Multimel N7-1000e

Leaflet accompanying the packaging: information for the user

Multimel N7-1000 E, infusion emulsion

You should read the contents of the leaflet before using the medicine, as it contains important information.

important for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Multimel N7-1000 E and what is it used for
• 2. Important information before taking Multimel N7-1000 E
• 3. How to take Multimel N7-1000 E
• 4. Possible side effects
• 5. How to store Multimel N7-1000 E
• 6. Contents of the packaging and other information

1. What is Multimel N7-1000 E and what is it used for

Multimel N7-1000 E is an infusion emulsion. It is packaged in a three-chamber bag.
The first chamber contains a glucose solution with calcium, the second chamber contains a fat emulsion, and
the third chamber contains an amino acid solution with electrolytes.
Pharmacotherapeutic group: solutions for parenteral nutrition/mixtures.
Multimel N7-1000 E is used for intravenous nutrition in adults and children over 2 years of age, when oral nutrition is not appropriate.
Multimel N7-1000 E should only be administered under medical supervision.

2. Important information before taking Multimel N7-1000 E

When not to use Multimel N7-1000 E:

• in the case of premature infants, infants, and children under 2 years of age;
• if the patient is allergic to eggs, soy, peanut proteins, corn/corn products (see also "Warnings and precautions" below) or any of the other ingredients of Multimel N7-1000 E;
• if the use of certain amino acids causes an abnormal reaction in the patient's body;
• if the patient has a particularly high level of fats in the blood (hyperlipidemia);
• -if the patient has severe hyperglycemia (too high blood sugar levels);
• if the patient's blood has an abnormally high content of any of the electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus).

In each case, the doctor will decide whether to administer the medicine based on factors such as age,
body weight, and the patient's clinical condition, taking into account the results of the tests performed.

Warnings and precautions

Before starting to take Multimel N7-1000 E, you should discuss it with your doctor or
nurse.
Too rapid administration of total parenteral nutrition solutions may result in death.
If unusual symptoms or signs of an allergic reaction occur, such as fever, chills, rash, or difficulty breathing, excessive sweating, nausea, and headache, the infusion should be stopped immediately. The medicine contains soybean oil and egg phosphatides. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins.
Multimel N7-1000 E contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn products (see "When not to use Multimel N7-1000 E" above).
Difficulty breathing may also be a sign of the formation of small particles blocking blood vessels in the lungs (pulmonary vascular embolism). You should tell your doctor or nurse if you experience any difficulty breathing. They will decide what action to take.
The antibiotic ceftriaxone must not be mixed or administered simultaneously with any solution containing calcium and administered intravenously (including Multimel N7-1000 E).
These medicines must not be administered simultaneously, even through different infusion lines or injection sites.
However, Multimel N7-1000 E and ceftriaxone can be administered sequentially, one after the other, if the infusion lines are changed or have been thoroughly flushed with a physiological saline solution between infusions to avoid precipitation (formation of calcium ceftriaxone particles).
The doctor will monitor and control the level of triglycerides (a type of fat found in the blood).
Certain medicines and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis after the insertion of a catheter (intravenous line) into the patient's vein. The doctor will carefully monitor the patient to detect any signs of infection. Patients requiring parenteral nutrition (administration of nutrients through a tube inserted into a vein) may be more susceptible to infection due to their clinical condition. The use of aseptic technique (free from germs) when inserting and maintaining the catheter and when preparing the medicine for nutrition can reduce the risk of infection.
The doctor should be informed:

• about severe kidney disease. The doctor should also be informed if the patient is undergoing dialysis (artificial kidney) or other methods of blood purification;
• about severe liver disease;
• about blood coagulation disorders;
• about adrenal insufficiency (adrenal gland failure). The adrenal glands are triangular glands located on top of the kidneys;
• about heart failure;
• about lung disease;
• about fluid accumulation in the body (overhydration);
• about insufficient fluid in the body (dehydration);
• about untreated high blood sugar levels (diabetes);
• about heart attack or shock caused by sudden heart failure;
• about severe metabolic acidosis (too acidic blood);
• about generalized infection (sepsis);
• about coma.

