Leaflet: information for the user

NUMETA G16%E emulsion for infusion

Read this leaflet carefully before you start using 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, consult your child's doctor, pharmacist, or nurse.
• If your child experiences any side effectsconsult your child's doctor, pharmacist, or nurse,even if they are not listed in this leaflet. See section 4.

1.What is Numeta G16%E and what it is used for

2.What you need to know before Numeta G16%E is administered to your child

3.How Numeta G16%E will be administered to your child

4.Possible side effects

5.Storage of Numeta G16%E

6.Contents of the pack and additional information

NumetaG16%Eis a specialized nutrition designedfor term newborns and up to 2 years old.It is administered through a tube connected to the vein of your child,whenthey are unable to eat all their food by mouth

Numetais presented in the form of a three-compartmental bag with three independent chambers that contain:

a 50% glucose solution

a pediatric amino acid solution with electrolytes at 5.9%

a 12.5% lipid emulsion (fats)

Depending on your child's needs, dos (or three of these solutions) are mixed in the bag before it is administered to your child.

NumetaG16%E should only be used under medical supervision.

Do not useNumetaG16%E in the following cases:

With 2 solutions mixed in the bag (“2 in1”):

• If your child is allergic to any of the proteins from egg, soy, or peanuts or to the ingredients in the glucose or amino acid bag (listed in section 6).
• If your child's body has trouble using the protein components.
• If your child has high levels of any of the electrolytes included inNumetaG16%Ein their blood.
• If your child is a newborn(≤ 28days of age)NumetaG16%E(or other solutions that contain calcium)should not be administered at the same time as ceftriaxona (a specific antibiotic) even if separate lines are used for infusion. There is a risk of particle formation in the newborn's blood that can be fatal).
• If your child has hyperglycemia (especially high levels of sugar in the blood).

With 3 solutions mixed in the bag (“3 in1”).

• All the situations mentioned in “2 in1”plus the following:
• If your child has a particularly high level of fats in their blood.

In all cases, your child's doctor will decide whether to administer this medication based on factors such as age, weight, and clinical condition, along with the results of all the tests performed.

Warnings and precautions

Consult your child's doctor or nurse before administeringNumetaG16%E.

When used in newborns and children under 2 years, the emulsion (in the bags and infusion equipment) must be protected from exposure to light until the infusion is complete. Exposure of NumetaG16%Eto ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light exposure.

Allergic reactions

The infusion must be stopped immediately if any sign or symptom of an allergic reaction (such as fever, sweating, chills, headache, skin rash, or difficulty breathing) appears.This medication contains soy oil, which rarely may cause hypersensitivity reactions.In rare cases, some people who are allergic to peanut proteins are also allergic to soy protein.

Numeta G16%E contains cornstarch-derived glucose, so it should be used with caution in patients with known allergy to corn or its products.

Risk of particle formation with ceftriaxona (antibiotic):

Do not mix or administer a specific antibiotic called ceftriaxona at the same time as a solution containing calcium (including Numeta G16%E) through a vein infusion.

Your doctor knows this and will not administer them together, not even through separate lines or different infusion sites.

However, your doctor may administer calcium and ceftriaxona sequentially one after the other if separate infusion lines are used, or if the lines are replaced or thoroughly flushed with physiological saline solution to avoid particle formation.

Formation of small particles in the blood vessels of the lungs:

Difficulty breathing can also be a sign of particle formation, which blocks the blood vessels in the lungs (pulmonary vascular precipitates). If your child experiences difficulty breathing, inform their doctor or nurse. They will decide on the necessary measures.

Infection and sepsis

Your doctor will closely monitor your child for any symptoms of infection. The application of an “aseptic technique” (germ-free technique) when placing and maintaining the catheter, as well as preparing the nutrition formula, can reduce the risk of infection.

Occasionally, children may develop infections and sepsis (bacteria in the blood) when they have a tube connected to their vein (intravenous catheter).Certain medications and diseases can increase the risk of developing sepsis or infection.Patients requiring parenteral nutrition (nutrition administered through a tube connected to their vein) are more likely to develop an infection due to their clinical condition.

Fatty acid overload syndrome

Cases of fatty acid overload syndrome have been described with similar products. A reduction in the ability to eliminate the lipids contained inNumeta G16%E, or an overdose,may cause a “fatty acid overload syndrome” (see sections 3 and 4 Adverse reactions).

Changes in blood chemistry levels

Your doctor will check and review your child's body fluids, blood chemistry levels, and other blood levels as sometimes,re-feedingsomeonewhois severelymalnourishedcanlead tochangesinbloodchemistrylevels.Fluid accumulation in tissues and swelling may also occur.It is recommended to start parenteral nutrition slowly and under supervision.

