Olimel N9-E emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olimel N9E emulsion for infusion

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Olimel N9E is and what it is used for

2. What you need to know before you are given Olimel N9E

3. How Olimel N9E will be administered to you

4. Possible side effects

5. How to store Olimel N9E

6. Contents of the pack and other information

1. What OLIMEL N9E is and what it is used for

Olimel is an infusion emulsion. It is supplied in a three-chamber bag.

One chamber contains a glucose solution with calcium, the second chamber contains a lipid emulsion, and the third chamber contains an amino acid solution with other electrolytes.

Olimel is used to provide nutrition to adults and children over two years of age through a tube inserted into a vein when normal oral feeding is not possible.

Olimel should only be used under medical supervision.

2. What you need to know before Olimel N9E is administered to you

Olimel N9E must not be administered:

• In premature neonates, infants, and children under two years of age
• If you are hypersensitive (allergic) to egg proteins, soybean seeds, peanuts, corn/corn products (see also section “Warnings and precautions” below), or to any of the other components of this medicine (listed in section 6)
• If your body has difficulty utilizing certain amino acids
• If you have particularly high levels of fat in your blood
• If you have hyperglycemia (excessively high blood sugar)
• If you have abnormally high levels of any electrolyte (sodium, potassium, magnesium, calcium, and/or phosphorus) in your blood

In all cases, your doctor will decide whether this medicine should be administered based on factors such as your age, weight, clinical condition, and the results of all tests performed.

Warnings and precautions

Consult your doctor or nurse before Olimel is administered to you.

Administering total parenteral nutrition (TPN) solutions too rapidly may cause injury or death.

Infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction occur (such as sweating, fever, chills, headache, skin rash, or difficulty breathing). This medicine contains soybean oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean seed proteins and peanut proteins have been observed.

Olimel contains glucose derived from corn, which may cause hypersensitivity reactions in individuals with allergy to corn or corn products (see section “Olimel N9E must not be administered” above).

Difficulty in breathing may also be a sign that small particles have formed in the lungs, blocking blood vessels (pulmonary vascular precipitates). If you experience any difficulty breathing, inform your doctor or nurse immediately. They will determine the appropriate action.

The antibiotic called ceftriaxone must not be mixed or administered simultaneously with solutions containing calcium (including Olimel) given by intravenous infusion.

These medicines must not be administered together, even through different infusion lines or infusion sites.

However, Olimel and ceftriaxone may be administered sequentially one after the other if different infusion sites are used, or if the infusion lines are replaced or thoroughly flushed with physiological saline solution between infusions to prevent precipitate formation (formation of ceftriaxone-calcium salt particles).

Certain medicines and medical conditions may increase the risk of developing infections or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when an intravenous catheter is placed in the vein. Your doctor will closely monitor you for signs of infection.

Patients requiring parenteral nutrition (administration of nutrients through a tube inserted into a vein) may be more prone to infections due to their medical condition. Using "aseptic techniques" (germ-free) when inserting and maintaining the catheter and when preparing the nutritional formula (TPN) can reduce the risk of infection.

If you are severely malnourished and require intravenous feeding, your doctor should start treatment slowly. You will also be monitored to prevent sudden changes in fluid, vitamin, electrolyte, and mineral levels.

Metabolic disorders and imbalances in your body's water and salt levels should be corrected before starting the infusion. Your doctor will monitor your condition during administration of this medicine and may adjust the dose or add other nutrients such as vitamins, electrolytes, and trace elements as appropriate.

Cases of liver disorders have been reported in patients receiving intravenous nutritional therapy, including problems with bile excretion (cholestasis), fat accumulation in the liver (hepatic steatosis), fibrosis, which may possibly lead to liver failure, as well as cholecystitis and cholelithiasis. The cause of these disorders is believed to be multifactorial and may vary between patients. If you experience symptoms such as nausea, vomiting, abdominal pain, or yellowing of the skin or eyes (jaundice), consult your doctor to identify possible causative and contributing factors and to consider potential therapeutic and preventive measures.