If the patient is a child, the doctor will carefully check the fluid and/or blood parameters.
During the use of Multimel and similar medicines, the occurrence of a fat overload syndrome has been reported. Reduced or limited ability of the body to eliminate fats contained in Multimel N7-1000 E may cause a "fat overload syndrome" (see section 4 - "Possible side effects").
Do not add any additional components to the bag without first checking their compatibility. This could cause the formation of particles or disruption of the stability of the fat emulsion. This can cause blockage of blood vessels.
If blood sugar levels increase excessively, the doctor should adjust the rate of administration of Multimel N7-1000 E or administer insulin to the patient.
In cases of severe malnutrition requiring intravenous administration of nutrients, it is recommended to start parenteral nutrition slowly and with caution.
Before starting the infusion, any disturbances in the water and electrolyte balance and metabolic disturbances of the patient should be corrected. The doctor will monitor the patient's condition during therapy and may change the dosage or, if necessary, recommend additional nutrients, such as vitamins, electrolytes, and trace elements.
During the administration of the medicine, the doctor will perform clinical and laboratory tests to check the effectiveness and safety of the medicine. If the patient receives the medicine for several weeks, blood tests will be performed regularly. These tests are particularly necessary in the case of certain diseases, such as liver failure, kidney failure, a disease in which amino acids cannot be properly processed by the body, a disease in which the blood has an excessively acidic pH, a disease in which the level of fats and cholesterol is higher than normal, diabetes, anemia, or difficulties with blood clotting.
If during the infusion, pain, burning, stiffness, swelling, or discoloration of the skin at the infusion site or leakage of the infusion occurs, you should tell your doctor or nurse. The administration will be stopped immediately and resumed in a different vein.

Children

If the patient is a child, you should be particularly careful to administer the correct dose.
Additional administration of vitamins and trace elements may be required, depending on the dose used and the duration of administration. Due to the increased susceptibility of children to the risk of infection, increased precautions should also be taken.

Multimel N7-1000E and other medicines

You should tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Multimel N7-1000 E should not be administered simultaneously with blood through the same infusion set.
Multimel N7-1000 E contains calcium. It should not be administered together with the antibiotic ceftriaxone or through the same tube, as particles may form. If the same infusion set is used to administer these medicines to the patient, one after the other, the set must be thoroughly flushed.
The olive oil and soybean oil present in Multimel N7-1000 E contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as coumarin. However, if the patient is taking anticoagulant medicines, they should inform their doctor.
The fats contained in this emulsion may interfere with the results of certain laboratory tests, provided that blood samples were taken before the elimination of fats (fats are usually eliminated after about 5-6 hours after their administration).
Multimel N7-1000 E with electrolytes contains potassium. Particular caution should be exercised in patients taking diuretic medicines, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used in hypertension), or immunosuppressive medicines.
Medicines of this type may cause an increase in potassium levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

3. How to take Multimel N7-1000 E

Multimel N7-1000 E can only be administered to adults and children over 2 years of age.
This is an infusion emulsion administered through a plastic tube exclusively into a large vein in the patient's chest.
Treatment can be continued for as long as necessary, depending on the patient's clinical condition.
Multimel N7-1000 E is intended for single use only.

Dosing - Adults

The dosage is determined by the doctor based on individual needs and the patient's clinical condition.
The maximum daily dose is 33 ml/kg body weight. For example: for a patient weighing 70 kg, the maximum daily dose should not exceed 2310 ml of infusion emulsion (33 ml of infusion emulsion multiplied by 70 kg).

Dosing - Children over 2 years of age

The dose of the medicine used in a child and the duration of administration are determined by the doctor. This depends on the age, body weight, growth, clinical condition, daily fluid volume, and energy and nitrogen requirements.

