Olimel N12E

OLIMEL N12E is presented in the form of a 3-compartment bag.
Each bag contains a glucose solution with calcium, a lipid emulsion and an amino acid solution with other electrolytes. (See Table 1.)

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Composition of the reconstituted emulsion after mixing the contents of the 3 compartments: See Table 2.

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Nutritional intakes of reconstituted emulsion for each of the bag sizes: See Table 3.

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After reconstitution: Emulsion for infusion.
Appearance prior to reconstitution: The amino acids and glucose solutions are clear, colourless or slightly yellow.
The lipid emulsion is homogenous with a milky appearance.
Excipients/Inactive Ingredients: Lipid emulsion compartment: Purified egg phospholipids, Glycerol, Sodium oleate, Sodium hydroxide (for pH adjustment), Water for injections.
Compartment of amino-acid solution with electrolytes: Glacial acetic acid (for pH adjustment), Water for injections.
Compartment of glucose solution with calcium: Hydrochloric acid (for pH adjustment), Water for injections.

Pharmacotherapeutic group: Solutions for parenteral nutrition/combinations. ATC code: B05BA10.
Pharmacology: Pharmacodynamics: OLIMEL's content in nitrogen (L series amino acids) and energy (glucose and triglycerides) enables maintaining an adequate nitrogen/energy balance.
This formulation also contains electrolytes.
The lipid emulsion included in OLIMEL N12E 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.
Olive oil contains significant amounts of alpha-tocopherol which, combined with a moderate PUFA intake, contribute to improved vitamin E status and the reduction of lipid peroxidation.
The amino acid solution contains 17 L-series amino acids (including 8 essential amino acids), which are required for protein synthesis.
Amino acids also represent an energy source. Their oxidation results in excretion of nitrogen in the form of urea.
The amino acid profile is as follows: Essential amino acids/total amino acids: 44.8%.
Essential amino acids (g)/total nitrogen (g): 2.8%.
Branched-chain amino acids/total amino acids: 18.3%.
The carbohydrate source is glucose.
Pharmacokinetics: The ingredients of OLIMEL N12E (amino acids, electrolytes, glucose and lipids) are distributed, metabolised and removed in the same way as if they had been administered individually.
Toxicology: Preclinical safety data: No preclinical studies with OLIMEL N12E have been performed.
Preclinical toxicity studies performed using the lipid emulsion contained in OLIMEL N12E have identified the changes, which are conventionally found with a high intake of a lipid emulsion: fatty liver, thrombocytopenia and elevated cholesterol.
Preclinical studies performed using the solutions of amino acids and glucose contained in OLIMEL N12E of different qualitative compositions and concentrations have not, however, revealed any specific toxicity.

OLIMEL N12E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Posology: OLIMEL N12E is not recommended for use in children less than 2 years of age due to inadequate composition and volume (see Precautions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
The maximum daily dose mentioned as follows should not be exceeded. 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 OLIMEL N12E. In those situations, health care professionals may consider adjusting the volume (dose) of OLIMEL N12E in order to meet these increased requirements.
In adults: The dosage depends on the patient's energy expenditure, clinical status, body weight, and the ability to metabolise the constituents of OLIMEL N12E, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.
The average daily requirements are: 0.16 to 0.35 g nitrogen/kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress. Special populations may require up to 0.4 g nitrogen/kg body weight (2.5 g of amino acids/kg); 20 to 40 kcal/kg; 20 to 40 mL fluid/kg, or 1 to 1.5 mL per expended kcal.
For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 26 mL/kg corresponding to 2.0 g/kg amino acids, 1.9 g/kg glucose, 0.9 g/kg lipids. For a 70 kg patient, this would be equivalent to 1,820 mL OLIMEL N12E per day, resulting in an intake of 138 g amino acids, 133 g glucose, and 64 g lipids (i.e., 1,171 non-protein kcal and 1,723 total kcal).
In Continuous Renal Replacement Therapy (CRRT): For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 33 mL/kg corresponding to 2.5 g/kg amino acids, 2.4 g/kg glucose, 1.2 g/kg lipids. For a 70 kg patient, this would be equivalent to 2,310 mL OLIMEL N12E per day, resulting in an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1,486 non-protein kcal and 2,187 total kcal).
In patients with morbid obesity: The dosage should be calculated on basis of the ideal body weight (IBW). For OLIMEL N12E, the maximal daily dose is defined by amino acids intake, 33 mL/kg IBW corresponding to 2.5 g/kg amino acids, 2.4 g/kg glucose, 1.2 g/kg lipids. For a 70 kg patient, this would be equivalent to 2,310 mL OLIMEL N12E per day, resulting in an intake of 175 g amino acids, 169 g glucose, and 81 g lipids (i.e., 1,486 non-protein kcal and 2,187 total kcal).
Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
For OLIMEL N12E, the maximal infusion rate is 1.3 mL/kg/hour, corresponding to 0.10 g/kg/hour amino acids, 0.10 g/kg/hour glucose, and 0.05 g/kg/hour lipids.
In children, greater than 2 years of age and adolescents: There have been no studies performed in the paediatric population.
The dosage depends on the patient's energy expenditure, clinical status, body weight, and the ability to metabolise constituents of OLIMEL N12E, as well as additional energy or proteins given orally/enterally; therefore, the bag size should be chosen accordingly.
In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered.
For OLIMEL N12E in the 2 to 11 year age group, amino acid and magnesium concentrations are the limiting factor for daily dose. In this age group, the amino acid concentration is the limiting factor for hourly rate. In the 12 to 18 year age group, amino acid and magnesium concentrations are the limiting factor for daily dose. In this age group, the amino acid concentration is the limiting factor for hourly rate. The resulting intakes are displayed as follows: See Table 4.

