Numeta g13% e preterm

Patient Information Leaflet

NUMETA G13%E Preterm, emulsion for infusion
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your child's doctor, pharmacist, or nurse.
• If your child experiences any adverse reactions, including any not listed in this leaflet, inform the attending doctor or nurse immediately. See section 4.

Table of contents

1. What NUMETA G13%E Preterm is and what it is used for
2. Important information before your child is given NUMETA G13%E Preterm
3. How to use NUMETA G13%E Preterm
4. Possible side effects
5. How to store NUMETA G13%E Preterm
6. Contents of the pack and other information

1. What NUMETA G13%E Preterm is and what it is used for

NUMETA G13%E Preterm is a specialized emulsion for parenteral nutrition intended for preterm newborns. It is administered via a catheter inserted into the child's vein when the child cannot receive all necessary nutrients orally.

NUMETA is supplied as a three-compartment bag, with each compartment containing:

• 50% glucose solution;
• 5.9% pediatric amino acid solution with electrolytes;
• 12.5% fat emulsion.

Depending on the child's needs, two or three of these solutions are mixed within the bag prior to administration.

NUMETA G13%E Preterm must only be used under medical supervision.

2. Important Information Before Administering NUMETA G13%E Preterm to a Child

When NUMETA G13%E Preterm Should Not Be Given to a Child:
For glucose and amino acid solutions with electrolytes mixed in the bag ("2 in 1"):

• if the child is allergic to eggs, soy, peanuts, or any of the other components of this medicine or to components of the container (listed in section 6);
• if the child’s body cannot utilize protein building blocks;
• if the child has high blood levels of any of the electrolytes present in NUMETA G13%E Preterm;
• NUMETA G13%E Preterm (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even using separate infusion lines. There is a risk of forming particles in the newborn's circulation, which may lead to death;
• if the child has hyperglycemia (especially high blood sugar levels).

For glucose, amino acid solutions with electrolytes and fat emulsion mixed in the bag ("3 in 1"):
In all the above-mentioned situations for the "2 in 1" solution, and additionally:

• if the child has particularly high levels of fats in the blood.

In all cases, the decision to administer NUMETA G13%E Preterm will be made by the physician, taking into account the child’s age, body weight, and clinical condition. The physician will also consider the results of all performed tests.

Warnings and Precautions

Before starting administration of NUMETA G13%E Preterm, discuss this with the attending physician or nurse.

When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from light until administration is complete. Exposure of NUMETA G13%E Preterm to ambient light, especially after mixing with trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by light protection.

Allergic Reactions:

Infusion must be stopped immediately if any signs or symptoms of an allergic reaction occur (such as fever, sweating, chills, headache, skin rash, or difficulty breathing). This medicine contains soy oil, which may rarely cause hypersensitivity reactions. In some individuals allergic to peanut proteins, allergy to soy proteins has also been rarely observed.

NUMETA G13%E Preterm contains glucose derived from corn starch. Therefore, NUMETA G13%E Preterm should be used with caution in patients diagnosed with allergy to corn or products containing corn.

Risk of precipitate formation with ceftriaxone (antibiotic):

Ceftriaxone must not be mixed or administered simultaneously with any calcium-containing solutions (including NUMETA G13%E Preterm) via intravenous infusion. The physician is aware of this and will not administer them simultaneously, even through different infusion lines or at different infusion sites.

Formation of small particles in pulmonary blood vessels:

Breathing difficulties may also indicate the formation of small particles blocking blood vessels in the lungs (pulmonary vascular precipitates). If the child develops any breathing difficulties, inform the physician or nurse immediately. They will decide on appropriate actions.

Infection and sepsis:

The physician will closely monitor the child for signs of infection. Adherence to aseptic techniques (procedures protecting against microorganisms) during catheter insertion and maintenance, and during preparation of the nutritional mixture, may reduce the risk of infection.

Sometimes, when a tube (intravenous catheter) is placed in a vein, the child may develop infection and sepsis (presence of bacteria in the blood). Certain medications and diseases may increase the risk of infection or sepsis. Patients requiring parenteral nutrition (nutrient delivery via a tube placed in a vein) may be at higher risk of infection due to their underlying health condition.

Fat overload syndrome:

Fat overload syndrome has been reported during use of similar medications. Reduced or limited ability of the body to eliminate fats contained in NUMETA G13%E Preterm, or overdose, may result in so-called fat overload syndrome (see sections 3 and 4).

