Nutriflex-Lipid Peri/Nutriflex Omega Special

Nutriflex-Lipid Peri/Nutriflex Omega Special

Manufacturer:

B. Braun

Distributor:

DKSH
/
Four Star
Full Prescribing Info
Contents
Parenteral nutritional formula.
Description
Nutriflex-Lipid Peri: Composition: The ready to use emulsion for infusion contains after mixing of the contents of the individual chambers: See Table 1.

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Nutriflex Omega Special: Composition: The ready-for-use emulsion for intravenous infusion contains after mixing the chamber contents: See Table 2.

Click on icon to see table/diagram/image

Excipients/Inactive Ingredients: Nutriflex-Lipid Peri: Citric acid monohydrate, egg lecithin, glycerol, sodium oleate, water for injections.
Nutriflex Omega Special: Citric acid monohydrate, egg lecithin, glycerol, sodium oleate, all-rac-α-tocopherol, sodium hydroxide (for pH adjustment) and water for injections.
Amino acids and glucose solutions: clear, colourless up to faintly straw-coloured solutions.
Lipid emulsion: white, milky oil-in-water emulsion.
Action
Pharmacotherapeutic group: Nutriflex-Lipid Peri: Emulsion for intravenous supply of amino acids, carbohydrates, fat and electrolytes.
Nutriflex Omega Special: Solution for parenteral nutrition, combinations. ATC code: B 05BA10.
Indications/Uses
Nutriflex-Lipid Peri: Supply of the daily requirement of energy, essential fatty acids, amino acids, electrolytes and fluids during parenteral nutrition for patients with mild to moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated.
Nutriflex Omega Special: Supply of energy and essential fatty acids including omega 3 and omega 6 fatty acids, amino acids, electrolytes and fluid in the parenteral nutrition of patients in states of moderate to severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage/Direction for Use
The dosage has to be adapted to the individual requirements of the patient.
It is recommended that Nutriflex-Lipid Peri/Nutriflex Omega Special be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications.
Nutriflex-Lipid Peri: Adults: The maximum daily dose amounts to 40 ml per kg body weight, corresponding to 1.28 g amino acids/kg body weight per day; 2.56 g glucose/kg body weight per day; 1.6 g lipid/kg body weight per day.
The maximum rate of infusion is 2.5 ml/kg body weight per hour, corresponding to 0.08 g amino acids/kg body weight per hour; 0.16 g glucose/kg body weight per hour; 0.1 g lipid/kg body weight per hour.
For a patient weighing 70 kg this corresponds to an infusion rate of 175 ml per hour. The amount of amino acid administered is then 5.6 g/hour, of glucose 11.2 g/hour and of lipid 7 g/hour.
Children over 2 years of age: The given dosage recommendations are guiding data based on average requirements. The dosage should be individually adapted according to age, development stage and illness. For calculation of dosage account must be taken of the hydration status of the paediatric patient.
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.
Daily dose during 3rd - 5th year of life: 45 ml/kg body weight, corresponding to 1.44 g amino acids/kg body weight per day; 2.88 g glucose/kg body weight per day; 1.8 g lipid/kg body weight per day.
Daily dose during 6th - 14th year of life: 30 ml/kg body weight, corresponding to 0.96 g amino acids/kg body weight per day; 1.92 g glucose/kg body weight per day; 1.2 g lipid/kg body weight per day.
The maximum rate of infusion is 2.5 ml/kg body weight per hour, corresponding to 0.08 g amino acids/kg body weight per hour; 0.16 g glucose/kg body weight per hour; 0.1 g lipid/kg body weight per hour.
Additional energy that may be required for paediatric patients should be administered in the form of glucose solutions or fat emulsions, as appropriate.
Method of administration: For intravenous infusion. Especially suitable for infusion into peripheral veins.
Preparation of the mixed solution: Remove the bag from its protective pack and proceed as follows: open out the bag and lay on a solid surface; open the peel seals to the two upper chambers by using pressure with both hands; briefly mix the contents of the bag together.
