Olimel N9E/PeriOlimel N4E

Olimel N9E/PeriOlimel N4E

Manufacturer:

Baxter Healthcare

Distributor:

Baxter Healthcare
/
Firma Chun Cheong
Full Prescribing Info
Contents
Parenteral nutrition.
Description
Olimel N9E: OLIMEL 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 content 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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PeriOlimel N4E: PERIOLIMEL 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 4.)

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Composition of the reconstituted emulsion after mixing the content of the 3 compartments: See Table 5.

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Nutritional intakes of reconstituted emulsion for each of the bag sizes: See Table 6.

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Excipients/Inactive Ingredients: Lipid emulsion compartment: Purified egg phosphatide, 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.
Pharmaceutical form: 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.
Action
Pharmacotherapeutic group: Solutions for parenteral nutrition, combinations. ATC Code: B05BA10.
Pharmacology: Pharmacodynamics: OLIMEL's/PERIOLIMEL'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/PERIOLIMEL is an association of refined olive oil and refined soybean 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 acids 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 acids 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/PERIOLIMEL (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/PERIOLIMEL have been performed.
Preclinical toxicity studies performed using the lipid emulsion contained in OLIMEL/PERIOLIMEL 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/PERIOLIMEL of different qualitative compositions and concentrations have not, however, revealed any specific toxicity.
Indications/Uses
OLIMEL/PERIOLIMEL 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.
Dosage/Direction for Use
Posology: OLIMEL/PERIOLIMEL 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 any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of OLIMEL/PERIOLIMEL. For example, paediatric patients may require greater than 0.2 mmol/kg/day of phosphate. In those situations, health care professionals may consider adjusting the volume (dose) of OLIMEL/PERIOLIMEL 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/PERIOLIMEL, 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 per kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress; 20 to 40 kcal/kg; 20 to 40 ml fluid /kg, or 1 to 1.5 ml per expended kcal.
For OLIMEL, the maximal daily dose is defined by amino acids intake, 35 ml/kg, corresponding to 2.0 g/kg amino acids, 3.9 g/kg glucose, 1.4 g/kg lipids, 1.2 mmol/kg sodium and 1.1 mmol/kg potassium. For a 70 kg patient, this would be equivalent to 2450 ml OLIMEL per day, resulting in an intake of 140 g amino acids, 270 g glucose and 98 g lipids (i.e. 2,058 non-protein kcal and 2,622 total kcal).
For PERIOLIMEL, the maximal daily dose is defined by fluid intake, 40 ml/kg, corresponding to 1 g/kg amino acids, 3 g/kg glucose, 1.2 g/kg lipids, 0.8 mmol/kg sodium and 0.6 mmol/kg potassium. For a 70 kg patient, this would be equivalent to 2,800 ml PERIOLIMEL per day, resulting in an intake of 71 g amino acids, 210 g glucose and 84 g lipids (i.e. 1,680 non-protein kcal and 1,960 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, the maximal infusion rate is 1.8 ml/kg/hour, corresponding to 0.10 g/kg/hour amino acids, 0.19 g/kg/hour for glucose and 0.07 g/kg/hour lipids.
For PERIOLIMEL, the maximal infusion rate is 3.2 ml/kg/hour, corresponding to 0.08 g/kg/hour amino acids, 0.24 g/kg/hour glucose and 0.10 g/kg/hour lipids.
In children greater than 2 years of age: 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/PERIOLIMEL, 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, in the 2 to 11 year age group, the limiting factors are phosphate concentration for daily dose (0.2 mmol/kg/day)a and lipid concentration for hourly rate. In the 12 to 18 year age group, the limiting factors are phosphate concentration for daily dose (0.2 mmol/kg/day)a and amino acid concentration for hourly rate. The resulting intakes are displayed as follows: See Table 7.

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For PERIOLIMEL, the limiting factors for the previously mentioned paediatric age groups are phosphate concentration for daily dose (0.2 mmol/kg/day)a and lipid concentration for hourly rate, resulting in the following intakes: See Table 8.