Changes in blood chemical composition:

The physician will monitor and track the child’s fluid status, blood chemistry, and levels of other substances during treatment with NUMETA G13%E Preterm. Sometimes, feeding severely malnourished individuals may cause significant changes in blood chemistry, which may require correction. Additional fluid accumulation in tissues and swelling (edema) may also occur. Slow and cautious initiation of parenteral nutrition is recommended.

Monitoring and Adjustment:

The physician will closely monitor and adjust the administration of NUMETA G13%E Preterm according to the child’s individual needs, especially in the following conditions:

• pulmonary edema (fluid in the lungs) or heart failure;
• severe liver dysfunction;
• disorders affecting normal nutrient absorption;
• high blood sugar levels;
• kidney problems;
• severe metabolic disorders (when metabolic processes do not function normally);
• blood coagulation disorders.

The child’s fluid status, liver function test results, and/or other blood test results will be carefully evaluated.

Information on the use of this medicine in preterm infants born before 28 weeks of gestation is limited.

Interaction of NUMETA G13%E Preterm with Other Medicines

Inform the physician about all medicines currently or recently used by the child, as well as any medicines planned for future use.

NUMETA G13%E Preterm must not be administered at the same time as:

• ceftriaxone (antibiotic), even via separate infusion lines, due to the risk of solid particle formation;
• blood through the same infusion set, due to the risk of pseudoagglutination (clumping of red blood cells);
• ampicillin, fosphenytoin, or furosemide through the same infusion line, due to the risk of solid particle formation.

Coumarin and warfarin (anticoagulants):

The physician will closely monitor the child if coumarin or warfarin is being used. These are anticoagulant drugs used to prevent blood clotting. Vitamin K1 is a natural component of olive oil and soy oil. Vitamin K1 may interact with drugs such as coumarin and warfarin.

Laboratory Tests:

The lipids contained in this emulsion may affect the results of certain laboratory tests. Laboratory tests should be performed at least 5 to 6 hours after lipid administration or after the last dose.

Drug Interactions with NUMETA G13%E Preterm Affecting Potassium Levels/Metabolism:

NUMETA G13%E Preterm contains potassium. High blood potassium levels may cause abnormal heart rhythms. Special care should be taken in patients receiving diuretics (medications intended to reduce fluid retention), ACE inhibitors (used for high blood pressure), angiotensin II receptor antagonists (used for high blood pressure), or immunosuppressive drugs (medications that may reduce the body’s normal immune response). These types of medications may increase potassium levels.

3. How to use the medicine NUMETA G13%E Preterm

The medicine NUMETA G13%E Preterm should always be administered to the child according to the doctor's instructions.
If in doubt, consult the doctor.
Age group
The medicine NUMETA G13%E Preterm has been designed to meet the nutritional needs of
prematurely born newborns.
The medicine NUMETA G13%E Preterm may not be suitable for some preterm infants, as their condition
may require an individually tailored composition to meet their specific nutritional needs. The doctor will decide whether this medicine is appropriate for the child.
Administration
This medicine is an infusion emulsion. It is administered through a plastic tube into a vein in the arm or into a large vein in the child's chest.
The doctor may decide not to administer lipids to the child. The NUMETA G13%E Preterm bag is
designed so that, if necessary, only the partition between the chamber containing amino acids/electrolytes and the chamber containing glucose can be broken. In such a case, the partition between the amino acid chamber and the lipid chamber remains intact. Thus, the contents of the bag can be administered without lipids.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light until the end of administration (see section 2).
Dosage and duration of treatment
The doctor will determine the dose of the medicine and how long it will be administered. The dose depends on the child's nutritional needs. The dose will be established based on the child's body weight, clinical condition, and the body's ability to metabolize and utilize the components of NUMETA G13%E Preterm.
Additional nutritional components or proteins may also be administered orally/enterally.
Accidental administration of a higher than recommended dose of NUMETA G13%E Preterm
Symptoms
An overdose of the medicine or too rapid administration may cause:

• nausea;
• vomiting;
• seizures;
• electrolyte disturbances (abnormal levels of electrolytes in the blood);
• symptoms of hypervolemia (increased circulating blood volume, excess fluid in blood vessels);
• acidosis (increased blood acidity). In such situations, the infusion should be stopped immediately. The doctor will decide whether further actions are required.