Your doctor should be informed if you have:

• Severe kidney problems. You should also inform your doctor if you are undergoing dialysis (artificial kidney) or any other type of blood-cleansing treatment
• Severe liver problems
• Blood coagulation disorders
• Adrenal gland dysfunction (adrenal insufficiency). The adrenal glands are triangular-shaped and located above the kidneys
• Heart failure
• Lung disease
• Fluid accumulation in the body (hyperhydration)
• Insufficient body fluid (dehydration)
• High blood sugar (diabetes mellitus) without treatment
• Heart attack or shock due to sudden heart failure
• Severe metabolic acidosis (excessively acidic blood)
• Systemic infection (septicemia)
• Coma

To monitor the effectiveness and safety of treatment, your doctor will perform laboratory and clinical tests while you are receiving this medicine. If you receive this medicine for several weeks, your blood will be tested regularly.

Reduced ability of the body to eliminate the fats contained in this medicine may lead to a "fat overload syndrome" (see section 4 “Possible side effects”).

If during infusion you feel pain, burning, swelling, or leakage at the infusion site, inform your doctor or nurse immediately. The infusion will be stopped immediately and restarted in another vein.

If your blood sugar levels become too high, your doctor will need to adjust the infusion rate of Olimel or administer medication to control blood sugar concentration (insulin).

Olimel must only be administered through a catheter inserted into a large vein in your chest (central vein).

Children and adolescents

If your child is under 18 years of age, special attention must be paid to administering the correct dose. Additional precautions are required due to children's increased susceptibility to infection risk. Supplementation with vitamins and trace elements is always necessary. Pediatric formulations should be used.

Use of Olimel with other medicines

Inform your doctor if you are taking or using, have recently taken or used, or might need to take or use any other medicines.

Concurrent administration of other medicines is generally not a contraindication. However, if you are taking any prescription or over-the-counter medicines, you should consult your doctor in advance so they can check for compatibility.

Inform your doctor if you are taking or receiving any of the following medicines:

• Insulin
• Heparin

Olimel must not be administered simultaneously with blood through the same infusion line.

Olimel contains calcium. It must not be administered together or through the same line as the antibiotic ceftriaxone, as precipitates may form. If the same device is used to administer these medicines sequentially, it must be thoroughly flushed.

Due to the risk of precipitation, Olimel must not be administered through the same infusion line or mixed with the antibiotic ampicillin or the antiepileptic drug fosphenytoin.

The olive and soybean oils present in Olimel contain vitamin K. This usually does not affect blood-thinning medicines (anticoagulants) such as coumarin. However, if you are taking anticoagulants, you must inform your doctor.

The lipids in this emulsion may interfere with the results of certain laboratory tests if blood samples are taken before the lipids have been cleared from your bloodstream (typically cleared after 5 to 6 hours without lipid infusion).

Olimel contains potassium. Caution is required in patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (medicines for high blood pressure), or immunosuppressants. These classes of medicines may increase potassium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before this medicine is administered to you.

There is insufficient experience with the use of Olimel in pregnant or breastfeeding women. Olimel may be used during pregnancy and breastfeeding if necessary. However, Olimel should only be administered to pregnant or breastfeeding women after careful consideration.

Driving and use of machines

Not applicable.

3. How Olimel N9E will be administered to you

Dosing

Olimel should only be administered to adults and children over two years of age.

It is an infusion emulsion, meaning it is given through a tube (catheter) into a large vein in your chest.

Olimel must be at room temperature before use.

Olimel is for single use only.

Dosing – Adults

Your doctor will determine the infusion rate based on your needs and clinical condition.

Administration may continue for as long as necessary, depending on your clinical status.

Dosing – Children over two years of age and adolescents

The doctor will decide the dose and duration of treatment based on age, weight, height, clinical condition, and the body's ability to metabolize and utilize the components of OLIMEL.

If you have been given more Olimel N9E than you should have

If the dose administered is too high or the infusion is too fast, the amino acid content may cause your blood to become too acidic, and signs of hypervolemia (increased volume of circulating blood) may occur. Blood and urine glucose levels may rise, a hyperosmolar syndrome (excessively viscous blood) may develop, and the lipid content may increase triglyceride levels in your blood. Administering the infusion too rapidly or in excessive volume may cause nausea, vomiting, chills, headache, flushing, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such cases, the infusion must be stopped immediately.

