Olimel peri n4e
Poland
Table of Contents
- 1. What OLIMEL PERI N4E, infusion emulsion is and what it is used for
- 2. Important information before administering OLIMEL PERI N4E, infusion emulsion
- 3. How to use OLIMEL PERI N4E, infusion emulsion
- 4. Possible adverse effects
- 5. How to store OLIMEL PERI N4E, infusion emulsion
- 6. Contents of the package and other information
- Information intended exclusively for professional medical personnel:
OLIMEL PERI N4E, infusion emulsion
Please read the leaflet carefully before the medicine is administered, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or nurse.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.
Table of contents of the leaflet
- What OLIMEL PERI N4E, infusion emulsion is and what it is used for
- Important information before administration of OLIMEL PERI N4E, infusion emulsion
- How to use OLIMEL PERI N4E, infusion emulsion
- Possible side effects
- How to store OLIMEL PERI N4E, infusion emulsion
- Contents of the pack and other information
1. What OLIMEL PERI N4E, infusion emulsion is and what it is used for
OLIMEL PERI is an infusion emulsion. The preparation is supplied in a three-compartment bag.
The first compartment contains a glucose solution with calcium, the second compartment contains a fat emulsion, and the third compartment contains an amino acid solution with other electrolytes.
OLIMEL PERI is used for intravenous nutrition via a catheter in adults and children above 2 years of age when oral nutrition is not appropriate.
OLIMEL PERI must only be administered under medical supervision.
2. Important information before administering OLIMEL PERI N4E, infusion emulsion
When not to use OLIMEL PERI N4E, infusion emulsion:
- in premature infants, newborns and children under 2 years of age;
- if the patient is allergic to eggs, soy, peanut proteins, corn/products containing corn (see also section "Warnings and precautions" below), or to any of the other ingredients of this medicine (listed in section 6);
- if administration of certain amino acids causes an abnormal reaction in the patient;
- if the patient has markedly elevated levels of fats in the blood;
- if the patient has hyperglycemia (excessively high blood sugar levels);
- if the patient has abnormally high levels of any electrolyte (sodium, potassium, magnesium, calcium and/or phosphorus) in the blood.
In every case, the physician will make the decision to administer the medicine based on factors such as the patient's age, body weight and overall health status, including results of laboratory tests.
Warnings and precautions
Before starting administration of OLIMEL PERI N4E, discuss this with the doctor or nurse.
Too rapid infusion of parenteral nutrition solutions may result in injury or death of the patient.
If unusual signs or symptoms of an allergic reaction occur (such as sweating, fever, chills, headache, skin rash or breathing difficulties), the infusion must be stopped immediately.
The medicine contains soybean oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-reactivity between soy proteins and peanut proteins has been observed.
OLIMEL PERI contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn-containing products (see section "When not to use OLIMEL PERI N4E, infusion emulsion:" above).
Breathing difficulties may also indicate the formation of small particles blocking blood vessels in the lungs (pulmonary vessel deposits). If any breathing difficulties occur, inform the doctor or nurse immediately. They will decide on appropriate actions.
The antibiotic ceftriaxone must not be mixed or administered simultaneously with any calcium-containing solutions (including OLIMEL PERI) administered by intravenous infusion.
These medicines must not be administered simultaneously even through separate infusion lines or different infusion sites.
However, OLIMEL PERI and ceftriaxone may be administered sequentially, one after the other, provided that the infusion lines are inserted at different sites, or are replaced or thoroughly flushed with saline solution between infusions to prevent precipitation (formation of calcium ceftriaxone salt particles).
Some medicines and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particularly high risk of infection or sepsis after insertion of a catheter (intravenous line) into the patient's vein. The physician will closely monitor the patient for any signs of infection. Patients requiring parenteral nutrition (administration of nutrients via a tube inserted into a vein) are, due to their clinical condition, at increased risk of developing infections. Strict aseptic procedures (ensuring absence of microorganisms) during catheter placement, handling, and preparation of the nutritional formulation (total parenteral nutrition) may reduce the risk of infection.