Overdose of the fats contained in NUMETA G13%E Preterm may lead to the occurrence of a "fat overload syndrome," which usually resolves after stopping the infusion. In newborns (infants) and young children (children under 2 years of age), fat overload syndrome has been associated with respiratory disturbances leading to reduced oxygen levels in the body (respiratory failure) and conditions leading to increased blood acidity (acidosis).
To prevent such situations, the doctor will systematically monitor the child's condition and perform blood tests during treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not every child will experience them.
If you notice any changes in your child's health during or after treatment, you should immediately inform the doctor or nurse.
Medical examinations performed by the physician while your child is receiving this medicine should minimize the risk of adverse effects.
If symptoms of an allergic reaction occur, the infusion must be stopped immediately and medical advice must be sought urgently. This may be serious, and symptoms may include:

• sweating
• chills
• headache
• skin rash
• difficulty breathing

Other observed adverse effects:
Common: may affect up to 1 in 10 people

• Low levels of phosphate in the blood (hypophosphatemia)
• High blood sugar levels (hyperglycemia)
• High levels of calcium in the blood (hypercalcemia)
• High levels of triglycerides in the blood (hypertriglyceridemia)
• Electrolyte disturbances (hyponatremia)

Uncommon: may affect up to 1 in 100 people

• High levels of lipids in the blood (hyperlipidemia)
• Condition in which bile cannot flow from the liver to the duodenum (cholestasis). The duodenum is part of the intestine.

Unknown frequency: frequency cannot be estimated from available data (These adverse effects have been reported only after peripheral administration of NUMETA G13%E Preterm and NUMETA G16%E with insufficient dilution.)

• Skin necrosis
• Soft tissue damage
• Extravasation

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

• Reduced or limited ability to clear lipids contained in NUMETA may lead to fat overload syndrome. The following signs and symptoms of this syndrome usually resolve after discontinuation of the fat emulsion infusion:
• Sudden and acute deterioration in the patient's clinical condition
• High levels of fat in the blood (hyperlipidemia)
• Fever
• Fatty infiltration of the liver (hepatomegalia)
• Worsening liver function
• Decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anemia)
• Decreased number of white blood cells, which may increase the risk of infection (leukopenia)
• Decreased number of platelets, which may increase the risk of bruising and/or bleeding (thrombocytopenia)
• Blood coagulation disorders affecting the blood's ability to form clots
• Respiratory disturbances leading to reduced oxygen levels in the body (respiratory failure)
• Conditions leading to increased blood acidity (acidosis)
• Coma requiring hospitalization
• Formation of small particles that may cause blockage of blood vessels in the lungs (pulmonary vessel deposits) or difficulty breathing.

Reporting adverse effects
If your child experiences any adverse effects, you should contact the doctor or nurse.
This also applies to any adverse effects not listed in this leaflet.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. 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
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 the medicine NUMETA G13%E Preterm

The medicine should be stored out of sight and reach of children when not in use.
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light until administration is complete (see section 2).
Do not use this medicine after the expiry date stated on the bag and outer packaging (MM/YYYY). The expiry date refers to the last day of the stated month.
Do not freeze.
Store in the protective bag.
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 pack and other information

What NUMETA G13%E Preterm looks like and contents of the pack
NUMETA G13%E Preterm is supplied in a three-compartment bag. The contents of each bag are sterile and consist of a glucose solution, an amino acid solution for paediatric use with electrolytes, and a lipid emulsion, as described below.

Container size	50% glucose solution	5.9% amino acid solution with electrolytes	12.5% fat emulsion
300 ml	80 ml	160 ml	60 ml

Appearance prior to preparation:

• Solutions in the chambers containing amino acids and glucose are clear, colourless or slightly yellow
• The lipid emulsion is a uniform, milky white liquid

Appearance after preparation:

• "2-in-1" infusion solutions (amino acids/electrolytes and glucose) are clear, colourless or slightly yellow
• The "3-in-1" infusion emulsion is uniform and milky white

The triple-chamber bag is a multilayer plastic bag.

To protect against exposure to air, the NUMETA G13%E Preterm bag is enclosed in a protective bag that prevents oxygen penetration and contains an oxygen absorber and an oxygen indicator.