High levels of magnesium in the blood

The amount of magnesium present in Numeta G16%E can cause high levels of magnesium in the blood. Among the signs of these high levels are weakness, slow reflexes, nausea, vomiting, low calcium levels in the blood, difficulty breathing, low blood pressure, and irregular heartbeats. Since it may be difficult to detect these signs, the doctor may monitor your child's blood values, especially if your child has risk factors related to high magnesium levels in the blood, including altered renal function. If magnesium levels in the blood are high, the infusion will be stopped or reduced.

Monitoring and adjustment

Your doctor will monitor and adjust the dose of Numeta G16%E to meet your child's individual needs if they present the following states:

• severe post-traumatic state
• severe diabetes mellitus
• shock
• myocardial infarction
• severe infection
• certain types of coma

Use with caution:

Numeta G16%Eshould be used with caution if your child has:

• pulmonary edema (fluid in the lungs) or heart failure,
• severe liver problems,
• problems absorbing nutrients,
• high sugar levels,
• renal problems,
• severe metabolic disorders (when the body cannot eliminate substances normally),
• coagulation disorders of the blood.

Your child's body fluid levels, liver function tests, and blood values will be carefully monitored.

Use of Numeta G16%E with other medications

Inform your doctor if your child is taking, has taken recently, or may need to take any other medication.

Numeta G16%E should not be administered at the same time as:

• ceftriaxona(a specific antibiotic) not even through separate infusion lines, due to the risk of particle formation.
• bloodthrough the same infusion line.Due to the risk of pseudoagglutination (red blood cells become clumped)
• ampicillin, fosphenytoin, and furosemidethrough the same infusion line,as there is a risk of particle formation.

Cumarina and warfarina (anticoagulants)

Your doctor will closely monitor your child if they are taking coumarin or warfarin. Soy oil and olive oil contain vitamin K1.Vitamin K1 can interfere with the action of medications like coumarin and warfarin.These medications are anticoagulants used to prevent blood clotting.

Laboratory tests

The lipids included in this emulsion can interfere with the results of certain laboratory tests.Laboratory tests can be performed after a period of5 to6 hours if no more lipids are administered.

Interaction of Numeta G16%E with medications that may affect potassium levels:

Numeta G16%Econtains potassium.High levels of potassium in the blood can cause abnormal heart rhythms.Special attention should be paid to patients taking diuretics (medications that reduce fluid retention), ACE inhibitorsor angiotensin II receptor antagonists(all of which are medications used to treat high blood pressure)or immunosuppressants (medications that can decrease the body's natural defenses).These types of medications can increase potassium levels.

Your child must always receive NumetaG16%Eexactly as directed by their doctor. Consult their doctor if you have any doubts.

Age range

NumetaG16%Eis designed to meet the nutritional needs of term-born children and children up to two years old.

The doctor will decide if this medication is suitable for your child.

Administration

This medication is an emulsion for infusion.It is administered through a plastic tube connected to a vein in the arm or a large vein in the chest of your child.

Your child's doctor may choose not to administer lipids to your child.The design of the NumetaG16%Ebottle allows the non-permanent seal between the chambers of the amino acids/electrolytes and glucose to be broken if necessary.The seal between the amino acid and lipid chambers remains intact in this case.The contents of the bottle can be infused without lipids.

When used in newborns and children under 2 years old, the emulsion (in the bags and administration equipment) must be protected from light exposure until the end of administration (see section 2).

Dosage and treatment duration

Your child's doctor will decide on the dose your child needs and how long it will be administered.The dose depends on your child's nutritional needs and will be based on their weight, medical condition, and their body's ability to digest and absorb the ingredients ofNumetaG16%E.Additional proteins or oral or intestinal nutrition may also be administered.

If your child receives moreNumetaG16%Ethan they should

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 915.620.420

Symptoms

Receiving too much medication or administering it too quickly may cause:

• nausea (feeling unwell)
• vomiting
• chills
• electrolyte imbalances (inappropriate levels of electrolytes in the blood)
• signs of hypervolemia (increased blood volume)
• acidosis (increased blood acidity)

In these cases, the infusion should be stopped immediately.Your child's doctor will decide if any further action is necessary.

A lipid overdose in Numeta G16%E may cause a "lipid overload syndrome," which is usually reversible once the infusion is stopped.In newborns (neonates) and young children (infants), lipid overload syndrome has been associated with respiratory problems that cause a decrease in oxygen levels in the body (respiratory distress) and conditions that cause an increase in blood acidity (acidosis).

