OliClinomel N4-550E/OliClinomel N7-1000E

Parenteral nutrition.

This medicinal product is presented in the form of a 3-compartment bag. There are four presentations, which have the following different volumes: See Table 1.

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Composition of a 1000 ml bag: Active substances are: OliClinomel N4-550E: See Table 2.

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OliClinomel N7-1000E: See Table 3.

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After the contents of the three compartments have been mixed, the ternary mixture provides the following quantities for all the different bag sizes: OliClinomel N4-550E: See Table 4.

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OliClinomel N7-1000E: See Table 5.

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Excipients/Inactive Ingredients: Lipid emulsion compartment: Purified egg phosphatide, Glycerol, Sodium oleate, Sodium hydroxide (for pH adjustment), Water for injection.
Amino acid solution compartment: Acetic acid (for pH adjustment), Water for injection.
Glucose solution compartment: Hydrochloric acid (for pH adjustment), Water for injection.

Pharmacotherapeutic group: Solutions for parenteral/mixed nutrition. ATC code: B05BA10.
Pharmacology: Pharmacodynamics: This is a ternary mixture enabling the nitrogen/energy balance to be maintained from the nitrogen source (L series amino acids) and energy in the form of glucose and essential fatty acids. In addition, this formulation contains electrolytes.
The amino acid solution contains 15 L series amino acids (including 8 essential amino acids), which are essential for protein synthesis.
The amino acids also represent an energy source, their oxidation resulting in excretion of nitrogen in the form of urea.
The amino acid profile is as follows: essential amino acids/total amino acids 40.5%; essential amino acids (g)/total nitrogen (g) 2.5; branched-chain amino acids/total amino acids 19%.
The carbohydrate source is glucose (80 g/l for OliClinomel N4-550E) and (160 g/l for OliClinomel N7-1000E).
The lipid emulsion is an association of refined olive oil and refined soya bean oil (ratio 80/20), with the following approximate distribution of fatty acids: 15% saturated fatty acids (SFA); 65% monounsaturated fatty acids (MUFA); 20% polyunsaturated essential fatty acids (PUFA).
The phospholipid/triglyceride ratio is 0.06.
The moderate essential fatty acid (EFA) content improves the status of their higher derivatives while correcting EFA deficiency.
Olive oil contains a significant amount of alpha tocopherol which, combined with a moderate intake of polyunsaturated essential fatty acids, contributes to improving vitamin E status and reducing lipid peroxidation.
Pharmacokinetics: The ingredients (amino acids, electrolytes, glucose, lipids) are distributed, metabolised and eliminated in the same way as if they were administered individually.
The pharmacokinetic properties of the amino acids administered intravenously are principally the same as those of amino acids supplied by oral feeding. Amino acids from food proteins, however, first pass through the portal vein before reaching the systemic circulation.
The elimination rate of lipid emulsions depends on particle size. Small lipid particles appear to delay elimination clearance whereas they increase lipolysis by lipoprotein lipase.
The size of the lipid particles in the emulsion contained in OliClinomel is close to the size of chylomicrons so that this emulsion therefore has a similar elimination rate.
Toxicology: Preclinical safety data: No preclinical studies have been performed on the finished product, OliClinomel.
Preclinical studies performed using the solutions of amino acids and glucose contained in OliClinomel of various composition and concentration have not, however, revealed any specific toxicity.
Preclinical toxicity studies performed using the lipid emulsion contained in OliClinomel have identified the changes usually found with a high intake of a lipid emulsion: fatty liver, thrombocytopenia and elevated cholesterol.