If the patient is severely malnourished and requires intravenous feeding, the physician should initiate treatment slowly. At the same time, the patient should be closely monitored to prevent sudden changes in fluid volume, and in levels of vitamins, electrolytes and minerals.
Electrolyte and metabolic imbalances should be corrected before starting the infusion. The physician will monitor the patient during therapy and may adjust the dosage or, if deemed necessary, prescribe additional nutritional supplements such as vitamins, electrolytes and trace elements.
Liver function abnormalities have been reported in patients receiving intravenous nutritional therapy, including impaired bile excretion (cholestasis), fat accumulation (hepatic steatosis), fibrosis, possibly leading to liver failure, as well as gallbladder inflammation and gallstones. The causes of these disorders may vary among different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, or yellowing of the skin or eyes (jaundice), contact the physician to identify possible causes, contributing factors, and appropriate therapeutic or preventive measures.
Inform the physician:
- about severe kidney diseases. Also inform the physician if the patient is undergoing dialysis (artificial kidney) or other blood purification methods;
- about severe liver diseases;
- about blood coagulation disorders;
- about adrenal gland dysfunction (adrenal insufficiency). Adrenal glands are triangular-shaped glands located on top of the kidneys;
- about heart failure;
- about lung disease;
- about fluid retention in the body (overhydration);
- about insufficient body water (dehydration);
- about untreated high blood glucose levels (diabetes);
- about myocardial infarction or shock caused by acute heart failure;
- about severe metabolic acidosis (excessively acidic blood);
- about systemic infection (sepsis);
- about coma.
To monitor the efficacy and safety of the medicine, the patient will undergo clinical and laboratory tests as prescribed by the physician during administration. If the medicine is administered for several weeks, the patient's blood will be tested regularly.
Reduced ability of the body to clear lipids from the administered preparation may lead to the so-called "fat overload syndrome" (see section 4 – "Possible side effects").
If pain, burning sensation, swelling at the infusion site, or leakage of the infused fluid occurs during infusion, inform the physician or nurse immediately. The infusion should be stopped immediately and restarted into another vein.
If blood glucose levels increase excessively, the physician should adjust the infusion rate of OLIMEL PERI or administer insulin to the patient to normalize blood sugar levels.
OLIMEL PERI may be administered through a catheter inserted into a vein in the arm or into a large central vein in the patient's chest (central vein).
Children and adolescents
When used in children under 18 years of age, particular caution is required to ensure correct dosing. Due to children's increased susceptibility to infection, enhanced precautions must be taken. Supplementation with vitamins and trace elements is always required. Pediatric formulations and dosages must be used for children.
OLIMEL PERI and other medicines
Inform the physician about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use.
Concurrent use of other medicines is usually not contraindicated. However, it is essential to inform the physician about all recently used medicines, including those available without prescription, to verify compatibility.
Inform the physician about the use or administration of:
- insulin,
- heparin.
OLIMEL PERI must not be administered simultaneously with blood through the same infusion set.
OLIMEL PERI contains calcium. It must not be administered together with the antibiotic ceftriaxone or through the same line, as particles may form. If these medicines are administered sequentially using the same device, it should be thoroughly flushed between infusions.
Due to the risk of precipitation, OLIMEL PERI should not be administered through the same infusion line or mixed with ampicillin (an antibiotic) or fosphenytoin (an anticonvulsant).
The olive oil and soybean oil present in OLIMEL PERI contain vitamin K. This usually does not affect the action of anticoagulant medicines such as coumarins. However, if the patient is taking anticoagulant medicines, this should be reported to the physician.
The lipids in the emulsion may interfere with the results of certain laboratory tests if blood samples are taken before lipids have been cleared from the patient's circulation (lipids are cleared from the blood 5 to 6 hours after lipid administration).
OLIMEL PERI contains potassium. Particular caution is required in patients taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used for hypertension), or immunosuppressive agents. These medicines may cause increased potassium levels in the blood.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician before receiving this medicine.