In severe cases, your doctor may need to perform temporary renal dialysis to help your kidneys eliminate the excess product.

To prevent these situations, your doctor will regularly monitor your condition and analyze your blood parameters.

If you have any further questions about the use of this product, ask your doctor.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 915.620.420

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If you notice that you do not feel as usual, inform your doctor or nurse immediately.

The tests your doctor performs while you are taking this medicine should minimize the risk of adverse effects.

If any abnormal sign or symptom of an allergic reaction occurs, such as sweating, fever, chills, headache, skin rash, or difficulty breathing, the infusion must be stopped immediately.

The following adverse effects have been reported with Olimel:

Frequency – Common: may affect up to 1 in 10 people

• Increased heart rate (tachycardia).
• Decreased appetite.
• Increased level of fats in the blood (hypertriglyceridemia).
• Abdominal pain.
• Diarrhea.
• Nausea.
• High blood pressure (hypertension).

Frequency – Not known: cannot be estimated from available data

• Hypersensitivity reactions including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, macular, generalized rash), itching, flushing, breathing difficulties.
• Leakage of the infusion into surrounding tissue (extravasation) may cause pain at the infusion site, irritation, swelling/edema, redness (erythema)/warmth, death of tissue cells (skin necrosis), or blisters/vesicles, inflammation, thickening or constriction of the skin.
• Vomiting.

The following adverse effects have been reported with other similar parenteral nutrition products:

Frequency – Very rare: may affect up to 1 in 10,000 people

• Reduced ability to eliminate lipids (fat overload syndrome), associated with a sudden and severe deterioration in the patient's medical condition. The following symptoms of fat overload syndrome are usually reversible when the lipid emulsion infusion is stopped:
  • Fever.
  • Decrease in red blood cells, which may cause paleness of the skin and weakness or difficulty breathing (anemia).
  • Low white blood cell count, which may increase the risk of infection (leukopenia).
  • Low platelet count, which may increase the risk of bruising and/or bleeding (thrombocytopenia).
  • Coagulation disorders affecting the blood's ability to clot.
  • Elevated levels of fats in the blood (hyperlipidemia).
  • Fat accumulation in the liver (hepatomegaly).
  • Worsening of liver function.
  • Central nervous system manifestations (e.g., coma).

Frequency – Not known: cannot be estimated from available data

• Allergic reactions.
• Problems with bile excretion (cholestasis).
• Abnormal blood tests for liver function.
• Increased liver size (hepatomegaly).
• Conditions associated with parenteral nutrition (see “Warnings and precautions” in section 2).
• Jaundice.
• Decrease in platelet count (thrombocytopenia).
• Increased levels of nitrogen in the blood (azotemia).
• Elevated liver enzymes.
• Formation of small particles that may lead to blockage of blood vessels in the lungs (pulmonary vascular precipitates), resulting in pulmonary vascular embolism and difficulty breathing (dyspnea).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olimel N9E

Keep this medicine 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 month indicated.

Do not freeze.

Store within the overpouch.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the container and other information

Composition of Olimel N9E

The active ingredients in each bag of the reconstituted emulsion are a 14.2% solution of L-amino acids (corresponding to 14.2 g/100 ml of 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, phosphate, acetate, chloride), a 20% lipid emulsion (corresponding to 20 g/100 ml of refined olive oil and refined soybean oil), and a 27.5% glucose solution (corresponding to 27.5 g/100 ml as glucose monohydrate) with calcium.

The other components are:

Lipid emulsion compartment	Amino acid solution compartment	Glucose solution compartment
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

Appearance of Olimel N9E and contents of the pack

Olimel is an infusion emulsion supplied in a 3-compartment bag. One compartment contains a lipid emulsion, another an amino acid solution with electrolytes, and the third a glucose solution with calcium. These compartments are separated by non-permanent seals. Prior to administration, the contents of the compartments must be mixed by rotating the bag on itself starting from the top of the bag until the seals are open.

Appearance prior to reconstitution:

• The amino acid and glucose solutions are clear, colourless or slightly yellowish.
• The lipid emulsion is homogeneous and milky white.