Parenteral nutrition for adults and children over two years of age, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Posology: Dosage depends on energy expenditure, the clinical condition, the patient's body weight and ability to metabolise the constituents of OliClinomel, as well as on energy intake or additional proteins taken orally or provided by enteral feeding. The size of bag must therefore be selected in consequence.
The prescription may be continued for as long as the patient's clinical condition makes it necessary.
In the adult: Requirements: Average nitrogen requirements are 0.16 to 0.35 g/kg/day (approximately 1 to 2 g of amino acids/kg/day). Energy requirements vary depending on the patient's nutritional condition and level of catabolism. On average, these are 20 to 40 kcal/kg/day. Average daily fluid requirements are usually within the range of 1 to 1.5 mL per expended kcal and require adjustment based on the patient's fluid and metabolic status.
Maximum daily dose: OliClinomel N4-550E: The maximum daily dose is 40 ml/kg body weight (equivalent to 0.88 g of amino acids, 3.2 g of glucose and 0.8 g of lipids, 0.84 mmol of sodium and 0.64 mmol of potassium per kg), i.e. 2800 ml of the emulsion for infusion for a patient weighing 70 kg.
OliClinomel N7-1000E: The maximum daily dose is 33 ml/kg body weight (equivalent to 1.32 g of amino acids, 5.28 g of glucose and 1.32 g of lipids, 1.06 mmol of sodium and 0.79 mmol of potassium per kg), i.e. 2310 ml of the emulsion for infusion for a patient weighing 70 kg.
In children above two years of age: No study has been undertaken in the paediatric population.
Energy requirements vary depending on patient's age, nutritional condition/state and level of catabolism.
Posology: The prescription is based on fluid intake and daily nitrogen requirements.
These intakes should be adjusted based on the child's hydration status.
The guidelines for maximal recommended hourly rate of infusion and volume per day for pediatric patients are: Maximum Daily Dose: OliClinomel N4-550E: See Table 6.

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OliClinomel N7-1000E: See Table 7.

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Maximum Hourly Rate: OliClinomel N4-550E: See Table 8.

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OliClinomel N7-1000E: See Table 9.

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Method of administration: For single use only.
After opening the bag, it is recommended to use the contents immediately and not to store them for later infusion.
Appearance following reconstitution: homogenous liquid with a milky appearance.
For instructions for preparation and handling of the emulsion for infusion, see "Special precautions for disposal and other handling" under Cautions for Usage.
BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL OR PERIPHERAL VEIN (because of the low osmolarity of OliClinomel N4-550E) (for OliClinomel N4-550 E only).
BY INTRAVENOUS ADMINISTRATION THROUGH A CENTRAL VEIN ONLY (because of the high osmolarity of OliClinomel N7-1000E) (for OliClinomel N7-1000E only).
The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours.
The administration flow rate must be adjusted based on the dose being administered, the characteristics of the final mixture to be administered, the daily volume intake and the duration of the infusion (see "Precautions").
It is customary to increase the administration rate gradually during the first hour.
Maximum infusion rate: As a general rule, do not exceed 3 ml (for OliClinomel N4-550E) or 1.5 ml (for OliClinomel N7-1000E) of the emulsion for infusion/kg/hour, i.e. 0.06 g of amino acids, 0.24 g of glucose and 0.06 g of lipids per kg body weight per hour.
The maximum daily dose should not be exceeded in adult and pediatric patients. Due to the static composition of the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag. In this situation the impact of any volume (dose) adjustments must be taken into consideration and the resultant effect this will have on the dosing of all other nutrient components of OliClinomel N4-550E/OliClinomel N7-1000E.

In the event of inappropriate administration (overdose and/or administration rate higher than recommended), nausea, vomiting, chills, headache, hot flush, hyperhidrosis and electrolyte disturbances and signs of HYPERvolaemia or acidosis may be observed.
Excessively rapid administration of total parenteral nutrition (TPN) solutions, including OliClinomel, can result in serious or fatal consequences (see "Precautions").
HYPERglycaemia, glucosuria and a HYPERosmolar syndrome may arise if excessive glucose is administered.
Too rapid infusion or administration of an inappropriate excessive volume may cause nausea, vomiting, chills and electrolyte disturbances.
In such situations, the infusion should be discontinued immediately.
The reduced or limited ability to metabolise the lipids in OliClinomel may result in a "fat overload syndrome", the results of which are usually reversible once the infusion of lipids has been discontinued (see also "Adverse Reactions").
In some serious cases, haemodialysis, haemofiltration or haemodiafiltration may be necessary.

The use of OliClinomel is contraindicated in the following cases: in premature neonates, infants and children less than 2 years old, as the calorie-nitrogen ratio and energy supplied are inappropriate; known hypersensitivity to egg, or soya proteins, components of the container, or to any of the ingredients, including active substances and/or excipients; congenital abnormality of amino acid metabolism; severe HYPERlipidaemia or severe lipid metabolism disorders characterised by HYPERtriglyceridaemia; severe HYPERglycaemia; pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorus.