Overdose of Multimel N7-1000 E

If the patient is administered too high a dose of the medicine or too rapid an infusion, the amino acids contained may contribute to an increase in blood acidity and an increase in fluid volume in the circulatory system. The glucose contained in the medicine may increase blood sugar levels and urine sugar levels, and the fats contained in the emulsion may increase triglyceride levels in the blood. Administration of too large a volume of Multimel N7-1000 E may cause nausea, vomiting, chills, chest pain, headache, irregular or rapid heartbeat, and electrolyte disturbances. In such a situation, the infusion should be stopped immediately.
In some severe cases, to support the patient's kidneys in eliminating the excess medicine, the doctor may use periodic dialysis treatment.
To prevent such situations, the doctor regularly monitors the patient's condition and checks blood parameters.
In case of doubts about the use of the medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any changes in your well-being during treatment or after its completion, you should immediately inform your doctor or nurse.
The tests performed by the doctor during the use of the medicine are intended to minimize the risk of side effects.
If any unusual signs or symptoms of an allergic reaction occur, such as elevated body temperature, chills, rash, or difficulty breathing, excessive sweating, nausea, and headache, the infusion should be stopped immediately.
The following side effects have been reported during the use of Multimel:

• allergic reactions

Frequency: unknown(cannot be determined based on available data)

• bronchospasm (asthma-like symptoms, as part of an allergic reaction)
• tremors
• diarrhea, nausea, vomiting
• unusual redness of the skin (flushing), excessive sweating
• limb pain, muscle cramps
• leakage of the infusion into surrounding tissues (extravasation), which can cause swelling/edema at the infusion site, pain, irritation, and inflammation of the vein, redness/warmth, local tissue loss, tissue necrosis, or blisters
• fever, chills, inflammation
• reduced or limited ability to eliminate fats contained in Multimel N7-1000 E may cause a "fat overload syndrome". This may be the result of overdose, but may also occur at the beginning of the infusion, even when the medicine is administered according to the instructions. This is associated with a sudden worsening of the patient's clinical condition. It is characterized by a high fat content in the blood, fever, liver steatosis (high fat content in the liver), and/or liver enlargement. It may also cause anemia (reduced red blood cell count, which can cause pale skin, weakness, or shortness of breath), reduced white blood cell and platelet count, blood clotting disorders, and/or coma.

The following side effects have been reported for similar medicines:
Frequency: unknown(cannot be determined based on available data)

• formation of small particles, which can lead to blockage of blood vessels in the lungs (pulmonary vascular embolism), causing pulmonary embolism and respiratory failure (respiratory failure)
• decreased platelet count (reduced number of blood cells responsible for blood clotting, causing bleeding, such as nosebleeds)
• difficulty in bile excretion (cholestasis), liver enlargement, jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders)
• hypersensitivity
• increased activity of liver enzymes, increased triglyceride levels in the blood, increased bilirubin levels in the blood
• increased nitrogen levels in the blood (azotemia)

In children, cases of decreased white blood cell and platelet count have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C
PL 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Multimel N7-1000 E

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container and outer packaging. The expiry date refers to the last day of the given month.
Do not freeze.
Store in protective packaging.
Store in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Multimel N7-1000 E contains

Active substances present in each bag of ready-to-use emulsion:

Active substances 1000 ml 1500 ml 2000 ml 2500 ml

Purified olive oil and
purified soybean oil*
100.00 g
L-alanine
8.28 g
12.42 g
16.56 g
20.70 g
L-arginine
4.60 g
6.90 g
9.20 g
11.50 g
Glycine
4.12 g
6.18 g
8.24 g
10.30 g
L-histidine
1.92 g
2.88 g
3.84 g
4.80 g
L-isoleucine
2.40 g
3.60 g
4.80 g
6.00 g
L-leucine
2.92 g
4.38 g
5.84 g
7.30 g
L-lysine
2.32 g
3.48 g
4.64 g
5.80 g
40.00 g
60.00 g
80.00 g
(corresponding to lysine hydrochloride)
(2.90 g)
(4.35 g)
(5.80 g)
(7.25 g)
L-methionine
1.60 g
2.40 g
3.20 g
4.00 g
L-phenylalanine
2.24 g
3.36 g
4.48 g
5.60 g
L-proline
2.72 g
4.08 g
5.44 g
6.80 g
L-serine
2.00 g
3.00 g
4.00 g
5.00 g
L-threonine
1.68 g
2.52 g
3.36 g
4.20 g
L-tryptophan
0.72 g
1.08 g
1.44 g
1.80 g
L-tyrosine
0.16 g
0.24 g
0.32 g
0.40 g
L-valine
2.32 g
3.48 g
4.64 g
5.80 g
Sodium acetate trihydrate
2.45 g
3.67 g
4.90 g
6.12 g
Sodium glycerophosphate pentahydrate
2.14 g
3.22 g
4.29 g
5.36 g
Potassium chloride
1.79 g
2.68 g
3.58 g
4.47 g
Magnesium chloride hexahydrate
0.45 g
0.67 g
0.90 g
1.12 g
Glucose
(corresponding to glucose monohydrate)
400.00 g
(440.00 g)
Calcium chloride dihydrate
0.30 g
0.44 g
0.59 g
0.74 g
Total energy value (kcal)
1200
1800
2400
3000
Non-protein energy value (kcal)
1040
1560
2080
2600
160.00 g
(176.00 g)
240.00 g
(264.00 g)
320.00 g
(352.00 g)
Other ingredients are purified egg phosphatides, glycerol, sodium oleate, sodium hydroxide, acetic acid, hydrochloric acid, and water for injections.

What Multimel N7-1000 E looks like and what the packaging contains

Multimel N7-1000 E is an infusion emulsion supplied in a 3-chamber bag, which is a multi-layer plastic bag. The inner (contact) layer of the bag is made of polymers (a mixture of polyolefin copolymers) and is compatible with the contents of the bag (amino acid solutions, glucose solutions, and fat emulsions) and permitted additives, and allows for the creation of breakable welds. The polymers used to make the coating layer are made of EVA (ethylene-vinyl acetate) and copolyester.
Before mixing the contents of the 3-chamber bag, the first chamber contains a homogeneous liquid with a milky appearance (fat emulsion), while the other two chambers (containing the amino acid solution with electrolytes and the glucose solution with calcium) contain colorless or slightly yellowish solutions, practically without visible particles. After mixing, Multimel N7-1000 E is an infusion emulsion with a uniform milky-white liquid appearance.
The bag is placed in a protective packaging that protects against oxygen, which contains an oxygen-absorbing sachet.

Package sizes

1000 ml bag: 6 bags in a cardboard box
1500 ml bag: 4 bags in a cardboard box
2000 ml bag: 4 bags in a cardboard box
2500 ml bag: 2 bags in a cardboard box
Not all package sizes may be marketed.

Marketing authorization holder:

To obtain information about Multimel N7-1000 E, you should contact the representative of the marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturer:

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

Date of last revision of the leaflet: 06.03.2020

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Information intended exclusively for healthcare professionals:

Multimel N7-1000 E, infusion emulsion

1. QUANTITATIVE COMPOSITION

After mixing the contents of the 3-chamber bag, the mixture has the form of a uniform emulsion with a milky appearance.
The ready-to-use emulsion after mixing contains the following ingredients in bags of different sizes:
** Including phosphates contained in the fat emulsion

2. DOSAGE AND ADMINISTRATION

The dosage is determined based on energy expenditure, the patient's clinical condition, body weight, and the ability to metabolize the components of Multimel N7-1000 E, as well as the energy and protein components additionally administered orally/enterally; therefore, the size of the bag should be chosen accordingly.
Administration can be continued for as long as necessary, depending on the patient's clinical condition.

Do not exceed the maximum daily dose in adults or children and adolescents. Due to the fixed composition of the multi-chamber bag,
it may not be possible to simultaneously meet all the nutritional needs of the patient. There may be a clinical situation in which the patient will require a different amount of nutrients than available in the fixed composition of the bag.
As a general rule, do not exceed a dose of 3 g of amino acids/kg body weight per day and (or) 17 g of glucose/kg body weight per day and (or) 3 g of fat/kg body weight per day and (or) 100 ml of fluid/kg body weight per day, except in special cases.
Multimel is intended for single use only.
The recommended duration of the infusion is from 12 to 24 hours.