Appearance after reconstitution: Homogeneous milky emulsion.

The triple-compartment bag is a multilayer plastic bag. The material of the inner layer (in contact) of the bag is designed to be compatible with approved components and additives.

To avoid contact with atmospheric oxygen, the bag is packaged in an overpouch acting as an oxygen barrier, which contains an oxygen-absorbing sachet.

Pack sizes

1000 ml bag: 1 cardboard box containing 6 bags

1500 ml bag: 1 cardboard box containing 4 bags

2000 ml bag: 1 cardboard box containing 4 bags

1 bag of 1000 ml, 1500 ml, and 2000 ml

Only some pack sizes may be marketed.

Marketing Authorization Holder

Baxter S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia), Spain

Manufacturer

Baxter S.A., Boulevard René Branquart, 80, 7860 Lessines, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France, Portugal, Estonia, Poland, Lithuania, Bulgaria, Romania, Latvia, Czech Republic, Belgium, Spain, Slovak Republic, Netherlands, Luxembourg, Slovenia, Italy, Greece, Cyprus: OLIMEL N9E

In some countries it is registered under different names as described below:

Austria: ZentroOLIMEL 5,7% mit Elektrolyten
Germany: Olimel 5,7% E
Denmark, Iceland, Sweden, Norway, Finland: Olimel N9E
United Kingdom, Ireland, and Malta: Triomel 9g/l nitrogen 1070 kcal/l with electrolytes
Hungary: Olimel 9 g/l nitrogén elektrolitokkal emulziós infúzió

Date of the most recent review of this summary: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Pharmacotherapeutic group: parenteral nutrition solutions / combinations
ATC code: B05 BA10

A. Qualitative and quantitative composition

Olimel is supplied in a three-compartment bag. Each bag contains a glucose solution with calcium, a lipid emulsion, and an amino acid solution with other electrolytes.

	Content per bag
	1000 ml	1500 ml	2000 ml
27.5% glucose solution (equivalent to 27.5 g/100 ml)	400 ml	600 ml	800 ml
14.2% amino acid solution (equivalent to 14.2 g/100 ml)	400 ml	600 ml	800 ml
20% lipid emulsion (equivalent to 20 g/100 ml)	200 ml	300 ml	400 ml

After mixing the contents of the 3 compartments, the composition of the reconstituted emulsion is indicated in the following table for each bag size.

Active Ingredients	1000 ml	1500 ml	2000 ml
Refined olive oil + refined soybean oila Alanine Arginine Aspartic acid Glutamic acid Glycine Histidine Isoleucine Leucine Lysine (equivalent to Lysine acetate) Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium acetate trihydrate Hydrated sodium glycerophosphate Potassium chloride Magnesium chloride hexahydrate Calcium chloride dihydrate Glucose (equivalent to glucose monohydrate)	40.00 g 8.24 g 5.58 g 1.65 g 2.84 g 3.95 g 3.40 g 2.84 g 3.95 g 4.48 g (6.32 g) 2.84 g 3.95 g 3.40 g 2.25 g 2.84 g 0.95 g 0.15 g 3.64 g 1.50 g 3.67 g 2.24 g 0.81 g 0.52 g 110.00 g (121.00 g)	60.00 g 12.36 g 8.37 g 2.47 g 4.27 g 5.92 g 5.09 g 4.27 g 5.92 g 6.72 g (9.48 g) 4.27 g 5.92 g 5.09 g 3.37 g 4.27 g 1.42 g 0.22 g 5.47 g 2.24 g 5.51 g 3.35 g 1.22 g 0.77 g 165.00 g (181.50 g)	80.00 g 16.48 g 11.16 g 3.30 g 5.69 g 7.90 g 6.79 g 5.69 g 7.90 g 8.96 g (12.64 g) 5.69 g 7.90 g 6.79 g 4.50 g 5.69 g 1.90 g 0.30 g 7.29 g 2.99 g 7.34 g 4.47 g 1.62 g 1.03 g 220.00 g (242.00 g)

(a) A mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%), corresponding to a ratio of essential fatty acids / total fatty acids of 20%.

