 ml/kg bw/day will provide 0.22 g nitrogen/kg bw/day (corresponding to 1.4 g amino acids/kg bw/day), 3.5 g glucose/kg bw/day, 1.6 g lipids/kg bw/day and a total energy of 35 kcal/kg bw/day (corresponding to 30 kcal/kg bw/day of non-protein energy).
Adolescents (12-18 years)
In adolescents, SmofKabiven Nutribase can be used as in adults.
Method of administration
Intravenous use, infusion into a central vein.
SmofKabiven Nutribase 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 Nutribase) should be provided according to the patient’s need. Mixing within the SmofKabiven Nutribase bag should only be done where compatibility has been shown, see section 6.6.
For instructions on preparation of the medicinal product before administration, see section 6.6.
4.3 Contraindications
- Hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients listed in section 6.1
- Severe hyperlipidaemia
- Severe liver insufficiency
- Severe blood coagulation disorders
- Congenital errors of amino acid metabolism
- Severe renal insufficiency without access to haemofiltration or dialysis
- Acute shock
- Uncontrolled hyperglycaemia
- Pathologically elevated serum levels of any of the included electrolytes
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency
- Haemophagocytotic syndrome
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma)
- Infants and children under 2 years of age
4.4 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. An overdose may lead to fat overload syndrome, see section 4.8.
SmofKabiven Nutribase 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 reaction 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.
Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
SmofKabiven Nutribase 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 central 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.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
The lipid content of SmofKabiven Nutribase may interfere with certain laboratory measurements (e.g., 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 Nutribase 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 Nutribase 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.
SmofKabiven Nutribase is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions if compatibility is not proven (see section 6.2).
Paediatric population
Due to composition of the amino acid solution in SmofKabiven Nutribase it is not suitable for the use in infants or children below 2 years of age. There is no clinical study experience of the use of SmofKabiven Nutribase in children and adolescents (age 2 to 18 years).
4.5 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 Nutribase is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no data on exposure of SmofKabiven Nutribase in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Parenteral nutrition may become necessary during pregnancy. SmofKabiven Nutribase should only be given to pregnant women after careful consideration.
Breastfeeding
There are no data available on exposure of SmofKabiven Nutribase in breast-feeding women. Components and metabolites of parenteral nutrition like SmofKabiven Nutribase are excreted in human milk. Parenteral nutrition may become necessary during lactation. SmofKabiven Nutribase should only be given to breast-feeding women after consideration of the potential risks and benefits.
Fertility
There are no data on fertility available.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 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 disorders | Lack of appetite, nausea, vomiting | ||
| Metabolism and nutrition disorders | Elevated plasma levels of liver enzymes | ||
| Vascular disorders | Hypotension, hypertension | ||
| General disorders and administration site conditions | Slight increase in body temperature. | Chills, dizziness, headache | Hypersensitivity-reactions (e.g. anaphylactic or anaphylactoid reactions, skin rash, urticaria, flush, headache), heat or cold sensation, paleness, cyanosis, pain in the neck, back, bones, chest and loins |
Should these side-effects occur the infusion of SmofKabiven Nutribase should be stopped or, if necessary, continued at a reduced dosage.
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 lipid metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, 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, lipid infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leukopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma. The symptoms are usually reversible if the infusion of the lipid emulsion is discontinued.
Excess of amino acid infusion
As with other amino acid solutions, the amino acid content in SmofKabiven Nutribase may cause undesirable effects when the recommended infusion rate is exceeded. These effects are nausea, vomiting, shivering and sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function, increased levels of nitrogen containing metabolites (e.g. creatinine, urea) may occur.
Excess of glucose infusion
If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.
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
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
See section 4.8 “Fat overload syndrome”, “Excess of amino acid infusion” and “Excess of glucose infusion”.
If symptoms of overdose of lipids or amino acids occur, the infusion should be slowed down or discontinued. There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.
Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemodiafiltration may be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solutions for parenteral nutrition. ATC code: B05BA10
Lipid emulsion
The lipid emulsion of SmofKabiven Nutribase is composed of SMOFlipid and has a particle size and biological properties similar to those of endogenous chylomicrons. The constituents of SMOFlipid, soya-bean oil, medium-chain triglycerides, olive oil and fish oil have except for their energy contents, their own pharmacodynamic properties.
Soya-bean oil has a high content of essential fatty acids. The omega-6 fatty acid linoleic acid is the most abundant (approx. 55-60%). Alpha-linolenic acid, an omega-3 fatty acid, constitutes about 8 %. This part of SmofKabiven Nutribase provides the necessary amount of essential fatty acids.
Medium-chain fatty acids are rapidly oxidised and provide the body with a form of immediately available energy.
Olive oil mainly provides energy in the form of mono-unsaturated fatty acids, which are much less prone to peroxidation than the corresponding amount of poly-unsaturated fatty acids.
Fish oil is characterised by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as prostaglandines, thromboxanes and leucotrienes.
Two studies providing home parenteral nutrition in patients in need of long-term nutrition support have been performed. The primary objective in both studies was to show safety. Efficacy was the secondary objective in one of the studies, which was done in paediatric patients. This study was stratified by age groups (1 month - <2 years, and 2 – 11 years respectively). Both studies showed that SMOFlipid has the same safety profile as the comparator (Intralipid 20%). Efficacy in the paediatric study was measured by weight gain, height, body mass index, pre-albumin, retinol binding protein and fatty acid profile. There was no difference between the groups in any of the parameters except the fatty acid profile after 4 weeks treatment. The fatty acid profile in the SMOFlipid patients revealed an increase in omega-3 fatty acids in plasma lipoproteins and red blood cells phospholipids and hence reflects the composition of the infused lipid emulsion.