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Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
In general, it is recommended to start the infusion for small children with low daily dose and gradually increase it up to the maximal dosage (see previous text).
Maximal infusion rate is 2.6 mL/kg/hour in children 2 to 11 years of age and 1.6 mL/kg/hour in children 12 to 18 years of age.
Method and duration of administration: For single use only.
It is recommended that, after opening the bag, the contents are used immediately and not stored for subsequent infusion.
After reconstitution, the mixture is homogenous 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.
Due to its high osmolarity, OLIMEL N12E must only be administered through a central vein.
The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.
Treatment with parenteral nutrition may be continued for as long as required by the patient's clinical conditions.

In the event of inappropriate administration (overdose and/or infusion rate higher than recommended), nausea, vomiting, chills, headache, hot flush, hyperhidrosis and electrolyte disturbances and signs of hypervolemia or acidosis may occur and result in severe or fatal consequences. In such situations, the infusion must be stopped immediately. If medically appropriate, further intervention may be indicated.
Hyperglycaemia, glucosuria, and a hyperosmolar syndrome may develop if glucose infusion rate exceeds clearance.
The reduced or limited ability to metabolise lipids may result in a "fat overload syndrome", the results of which are usually reversible after the infusion of the lipid emulsion is stopped (see also Adverse Reactions).
In some serious cases, haemodialysis, haemofiltration or haemodiafiltration may be necessary.

The use of OLIMEL N12E is contraindicated in the following situations: In premature neonates, infants, and children less than 2 years of age.
Hypersensitivity to egg, soya-bean, peanut proteins, or corn/corn products (see Precautions) or to any of the active substances or excipients, listed in Description.
Congenital abnormalities of amino acid metabolism.
Severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridaemia.
Severe hyperglycaemia.
Pathologically-elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus.