Pack sizes
300 ml bags: 10 bags in a cardboard box
1 bag of 300 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
Manufacturer
Baxter S.A.
Boulevard René Branquart 80
7860 Lessines
Belgium

This medicinal product is authorised in the European Economic Area member states under the following names:

Country	Name
Austria Germany	Numeta G 13 % E Emulsion zur Infusion
Belgium Luxembourg	NUMETZAH G13%E, émulsion pour perfusion
France	NUMETAH G13%E PREMATURES, emulsion pour perfusion
Denmark Norway Sweden	Numeta G13E
Czech Republic	NUMETA G 13 % E
Greece	NUMETA Preterm G 13 E
Netherlands	NUMETA G13%E emulsie voor infusie
Ireland Malta United Kingdom	Numeta G13%E Preterm, Emulsion for Infusion
Italy	NUMETA G13E emulsione per infusione
Finland	Numeta G13E infuusioneste, emulsio
Poland	NUMETA G13%E Preterm
Portugal	Numeta G13%E
Spain	NUMETA G13%E, emulsión para perfusión

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Information intended exclusively for healthcare professionals or medical personnel*
*In some cases, this medicine may be administered at home by parents or other caregivers.
In such cases, parents/caregivers should read the information below.
Do not introduce additional components into the bag without first checking compatibility.
This could lead to formation of particulate matter or destabilization of the fat emulsion, which
may result in vascular occlusion.
The NUMETA G13%E Preterm medicine should reach room temperature before use.
Before administering NUMETA G13%E Preterm, prepare the bag as shown below.
Ensure that the bag is undamaged. The bag may only be used if it is intact. Below are the characteristics of an undamaged bag:

• Compartments are intact, indicated by the absence of mixing between the contents of any of the three chambers.
• The solutions containing amino acids and glucose are clear, colorless or slightly yellow, and free from visible particles.
• The fat emulsion is a uniform milky white liquid.

Before removing the protective overpouch, check the color of the oxygen indicator.

• Compare it with the reference color printed next to the OK symbol and shown in the printed area of the indicator label.
• Do not use the medicine if the color of the oxygen indicator does not match the reference color printed next to the OK symbol. Figures 1 and 2 illustrate how to remove the protective overpouch. Discard the protective overpouch, oxygen indicator, and oxygen absorber.

Figure 1 Figure 2
Preparation of the mixed emulsion:

• Before breaking the seals, ensure the medicine has reached room temperature.
• Place the bag on a flat, clean surface.

Activation of the three-chamber bag (mixing 3 solutions by opening two peelable seals)
Step 1: Begin rolling the bag from the side with the hanger.

Step 2: Press until the seals open.

PRESS
Step 3: Change direction by rolling the bag toward the hanger.
Continue until the seal is fully opened.
Repeat the same procedure to completely open the second seal.

PRESS

Step 4: Rotate the bag at least three times to thoroughly mix the contents.
The mixed solution should appear as a milky white emulsion.

Step 5: Remove the protective cap from the medication administration port and insert the intravenous administration set.

Activation of the two-chamber bag (mixing 2 solutions by opening the peelable seal between
the chambers containing amino acids and glucose)
Step 1: To mix only 2 solutions, roll the bag starting from the upper corner (with the hanger) adjacent to the seal separating the solutions.
Press to open the seal separating the glucose and amino acid compartments.

PRESS
Step 2: Position the bag so that the fat emulsion chamber is closest to the user.
Roll the bag while protecting the fat emulsion chamber with your hands.

Step 3: Press with one hand and roll the bag toward the tubing end.

PRESS

Step 4: Change direction by rolling the bag toward the upper end (with the hanger).
Press with the other hand until the seal separating the amino acid and glucose solutions is completely broken.

PRESS

Step 5: Rotate the bag at least three times to thoroughly mix the contents.
The mixed solution should be clear, colorless or slightly yellow.

Step 6: Remove the protective cap from the medication administration port and insert the intravenous administration set.

During the first hour, the infusion rate should be gradually increased. The infusion rate must be adjusted based on the following factors:

• dose administered;
• total daily volume administered;
• duration of infusion.

Method of administration:
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from light until the end of administration.
A 1.2-micron filter is recommended for administration of NUMETA G13%E Preterm.
Due to its high osmolarity, undiluted NUMETA G13%E Preterm must be administered only through a central vein.
Appropriate dilution of NUMETA G13%E Preterm with water for injections reduces osmolarity and allows infusion into a peripheral vessel. The formula below illustrates the effect of dilution on the osmolarity of the medicine.