Excessively rapid administration of total parenteral nutrition (TPN) solutions, including OliClinomel, can result in serious or fatal consequences.
The infusion must be stopped immediately if any sign or symptom of an allergic reaction (such as perspiration, fever, chills, headache, skin rashes, dyspnoea or bronchospasm) develops. This medicinal product contains egg and soya oil phosphatides. Egg and soya proteins can induce hypersensitivity reactions. Cross-allergy reactions between soya and peanut proteins have been observed.
Solutions containing dextrose, should be used with caution, in patients with known allergy to corn or corn products.
Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including OLICLINOMEL, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt.
If the same infusion line is used for sequential administration, the line must be thoroughly flushed with a compatible fluid between infusions. This only applies to products containing electrolytes.
Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress 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 precipitate formation in the blood stream have also been reported.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
Specific clinical monitoring is necessary when an intravenous infusion is being initiated.
Severe water/electrolyte imbalance disorders, severe fluid overload conditions and serious metabolism disorders must be corrected before beginning the infusion.
Do not add any other medicinal products or substances to any component of the bag or to the reconstituted emulsion without having previously checked their compatibility and the stability of the resulting preparation (in particular the stability of the lipid emulsion). The addition of an excess of calcium and phosphorus may cause calcium phosphate precipitates to be formed. The formation of precipitates or the destabilisation of the lipid emulsion could cause vascular occlusion (see "Incompatibilities" and "Special precautions for disposal and other handling" under Cautions for Usage).
Infection of the vascular access and septicaemia are complications that can arise in patients receiving parenteral nutrition, in particular in the event of poor catheter maintenance, or contaminated solutions, disease or the use of medicinal products with immunosuppressant effects. Careful attention to signs, symptoms and laboratory test results to detect a fever/chills, leukocytosis, technical complications related to the access device and HYPERglycaemia can help detect any infection early. Patients who need parenteral nutrition are often prone to complications involving infection because of HYPERglycemia, malnutrition and/or an underlying pathology. The risk of septic complications can be reduced by being careful to work in aseptic conditions when inserting and maintaining the catheter, and when preparing the nutritional formulation.
Monitor the water/electrolyte balance, serum osmolarity, serum triglycerides, the acid/base balance, blood glucose, liver and renal function, coagulation tests and blood counts, including platelet count, throughout the treatment.
Metabolic complications may occur if the supply of nutrients is not adapted to the requirements of the patient or if the metabolic capacity of a particular dietary component is not evaluated correctly. Undesirable metabolic effects may arise following the administration of excessive or insufficient nutrients, or inadequacy in a mixture, in relation to the requirements of a particular patient.
Serum triglyceride concentrations and the ability to eliminate lipids must be checked regularly.
Serum triglyceride concentrations must not exceed 3 mmol/l during the infusion. This concentration should be determined after at least 3 hours of continuous infusion.
If a lipid metabolism abnormality is suspected, it is recommended to perform this test daily, by measuring serum triglycerides after a period of 5 to 6 hours without administering lipids. In adults, the serum must be clear in less than 6 hours after stopping the infusion containing the lipid emulsion. The next infusion should only be administered when the plasma triglyceride concentration has returned to normal values.
Fat overload has been reported with similar products. The reduced or limited ability to metabolise the lipids in OliClinomel may result in a "fat overload syndrome", which may be caused by overdose, but the signs and symptoms of this syndrome can also occur when the product is administered according to the instructions (see also "Adverse Reactions").
In the event of HYPERglycaemia, the rate of infusion of OliClinomel must be adjusted and/or insulin must be administered.
Although OliClinomel N4-550E can be administered through a peripheral vein, thrombophlebitis can develop. The site of catheter implantation must be checked daily to detect any sign of thrombophlebitis (for OliClinomel N4-550E only).