An excessively fast administration of total parenteral nutrition (TPN) solutions may result in severe or fatal consequences.
The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes, or dyspnea) develop. This medicinal product contains soya-bean oil, and egg phospholipids. Soya-bean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soya-bean and peanut proteins have been observed.
OLIMEL N12E contains glucose derived from corn, which may cause hypersensitivity reactions in patients with allergy to corn or corn products (see Contraindications).
Ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions even via different infusion lines or different infusion sites. Ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions (see Interactions and Incompatibilities under Cautions for Usage).
Pulmonary vascular precipitates causing pulmonary vascular embolism and respiratory 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 formation of calcium phosphate precipitates (see Incompatibilities under Cautions for Usage). Suspected precipitate formation in the blood stream has 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 respiratory distress occur, the infusion should be stopped and medical evaluation initiated.
Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, the stability of the lipid emulsion). Formation of precipitates or destabilisation of the lipid emulsion could result in vascular occlusion (see Incompatibilities and Special precautions for disposal and other handling under Cautions for Usage).
Vascular-access infection and sepsis are complications that may occur in patients receiving parenteral nutrition, particularly in case of poor maintenance of catheters, immunosuppressive effects of illness or drugs. Careful monitoring of signs, symptoms, and laboratory test results for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognise early infections. Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state. The occurrence of septic complications can be decreased with heightened emphasis on aseptic techniques in catheter placement and maintenance, as well as aseptic techniques in the preparation of the nutritional formula.
Specific clinical monitoring is required when an intravenous infusion is started.
Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion.
Monitor water and electrolyte balance, serum osmolarity, serum triglycerides, acid/base balance, blood glucose, liver and kidney function tests, coagulation tests, and blood count, including platelets, throughout treatment.
Elevated liver enzymes and cholestasis have been reported with similar products.
Monitoring of serum ammonia should be considered if hepatic insufficiency is suspected.
Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed. Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs.
Administration of amino acid solutions may precipitate acute folate deficiency; folic acid is, therefore, recommended to be given daily.
Extravasation: 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. Depending on the extravasated product (including the product(s) being mixed with OLIMEL N12E, 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. In case of large extravasation, plastic surgeon advice should be sought within the first 72 hours.
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 central vein.
Hepatic Insufficiency: Use with caution in patients with hepatic insufficiency because of the risk of developing or worsening neurological disorders associated with hyperammonaemia. Regular clinical and laboratory tests are required, particularly liver function parameters, blood glucose, electrolytes and triglycerides.
Renal Insufficiency: Use with caution in patients with renal insufficiency, particularly if hyperkalaemia is present, because of the risk of developing or worsening metabolic acidosis and hyperazotaemia if extra-renal waste removal is not being performed. Fluid, triglycerides and electrolyte status should be closely monitored in these patients.
Hematologic: Use with caution in patients with coagulation disorders and anaemia. Blood count and coagulation parameters should be closely monitored.
Endocrine and Metabolism: Use with caution in patients with: Metabolic acidosis. Administration of carbohydrates is not recommended in the presence of lactic acidosis. Regular clinical and laboratory tests are required.
Diabetes mellitus. Monitor glucose concentrations, glucosuria, ketonuria and, where applicable adjust insulin dosages.
Hyperlipidaemia due to the presence of lipids in the emulsion for infusion. Regular clinical and laboratory tests are required.
Amino acid metabolism disorders.
Hepatobiliary disorders: Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition. The etiology of these disorders is thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
Serum triglyceride concentrations and the ability of the body to remove lipids must be checked regularly. Serum triglyceride concentrations must not exceed 3 mmol/L during the infusion.
If a lipid metabolism abnormality is suspected, it is recommended to measure daily serum triglyceride levels 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 must only be administered when the serum triglyceride concentrations have returned to baseline values.
Fat overload syndrome has been reported with similar products. The reduced or limited ability to metabolise the lipids contained in OLIMEL N12E may result in a "fat overload syndrome" which may be caused by overdose; however, the signs and symptoms of this syndrome may also occur when the product is administered according to instructions (see also Adverse Reactions).
In the event of hyperglycaemia, the infusion rate of OLIMEL N12E must be adjusted and/or insulin administered.
DO NOT ADMINISTER THROUGH A PERIPHERAL VEIN.
Although there is a natural content of trace elements and vitamins in the product, the levels are insufficient to meet body requirements. Trace elements and vitamins should be added in sufficient quantities to meet individual patient requirements and to prevent deficiencies from developing. See instructions for making additions to this product.
Caution should be exercised in administering OLIMEL N12E to patients with increased osmolarity, adrenal insufficiency, heart failure or pulmonary dysfunction.
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, or water-soluble vitamins. These changes can occur within 24 to 48 hours; therefore, careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, trace elements, and vitamins.
Do not connect bags in series in order to avoid the possibility of air embolism due to residual gas contained in the primary bag.
To avoid risks associated with excessively rapid infusion rates, it is recommended to use a continuous and controlled infusion.
OLIMEL N12E must be administered with caution to patients with a tendency towards electrolyte retention.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of trace elements, in particular copper and zinc. This should be taken into account in the dosing of trace elements, especially during long-term intravenous nutrition.
Interference with laboratory tests: The lipids contained in this emulsion may interfere with the results of certain laboratory tests (see Interactions).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: When administered to children greater than 2 years of age, it is essential to use a bag that has a volume corresponding to the daily dosage.
OLIMEL N12E is not suitable for use in children less than 2 years of age because: The glucose intake is too low, leading to a low glucose/lipid ratio; The absence of cysteine makes the amino acid profile inadequate; Calcium is too low.
Vitamin and trace elements supplementation is always required. Paediatric formulations must be used.
Use in the Elderly: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Pregnancy: There are no clinical data from the use of OLIMEL N12E in pregnant women. No animal reproductive studies have been performed with OLIMEL N12E (see Pharmacology: Toxicology: Preclinical safety data under Actions). Taking into account the use and indications of OLIMEL N12E, the product may be considered during pregnancy, if necessary. OLIMEL N12E should only be given to pregnant women after careful consideration.
Breast-feeding: There is insufficient information on the excretion of OLIMEL N12E components/metabolites in human milk. Parenteral nutrition may become necessary during breast-feeding. OLIMEL N12E should only be given to breast-feeding women after careful consideration.
Fertility: No adequate data are available.