The table below provides examples of osmolarity of the activated two-chamber bag and the activated three-chamber bag after addition of water for injections:

	Amino acids and glucose (activated W2K)	Amino acids, glucose and lipids (activated W3K)
Initial volume in bag (ml)	240	300
Initial osmolarity (mOsm/l approximately)	1400	1150
Volume of added water (ml)	240	300
Final volume after addition (ml)	480	600
Osmolarity after addition (mOsm/l approximately)	700	575

Addition of additional components:
Exposure of parenteral nutrition solutions to light, especially after mixing with trace elements and/or vitamins, may have an adverse effect on clinical outcomes in neonates due to the formation of peroxides and other degradation products. When used in neonates and children below 2 years of age, NUMETA G13%E Preterm must be protected from exposure to ambient light until the end of administration.
Compatible additional components may be added to the reconstituted mixture via the injection site (after opening the breakable seals and mixing the contents of two or three compartments). Vitamins may also be added to the glucose compartment prior to reconstitution (before opening the breakable seals and mixing the solutions and emulsion).
Possible additions of ready-to-use trace element solutions (identified as TE1 and TE4), vitamins (identified as lyophilisate V1 and emulsion V2), and electrolytes in specified quantities are presented in Tables 1–4.

1. 1. Compatibility with TE4, V1 and V2

Table 1: 3-in-1 compatibility (activated W3K) with and without dilution with water

For 300 ml (after mixing 3 compartments, with lipids)
	Addition without dilution			Addition with dilution
Additional components	Contained amount	Maximum added amount	Maximum total amount	Contained amount	Maximum added amount	Maximum total amount
Sodium (mmol)	6.6	5.0	11.6	6.6	5.0	11.6
Potassium (mmol)	6.2	4.2	10.4	6.2	4.2	10.4
Magnesium (mmol)	0.47	0.83	1.3	0.47	0.83	1.3
Calcium (mmol)	3.8	3.5	7.3	3.8	3.5	7.3
Phosphates* (mmol)	3.8	2.5	6.3	3.8	2.5	6.3
Trace elements and vitamins		15 ml TE4 + 1.5 vials V1 + 25 ml V2	15 ml TE4 + 1.5 vials V1 + 25 ml V2		15 ml TE4 + 1.5 vials V1 + 25 ml V2	15 ml TE4 + 1.5 vials V1 + 25 ml V2
Water for injection					300 ml	300 ml

Table 2: Compatibility of 2-in-1 (activated W2K) with dilution in water and without dilution

For 240 ml (after mixing 2 chambers, without lipids)
	Addition without dilution			Addition with dilution
Additional components	Contained amount	Maximum added amount	Maximum total amount	Contained amount	Maximum added amount	Maximum total amount
Sodium (mmol)	6.4	17.6	24	6.4	0.0	6.4
Potassium (mmol)	6.2	17.8	24	6.2	0.0	6.2
Magnesium (mmol)	0.47	2.13	2.6	0.47	0.0	0.47
Calcium (mmol)	3.8	3.5	7.3	3.8	0.0	3.8
Phosphates* (mmol)	3.2	4.0	7.2	3.2	0.0	3.2
Trace elements and vitamins		2.5 ml TE4 + ¼ vial V1	2.5 ml TE4 + ¼ vial V1		2.5 ml TE4 + ¼ vial V1	2.5 ml TE4 + ¼ vial V1
Water for injections					240 ml	240 ml

1. 2. Compatibility with TE1, V1 and V2 Table 3: 3-in-1 compatibility (activated W3K) with and without dilution in water

For 300 ml (after mixing 3 compartments, with lipids)
	Addition without dilution			Addition with dilution
Additional components	Contained amount	Maximum added amount	Maximum total amount	Contained amount	Maximum added amount	Maximum total amount
Sodium (mmol)	6.6	5.0	11.6	6.6	0.0	6.6
Potassium (mm0l)	6.2	4.2	10.4	6.2	0.0	6.2
Magnesium (mmol)	0.47	0.83	1.3	0.47	0.0	0.47
Calcium (mmol)	3.8	1.9	5.7	3.8	0.0	3.8
Phosphates* (mmol)	3.8	2.5	6.3	3.8	0.0	3.8
Trace elements and vitamins		2.5 ml TE1 + ¼ vial V1 + 2.5 ml V2	2.5 ml TE1 + ¼ vial V1 + 2.5 ml V2		2.5 ml TE1 + ¼ vial V1 + 2.5 ml V2	2.5 ml TE1 + ¼ vial V1 + 2.5 ml V2
Water for injections					300 ml	300 ml