Preparation for infusion: fold the two empty chambers backwards; hang the mixing bag on the infusion stand by the centre hanging loop; remove the protective cap from the run-out port and carry out infusion using the normal technique.
Duration of use: The duration of treatment for the indications stated should not exceed 7 days.
Nutriflex Omega Special: Adults: The maximum daily dose amounts to 35 ml per kg body weight, corresponding to 2.0 g amino acids per kg body weight per day; 5.04 g glucose per kg body weight per day; 1.4 g lipid per kg body weight per day.
The maximum rate of infusion is 1.7 ml per kg body weight per hour, corresponding to 0.1 g amino acids per kg body weight per hour; 0.24 g glucose per kg body weight per hour; 0.07 g lipid per kg body weight per hour.
For a patient weighing 70 kg this corresponds to an infusion rate of 119 ml per hour. The amount of amino acid administered is then 6.8 g per hour, of glucose 17.1 g per hour and of lipid per 4.8 g per hour.
In general, it is recommended that the maximum amount of energy should not exceed 40 kcal per kg body weight per day. If specially indicated e.g. for burned patients higher dosage is possible.
Children: Safety and efficacy in children and adolescents have not been established.
Duration of use: The duration of treatment for the indications stated is not limited. During long-term administration of Nutriflex Omega special it is necessary to provide for appropriate replacement of trace elements and vitamins.
Method of administration: Intravenous use. For central venous infusion only.
Overdosage
Nutriflex-Lipid Peri: Overdose of Nutriflex-Lipid Peri is not to be expected on proper administration.
Symptoms of fluid and electrolyte overdose: Hypertonic hyperhydration, electrolyte imbalance and pulmonary oedema.
Symptoms of amino acid overdose: Renal amino acid losses with consecutive amino acid imbalances, sickness, vomiting and shivering.
Symptoms of glucose overdose: Hyperglycaemia, glucosuria, dehydration, hyperosmolality, hyperglycaemic and hyperosmolar coma.
Symptoms of fat overdose: Lipid overdose may lead to the overload syndrome, characterised (for example) by fever, headache, abdominal pain, fatigue, hyperlipaemia, hepatomegaly with or without jaundice, splenomegaly, pathological disturbances of liver function, anaemia, reduction in platelet count, reduction in white cell count, haemorrhagic diathesis and haemorrhage, alteration or depression of blood coagulation factors (bleeding time, coagulation time, prothrombin time etc.). The plasma triglyceride concentration should not exceed 3 mmol/l during infusion.
Emergency treatment, antidotes: Immediate cessation of infusion is indicated for overdose. Further therapeutic measures depend on the particular symptoms and their severity. When infusion is recommenced after the symptoms have declined it is recommended that the infusion rate be raised gradually with monitoring at frequent intervals.
Nutriflex Omega Special: Symptoms of fluid and electrolyte overdose: Hypertonic hyperhydration, electrolyte imbalance and pulmonary oedema.
Symptoms of amino acid overdose: Renal amino acid losses with consecutive amino acid imbalances, sickness, vomiting and shivering.
Symptoms of glucose overdose: Hyperglycaemia, glucosuria, dehydration, hyperosmolality, hyperglycaemic - hyperosmolar coma.
Symptoms of lipid overdose: See Adverse Reactions.
Treatment: Immediate cessation of infusion is indicated for overdose. Further therapeutic measures depend on the particular symptoms and their severity. When infusion is recommenced after the symptoms have declined it is recommended that the infusion rate be raised gradually with monitoring at frequent intervals.
Contraindications
This product must not be administered in the presence of the following conditions: disturbances of amino acid metabolism; disturbances of lipid metabolism; hyperkalaemia; unstable metabolism (e.g. severe post-aggression syndrome, unstabilized diabetic metabolic situation, coma of unknown origin); hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour; acidosis; intrahepatic cholestasis; severe hepatic insufficiency; manifest cardiac insufficiency; aggravating haemorrhagic diatheses; acute phases of cardiac infarction and stroke; acute thromboembolic events, lipid embolism.