There is insufficient experience regarding the use of OLIMEL PERI N4E in pregnant or breastfeeding women. If necessary, administration of OLIMEL PERI N4E during pregnancy or breastfeeding may be considered. OLIMEL PERI N4E should be administered to pregnant or breastfeeding women only after careful consideration.
Driving and operating machinery
Not applicable.
3. How to use OLIMEL PERI N4E, infusion emulsion
Dosage
OLIMEL PERI must be used only in adults and in children above the age of 2 years.
The medicine is an infusion emulsion administered through a tube (catheter) into a vein in the arm or into a large vein in the patient's chest.
Before administration, OLIMEL PERI should be at room temperature.
OLIMEL PERI is intended for single use only.
Infusion of one bag usually lasts from 12 to 24 hours.
Dosage – adults
The infusion rate will be determined by the physician according to the patient's needs and clinical condition.
The medicine may be administered as long as necessary, depending on the patient's clinical status.
Dosage – children above two years of age and adolescents
The dose and duration of treatment are determined by the physician. This depends on age, body weight, height, health status, and the body's ability to metabolize and utilize the components of OLIMEL PERI N4E.
Overdose of OLIMEL PERI N4E, infusion emulsion
If too high a dose is administered or the infusion rate is too fast, the amino acids contained in the product may contribute to increased blood acidity and symptoms of hypervolemia (increased circulating blood volume). Blood and urinary glucose levels may rise, leading to hyperosmolar syndrome (excessive blood viscosity), and the fats contained in the emulsion may increase blood triglyceride levels. Administration of OLIMEL PERI at too rapid an infusion rate or in excessive volume may cause nausea, vomiting, chills, headache, hot flushes, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such cases, the infusion must be stopped immediately.
In severe cases, the physician may need to subject the patient to temporary kidney dialysis to assist the kidneys in eliminating the excess product.
To prevent such situations, the physician regularly monitors the patient's condition and checks blood parameters.
If you have any doubts regarding the use of this medicine, consult your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you notice any changes in your condition during or after treatment, you should immediately inform your doctor or nurse.
Examinations performed by a doctor during the patient's treatment should minimize the risk of adverse effects.
If any unusual signs or symptoms of an allergic reaction occur, such as excessive sweating, fever, chills, headache, skin rash, or breathing difficulties, the infusion should be stopped immediately.
The following adverse effects have been reported during the use of OLIMEL PERI:
Frequency — Common: may affect up to 1 in 10 people
- Increased heart rate (tachycardia);
- Decreased appetite;
- Increased blood lipid levels (hypertriglyceridemia);
- Abdominal pain;
- Diarrhea;
- Nausea;
- Increased blood pressure (hypertension).
Frequency — Not known: frequency cannot be estimated based on available data
- Hypersensitivity reactions, including sweating, fever, chills, headache, skin rash (erythematous, nodular, pustular, macular, generalized rash), itching, hot flushes, breathing difficulties;
- Leakage of infusion into surrounding tissue (extravasation) may cause pain, irritation, swelling/edema, redness (erythema)/warmth, tissue cell death (skin necrosis), or blisters/bulbous lesions, inflammation, thickening or tightening of the skin at the infusion site;
- Vomiting.
When using similar parenteral nutrition preparations, the following adverse effects have been reported:
Frequency — Very rare: may affect up to 1 in 10,000 people
- Reduced ability to clear lipids (fat overload syndrome) associated with sudden deterioration in the patient's condition. The symptoms of fat overload syndrome listed below usually resolve after discontinuation of the fat emulsion infusion:
- Fever
- Decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anemia)
- Low white blood cell count, which may increase the risk of infections (leukopenia)
- Low platelet count, which may increase the risk of bruising and/or bleeding (thrombocytopenia)
- Coagulation disorders affecting blood clotting ability
- High blood fat levels (hyperlipidemia)
- Fatty deposits in the liver (hepatomegaly)
- Worsening liver function
- Central nervous system symptoms (e.g., coma).