Potential undesirable effects may occur as a result of inappropriate use (for example: overdose, excessively fast infusion rate) (see Precautions and Overdosage).
At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion: The following adverse drug reactions (ADRs) were reported with OLIMEL N9-840 in a randomised, double-blind, active-controlled, efficacy and safety study. Twenty-eight patients with various medical conditions (i.e., postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) were included and treated; patients in the OLIMEL group received drug product up to 40 mL/kg/d over 5 days.
The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to OLIMEL. (See Table 5.)

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The following class-like-adverse drug reactions (ADRs) have been described in other sources in relation to similar parenteral nutrition products; the frequency of these events is not known: Blood and Lymphatic System Disorders: Thrombocytopenia.
Hepatobiliary Disorders: Cholestasis, Hepatomegaly, Jaundice.
Immune System Disorders: Hypersensitivity.
Injury, poisoning and procedural complications: Parenteral nutrition associated liver disease (see Precautions).
Investigations: Blood alkaline phosphatase increased, Transaminases increased, Blood bilirubin increased, Elevated liver enzymes.
Renal and Urinary Disorders: Azotemia.
Vascular disorders: Pulmonary vascular precipitates (pulmonary vascular embolism and respiratory distress) (see Precautions).
Fat overload syndrome (very rare): Fat overload syndrome has been reported with similar products. This may be caused by inappropriate administration (e.g. overdose and/or infusion rate higher than recommended, see Overdosage); 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 contained in OLIMEL N12E accompanied by prolonged plasma clearance may result in a "fat overload syndrome". This syndrome is associated with a sudden deterioration in the patient's clinical condition and is characterised by findings such as fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g. coma). The syndrome is usually reversible when infusion of the lipid emulsion is stopped.
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 the relevant national reporting system.

No interaction studies have been performed.
OLIMEL N12E must not be administered simultaneously with blood through the same infusion tubing because of the possibility 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 are eliminated (these are generally eliminated after a period of 5 to 6 hours without receiving lipids).
Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing intravenous solutions, including OLIMEL N12E, through the same infusion line (e.g., via Y-site). However, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see Precautions and Incompatibilities under Cautions for Usage).
OLIMEL N12E contains vitamin K, naturally present in lipid emulsions. The amount of vitamin K in recommended doses of OLIMEL N12E are not expected to influence effects of coumarin derivatives.
Due to the potassium content of OLIMEL N12E, special care should be taken 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 or cyclosporine in view of the risk of hyperkalaemia.
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.