The excipients are:

Lipid emulsion compartment	Amino acid solution compartment with electrolytes	Glucose solution compartment with calcium
Purified egg phospholipids, glycerol, sodium oleate, sodium hydroxide (for pH adjustment), water for injectable preparations	Glacial acetic acid (for pH adjustment), water for injectable preparations	Hydrochloric acid (for pH adjustment), water for injectable preparations

The reconstituted emulsion provides the following for each bag size:

	1000 ml	1500 ml	2000 ml
Lipids	40 g	60 g	80 g
Amino Acids	56.9 g	85.4 g	113.9 g
Nitrogen	9.0 g	13.5 g	18.0 g
Glucose	110.0 g	165.0 g	220.0 g
Energy:
Approximate total calories	1070 kcal	1600 kcal	2140 kcal
Non-protein calories	840 kcal	1260 kcal	1680 kcal
Glucose calories	440 kcal	660 kcal	880 kcal
Lipid calories (a)	400 kcal	600 kcal	800 kcal
Non-protein calories / nitrogen ratio	93 kcal/g	93 kcal/g	93 kcal/g
Glucose calories / lipid calories ratio	52/48	52/48	52/48
Lipid calories / total calories	37%	37%	37%
Electrolytes:
Sodium	35.0 mmol	52.5 mmol	70.0 mmol
Potassium	30.0 mmol	45.0 mmol	60.0 mmol
Magnesium	4.0 mmol	6.0 mmol	8.0 mmol
Calcium	3.5 mmol	5.3 mmol	7.0 mmol
Phosphate (b)	15.0 mmol	22.5 mmol	30.0 mmol
Acetate	54 mmol	80 mmol	107 mmol
Chloride	45 mmol	68 mmol	90 mmol
pH	6.4	6.4	6.4
Osmolality	1310 mOsm/L	1310 mOsm/L	1310 mOsm/L

a Includes calories from purified egg phospholipids

b Includes phosphate provided by the lipid emulsion

B. Posology and method of administration

Posology

The use of Olimel is not recommended in children under 2 years of age, as neither the composition nor the volume are appropriate (see sections 4.4, 5.1 and 5.2 of the Summary of Product Characteristics).

The maximum daily dose mentioned below must not be exceeded. Due to the fixed composition of the multi-compartment bag, it may not be possible to simultaneously meet all the patient's nutrient requirements. There may be clinical situations in which the patient requires nutrient amounts differing from those in the bag's composition. In such cases, any adjustment in volume (dose) must take into account the resulting effect on the dosing of the other nutrients in OLIMEL.

In adults

The dose depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of Olimel, as well as on additional energy or protein administered orally or enterally. Therefore, the appropriate bag size should be selected.

Average daily requirements are:

• 0.16 to 0.35 g of nitrogen/kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and level of catabolic stress.
• 20 to 40 kcal/kg.
• 20 to 40 ml of fluid/kg, or 1 to 1.5 ml per kcal expended.

For Olimel, the maximum daily dose is defined by amino acid intake: 35 ml/kg, corresponding to 2.0 g/kg of amino acids, 3.9 g/kg of glucose, 1.4 g/kg of lipids, 1.2 mmol/kg of sodium, and 1.1 mmol/kg of potassium. For a 70 kg patient, this would correspond to 2450 ml of Olimel per day, providing 140 g of amino acids, 270 g of glucose, and 98 g of lipids, i.e., 2058 non-protein kcal and 2622 total kcal.

Normally, the infusion rate should be gradually increased during the first hour, then adjusted according to the dose being administered, the daily volume intake, and the duration of infusion.

For Olimel, the maximum infusion rate is 1.8 ml/kg/hour, corresponding to 0.10 g/kg/hour of amino acids, 0.19 g/kg/hour of glucose, and 0.07 g/kg/hour of lipids.

In children over 2 years of age and adolescents

No studies have been conducted in the pediatric population.

The dose depends on the patient's energy expenditure, clinical condition, body weight, and ability to metabolize the components of Olimel, as well as on additional energy or protein administered orally or enterally. Therefore, the appropriate bag size should be selected.