Frequency — Not known: frequency cannot be estimated based on available data
- Allergic reactions;
- Abnormal blood test results regarding liver function;
- Problems with bile excretion (cholestasis);
- Enlargement of the liver (hepatomegaly);
- Liver diseases associated with parenteral nutrition (see "Warnings and precautions" in section 2);
- Jaundice;
- Decreased platelet count (thrombocytopenia);
- Increased blood nitrogen levels (azotemia);
- Increased liver enzyme activity;
- Formation of small particles that may block blood vessels in the lungs (pulmonary vascular deposits), leading to pulmonary embolism and breathing difficulties (respiratory failure).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.
5. How to store OLIMEL PERI N4E, infusion emulsion
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and outer packaging (MM/YYYY). The expiry date refers to the last day of the specified month.
Do not freeze.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the package and other information
What Olimel Peri N4E, infusion emulsion contains
The active substances in each bag of ready-to-use emulsion are: 6.3% (corresponding to 6.3 g/100 ml)
solution of L-amino acids (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (as lysine acetate),
methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, aspartic acid, glutamic acid)
with electrolytes (sodium, potassium, magnesium, phosphates, acetates, chlorides),
15% (corresponding to 15 g/100 ml) fat emulsion (purified olive oil and purified soybean oil), and
18.75% (corresponding to 18.75 g/100 ml) glucose solution (as glucose monohydrate) with calcium.
Other ingredients of the medicinal product are:
| Chamber containing fat emulsion | Chamber containing amino acid solution | Chamber containing glucose solution |
| Purified egg yolk phospholipids, glycerol, sodium oleate, sodium hydroxide (for pH adjustment), water for injections | Glacial acetic acid (for pH adjustment), water for injections | Hydrochloric acid (for pH adjustment), water for injections |
What OLIMEL PERI N4E, infusion emulsion looks like and what the packaging contains
OLIMEL PERI is an infusion emulsion supplied in a three-compartment bag. The first compartment contains a fat emulsion, the second compartment contains an amino acid solution with electrolytes, and the third compartment contains a glucose solution with calcium. The compartments are separated from each other by non-permeable seals. Before administration, the contents of each compartment should be mixed by folding the bag towards itself, starting from the top of the bag, until the seals open.
Appearance before mixing:
- Amino acid and glucose solutions are clear, colourless or slightly yellow.
- The fat emulsion is homogeneous with a milky appearance.
Appearance after mixing: homogeneous emulsion with a milky appearance.
The 3-compartment bag is a multilayer plastic bag. The inner (contact) layer of the bag is compatible with the components and permitted additives.
To prevent contact with oxygen present in the air, the bag is packed in an oxygen-protective packaging with an oxygen-absorbing sachet.
Packaging sizes
1000 ml bag: 1 cardboard box containing 6 bags
1500 ml bag: 1 cardboard box containing 4 bags; 1 cardboard box containing 5 bags
2000 ml bag: 1 cardboard box containing 4 bags; 1 cardboard box containing 5 bags
2500 ml bag: 1 cardboard box containing 2 bags
1 bag of 1000 ml, 1500 ml, 2000 ml and 2500 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Polska Sp. z o.o.
Ul. Kruczkowskiego 8
00-380 Warsaw, Poland
Manufacturer
BAXTER S.A.
Boulevard Rene Branquart, 80
7860 Lessines, Belgium
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
France, Portugal, Bulgaria, Romania, Czech Republic, Belgium, Spain, Slovakia, Luxembourg, Slovenia, Hungary: PERIOLIMEL N4E
In some countries it is registered under a different trade name as described below:
Estonia, Poland, Lithuania, Latvia, Greece, Cyprus: OLIMEL PERI N4E
Netherlands: Olimel Perifeer N4E
Italy: OLIMEL Periferico N4E
Austria: PeriOLIMEL 2,5 % mit Elektrolyten
Germany: Olimel Peri 2,5% E
Denmark, Iceland, Sweden, Norway, Finland: Olimel Perifer N4E
United Kingdom, Ireland, Malta: Triomel Peripheral 4g/l nitrogen 700 kcal/l with electrolytes
Information intended exclusively for professional medical personnel:
Pharmacotherapeutic group: parenteral nutrition solutions / mixtures
ATC code: B05 BA10.
A. QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL PERI is in the form of a three-compartment bag.
Each bag contains a glucose solution with calcium, a fat emulsion, and an amino acid solution with other electrolytes:
| Contents per bag | ||||
| 1000 ml | 1500 ml | 2000 ml | 2500 ml | |
| 18.75% glucose solution (equivalent to 18.75 g/100 ml) | 400 ml | 600 ml | 800 ml | 1000 ml |
| 6.3% amino acid solution (equivalent to 6.3 g/100 ml) | 400 ml | 600 ml | 800 ml | 1000 ml |
| 15% fat emulsion (equivalent to 15 g/100 ml) | 200 ml | 300 ml | 400 ml | 500 ml |
Composition of the ready emulsion after mixing the contents of three compartments:
| Active substances | 1000 ml | 1500 ml | 2000 ml | 2500 ml |
| Purified olive oil + purified soybean oil | 30.00 g | 45.00 g | 60.00 g | 75.00 g |
| Alanine | 3.66 g | 5.50 g | 7.33 g | 9.16 g |
| Arginine | 2.48 g | 3.72 g | 4.96 g | 6.20 g |
| Aspartic acid | 0.73 g | 1.10 g | 1.46 g | 1.83 g |
| Glutamic acid | 1.26 g | 1.90 g | 2.53 g | 3.16 g |
| Glycine | 1.76 g | 2.63 g | 3.51 g | 4.39 g |
| Histidine | 1.51 g | 2.26 g | 3.02 g | 3.77 g |
| Isoleucine | 1.26 g | 1.90 g | 2.53 g | 3.16 g |
| Leucine | 1.76 g | 2.63 g | 3.51 g | 4.39 g |
| Lysine (corresponds to lysine acetate) | 1.99 g (2.81 g) | 2.99 g (4.21 g) | 3.98 g (5.62 g) | 4.98 g (7.02 g) |
| Methionine | 1.26 g | 1.90 g | 2.53 g | 3.16 g |
| Phenylalanine | 1.76 g | 2.63 g | 3.51 g | 4.39 g |
| Proline | 1.51 g | 2.26 g | 3.02 g | 3.77 g |
| Serine | 1.00 g | 1.50 g | 2.00 g | 2.50 g |
| Threonine | 1.26 g | 1.90 g | 2.53 g | 3.16 g |
| Tryptophan | 0.42 g | 0.64 g | 0.85 g | 1.06 g |
| Tyrosine | 0.06 g | 0.10 g | 0.13 g | 0.16 g |
| Valine | 1.62 g | 2.43 g | 3.24 g | 4.05 g |
| Sodium acetate trihydrate | 1.16 g | 1.73 g | 2.31 g | 2.89 g |
| Sodium glycerophosphate hydrate | 1.91 g | 2.87 g | 3.82 g | 4.78 g |
| Potassium chloride | 1.19 g | 1.79 g | 2.38 g | 2.98 g |
| Magnesium chloride hexahydrate | 0.45 g | 0.67 g | 0.90 g | 1.12 g |
| Calcium chloride dihydrate | 0.30 g | 0.44 g | 0.59 g | 0.74 g |
| Glucose (corresponds to monohydrate glucose) | 75.00 g (82.50 g) | 112.50 g (123.75 g) | 150.00 g (165.00 g) | 187.50 g (206.25 g) |
The excipients are:
| Chamber containing fat emulsion | Chamber containing amino acid solution with electrolytes | Chamber containing glucose solution with calcium |
| Purified egg phospholipids, glycerol, sodium oleate, sodium hydroxide (for pH adjustment), water for injections | Glacial acetic acid (for pH adjustment), water for injections | Hydrochloric acid (for pH adjustment), water for injections |
Nutritional values of the ready-to-use emulsion, according to bag sizes:
| 1000 ml | 1500 ml | 2000 ml | 2500 ml | |
| Fats | 30 g | 45 g | 60 g | 75 g |
| Amino acids | 25.3 g | 38.0 g | 50.6 g | 63.3 g |
| Nitrogen | 4.0 g | 6.0 g | 8.0 g | 10.0 g |
| Glucose | 75.0 g | 112.5 g | 150.0 g | 187.5 g |
| Energy value: Total energy value approximately Non-protein energy value Glucose energy value Fat energy value Ratio: non-protein energy value/nitrogen Ratio: glucose energy value/fat energy value Fat/total calories | 700 kcal 600 kcal 300 kcal 300 kcal 150 kcal/g 50/50 43% | 1050 kcal 900 kcal 450 kcal 450 kcal 150 kcal/g 50/50 43% | 1400 kcal 1200 kcal 600 kcal 600 kcal 150 kcal/g 50/50 43% | 1750 kcal 1500 kcal 750 kcal 750 kcal 150 kcal/g 50/50 43% |