General contraindications to parenteral nutrition are: unstable circulatory status with vital threat (states of collapse and shock); inadequate cellular oxygen supply; states of hyperhydration; disturbances of the electrolyte and fluid balance; acute pulmonary oedema; decompensated cardiac insufficiency.
Use in Children: On account of its composition, Nutriflex-Lipid Peri and Nutriflex Omega Special should not be used for neonates, infants and children under 2 years of age.
Nutriflex-Lipid Peri: known hypersensitivity to egg or soya-bean protein or to any of the ingredients; hyponatraemia; severe renal insufficiency.
Nutriflex Omega Special: known hypersensitivity to egg, fish or soy protein, peanut oil or to any of the excipients; hypernatraemia; severe renal insufficiency without access to haemofiltration or dialysis.
Special Precautions
Caution should be exercised in cases of increased serum osmolarity.
As for all large-volume infusion solutions Nutriflex-Lipid Peri/Nutriflex Omega Special should be administered with caution to patients with impaired cardiac or renal function. Disturbances of the fluid, electrolyte or acid-base balance, e.g. hyperhydration (for Nutriflex-Lipid Peri), hypertonic dehydration (for Nutriflex Omega Special), hyperkalaemia, acidosis, should be corrected before the start of infusion.
Too rapid infusion can lead to fluid overload with pathological serum electrolyte concentrations, hyperhydration and pulmonary oedema.
The serum triglyceride concentration should be monitored when infusing Nutriflex-Lipid Peri/Nutriflex Omega Special. Fasting lipaemia should be excluded in patients with suspected disturbances of lipid metabolism before starting infusion.
The administration of lipids is contra-indicated if there is fasting lipaemia. The presence of hypertriglyceridaemia 12 hours after lipid administration also indicates a disturbance of lipid metabolism.
Nutriflex-Lipid Peri/Nutriflex Omega Special should be administered cautiously to patients with disturbances of lipid metabolism, e.g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), pulmonary disease (for Nutriflex Omega Special only) and sepsis. If Nutriflex-Lipid Peri/Nutriflex Omega Special is given to patients with these conditions, close monitoring of serum triglycerides is mandatory.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
Depending on the patient's metabolic condition, occasional hypertriglyceridaemia or increases of the blood glucose concentration may occur. If the plasma triglyceride concentration rises to more than 3 mmol/l during administration of lipid it is recommended that the infusion rate should be reduced. Should the plasma triglyceride concentration remain above 3 mmol/l the administration should be stopped until the level normalizes.
As with all solutions containing carbohydrates the administration of Nutriflex-Lipid Peri/Nutriflex Omega Special 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.
A dose reduction or interruption of administration is also indicated if the blood glucose concentration rises to more than 14 mmol/l (250 mg/dl) when administering the lipid/product.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, especially copper and, in particular, zinc. This should be considered in the dosing of trace elements, especially during long-term intravenous nutrition.
Nutriflex-Lipid Peri/Nutriflex Omega Special should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.
Moreover controls of the serum electrolyte levels, the water balance, the acid-base balance and - during long-term administration - of blood cell counts, coagulation status and hepatic function are necessary.
The fat content may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been adequately cleared from the blood stream.
Substitution of electrolytes, vitamins and trace elements may be necessary as required.
As Nutriflex-Lipid Peri/Nutriflex Omega Special contains zinc and magnesium, care should be taken when it is co-administered with solutions containing these elements.
As with all intravenous solutions strict aseptic precautions are necessary for the infusion of Nutriflex-Lipid Peri/Nutriflex Omega Special.
Nutriflex-Lipid Peri/Nutriflex Omega Special is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions.
Nutriflex Omega Special: There is as yet no clinical experience of the use of Nutriflex Omega special in children and adolescents.