Furthermore, daily requirements for fluid, nitrogen, and energy continuously decrease with age: Two age groups are considered, one between 2 and 11 years, and another from 12 to 18 years.

For Olimel N9E, in the 2 to 11-year age group, magnesium concentration is the limiting factor for the daily dose, while glucose concentration limits the hourly rate. In the 12 to 18-year age group, the limiting factors for the daily dose are amino acid and magnesium concentrations, and amino acid concentration limits the hourly rate. The resulting intakes are as follows:

Constituent	From 2 to 11 years	From 12 to 18 years
Recommendeda	OLIMEL N9E Vol. Max	Recommendeda	OLIMEL N9E Vol. Max
Maximum daily dose
Liquid (ml/kg/day)	60 – 120	25	50 – 80	35
Amino acids (g/kg/day)	1 – 2 (up to 2.5)	1.4	1 – 2	2.0
Glucose (g/kg/day)	1.4 – 8.6	2.8	0.7 – 5.8	3.9
Lipids (g/kg/day)	0.5 – 3	1.0	0.5 – 2 (up to 3)	1.4
Total energy (kcal/kg/day)	30 – 75	26.8	20 – 55	37.5
Maximum rate per hour
OLIMEL N9E (ml/kg/h)		3.3		2.1
Amino acids (g/kg/h)	0.20	0.19	0.12	0.12
Glucose (g/kg/h)	0.36	0.36	0.24	0.23
Lipids (g/kg/h)	0.13	0.13	0.13	0.08

a: Recommended values in the 2018 ESPGHAN/ESPEN/ESPR Guidelines

Administration rate should normally be gradually increased during the first hour, then adjusted according to the dose being administered, daily volume intake, and duration of infusion.

In general, for small children, it is recommended to start infusion with a reduced daily dose and gradually increase it to the maximum dose (see previous section).

Method and duration of administration

For single use only.

Once the bag has been opened, its contents should be used immediately and must not be saved for subsequent infusions.

After reconstitution, the mixture appears as a homogeneous emulsion resembling milk.

For instructions on preparation and handling of the infusion emulsion, see section 6.6 of the Summary of Product Characteristics.

Due to its high osmolarity, Olimel must only be administered via a central vein.

The recommended duration for infusion of a parenteral nutrition bag is between 12 and 24 hours.

Parenteral nutrition treatment may continue for as long as the patient's clinical condition requires.

C. Incompatibilities

No other medicinal product or drug should be added to any of the components of the bag or to the reconstituted emulsion without first confirming the compatibility and stability of the resulting preparation (specifically, the stability of the lipid emulsion).

Incompatibilities may occur, for example, due to excessive acidity (low pH) or inappropriate levels of divalent cations (Ca²⁺ and Mg²⁺), which may destabilize the lipid emulsion.

As with any parenteral nutrition mixture, the proportions of calcium and phosphate must be taken into account. Excessive addition of calcium and phosphate, particularly in the form of mineral salts, may lead to precipitation of calcium phosphate.

Olimel contains calcium ions, which poses an additional risk of coagulation in citrate-anticoagulated/stored blood or its components.

Ceftriaxone must not be mixed or administered together with intravenous solutions containing calcium, including Olimel, through the same infusion line (e.g., Y-connector) due to the risk of ceftriaxone-calcium salt precipitation (see sections 4.4 and 4.5 of the Summary of Product Characteristics). Ceftriaxone and calcium-containing solutions may be administered sequentially one after the other if different infusion sites are used, or if the infusion lines are replaced or flushed appropriately.

Due to the risk of precipitation, Olimel must not be administered through the same infusion line or mixed with ampicillin or fosphenytoin.

Check compatibility with solutions administered simultaneously through the same administration set, catheter, or cannula.

Olimel must not be administered before, simultaneously, or after blood through the same equipment due to the risk of pseudoagglutination.

D. Special precautions for disposal and other handling

Table 1 provides an overview of the preparation steps for administering Olimel.

To open

Remove the protective overwrap.

Discard the oxygen-absorbing sachet.