Dosing and infusion rate - Adults

The average nitrogen requirement is from 0.16 to 0.35 g/kg body weight per day (about 1 to 2 g of amino acids/kg body weight per day).
Energy requirements vary depending on the patient's nutritional status and level of catabolism. On average, it is from 20 to 40 kcal/kg body weight per day.
Maximum daily dose:
For Multimel N7-1000 E:The maximum daily dose depends on the energy value of the components of the product. The maximum daily dose is 33 ml/kg body weight (corresponding to 1.32 g of amino acids, 5.28 g of glucose, 1.32 g of fat, 1.06 mmol of sodium, and 0.79 mmol of potassium/kg body weight), i.e. 2310 ml of infusion emulsion for a patient weighing 70 kg.
Maximum infusion rate
As a general rule, do not exceed an infusion rate of 0.10 g of amino acids/kg body weight per hour and (or) 0.25 g of glucose/kg body weight per hour and (or) 0.15 g of fat/kg body weight per hour, except in special cases.
For Multimel N7-1000 E:As a general rule, do not exceed an infusion rate of 1.5 ml/kg body weight per hour, i.e. 0.06 g of amino acids, 0.24 g of glucose, and 0.06 g of fat/kg body weight per hour.

Dosing and infusion rate - Children over 2 years of age and adolescents

No studies have been conducted in children and adolescents.
Dosing is determined based on fluid intake and daily nitrogen requirements.
The intake should be adjusted taking into account the child's hydration status.
Daily fluid, nitrogen, and energy requirements constantly decrease with age.
Guidelines for the maximum recommended infusion rate per hour and volume per day for children and adolescents are:

Multimel N7-1000 E:

Maximum daily dose:

Maximum infusion rate per hour

Route of administration

Multimel N7-1000 E should be administered intravenously through a central vein.
The infusion rate should be adjusted according to the dose administered, the characteristics of the final mixture, the total volume to be administered in 24 hours, and the duration of the infusion.

3. SPECIAL WARNINGS AND PRECAUTIONS FOR USE

4. PRACTICAL INFORMATION ON PREPARATION FOR

ADMINISTRATION OF THE MEDICINAL PRODUCT AND DISPOSAL OF ITS

RESIDUES

Multimel N7-1000 E should only be used if:

• the bag is not damaged
• the welds are not damaged
• the amino acid and glucose solutions are clear, colorless, or slightly yellow, and practically do not contain visible particles
• the fat emulsion is a homogeneous liquid with a milky appearance.

Before use, the Multimel N7-1000 E product should be brought to room temperature.
Administration should only be performed after breaking the welds separating the 3 compartments of the bag and mixing the contents of the 3 compartments, as shown below.
It should be ensured that the ready-to-use infusion emulsion does not show signs of phase separation.

1. 2. 3.

Tear the protective packaging
from the top.
Remove the front part of the
protective packaging to expose
the Multimel N7-1000 E bag. Discard
the protective packaging and the
oxygen absorber.
Place the bag on a flat, horizontal,
and clean surface with the
handle facing upwards.

4. 5. 6.

Lift the bag by the handle to
remove the liquid from the top
part of the bag.
Firmly roll the bag with both
hands, starting from the top of
the bag, until the welds are broken
(approximately halfway through
their length).
Mix the contents of the bag by
rotating it at least 3 times.
Ensure that the mixture is homogeneous and that phase separation does not occur.
Suspend the bag. Remove the
plastic cover from the injection site
of the infusion set.
Insert the infusion set needle
firmly into it.
After opening the bag, the contents should be used immediately. The opened bag should not be stored for subsequent infusions.
Partially used bags should not be reconnected.
Bags should not be connected in series to avoid air embolisms caused by residual gas in the first bag.
For single use only. Any unused product or waste and the entire infusion set should be disposed of.
Partially used bags should not be stored and all components of the set should be discarded after use.