Amino acids and electrolytes
The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any surplus is channelled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.
Glucose
Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.
5.2 Pharmacokinetic properties
Lipid emulsion
The individual triglycerides in SMOFlipid have different clearance rates but SMOFlipid as a mixture is eliminated faster than long chain triglycerides (LCT). Olive oil has the slowest clearance rate of the components (somewhat slower than LCT) and medium chain triglycerides (MCT) the fastest. Fish oil in a mixture with LCT has the same clearance rate as LCT alone.
Amino acids and electrolytes
The principal pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same as for amino acids and electrolytes supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly.
Glucose
The pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by ordinary food.
5.3 Preclinical safety data
Preclinical safety studies with SmofKabiven Nutribase or Aminoven have not been performed. However, preclinical data for SMOFlipid as well as for comparable amino acid and glucose solutions of various concentrations and sodium glycerophosphate reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
No teratogenic effects or other embryotoxic injuries could be observed in rabbits with amino acid solutions and are not to be expected from lipid emulsions and sodium glycerophosphate when giving at the recommended doses as substitution therapy. Nutritional products (amino acid solutions, lipid emulsions, and sodium glycerophosphate) used in replacement therapy at physiological levels are not expected to be embryotoxic, teratogenic, or to influence reproductive performance or fertility.
In a local tolerance study with SMOFlipid in rabbits a slight, transient inflammation after intra-arterial, paravenous or subcutaneous administration was observed. After intra-muscular administration a moderate transient inflammation and tissue necrosis were seen in some animals. In a test in guinea pigs (Maximisation test) fish oil showed moderate dermal sensitisation. A systemic antigenicity test gave no indication of evidence of anaphylactic potential of fish oil.
SmofKabiven Nutribase is a product with very similar qualitative composition as SmofKabiven (same amino acid solution, same lipid emulsion and lower glucose amount). Intravenous infusion of SmofKabiven (the intended route of administration for SmofKabiven and SmofKabiven Nutribase), as well as intraarterial, intramuscular, paravenous and subcutaneous injections did not reveal any drug substance-related changes in rabbits.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Purified egg phospholipids
all-rac-α-Tocopherol
Sodium hydroxide (pH adjuster)
Sodium oleate
Acetic acid, glacial (pH adjuster)
Water for injections
6.2 Incompatibilities
SmofKabiven Nutribase may only be mixed with other medicinal products for which compatibility has been documented, see section 6.6.
6.3 Shelf life
Shelf life of the medicinal product as packaged for sale
2 years
Shelf life after mixing
Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
Shelf life after mixing with compatible medicinal products From a microbiological point of view, the product should be used immediately when additions have been made.
6.4 Special precautions for storage
Do not store above 25°C. Do not freeze. Store in overpouch.
Shelf life after mixing: See section 6.3.
Shelf life after mixing with compatible medicinal products: See section 6.3.
6.5 Nature and contents of container
The container consists of a multichamber inner bag and an overpouch. The inner bag is separated into three chambers by peelable seals. An oxygen absorber is placed between the inner bag and the overpouch. The inner bag is made of a multilayer polymer film, Biofine.
The Biofine inner bag film consists of poly(propylene-co-ethylene), synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) and synthetic rubber poly(styrene-block-isoprene) (SIS). The infusion and additive ports are made of polypropylene and synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) equipped with synthetic polyisoprene (latex-free) stoppers. The blind port, which is only used during manufacturing, is made of polypropylene equipped with a synthetic polyisoprene (latex-free) stopper.
Pack sizes:
1 x 1026 ml, 4 x 1026 ml
1 x 1539 ml, 4 x 1539 ml
1 x 2052 ml, 4 x 2052 ml
1 x 2565 ml, 3 x 2565 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Instructions for use
Do not use if package is damaged. Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.
After separation of the peelable seals the bag should be inverted three times to ensure a homogenous white emulsion mixture, which does not show any evidence of phase separation.
Compatibility
The compatibility table below shows possible additions with the named branded products Dipeptiven, Addaven, Vitalipid N Adult/Infant and Soluvit N (lyophilized). Generated data supports additions to the activated bag according to the summary table below:
| Maximal total contents | |
| SmofKabiven Nutribase bag size | 1026 mL, 1539 mL, 2052 mL and 2565 mL |
| Additive | Volume |
| Dipeptiven | 0 - 300 mL |
| Addaven | 0 - 10 mL |
| Soluvit N | 0 - 1 vial |
| Vitalipid N Adult/Infant | 0 - 10 mL |
Note: This table is intended to present compatibility. It is not a dosing guideline.
Addition should be made aseptically.
For single use only. Any unused medicinal product remaining after infusion must be discarded.
Any unused medicinal product or waste material should be disposed in accordance with local requirement
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way, Manor Park, Runcorn, WA7 1NT
8 MARKETING AUTHORISATION NUMBER(S)
PL 08828/0319
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/01/2022
10 DATE OF REVISION OF THE TEXT
17/01/2022