To prevent these reactions, your child's doctor will regularly monitor your child's condition and analyze their blood levels during treatment.

Like all medicines, this medicine may cause side effects, although not all children will experience them.

If you notice any change in how your child feels during treatment or after it, inform the doctor or nurse immediately.

The tests the doctor will perform on your child while receiving this medicine should minimize the risk of side effects.

If symptoms of an allergic reaction occur, the infusion must be stopped and the doctor contacted immediately. This can be serious and symptoms may include:

Other side effects that have been observed are:

Frequent: may affect up to 1 in 10 people

• Low blood phosphate level (hypophosphatemia).
• High blood sugar level (hyperglycemia).
• High blood calcium level (hypercalcemia).
• High blood triglyceride level (hypertriglyceridemia).
• Electrolyte imbalance (hyponatremia).

Rare: may affect up to 1 in 100 people

• High blood lipid level (hyperlipidemia).
• A condition in which bile cannot flow from the liver to the duodenum (cholestasis). The duodenum is part of the intestine.

Unknown: the frequency cannot be estimated from available data (these side effects have been reported with Numeta G13%E and G16%E when administered peripherally with insufficient dilution).

-Skin necrosis

-Soft tissue damage

-Extravasation

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

-The reduced or limited ability to eliminate the lipids contained in Numeta may lead to a "fat overload syndrome". The following signs and symptoms of this syndrome are usually reversible when the infusion of the lipid emulsion is stopped:

• • Sudden and severe deterioration of the patient's medical condition.
  • High blood fat level (hyperlipidemia).
  • Fever.
  • Fatty infiltration of the liver (hepatomegaly).
  • Worsening of liver function.
  • Anemia, which may cause pale skin and weakness or difficulty breathing.
  • Leukopenia, which may increase the risk of infection.
  • Thrombocytopenia, which may increase the risk of bleeding or bruising.
  • Blood clotting disorders, which affect the blood's ability to clot.
  • Respiratory disorder that reduces oxygen in the body (breathing difficulty).
  • Conditions that cause an increase in blood acidity (acidosis).
  • Coma that requires hospitalization.
• Formation of small particles that may cause blockage of blood vessels in the lungs (pulmonary vascular precipitates) or breathing difficulty.

Reporting of side effects:

If your child experiences any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children when not in use.

When used in newborns and children under 2 years, the emulsion (in the bags and administration equipment) must be protected from light exposure until the administration is completed (see section 2).

Do not usethis medicationafter the expiration date appearing on the bag and outer packaging (MM/YYYY).The expiration date is the last day of the month indicated.

Do not freeze.

Store in the overbag.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that are no longer needed. This will help protect the environment.

Product Appearance and Packaging Contents

NumetaG16%Eis presented in a three-chambered pouch.Each pouch contains a sterile combination of a glucose solution, a pediatric amino acid solution with electrolytes, and a lipid emulsion, as described below:

Appearance before reconstitution:

• The amino acid and glucose solution chambers are transparent, colorless, or slightly yellowish.
• The lipid emulsion chamber has a milky and white appearance.

Appearance after reconstitution:

• The "2 in 1" solution is transparent, colorless, or slightly yellowish.
• The "3 in 1" lipid infusion has a uniform milky and white appearance.

The three-chambered pouch is a multi-layer plastic pouch.

To prevent air contact, Numeta is packaged in an oxygen barrier overpouch containing a sticker with an oxygen absorber and an oxygen indicator.

Package Sizes

500 ml pouch: 6 units per carton

1 x 500 ml pouch

Only certain package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Baxter, S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Responsible Manufacturer

Baxter S.A.

Boulevard Rene Branquart, 80

7860 Lessines

Belgium

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

Last Review Date of this Leaflet: May 2024

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

---------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:*

(*) Please note that in certain cases, these medicines may be administered at home by parents or other caregivers. In these cases, parents/caregivers should read the following information.

Do not add any medication to the pouch without first checking compatibility.Particulates may form or the lipid emulsion may break down, which could block blood vessels.

Numeta G16%E must be at room temperature before use.

Before administering Numeta G16%E, you must prepare the pouch as described below.

Ensure the pouch is not damaged and use it only if it is not damaged.A non-damaged pouch has the following appearance:

• The non-permanent seals are intact. This is observed because there is no mixing of the three chambers.
• The amino acid and glucose solution chambers are transparent, colorless, or slightly yellowish and have no visible particles.
• The lipid emulsion chamber has a milky and white appearance.