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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 previously mentioned).
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 Cautions for Usage.
Due to its high osmolarity, OLIMEL can only be administered through a central vein.
Due to its low osmolarity, PERIOLIMEL can be administered through a peripheral or 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.
Overdosage
In the event of inappropriate administration (overdose and/or infusion rate higher than recommended), signs of hypervolemia and acidosis may occur.
An excessively fast infusion or administration of an inappropriately large volume of the product may cause nausea, vomiting, chills and electrolyte disturbances. In such situations the infusion must be stopped immediately.
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, hemofiltration or haemodiafiltration may be necessary.
Contraindications
The use of OLIMEL/PERIOLIMEL is contraindicated in the following situations: In premature neonates, infants and children less than 2 years of age; Hypersensitivity to egg, soybean, or peanut proteins, 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 characterized by hypertriglyceridaemia; Severe hyperglycaemia; Pathologically-elevated plasma concentration of sodium, potassium, magnesium, calcium and/or phosphorus.
Special Precautions
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 dyspnoea) develop. This medicinal product contains soybean oil and egg phosphatides. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.
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 destabilization of the lipid emulsion could result in vascular occlusion (see Incompatibilities and Special precautions for disposal and other handling under Cautions for Usage).
Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion.
Specific clinical monitoring is required when an intravenous infusion is started.
Vascular-access infection and sepsis are complications that may occur in patients receiving parenteral nutrition, particularly in cases of poor maintenance of catheters, immunosuppressive effects of illness or drugs. Careful monitoring of signs, symptoms and laboratory test results for fever/chills, leucocytosis, technical complications with the access device and hyperglycaemia can help recognize early infections. Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state. The occurence 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.
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. PERIOLIMEL: When involving extremity, the concerned limb should be elevated.
Depending on the extravasated product (including the product(s) being mixed with OLIMEL/PERIOLIMEL, 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 four hours during the first 24 hours, then once daily.
For OLIMEL, the infusion should not be restarted in the same central vein.
For PERIOLIMEL, the infusion should not be restarted in the same peripheral or 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 electrolytes status should be closely monitored in these patients.
Haematologic: 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: The 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.
Serum triglycerides concentrations and the ability of the body to remove lipids must be checked regularly.
Serum triglycerides concentrations must not exceed 3 mmol/l during the infusion.
If a lipid metabolism abnormality is suspected, it is recommended to measure serum daily 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/PERIOLIMEL 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/PERIOLIMEL must be adjusted and/or insulin administered.
Do not administer OLIMEL through a peripheral vein.
For PERIOLIMEL, thrombophlebitis may develop if peripheral veins are used. The catheter insertion site must be monitored daily for local signs of thrombophlebitis.
When making additions, the final osmolarity of the mixture must be measured before administration. The mixture obtained must be administered through a central or peripheral venous line depending on its final osmolarity. If the final mixture administered is hypertonic, it may cause irritation of the vein when administered into 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, and these should be added to prevent deficiencies from developing. See instructions for making additions to this product.
Caution should be exercised in administering OLIMEL/PERIOLIMEL 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.
Special precautions in paediatrics: 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/PERIOLIMEL 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 acids profile inadequate; Calcium is too low; The bag volumes are not appropriate.
In children greater than 2 years of age, the amount of phosphate limits the daily intakes; therefore, all macronutrients and calcium should be supplemented.
Maximal infusion rate for OLIMEL is 3.3 ml/kg/hour in children of 2 to 11 years of age and 2.1 ml/kg/hour in children 12 to 18 years of age.
Maximal infusion rate for PERIOLIMEL is 4.3 ml/kg/hour in children 2 to 18 years of age.
Vitamin and trace elements supplementation is always required. Paediatric formulations must be used.
To avoid risks associated with excessively rapid infusion rates, it is recommended to use a continuous and controlled infusion.
OLIMEL/PERIOLIMEL 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.
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 Pregnancy & Lactation
There are no clinical data from the use of OLIMEL/PERIOLIMEL in pregnant or lactating women. Taking into account the use and indications of OLIMEL/PERIOLIMEL, the product may be considered during pregnancy and breastfeeding, if necessary.
Adverse Reactions
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/day over 5 days. (See Table 9.)

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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: cholestase, heptomegaly, jaundice.
Immune system disorders: hypersensitivity.
Investigations: Blood alkaline phosphatase increased, transaminases increased, blood bilirubin increased, elevated liver enzymes.
Renal and urinary disorders: azotaemia.
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/PERIOLIMEL, 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 characterized by findings such as fever, anaemia, leukopoenia, 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.
Drug Interactions
No interaction studies have been performed.
OLIMEL/PERIOLIMEL 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/PERIOLIMEL, 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/PERIOLIMEL contains vitamin K, naturally present in lipid emulsions. The amount of vitamin K in recommended doses of OLIMEL/PERIOLIMEL are not expected to influence effects of coumarin derivatives.
Due to the potassium content of OLIMEL/PERIOLIMEL, 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.
Caution For Usage
Special precautions for disposal and other handling: To open: Remove the protective overpouch.
Discard the oxygen absorber / oxygen indicator sachet.
Confirm the integrity of the bag and of the non-permanent seals. Use only if the bag is not damaged, if the non-permanent seals are intact (i.e. no mixture of the contents of the 3 compartments), if the amino acids 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 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 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 addition (including vitamins) may be made into the reconstituted mixture (after the non-permanent 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 non-permanent seals and before mixing the 3 compartments).
When making additions to formulations containing electrolytes, the amount of electrolytes already present in the bag should be taken into account.
Additions must be performed by qualified personnel under aseptic conditions.
OLIMEL may be supplemented with electrolytes according to Table 10 as follows: See Table 10.

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PERIOLIMEL may be supplemented with electrolytes according to Table 11 as follows: See Table 11.

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Trace elements and vitamins: Stability has been demonstrated with commercially-available preparations of vitamins and trace elements (containing up to 1 mg of iron).
Compatibility for other additives is available upon request.
When making additions, the final osmolarity of the mixture must be measured before administration via a peripheral vein.
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.
Administration: For single use only.
Only administer the product after the non-permanent 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 content 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.
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 destabilize 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/PERIOLIMEL 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/PERIOLIMEL, through the same infusion line (e.g., via Y-connector) because of the risk of precipitation of ceftriaxone-calcium salt (see Precautions and Interactions).
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.
Storage
Do not freeze.
Store in the overpouch.
For storage conditions of the reconstituted medicinal product, see Shelf life.
Shelf life: 2 years if the overwrap is not damaged.
After reconstitution: It is recommended that the product be used immediately after the non-permanent seals between the 3 compartments have been opened. However, the stability of the reconstituted emulsion has been demonstrated for 7 days (between 2°C and 8°C) followed by 48 hours at temperature not exceeding 25°C.
After addition of supplements (electrolytes, trace elements and vitamins; see Cautions for Usage): For specific admixtures, in-use stability has been demonstrated for 7 days (between 2°C and 8°C) followed by 48 hours at temperature not exceeding 25°C.
From a microbiological point of view, any admixture should be used immediately. If not used immediately, 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 to 8°C, unless addition of supplements has taken place in controlled and validated aseptic conditions.
ATC Classification
B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Olimel N9E emulsion for infusion 1,000 mL x 6's, 1,500 mL x 4's, 2,000 mL x 4's. PeriOlimel N4E emulsion for infusion 1,500 mL x 4's, 2,000 mL x 4's.
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