| Electrolytes: Sodium Potassium Magnesium Calcium Phosphatesb Acetates Chlorides | 21 mmol 16.0 mmol 2.2 mmol 2.0 mmol 8.5 mmol 27 mmol 24 mmol | 31.5 mmol 24.0 mmol 3.3 mmol 3.0 mmol 12.7 mmol 41 mmol 37 mmol | 42.0 mmol 32.0 mmol 4.4 mmol 4.0 mmol 17.0 mmol 55 mmol 49 mmol | 52.5 mmol 40.0 mmol 5.5 mmol 5.0 mmol 21.2 mmol 69 mmol 61 mmol |
| pH | 6.4 | 6.4 | 6.4 | 6.4 |
| Osmolarity | 760 mOsm/L | 760 mOsm/L | 760 mOsm/L | 760 mOsm/L |
B. DOSAGE AND ADMINISTRATION
Dosage
OLIMEL PERI is not recommended for use in children under 2 years of age due to its unsuitable composition and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).
The maximum daily dose specified below should not be exceeded. Due to the fixed composition of the multi-chamber bag, it may not be possible to simultaneously meet all the patient's nutritional requirements. There may be clinical situations in which patients require different amounts of nutrients than those contained in the fixed-composition bag. In such cases, any change in volume (dose) should take into account its impact on the dosing of all other nutrients in the medicinal product OLIMEL PERI.
Adults
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL PERI, as well as on additional energy components or proteins administered orally/enterally; therefore, the appropriate bag size should be selected.
Average daily requirements are:
- 0.16 to 0.35 g nitrogen/kg body weight (1 to 2 g amino acids/kg), depending on the patient's nutritional status and degree of catabolism,
- 20 to 40 kcal/kg,
- 20 to 40 ml fluid/kg or 1 to 1.5 ml per kcal consumed.
For the product OLIMEL PERI, the maximum daily dose has been defined based on an intake of 40 ml fluid/kg, corresponding to 1 g amino acids/kg, 3 g glucose/kg, 1.2 g lipids/kg, 0.8 mmol sodium/kg, and 0.6 mmol potassium/kg. For a 70 kg patient, this would correspond to 2800 ml of OLIMEL PERI per day, resulting in an intake of 71 g amino acids, 210 g glucose, and 84 g lipids (i.e., 1680 kcal non-protein and total of 1960 kcal).
Typically, the infusion rate should be gradually increased during the first hour, after which the infusion rate should be appropriately adjusted according to the dose, daily volume of the medicinal product administered, and duration of infusion.
For the product OLIMEL PERI, the maximum infusion rate is 3.2 ml/kg/hour, corresponding to 0.08 g amino acids/kg/hour, 0.24 g glucose/kg/hour, and 0.10 g lipids/kg/hour.
Children over 2 years of age and adolescents
Clinical studies have not been conducted in the pediatric population.
Dosage depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of OLIMEL PERI, as well as on additional energy components or proteins administered orally/enterally; therefore, the appropriate bag size should be selected.
Furthermore, daily requirements for fluids, nitrogen, and energy continuously decrease with age. Two age groups have been considered: 2 to 11 years and 12 to 18 years.