Before opening the overpouch, examine the color of the oxygen absorber.

• 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 product if the oxygen absorber color does not match the reference color printed next to the OK symbol.

Figures 1 and 2 illustrate how to remove the overpouch. Dispose of it along with the oxygen indicator and absorber.

Figure 1Figure 2

Pouch Preparation

• Ensure the product is at room temperature before breaking the non-permanent seals.
• Place the pouch on a clean and flat surface.

Activating the 3-chamber pouch (breaking the two non-permanent seals)

Step 1: Roll the pouch from the D-loop side.

Step 2: Press until the non-permanent seals open.

Step 3: Change direction and roll the pouch towards the D-loop until the seal is completely open. Follow the same steps to open the second non-permanent seal.

Step 4: Turn the pouch back at least three times to mix the contents well. The appearance of the mixed solution should be a white and milky emulsion.

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

Activating the 2-chamber pouch (breaking the non-permanent seal between the amino acid and glucose chambers)

Step 1: To break only the amino acid/glucose seal, start rolling the pouch from the D-loop side of the seal separating the amino acid and glucose chambers and press to open the seal separating both compartments.

Step 2: Place the pouch so that the lipid emulsion chamber is facing the operator and roll the pouch while protecting the lipid emulsion chamber with your palms.

Step 3: With one hand, apply pressure by rolling the pouch towards the tubes.

Step 4: Next, change direction and roll the pouch towards the D-loop, pressing with the other hand until the seal separating the amino acid and glucose solutions is completely open.

Step 5: Turn the pouch back at least three times to mix the contents well. The appearance of the mixed solution should be transparent, colorless, or slightly yellowish.

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

The administration rate should be gradually increased during the first hour and adjusted according to the following factors:

The dose to be administered

The daily fluid intake

The duration of the infusion.

Administration Form

When used in newborns and children under 2 years, the emulsion (in the pouch and in the administration equipment) should be protected from light exposure until the end of administration.

It is recommended to use a 1.2-micron filter for the administration of Numeta G16%E.

Due to its high osmolarity, Numeta G16%E can only be administered undiluted through a central vein; however, a suitable dilution of Numeta G16%E with water for injection reduces the osmolarity and allows peripheral infusion.

The following formula indicates the impact of dilution on the osmolarity of the pouches.

The following table shows examples of osmolarity for the 2- and 3-chamber pouches activated after adding water for injection:

Adding Medication

The mixtures containing oligoelements and vitamins should be protected from light, from the administration point and during administration. Exposure to ambient light generates peroxides and other degradation products that can be reduced with photoprotection.

Medicaments compatible with the product can be added to the reconstituted mixture (after opening the non-permanent seals and mixing the contents of the two or three chambers) through the administration port.

Vitamins can also be added to the glucose chamber before reconstituting the mixture (before opening the non-permanent seals and mixing the solutions and emulsion).

Tables 1-6 show the possible additions of commercially available oligoelement solutions (identified as TE1, TE2, and TE4), vitamins (identified as lyophilized V1 and emulsion V2), and electrolytes in defined quantities.

1Compatibility with TE4, V1, and V2

Table 1: Compatibility of 3-in-1 (B3C activated) with or without dilution in water

* Fosfato orgánico

Table 2: Compatibility of 2-in-1 (B2C activated) with or without dilution in water

* Fosfato orgánico

2Compatibility with TE1, V1, and V2

Table 3: Compatibility of 3-in-1 (B3C activated) with or without dilution in water

* Fosfato orgánico

Table 4: Compatibility of 2-in-1 (B2C activated) with or without dilution in water

* Fosfato orgánico

3Compatibility with TE2, V1, and V2

Table 5: Compatibility of 3-in-1 (B3C activated) with or without dilution in water

Country of registration

Spain

Active substance

AlaninaArgininaAspartico acidoCisteinaGlutamico acidoGlicinaHistidinaIsoleucinaLeucinaLisina monohidratoLisinaMetioninaOrnitina hidrocloruroOrnitinaFenilalaninaProlinaSerinaTaurinaTreoninaL-triptofanoTirosinaValinaSodio cloruroAcetato potasioCalcio cloruro dihidratoAcetato magnesio tetrahidratoGlicerofosfato sodioGlucosa monohidratoGlucosa anhidraAceite de soja aceite de oliva

Prescription required

Yes

Manufacturer

Baxter S.L.

Composition

Glicerol (e 422) (14,10 g mg), Oleato de sodio (0,19 g mg), Hidroxido de sodio (e 524) (C.S. - mg)

This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.

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