Additional components

Other medicinal products or substances should not be added to any of the bag compartments or to the ready-to-use emulsion without first checking their compatibility and stability of the resulting mixture (in particular, the stability of the fat emulsion).
Multimel N7-1000 E may be used without introducing additional components or, if necessary, after adding electrolytes, trace elements, or vitamins.
The bag capacity is sufficient to allow the introduction of additional components, such as vitamins, electrolytes, and trace elements. All additional components (including vitamins) can be introduced into the ready-to-use emulsion (after breaking the welds and mixing the contents of the 3 compartments).
Vitamins can also be added to the glucose solution compartment before preparing the ready-to-use emulsion (before breaking the welds and mixing the solutions and emulsions).
When introducing additional components to the product, the final osmolality of the mixture should be measured before administration to a peripheral vein.
The following can be added to Multimel N7-1000 E:

• electrolytes: the amount of electrolytes already present in the bag should be taken into account; the stability of the mixture containing up to 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium, and 5 mmol of calcium per liter of the three-component mixture has been demonstrated;
• organic phosphates: the stability of the mixture containing up to 15 mmol of added phosphates per bag has been demonstrated.

Trace elements and vitamins: stability has been demonstrated after the addition of commercially available vitamin and trace element products (containing up to 1 mg of iron). Compatibility with other additional components is available upon request.
Additional components must be introduced by qualified personnel under aseptic conditions.
Additional components are introduced through the injection site using a needle:

• prepare the injection site;
• insert the needle into the injection site and inject;
• mix the contents of the bag with the added components.

Interactions with other medicinal products

No interaction studies have been performed with Multimel.
Multimel N7-1000 E contains vitamin K, naturally present in fat emulsions. The amount of vitamin K in the recommended doses of Multimel N7-1000 E should not affect the action of coumarin derivatives.
Ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium, including Multimel N7-1000 E, through the same infusion line due to the risk of precipitation of ceftriaxone calcium salts.
Ceftriaxone and calcium-containing solutions may be administered sequentially, one after the other, if infusion lines are used at different sites or if the infusion lines are replaced or thoroughly flushed between infusions with a physiological saline solution to avoid the formation of precipitates.
Due to the potassium content in Multimel N7-1000 E, caution should be exercised when using it in patients treated with potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene), ACE inhibitors, angiotensin II receptor antagonists, or immunosuppressive agents: tacrolimus and cyclosporin, due to the risk of hyperkalemia.
The fats contained in this emulsion may interfere with the results of certain laboratory tests (e.g., bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin), provided that blood samples were taken before the elimination of fats (fats are usually eliminated after about 5-6 hours after discontinuation of their administration).

Incompatibilities

This emulsion for infusion should not be administered simultaneously with blood through the same infusion set.
Multimel N7-1000 E contains calcium ions, which pose an additional risk of coagulation and precipitate formation in citrate-anticoagulated/preserved blood or blood components.
The cause of incompatibility may be, for example, excessive acidity (low pH) or inappropriate content of divalent cations (Ca and Mg), which may adversely affect the stability of the fat emulsion.
As with any parenteral nutrition mixture, the content of calcium and phosphorus should be considered. Excessive addition of calcium or phosphorus, especially in the form of mineral salts, may lead to the formation of calcium phosphate precipitates.
The compatibility of the product with solutions administered simultaneously through the same infusion set, catheter, or cannula should be checked.
Ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium, including Multimel N7-1000 E, through the same infusion line (e.g., a Y-connector), due to the risk of precipitation of ceftriaxone calcium salts (see section "Interactions").

5. SHELF LIFE

2 years, if the protective packaging is not damaged.
The product should be used immediately after opening the welds separating the contents of the 3 compartments. However, it has been demonstrated that the ready-to-use emulsion remains stable for 7 days at a temperature of +2 °C to +8 °C and then for an additional 48 hours at a temperature not exceeding +25 °C.
After introducing additional components (electrolytes, trace elements, vitamins) the ready-to-use Multimel N7-1000 E emulsion (see previous section) remains chemically and physically stable for 7 days at a temperature of 2 °C to 8 °C and then for an additional 48 hours at a temperature below 25 °C. From a microbiological point of view, any ready-to-use mixture containing additional components should be used immediately. Otherwise, the user is responsible for the time and conditions of storage of the mixture until use. However, such a mixture should not be stored for more than 24 hours at 2-8 °C, unless the introduction of additional components was performed under controlled and validated aseptic conditions.