Table 4: Compatibility of 2-in-1 (activated W2K) with dilution in water and without dilution

For 240 ml (after mixing 2 compartments, without lipids)
	Addition without dilution			Addition with dilution
Additional components	Contained amount	Maximum added amount	Maximum total amount	Contained amount	Maximum added amount	Maximum total amount
Sodium (mmol)	6.4	17.6	24	6.4	0.0	6.4
Potassium (mmol)	6.2	17.8	24	6.2	0.0	6.2
Magnesium (mmol)	0.47	2.13	2.6	0.47	0.0	0.47
Calcium (mmol)	3.8	3.5	7.3	3.8	0.0	3.8
Phosphates* (mmol)	3.2	4.0	7.2	3.2	0.0	3.2
Trace elements and vitamins		2.5 ml TE1 + ¼ vial V1	2.5 ml TE1 + ¼ vial V1		2.5 ml TE1 + ¼ vial V1	2.5 ml TE1 + ¼ vial V1
Water for injections					240 ml	240 ml

The composition of preparations containing vitamins and trace elements is presented in Tables 5 and 6.
Table 5: Composition of the ready-to-use trace elements preparation used:

Composition per vial	TE1 (10 ml)	TE4 (10 ml)
Zinc	38.2 µmol or 2.5 mg	15.3 µmol or 1 mg
Selenium	0.253 µmol or 0.02 mg	0.253 µmol or 0.02 mg
Copper	3.15 µmol or 0.2 mg	3.15 µmol or 0.2 mg
Iodine	0.0788 µmol or 0.01 mg	0.079 µmol or 0.01 mg
Fluoride	30 µmol or 0.57 mg
Manganese	0.182 µmol or 0.01 mg	0.091 µmol or 0.005 mg

Table 6: Composition of the ready-to-use vitamin preparation used:

Composition per vial	V1	V2
Vitamin B1	2.5 mg
Vitamin B2	3.6 mg
Nicotinamide	40 mg
Vitamin B6	4.0 mg
Pantothenic acid	15.0 mg
Biotin	60 µg
Folic acid	400 µg
Vitamin B12	5.0 µg
Vitamin C	100 mg
Vitamin A		2300 IU
Vitamin D		400 IU
Vitamin E		7 IU
Vitamin K		200 µg

Adding additional components:

• Aseptic conditions must be maintained.
• Prepare the injection site on the bag.
• Puncture the injection site and add the additional components using an injection needle or a drug preparation device.
• Mix the bag contents thoroughly with the added components.

Preparation of infusion:

• Aseptic conditions must be maintained.
• Hang the bag.
• Remove the plastic protector from the medication administration port.
• Firmly insert the infusion set spike into the medication administration port.

Administration of infusion:

• For single use only.
• Administer the medicinal product only after breaking the seals between two or three chambers and mixing the contents of two or three chambers.
• Ensure that the final emulsion from the activated three-chamber infusion bag shows no phase separation, or that the final solution from the two-chamber infusion bag contains no solid particles.
• Immediate use after opening the peelable seals is recommended. NUMETA G13%E Preterm must not be stored for subsequent infusion.
• Do not connect partially used bags.
• To avoid air embolism caused by residual air in the first bag, do not connect bags in series.
• A 1.2 micron filter is recommended for administration of NUMETA G13%E Preterm.
• When used in neonates and children under 2 years of age, protect from light until the end of administration. Exposure of NUMETA G13%E Preterm to ambient light, especially after mixing with trace elements and (or) vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by protecting from light.
• Any unused medicinal product residues, waste, and all required single-use administration sets should be disposed of properly.

Shelf life after mixing solutions
The medicinal product should be used immediately after opening the peelable seals between two or three chambers.
Stability studies of the mixtures have been conducted for 7 days at a temperature of 2°C to 8°C, followed by 48 hours at 30°C.