If supplements are added, the final osmolarity of the mixture should be determined before administration. The final mixture will be administered intravenously through a central or peripheral vein according to the final osmolarity. If the final mixture being administered is HYPERtonic, it may cause vein irritation when administered into a peripheral vein.
Although the product naturally contains vitamins and trace elements, the quantities are not enough to meet the needs of the organism, trace elements and vitamins should be added in sufficient quantities to meet individual patient requirements and to prevent deficiencies from developing. Refer to the instructions concerning supplementing this product (see "Special precautions for disposal and other handling" under Cautions for Usage).
Caution should be exercised in administering OliClinomel to patients with increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction. Fluid status should be closely monitored.
Providing nourishment to patients in a state of advanced malnutrition can result in refeeding syndrome characterised by intracellular displacement of potassium, phosphorus and magnesium, with anabolism in the patient. Thiamine deficiency and fluid retention are also possible. These complications can be prevented through attentive monitoring and a gradual increase in the supply of nutrients, while being careful to avoid overfeeding. This syndrome has been reported with similar products.
Do not connect bags in series, in order to avoid the possibility of gas embolism due to air contained in the main bag.
Hepatic insufficiency: Exercise caution in patients with hepatic insufficiency, including cholestasis or elevated liver enzymes, because of the risk of neurological disorders developing or worsening, associated with HYPERammonaemia. Regular clinical examinations and lab tests are required/necessary, particularly liver function parameters, blood glucose, electrolytes and triglycerides.
Renal insufficiency: Exercise caution in patients with renal insufficiency, in particular if there is HYPERkalaemia, because of the risk of metabolic acidosis and HYPERazotaemia developing or worsening if extra-renal waste is not being removed. The fluid balance, triglycerides and electrolytes must be closely monitored in these patients.
Blood disorders: Exercise caution in patients with coagulation disorders and anaemia. The complete blood count and coagulation parameters must be closely monitored.
Endocrine and metabolic disorders: Exercise caution in patients with: Metabolic acidosis: administration of carbohydrates is not recommended in the presence of lactic acidosis. Regular clinical examinations and laboratory tests are necessary.
Diabetes: monitor glucose concentrations, glucosuria, ketonuria and, where applicable, adjust insulin dosages.
HYPERlipidaemia, because of the presence of the lipids in the emulsion for infusion. Regular clinical examinations and laboratory tests are necessary.
Amino acid metabolism disorders.
Extravasation: Extravasation has been reported with the administration of OliClinomel.
Catheter site should be monitored regularly to identify signs of extravasation. If extravasation occurs, the administration should be stopped immediately, keeping the inserted catheter or cannula in place for immediate management of the patient. If possible, aspiration should be performed through the inserted catheter/cannula in order to reduce the amount of fluid present in the tissues before removing the catheter/cannula.
When involving an extremity, the concerned limb should be elevated (for OliClinomel N4-550E only).
Depending on the extravasated product (including the product(s) being mixed with OLICLINOMEL, if applicable) and the stage/extent of any injury, appropriate specific measures should be taken. Options for management may include non-pharmacologic, pharmacologic and/or surgical intervention. If there is any deterioration of the affected area (continued pain, necrosis, ulceration, suspected compartment syndrome), surgery should be consulted immediately.
The extravasation site should be monitored at least every 4 hours during the first 24 hours, then once daily.
The infusion should not be restarted in the same peripheral or central vein (for OliClinomel N4-550E) or the same central vein (for OliClinomel N7-1000E).
Effects on ability to drive and use machines: No studies of the effects on the ability to drive and use machines have been performed.
Use in Children: If administered to children over two years of age, it is essential to use a bag with a volume corresponding to the daily dose.
Vitamin and trace element supplementation is always required. Paediatric formulations should be used.