For the product OLIMEL PERI N4E in both age groups, the limiting factor for the daily dose is magnesium concentration. In the 2 to 11-year age group, the limiting factor for the hourly administration rate is lipid concentration. In the 12 to 18-year age group, the limiting factor for the hourly administration rate is glucose concentration. The resulting intakes are presented below:
| Active ingredient | 2 to 11 years | 12 to 18 years | ||
| Recommended | Maximum volume OLIMEL PERI N4E | Recommended | Maximum volume OLIMEL PERI N4E | |
| Maximum daily dose | ||||
| Fluids (ml/kg/day) | 60 - 120 | 45 | 50 - 80 | 45 |
| Amino acids (g/kg/day) | 1 - 2 (up to 2.5) | 1.1 | 1 - 2 | 1.1 |
| Glucose (g/kg/day) | 1.4 – 8.6 | 3.4 | 0.7 – 5.8 | 3.4 |
| Fats (g/kg/day) | 0.5 - 3 | 1.4 | 0.5 - 2 (up to 3) | 1.4 |
| Total energy value (kcal/kg/day) | 30 – 75 | 31.5 | 20 – 55 | 31.5 |
| Maximum infusion rate per hour | ||||
| OLIMEL PERI N4E (ml/kg/hour) | 4.3 | 3.2 | ||
| Amino acids (g/kg/hour) | 0.20 | 0.11 | 0.12 | 0.08 |
| Glucose (g/kg/hour) | 0.36 | 0.33 | 0.24 | 0.24 |
| Fats (g/kg/hour) | 0.13 | 0.13 | 0.13 | 0.10 |
Typically, the infusion rate should be gradually increased during the first hour, and then adjusted according to the administered dose, daily volume of the medicinal product, and duration of infusion.
Generally, in small children, it is recommended to start with a low daily dose and gradually increase it to the maximum dosage (see above).
Method and duration of administration
For single use only.
It is recommended to use the contents of the bag immediately after opening and not to store for subsequent infusions.
After mixing, a homogeneous milky-appearing emulsion is obtained.
Instructions for preparation and administration of the infusion emulsion are provided in section 6.6 of the SmPC.
Due to its low osmolarity, OLIMEL PERI may be administered via either peripheral or central veins.
The recommended duration of infusion for the parenteral nutrition bag is 12 to 24 hours.
Parenteral nutrition treatment may be continued as long as clinically indicated.
C. PHARMACEUTICAL INCOMPATIBILITIES
Do not add any medicinal products or substances to any of the bag components or to the final emulsion without prior confirmation of their compatibility and stability of the resulting product (especially stability of the lipid emulsion).
Incompatibilities may arise, for example, due to excessive acidity (low pH) or inappropriate content of divalent cations (Ca and Mg), which may destabilize the lipid emulsion.
As with the preparation of other parenteral nutrition mixtures, the ratio of calcium and phosphate content should be considered. Excessive addition of calcium and phosphate, particularly in the form of inorganic salts, may lead to precipitation of calcium phosphate.
OLIMEL PERI contains calcium ions, posing an additional risk of precipitating clots in blood products or blood components containing citrate as an anticoagulant/preservative.
Ceftriaxone must not be mixed or co-administered simultaneously with intravenous solutions containing calcium, including OLIMEL PERI, via the same infusion line (e.g., using a Y-connector) due to the risk of precipitation of ceftriaxone-calcium salts (see sections 4.4 and 4.5 of the SmPC). Ceftriaxone and calcium-containing solutions may be administered consecutively if infusion lines are placed in different sites or are replaced or thoroughly flushed with physiological saline between infusions to prevent precipitation.
Due to the risk of precipitation, OLIMEL PERI must not be administered through the same infusion line or mixed with ampicillin or fosphenytoin.
Compatibility with solutions administered simultaneously through the same infusion set, catheter, or cannula should be verified.
Due to the risk of pseudoagglutination, this product must not be administered before, during, or after blood transfusion through the same infusion set.
D. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION
OF THE MEDICINAL PRODUCT FOR ADMINISTRATION
The steps for preparing OLIMEL PERI for administration are illustrated in Figure 1.
Opening
Remove the outer protective bag.
