Prospect: information for the user

NUMETA G13%E emulsion for perfusion

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If your child experiences adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this prospect. See section 4.

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

2.What you need to know before Numeta G13%E is administered to your child

3.How Numeta G13%E will be administered

4.Possible adverse effects

5.Storage of Numeta G13%E

6.Contents of the package and additional information

Numeta G13%E is a specialized emulsion for nutritional support designed for premature newborns. It is administered through a tube connected to the vein of your child when they are unable to consume all their food through the mouth.

Numeta is presented in the form of a tricompartimental bag with three independent chambers containing:

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, two or three of these solutions are mixed in the bag before it is administered to your child.

Numeta G13%E should only be used under medical supervision.

Numeta G13%Eshould not be administered to your child in the following cases:

With the glucose and amino acids/electrolytes mixed in the bag (“2 in 1”):

• If your child is allergic to eggs, soy, peanuts, or any of the ingredients of this medication or component of the packaging (including in section 6).
• If your child's body has problems using the constituents of proteins.
• If your child has high concentrations of any of the electrolytes included in Numeta G13%E in their blood.
• Numeta G13%E (or other solutions containing calcium) should not be administered at the same time as ceftriaxone (an antibiotic), even if used through different infusion lines. There is a risk of formation of particles in the newborn's bloodstream that can be fatal.
• If your child has hyperglycemia (especially high levels of sugar in the blood).

With the glucose, amino acids/electrolytes, and lipids mixed in the bag (“3 in 1”).

All the situations mentioned for the “2 in 1”, plus the following:

• If your child has a particularly high level of fats in their blood.

In all cases, the doctor will decide whether to administer this medication to your child based on factors such as age, weight, and clinical condition. They will also take into account the results of all the tests performed.

Warnings and precautions

Consult your child's doctor or nurse before administering Numeta G13%E.

When used in newborns and children under 2 years, the emulsion (in the bags and infusion equipment) should be protected from exposure to light until the end of administration. Exposure of Numeta G13%E to 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 exposure to light.

Allergic reactions:

The infusion should 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 also are allergic to soybean proteins.

Numeta G13%E contains glucose derived from cornstarch, so it should be used with caution in patients with known allergy to corn or its products.

Risk of particle formation with ceftriaxone (antibiotic):

Do not mix or administer a specific antibiotic called ceftriaxone at the same time as a solution containing calcium (including Numeta G13%E) through a vein infusion.

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

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 of the lungs (pulmonary vascular precipitates). If your child experiences difficulty breathing, inform your child's doctor or nurse. They will decide on the necessary measures.

Infection and sepsis:

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

In some cases, children may develop infections and sepsis (bacteria in the blood) when they have a tube connected to a vein (intravenous catheter). Certain medications and diseases can increase the risk of developing infection or sepsis. Patients who require parenteral nutrition (nutrition administered through a tube connected to a vein in their child) have a higher risk of developing an infection due to their clinical condition.

Fatty acid syndrome:

Cases of fatty acid syndrome have been described with similar products. A reduction or limitation of the body's ability to eliminate the fats contained in Numeta G13%E, or an overdose, can cause a “fatty acid syndrome” (see sections 3 and 4).

Change in blood chemistry levels:

The doctor will check and review your child's liquids, blood chemistry, and other blood values during treatment with Numeta G13%E. In some cases, refeeding someone who is severely malnourished can lead to changes in blood chemistry levels that may need to be corrected. It is also possible to produce excess fluid in tissues and swelling. It is recommended to start parenteral nutrition slowly and under supervision.

Monitoring and adjustment

The doctor will closely monitor and adjust the dose of Numeta G13%E to your child's individual needs, especially if they have the following conditions:

• Severe post-traumatic states.
• Severe diabetes mellitus.
• Shock.
• Heart attack.
• Severe infection.
• Certain types of coma.

Use with caution:

Numeta G13%E should 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 break down substances normally).
• Blood clotting disorders.

The levels of fluids in your child's body, liver function tests, and blood values will be carefully monitored.

There are few data on the administration of this medication in premature children under 28 weeks of gestational age.

Use of Numeta G13%E with other medications

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

Numeta G13%Eshould not be administered at the same time as:

• ceftriaxona(an antibiotic) or 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).
• ampicilina,fosfenitoina, and furosemidathrough the same infusion line, as there is a risk of particle formation.

Cumarina and warfarina (anticoagulants)

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

Laboratory tests

The lipids included in this emulsion can interfere with the results of certain laboratory tests. Laboratory tests can be performed 5 to 6 hours after administering lipids or if no more lipids are administered.