Check the integrity of the bag and the non-permanent seals. Use only if the bag is undamaged, the non-permanent seals are intact (i.e., the contents of the three compartments have not been mixed), the amino acid solution and glucose solution are clear, colorless or slightly yellowish, practically free from visible particles, and the lipid emulsion is a homogeneous milky-appearing liquid.

Mixing the solutions and emulsion

Ensure the product is at room temperature when breaking the non-permanent seals.

Manually roll the bag upon itself, starting from the top of the bag (hanger end). The non-permanent seals will disappear from the side near the inlets. Continue rolling until the seals open approximately halfway along their length.

Mix the bag by inverting it at least three times.

The appearance after reconstitution is a homogeneous emulsion resembling milk.

Additions

The bag has sufficient capacity to allow addition of vitamins, electrolytes, and trace elements.

Any additions (including vitamins) must be made to the reconstituted mixture (after breaking the non-permanent seals and mixing the contents of the three compartments).

Vitamins may also be added to the glucose compartment before reconstitution (before breaking the non-permanent seals and mixing the contents of the three compartments).

When making additions to formulations containing electrolytes, the amount of electrolytes already present in the bag must be taken into account.

All additions must be performed by trained personnel under aseptic conditions.

Olimel may be supplemented with electrolytes according to the following table:

Per 1000 ml
	Level included	Maximum additional added	Total maximum level
Sodium	35 mmol	115 mmol	150 mmol
Potassium	30 mmol	120 mmol	150 mmol
Magnesium	4.0 mmol	1.6 mmol	5.6 mmol
Calcium	3.5 mmol	1.5 (0.0(a)) mmol	5.0 (3.5(a)) mmol
Inorganic phosphate	0 mmol	3.0 mmol	3.0 mmol
Organic phosphate	15 mmol(b)	10 mmol	25 mmol(b)

a Value corresponding to the addition of inorganic phosphate

b Including phosphate provided by the lipid emulsion

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 with other additives is available upon request.

When additives are added, the final osmolarity of the mixture must be measured before administration via a peripheral vein.

For adding components:

• Must be performed under aseptic conditions.
• Prepare the injection site of the bag.
• Pierce the injection site and inject the additives using an injection needle or a reconstitution device.
• Mix the contents of the bag and the additives thoroughly.

Preparation of the infusion

Must be performed under aseptic conditions.

Hang the bag.

Remove the plastic protector from the administration outlet.

Firmly insert the spike of the infusion set into the administration outlet.

Table 1: Preparation steps for Olimel administration

1.		2.		3.
Break from the top to open the overpouch.	Remove the front part of the overpouch to access the Olimel bag. Discard the overpouch and the oxygen sachet.	Place the bag on a clean, flat surface with the handle facing you.
4.		5.		6.
Lift the hanger area to remove the solution from the top of the bag. Roll tightly the top of the bag until the seals are fully open (approximately halfway).	Mix the contents by inverting the bag at least three times.	Hang the bag. Rotate the protector to remove it from the administration port. Firmly connect the spike connector.

Administration

For single use only.

Administer the product only after the non-permanent seals between the three compartments have been broken and the contents of the three compartments have been mixed.

Ensure that the final emulsion for infusion shows no phase separation.

After opening the bag, the contents must be used immediately. An opened bag must never be stored for subsequent infusion. Do not reconnect a partially used bag.

Do not connect bags in series to avoid the risk of gas embolism due to residual gas in the first bag.

All unused medicinal product, materials that have been in contact with it, and all necessary devices must be discarded.

Extravasation

The catheter site should be regularly inspected for signs of extravasation.

If extravasation occurs, administration must be stopped immediately, while maintaining the cannula or catheter in place to allow immediate treatment of the patient. If possible, aspiration should be performed through the inserted cannula/catheter to reduce the amount of fluid present in the tissues before removing the cannula/catheter.

Specific measures should be taken depending on the stage or extent of any injury caused by the extravasated product (including the product(s) mixed with Olimel).

Treatment options may include pharmacological, non-pharmacological methods, and/or surgical intervention. In case of significant extravasation, a plastic surgeon should be consulted within the first 72 hours.

The extravasation site should be inspected at least every 4 hours during the first 24 hours, and then once daily.

Infusion must not be resumed in the same central vein.