Discard the sachet containing the oxygen absorber.
Ensure that the bag and seals are undamaged. Use only if the bag is intact and the seals are unbroken (i.e., the contents of the three compartments have not been mixed), the amino acid and glucose solutions are clear, colorless or slightly yellow, practically free from visible particles, and the lipid emulsion is homogeneous and milky-appearing.
Mixing solutions and emulsion
Before breaking the seals, ensure the product is at room temperature.
Starting from the top of the bag (near the port), roll the bag downward with both hands. The seals will break progressively from the port side. Continue rolling the bag until the seals are broken along half their length.
Mix thoroughly by rotating the bag at least three times.
After mixing, the product forms a homogeneous milky-appearing emulsion.
Additional components
The bag capacity allows for the addition of vitamins, electrolytes, and trace elements.
All additives (including vitamins) should be introduced into the final emulsion (after breaking the seals and mixing the contents of the three compartments).
Vitamins may also be added to the glucose compartment prior to preparing the final emulsion (before breaking the seals and mixing the contents of the three compartments).
When adding components containing electrolytes, the existing electrolyte content in the bag must be taken into account.
Additional components must be added by qualified personnel under aseptic conditions.
Electrolytes may be added to OLIMEL PERI according to the table below:
| Per 1000 ml | |||
| Content | Maximum addition | Maximum content | |
| Sodium | 21 mmol | 129 mmol | 150 mmol |
| Potassium | 16 mmol | 134 mmol | 150 mmol |
| Magnesium | 2.2 mmol | 3.4 mmol | 5.6 mmol |
| Calcium | 2.0 mmol | 3.0 (1.5a) mmol | 5.0 (3.5a) mmol |
| Inorganic phosphates | 0 mmol | 8.0 mmol | 8.0 mmol |
| Organic phosphates | 8.5 mmolb | 15.0 mmol | 23.5 mmolb |
Trace elements and vitamins:
Stability has been demonstrated after addition of commercially available vitamin and trace element products
(containing up to a maximum of 1 mg of iron).
Compatibility with other additional components is available upon request.
When adding additional components, the final osmolarity of the mixture must be measured before administration via peripheral vein.
When introducing additional components, the following steps must be taken:
- maintain aseptic conditions,
- prepare the injection site on the bag,
- puncture the injection site and inject the additional components using an injection needle or a pharmaceutical preparation device,
- mix the contents of the bag thoroughly after adding the components.
Preparation of infusion
Maintain aseptic conditions.
Hang the bag.
Remove the plastic protector from the medication administration port.
Firmly insert the infusion set spike into the medication administration port.
Figure 1. Steps for preparing OLIMEL PERI for administration.
Administration
For single use only.
Administer the product only after breaking the seals between the 3 chambers and thoroughly mixing their contents.
Ensure that no phase separation occurs in the final infusion emulsion.
After opening, the bag contents must be used immediately. Do not store an opened bag for subsequent infusions. Do not reconnect partially used bags.
To avoid the risk of air embolism caused by gas present in the first bag, do not connect bags in series.
Any unused product or waste material, as well as the entire infusion set, must be discarded.
Extravasation
The catheter insertion site must be regularly monitored for signs of extravasation.
In case of extravasation, administration of the preparation must be immediately stopped, leaving the inserted catheter or cannula in place to allow immediate initiation of therapeutic measures. If possible, aspirate fluid through the catheter/cannula before removing it to reduce the amount of fluid in the tissues. If extravasation occurred in a limb, elevate the affected limb.
Depending on the type of extravasated product (including mixed product(s) with OLIMEL PERI, if applicable) and the extent/severity of potential injury, appropriate specific countermeasures should be taken. Therapeutic management options may include non-pharmacological treatment, pharmacological treatment, and/or surgical intervention. In cases of large-volume extravasation, consultation with a plastic surgeon should occur within 72 hours.
The extravasation site must be monitored at least every four hours during the first 24 hours, then once daily.
Infusion should not be restarted through the same peripheral or central vein.
Baxter and Olimel Peri are trademarks of Baxter International Inc.