Fertility, pregnancy and lactation: There are at present no sufficiently relevant clinical data to assess the tolerance of the ingredients in OliClinomel in women who are pregnant or breast-feeding.
In the absence of data, the prescriber must weigh the risks against the benefits before deciding to administer this emulsion either during pregnancy or to women who are breast-feeding.

Undesirable effects may occur as a result of inappropriate use (for example overdose, too fast administration rate (see "Precautions" and "Overdosage").
On initiating an intravenous infusion, the appearance of signs or symptoms of an allergic reaction (such as perspiration, fever, chills, headache, skin rash, dyspnoea, bronchospasm) must result in its immediate discontinuation.
OLICLINOMEL N4-550E, N7-1000E, and N8-800 have been used in four (4) clinical studies. Three (3) studies evaluated the ease of use and the safety, and the nutritional efficiency of the product with 2 of the 3 studies in patients undergoing gastrointestinal surgery for gastric cancer. The third study was in hospitalized patients with various diagnoses requiring parenteral nutrition (31% surgery, 23% trauma, 51% medical patients). The medical patients had a variety of disorders that included cardiac, respiratory, gastrointestinal, metabolic, nervous system, infectious, renal, and neoplastic disease. The last study was to assess the safety and efficacy of OLICLINOMEL and was in patients admitted to a surgical service. Of those, 86.3% underwent surgery (most were abdominal surgery for gastrointestinal disease).
The data collected (286 patients) from these 4 clinical trials and in addition from post-marketing experience indicate the following adverse reactions to a medicinal product related to OliClinomel. (See Table 10.)

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Fat overload syndrome (very rare): "Fat overload syndrome" may be caused by inappropriate administration e.g. overdose and/or infusion rate higher than recommended; however the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions. The reduced or limited ability to metabolise the lipids in OliClinomel, accompanied by prolonged plasma clearance may result in a "fat overload syndrome". This syndrome is associated with a sudden change in the patient's clinical condition, and is characterised by findings such as HYPERlipidaemia, fever, fatty infiltration of the liver, hepatomegaly, deteriorating liver function, anaemia, leukopenia, thrombocytopenia, coagulation disorders and central nervous system manifestations (e.g. coma), requiring hospitalisation. These symptoms are reversible if the lipid emulsion is discontinued.
Paediatric population: Thrombocytopenia has been reported in children receiving lipid infusions.
Post-Marketing Adverse Reactions: In addition, the following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity.
IMMUNE SYSTEM DISORDERS: Bronchospasm (as part of an allergic reaction).
METABOLISM AND NUTRITION DISORDERS: Fat overload syndrome.
NERVOUS SYSTEM DISORDERS: Tremor.
HEPATOBILIARY DISORDERS: Cholestasis, Jaundice.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Erythema, Hyperhidrosis.
MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS: Musculoskeletal pain, Back pain, Muscle spasm.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Catheter site phlebitis, Infusion site oedema, Chest pain/discomfort, Feeling hot.
INVESTIGATIONS: Blood bilirubin increased, Hepatic enzymes abnormal.
Other (Class) Reactions: The following has been reported with other similar products: Pulmonary vascular precipitates (Pulmonary vascular emboli and Pulmonary distress) (see Precautions).

No interaction study has been performed.
Ceftriaxone must not be co-administered with IV solutions containing calcium, because of the risk of precipitation of ceftriaxone-calcium salt. If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid (e.g. physiological salt solution) to avoid precipitation.
OliClinomel contains vitamin K, naturally present in lipid emulsions. The vitamin K content in the recommended doses of OliClinomel should not have any effect on the effects of coumarin derivatives, including warfarin.
This emulsion for infusion must not be administered simultaneously with blood through the same infusion tubing because of the risk of pseudoagglutination.
The lipids contained in this emulsion may interfere with the results of certain laboratory tests (for example bilirubin, lactate dehydrogenase, oxygen saturation, blood haemoglobin) if the blood sample is taken before the lipids have been eliminated (these are generally eliminated after a period of 5 to 6 hours without receiving lipids).
Because of the potassium content in OliClinomel, it is advisable to exercise caution in patients treated with potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene), angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine in view of the risk of HYPERkalemia.