There is only limited experience of its use in patients with diabetes mellitus or renal failure.
Vitamin E can interfere with the effect of vitamin K in clotting factor synthesis. This should be considered in patients with blood coagulation disorders or suspected vitamin K deficiency.
Use In Pregnancy & Lactation
Nutriflex-Lipid Peri: Nutriflex-Lipid Peri should only be used in pregnancy if there is an imperative indication. This medicine manufactured with soya-bean oil contains phytosterols in concentrations that could lead to disturbances of fertility, according to results of testing of the purified substance in animal experiments. At present there are no studies available making a risk-benefit assessment possible with regard to effects on the embryo or the fetus.
Breast-feeding is not recommended if women need parenteral nutrition in that time.
Nutriflex Omega Special: Pregnancy: There is no experience of the use of Nutriflex Omega special in pregnant women. Parenteral nutrition may become necessary during pregnancy. Nutriflex Omega special should only be given to pregnant women after careful consideration.
Lactation: There is no experience of the use of Nutriflex Omega special in nursing mothers. It is as yet not known if Nutriflex Omega special crosses the placental barrier or is excreted in breast milk. No respective data are available from animal experiments either. Breast-feeding is not recommended to mothers on parenteral nutrition.
Adverse Reactions
Nutriflex-Lipid Peri: Possible early reactions on the administration of lipid emulsions are: slight increase in temperature, flush, cold feeling, shivering, loss of appetite, nausea, vomiting, respiratory distress, headache, pain in the back, bones, chest and lumbar region, fall or increase in blood pressure (hypotension, hypertension), hypersensitivity reactions (e.g. anaphylactic reactions, dermal eruptions).
Hot flushes or bluish discoloration of the skin due to reduced oxygen content of the blood (cyanosis) can occur as side effects.
If these side effects occur the infusion should be discontinued or, if appropriate, the infusion should be continued at a lower dose level.
Attention should be paid to the possibility of an overloading syndrome. This can occur as a result of individually varying, genetically determined metabolic conditions and can occur at different rates and after differing doses depending on previous disorders.
Overloading syndrome is associated with the following symptoms: enlargement of the liver (hepatomegaly) with and without jaundice (icterus), enlargement of the spleen (splenomegaly), fatty infiltration of the organs, pathological hepatic function parameters, anaemia, reduction of white cell count (leucopenia), reduction of platelet count (thrombocytopenia), a tendency to haemorrhage and haemorrhages, alterations or reduction in the blood coagulation factors (bleeding time, coagulation time, prothrombin time etc.), fever, hyperlipaemia, headache, stomache ache, fatigue.
If signs of vein wall irritation, phlebitis, or thrombophlebitis occur, change of the infusion site should be considered.
Please inform the doctor or pharmacist if the patient notices any undesirable effect that is not mentioned.
Nutriflex Omega Special: The following listing includes a number of systemic reactions that may be associated with the use of Nutriflex Omega special. Under conditions of correct use, in terms of dosing monitoring, observation of safety restrictions and instructions, most of them are rare (≥ 1/10,000 to < 1/1,000).
Blood and lymphatic system disorders: Very rare (< 1/10,000): Hypercoagulation.
Immune system disorders: Rare (≥ 1/10,000 to < 1/1,000): Allergic reactions (e.g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema).
Metabolism and nutrition disorders: Very rare (< 1/10,000): Hyperlipidaemia, hyperglycaemia, metabolic acidosis, ketoacidosis.
The frequency of these undesirable effects is dose-dependent and may be higher under the conditions of absolute or relative lipid overdose.
Nervous system disorders: Rare (≥ 1/10,000 to < 1/1,000): Drowsiness.
Vascular disorders: Rare (≥ 1/10,000 to < 1/1,000): Hypertension or hypotension, flush.
Respiratory, thoracic and mediastinal disorders: Rare (≥ 1/10,000 to < 1/1,000): Dyspnoea, cyanosis.