Shelf life after adding additional components (electrolytes, trace elements, vitamins, water)
For certain additional components, physical stability of NUMETA has been demonstrated for 7 days at a temperature of 2°C to 8°C, followed by 48 hours at 30°C.
Information regarding these additional components is provided in section 6.6 of the Summary of Product Characteristics.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user, but must not exceed 24 hours at a temperature of 2°C to 8°C, unless the preparation/dissolution/addition of components was carried out under controlled and validated aseptic conditions.

Do not use NUMETA G13%E Preterm if the bag is damaged. The following are signs of a damaged bag:

• Peelable seals are open
• Any of the chambers already contains a mixture of solutions
• Solutions containing amino acids and glucose are not clear, colorless or slightly yellow, and (or) contain visible particles
• The fat emulsion is not a uniform milky white liquid.

Medicinal products must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

What NUMETA G13%E Preterm contains
Active substances:

Active substance	Activated W2K (240 ml)	Activated W3K (300 ml)
Amino acid chamber
Alanine	0.75 g	0.75 g
Arginine	0.78 g	0.78 g
Aspartic acid	0.56 g	0.56 g
Cysteine	0.18 g	0.18 g
Glutamic acid	0.93 g	0.93 g
Glycine	0.37 g	0.37 g
Histidine	0.35 g	0.35 g
Isoleucine	0.62 g	0.62 g
Leucine	0.93 g	0.93 g
Lysine monohydrate (equivalent to lysine)	1.15 g (1.03 g)	1.15 g (1.03 g)
Methionine	0.22 g	0.22 g
Ornithine hydrochloride (equivalent to ornithine)	0.30 g (0.23 g)	0.30 g (0.23 g)
Phenylalanine	0.39 g	0.39 g
Proline	0.28 g	0.28 g
Serine	0.37 g	0.37 g
Taurine	0.06 g	0.06 g
Threonine	0.35 g	0.35 g
Tryptophan	0.19 g	0.19 g
Tyrosine	0.07 g	0.07 g
Valine	0.71 g	0.71 g
Potassium acetate	0.61 g	0.61 g
Calcium chloride dihydrate	0.55 g	0.55 g
Magnesium acetate tetrahydrate	0.10 g	0.10 g
Sodium glycerophosphate hydrate	0.98 g	0.98 g
Glucose chamber
Glucose monohydrate (equivalent to anhydrous glucose)	44.00 g (40.00 g)	44.00 g (40.00 g)
Lipid chamber
Refined olive oil (approx. 80%) + refined soybean oil (approx. 20%)		7.5 g

The solution/emulsion after mixing contains the following ingredients:

Composition
	Activated W2K		Activated W3K
Per unit volume (ml) Nitrogen (g) Amino acids (g) Glucose (g) Lipids (g) Energy value Total energy value (kcal)	240 1.4 9.4 40.0 0 198	100 0.59 3.9 16.7 0 82	300 1.4 9.4 40.0 7.5 273	100 0.47 3.1 13.3 2.5 91
Non-protein energy value (kcal) Glucose energy value (kcal) Lipid energy value (kcal) Non-protein energy value/nitrogen (kcal/g N) Lipid energy value/non-protein energy value (%) Lipid energy value/total energy value (%) Electrolytes Sodium (mmol) Potassium (mmol) Magnesium (mmol) Calcium (mmol) Phosphatesb (mmol) Acetate (mmol) Malate (mmol) Chloride (mmol)	160 160 0 113 Not applicable Not applicable 6.4 6.2 0.47 3.8 3.2 7.2 3.2 9.3	67 67 0 113 Not applicable Not applicable 2.7 2.6 0.20 1.6 1.3 3.0 1.3 3.9	235 160 75 165 32 28 6.6 6.2 0.47 3.8 3.8 7.2 3.2 9.3	78 53 25 165 32 28 2.2 2.1 0.16 1.3 1.3 2.4 1.1 3.1
pH (approximate) Approximate osmolarity (mOsm/l)	5.5 1400	5.5 1400	5.5 1150	5.5 1150

This includes the energy value of egg yolk phospholipids for injection.
This includes phosphates from egg yolk phospholipids for injection, which are components of the lipid emulsion.
Other components:
L-malic acid
Hydrochloric acid
Egg yolk phospholipids for injection
Glycerol
Sodium oleate
Sodium hydroxide
Water for injections
to adjust pH
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