Interaction of Numeta with medications that may affect potassium levels:

Numeta G13%Econtains potassium. High levels of potassium in the blood can cause an abnormal heart rhythm. Special attention should be paid to patients taking diuretics (medications that reduce fluid retention), ACE inhibitors (medications used to treat high blood pressure), angiotensin receptor antagonists (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 be given Numeta G13%E exactly as directed by their doctor. Consult your doctor if you have any doubts.

Age Group

Numeta G13%E has been designed to meet the nutritional needs of premature newborns.

Numeta G13%E may not be suitable for some premature babies, as their clinical condition may require customized formulations that meet their specific nutritional needs. 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 your child's arm or a large vein in their chest.

The doctor may choose not to administer lipids to your child. The design of the Numeta G13%E bag allows the non-permanent seal between the amino acid/electrolyte and glucose chambers to be broken, if necessary. The seal between the amino acid and lipid chambers remains intact in this case. The bag contents can be infused without lipids.

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

Dosage and Treatment Duration

The doctor will decide on the dose your child needs and how long they will receive it. 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 of Numeta G13%E. Additional proteins or oral or intestinal nutrition may also be administered.

If your child is given more Numeta G13%E than they should

In case of overdose or accidental ingestion, consult the Poison 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, too much fluid in the blood vessels).
• Acidosis (increased blood acidity).

In these cases, the infusion should be stopped immediately. The doctor will decide if further action is necessary.

A lipid overdose in Numeta G13%E may cause a "lipid overload syndrome," which is usually reversible once the infusion is interrupted. In newborns (neonates) and young children (infants), lipid overload syndrome has been associated with respiratory problems that cause reduced oxygen levels in the body (respiratory distress) and conditions that cause increased blood acidity (acidosis).

To prevent these reactions, the 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 should 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 inadequate 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 increased blood acidity (acidosis).
  • Coma that requires hospitalization.
• Formation of small particles that may cause blockage of the 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 not listed 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 use this medication after 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.

Aspect ofNumeta G13%Eand packaging contents

Numeta G13%E is presented in a three-chamber bag. Each bag 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 solutions in the chambers are transparent, colorless, or slightly yellowish.
• The lipid emulsion chamber contains a uniform white milky liquid.

Appearance after reconstitution:

• The "2 in 1" infusion solution (amino acids/electrolytes and glucose) is transparent, colorless, or slightly yellowish.
• The "3 in 1" infusion emulsion has a uniform white milky appearance.

The three-compartment bag is a multilayer plastic bag.

To prevent air contact, Numeta G13%E is packaged in the interior of an oxygen barrier overbag, which also contains an oxygen absorber and an oxygen indicator.

Package sizes

300 ml bag: 10 units per carton

1 x 300 ml bag

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Baxter, S.L.

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

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 this product 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 bag without first checking compatibility. Particles may form or the lipid emulsion may break down, which may block blood vessels.

Numeta G13%E must be at room temperature before use.

Before administering Numeta G13%E, you must prepare the bag as shown below.

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

Before opening the overbag, examine 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 product if the oxygen indicator color does not match the reference color printed next to the OK symbol.

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

Figure 1Figure 2

Preparing the mixture

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

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

Step 1: Roll the bag from the D-hanger side.

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

Step 3: Reverse the direction and roll the bag towards the D-hanger until the seal is completely open. Follow the same steps to open the second non-permanent seal.

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

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

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

Step 1: To break only the non-permanent seal between amino acids/glucose, start rolling the bag from the D-hanger side of the seal that separates the amino acid and glucose chambers and press to open the seal that separates both compartments.

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

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

Step 4: Then, reverse the direction and roll the bag towards the D-hanger, pressing with the other hand until the seal that separates the amino acid and glucose solutions is completely open.

Step 5: Turn the bag 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 point 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 intake volume

The duration of the infusion.

Administration form

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

It is recommended to use a 1.2-micron filter for the administration of Numeta G13%E.

Due to its high osmolarity, Numeta G13%E can only be administered undiluted through a central vein; however, a suitable dilution of Numeta G13%E with injectable water reduces the osmolarity and allows peripheral infusion. The following formula indicates the impact of dilution on the osmolarity of the bags:

The following table shows examples of osmolarity for the addition of 2- and 3-chamber bags activated after adding injectable water:

Adding medication

The exposure of parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, Numeta G13%E should be protected from ambient light until the end of administration.

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

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 1-4 show the possible additions of commercially available oligoelement solutions (identified as TE1 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

* Organic phosphate

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

* Organic phosphate

2Compatibility with TE1, V1, and V2

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

* Organic phosphate

3Compatibility with TE1, V1, and V2

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

* Organic phosphate

The composition of the commercially available oligoelement preparations used is shown below in Tables 5 and 6:

Table 5: Composition of the commercially available oligoelement preparations used:

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