Incompatibilities: Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, the stability of the lipid emulsion).
Incompatibilities may be produced, for example, by excessive acidity (low pH) or inappropriate content of divalent cations (Ca²⁺ and Mg²⁺), which may destabilise the lipid emulsion.
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 the formation of calcium phosphate precipitates.
OLIMEL N12E contains calcium ions which pose additional risk of coagulation precipitated in citrate anticoagulated/preserved blood or components.
Ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing solutions, including OLIMEL N12E, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt (see Precautions and Interactions).
Due to the risk of precipitation, OLIMEL N12E should not be administered through the same infusion line or admixed together with ampicillin or fosphenytoin.
Check compatibility with solutions administered simultaneously through the same administration set, catheter, or cannula.
Do not administer before, simultaneously with, or after blood through the same equipment because of the risk of pseudoagglutination.
Special precautions for disposal and other handling: To open: Remove the protective overpouch.
Discard the oxygen absorber sachet.
Confirm the integrity of the bag and of the nonpermanent seals. Use only if the bag is not damaged; if the nonpermanent seals are intact (i.e., no mixture of the contents of the 3 compartments); if the amino acid solution and the glucose solution are clear, colourless, or slightly yellow, and practically free of visible particles; and if the lipid emulsion is a homogeneous liquid with a milky appearance.
Mixing the solutions and the emulsion: Ensure that the product is at room temperature when breaking the nonpermanent seals.
Manually roll the bag onto itself, starting at the top of the bag (hanger end). The nonpermanent seals will disappear from the side near the inlets. Continue to roll the bag until the seals are open along approximately half of their length.
Mix by inverting the bag at least 3 times.
After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.
Additions: The capacity of the bag is sufficient to enable additions such as vitamins, electrolytes, and trace elements. Any additions (including vitamins) may be made into the reconstituted mixture (after the nonpermanent seals have been opened and after the contents of the 3 compartments have been mixed).
Vitamins may also be added into the glucose compartment before the mixture is reconstituted (before opening the nonpermanent seals and before mixing the 3 compartments).
Additions must be performed by qualified personnel under aseptic conditions.
OLIMEL N12E formulation may be supplemented with electrolytes, inorganic/organic phosphate and with commercially available preparations of multi-vitamin products (such as Cernevit) and multi-trace element products (such as Nutryelt). The maximal total levels for additions listed in the table as follows were demonstrated by stability data and should not be considered dosage recommendations. The supplementation should be dictated by the patient's clinical needs and should not exceed nutritional guidelines. The electrolytes already present in the bag should be taken into account when reaching the maximal total level.
Compatibility may vary between products from different sources and health care professionals are advised to carry out appropriate checks when mixing OLIMEL N12E with other parenteral solutions. (See Tables 6 and 7.)

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To perform an addition: 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 content of the bag and the additives.
Preparation of the infusion: Aseptic conditions must be observed.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the spike of the infusion set into the administration outlet.
Preparation steps for the administration of OLIMEL: 1. Tear from the top to open the overpouch.
2. Peel the front of the overpouch to reveal the OLIMEL bag. Discard the overpouch and oxygen absorber sachet.
3. Place the bag flat on a horizontal and clean surface with the handle facing in front of the patient.
4. Lift the hanger area to remove solution from the upper bag. Roll the upper part of the bag firmly until peal seals are fully open (approximately half way).
5. Mix by turning the bag upside-down at least 3 times.
6. Hang the bag. Twist off the protector from the administration outlet. Firmly plug the spike connector.
Administration: For single use only.
Only administer the product after the nonpermanent seals between the 3 compartments have been broken and the contents of the 3 compartments have been mixed.
Ensure that the final emulsion for infusion does not show any evidence of phase separation.
After opening the bag, the contents must be used immediately. The opened bag must never be stored for a subsequent infusion. Do not reconnect any partially used-bag.
Do not connect bags in series in order to avoid the possibility of air embolism due to gas contained in the primary bag.
Any unused product or waste material and all necessary devices must be discarded.

Do not freeze.
Store in the overpouch.
For storage conditions of the reconstituted medicinal product, see Shelf life as follows.
Shelf life: 21 months at 30°C if the overwrap is not damaged.
After reconstitution: Chemical and physical in-use stability has been demonstrated for 7 days at 2°C-8°C followed by 48 hours at temperature not exceeding 30°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, unless reconstitution has taken place in controlled and validated aseptic conditions.
After addition of supplements (electrolytes, trace elements and vitamins; see Special precautions for disposal and other handling under Cautions for Usage): For specific admixtures, chemical and physical in-use stability has been demonstrated for 7 days at 2°C-8°C followed by 48 hours at temperature not exceeding 30°C.
From a microbiological point of view, any admixture should be used immediately. If not used immediately, in-use storage times and conditions, after mixing and prior to use, are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless addition of supplements has taken 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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