Incompatibilities: Do not add other medicinal products or substances to one of the three chambers of the bag or to the reconstituted emulsion without having first checked the compatibility and stability of the resulting preparation (in particular the stability of the lipid emulsion or formation of precipitates) (See 'Special precautions for disposal and other handling' as follows).
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in formation of calcium phosphate precipitates.
Incompatibilities may be produced, for example excessive acidity (low pH) or an inappropriate divalent cation content (Ca²⁺ and Mg²⁺), which may destabilise the lipid emulsion.
Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Oliclinomel, through the same infusion line because of the risk of precipitation of ceftriaxone-calcium salt (see 'Interactions').
Check compatibility with solutions administered simultaneously through the same infusion set, catheter or cannula.
Do not administer before, simultaneously with or after blood through the same equipment, because of the risk of pseudoagglutination.
Oliclinomel contains calcium ions which pose additional risk of coagulation precipitates in citrate anticoagulated/preserved blood or components.
Special precautions for disposal and other handling: a. Opening: Tear the protective overwrap.
Discard the oxygen absorber sachet after removing the overwrap.
Confirm the integrity of the bag and of the non-permanent seals.
Use only if the bag is undamaged, if the non-permanent seals are intact (i.e. no mixing of the contents of the three compartments) and if the amino acid solution and the glucose solution are clear, colourless or slightly yellowish, practically free of visible particles and the lipid emulsion is a homogeneous liquid with a milky appearance.
b. Mixing the solutions and the emulsion: Ensure that the product is at room temperature when breaking the non-permanent seals.
Manually roll the bag onto itself, starting at the top of the bag (hanger end). The non-permanent seals will disappear from the side near the inlets. Continue to roll until the seals are open along half of their length. Mix by inverting the bag at least 3 times.
c. Setting up the infusion: Work in aseptic conditions.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the spike of the infusion set into the administration outlet.
d. Supplementation: The capacity of the bag is sufficient to allow the addition, such as, of vitamins, electrolytes and trace elements. Any addition (including vitamins) may be made into the reconstituted mixture (after the non-permanent seals have been opened and the contents of the three compartments mixed).
Vitamins may also be added into the glucose compartment before the mixture has been reconstituted (before opening the non-permanent seals and before mixing the solutions and the emulsion).
If supplements are added, the final osmolarity of the mixture should be determined before administration via a peripheral vein.
OliClinomel may be supplemented with: Electrolytes: the electrolytes already in the bag must be taken into account. Stability has been demonstrated up to a total quantity of 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium and 5 mmol of calcium per litre of the ternary mixture.
Organic phosphate and inorganic phosphate: The information was shown in the following table. (See Table 11.)

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Trace elements and vitamins: stability has been demonstrated with vitamin and trace element preparations available on the market (containing up to 1 mg of iron).
Compatibility with other additives is available on request.
Supplements must be added by qualified personnel working in aseptic conditions.
These supplements are added into the injection site using a needle: Aseptic conditions must be observed.
Prepare the injection site of the bag.
Puncture the injection site and inject the additives using an injection needle or a reconstitution device.
Mix the content of the bag and the additives.
e. Administration: For single use only.
Only administer the product after the non-permanent seals between the three compartments have been broken and the contents of the three compartments mixed.
Check that there is no trace of phase separation in the final emulsion for infusion.
The contents of an opened bag must be used immediately. An opened bag must never be kept for later infusion.
Never reconnect a partly used bag.
Do not connect bags in series in order to avoid a gas embolism due to air contained in the first bag.
Any unused product or waste material and all necessary devices must be discarded.
Do not store a partly used bag and discard all the related equipment after use.

Do not freeze.
Store in overpouch.
Keep the container in the outer carton in order to protect from light.
For storage of the reconstituted emulsion, see "Shelf-life" as follows.
Shelf-life: 2 years if the overwrap is not damaged.
It is recommended to use the product immediately once the non-permanent seals between the three compartments have been opened.
Nevertheless, the reconstituted emulsion has been shown to be stable for a maximum of 7 days between 2°C and 8°C, followed by a maximum of 48 hours at temperatures not exceeding 25°C.
After adding supplements (electrolytes, organic phosphate, trace elements, vitamins; see "Special precautions for disposal and other handling" under Cautions for Usage).
Physical and chemical stability of the mixtures defined has been demonstrated over 7 days at temperatures between 2°C and 8°C followed by 48 hours at temperatures not exceeding 25°C. From a microbiological point of view, any mixture should be used immediately.
If the product is not used immediately, storage times and conditions prior to use are the responsibility of the user and should not normally be longer than 24 hours at 2°C to 8°C, unless addition of supplements took place in controlled and validated aseptic conditions.

Parenteral Nutritional Products

B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

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