Gastrointestinal disorders: Uncommon (≥ 1/1,000 to < 1/100): Nausea, vomiting, loss of appetite.
Skin and subcutaneous tissue disorders: Rare (≥ 1/10,000 to < 1/1,000): Erythema.
General disorders and administration site conditions: Rare (≥ 1/10,000 to < 1/1,000): Headache, elevated body temperature, sweating, feeling cold, chills, pain in the back, bones, chest and lumbar region.
Very rare (< 1/10,000): Fat overload syndrome (see details as follows).
Should adverse reactions occur or should the triglyceride level rise above 3 mmol/l during infusion, the infusion of Nutriflex Omega special should be stopped or, if necessary, continued at a reduced dosage.
If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Triglycerides that contain omega-3 fatty acids may increase bleeding time and inhibit platelet aggregation. In patients with aspirin-induced asthma, pulmonary function may deteriorate as well.
Nausea, vomiting, lack of appetite and hyperglycaemia are symptoms often related to conditions indicating parenteral nutrition or may be associated with parenteral nutrition.
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, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis 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 Nutriflex Omega special should be discontinued immediately.
Note: Patients should inform their doctor or pharmacist if they notice any side effect not mentioned.
Drug Interactions
Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only 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. This may interfere with the therapeutic effect of coumarin derivatives which should be closely monitored in patients treated with such drugs.
Nutriflex Omega Special: Potassium containing solutions like Nutriflex Omega special should be used with caution in patients receiving drugs that increase serum potassium concentration (e.g. potassium-sparing diuretics, ACE inhibitors, cyclosporine or tacrolimus).
Caution For Usage
Nutriflex Omega Special: Instructions for disposal/use/handling: No special requirements are needed for disposal of container, overwrap and oxygen absorber.
Only use bags that are undamaged and in which the amino acid and glucose solutions are clear and free of particles. Do not use bags where there is a discolouration or discernible phase separation (oil drops) in the chamber containing lipid emulsion.
Preparation of the mixed emulsion: Remove the bag from its protective overwrap and proceed as follows: Put the bag on a solid surface; Open the peel seams of the two upper chambers by pushing with both hands; Mix the contents of the bag thoroughly.
Preparation for infusion: Fold the bag and hang it on the infusion stand by the centre hanging loop; Remove the protective cap from the set port and carry out infusion using the standard technique.
The mixture is a milky white homogenous oil in water emulsion.
The emulsion should always be brought to room temperature prior to infusion.
If filters are used they must be lipid-permeable.
The emulsion is to be used immediately after opening of the container.
Incompatibilities: Nutriflex Omega special must not be used as a carrier solution for pharmaceuticals or be mixed with other infusion solutions without testing, since it is not possible to guarantee adequate stability of the emulsion.
Storage
Nutriflex-Lipid Peri: The emulsion is to be used immediately after mixing. It can be stored at 2 - 8 °C over 4 days, plus 48 hours at 25 °C.
Protect from light and do not store above 25 °C.
Do not freeze. If accidentally frozen, discard the bag.
Nutriflex Omega Special: Do not store above 25 °C. Do not freeze. If accidentally frozen, discard the bag.
Keep the bags in the outer carton in order to protect from light.
Storage after removing the protective pack and after mixing of the contents of the bag: Chemical and physical in-use stability after mixing the contents has been demonstrated for 7 days at 2-8°C and additional 48 hours at 25°C.
Storage after admixture of compatible additives: 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 to 8°C unless admixture has taken place in controlled and validated aseptic conditions.
Nutriflex Omega special is supplied in single dose containers. Unused residues must be discarded.
ATC Classification
V06DX - Other combinations of nutrients ; Used as general nutrients.
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Nutriflex-Lipid Peri: 1,250 mL x 5's, 1,875 mL x 5's. Nutriflex Omega Special: Infusion 1,250 mL x 5's, 1,875 mL x 5's.
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