Leaflet: information for the user

NUMETA G19%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 G19%E and what it is used for

2.What you need to know before Numeta G19%E is administered to your child

3.How Numeta G19%E will be administered to your child

4.Possible side effects

5.Storage of Numeta G19%E

6.Contents of the pack and additional information

Numeta G19 %E is a specialized nutrition designed for children over 2 years old and adolescents up to 18 years old.It is administered through a tube connected to the vein of your child,whenhe is unable to eat all his foods 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 the needs of your child, dos (or three of these solutions) are mixed in the bag before it is administered to your child.

Numeta G19%Eshould only be used under medical supervision.

No use Numeta G19%Ein the following cases:

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

• If your child is allergic to any of the proteins from eggs, soy, or peanuts or to the ingredients in the glucose or amino acid bag (listed in section 6).
• If your child's body has problems using the protein constituents.
• If your child has high concentrations of any of the electrolytes included in Numeta G19%E in their blood.
• 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 status, along with the results of all the tests performed.

Warnings and precautions

Consult your child's doctor or nurse before administering Numeta G19%E.

Allergic reactions

The infusion should be stopped immediately if any sign or symptom of an allergic reaction appears (such as fever, sweating, chills, headache, skin rash, or difficulty breathing).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 soybean proteins.

Numeta G19%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 ceftriaxone (antibiotic):

Ceftriaxone should not be mixed or administered at the same time as a solution containing calcium (including Numeta G19%E) through a vein infusion.

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

However, your doctor may administer calcium and ceftriaxone sequentially one after the other if used through different infusion lines, 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 may 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 your child's 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, may 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 their vein (intravenous catheter).Certain medications and diseases may increase the risk of developing sepsis or infection.Patients requiring parenteral nutrition (nutrition administered through a tube connected to their vein) have a higher chance of developing an infection due to their clinical status.

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 in Numeta G19%E, or an overdose, may cause a “fatty acid overload syndrome” (see sections 3 and 4).

Changes in blood chemistry levels

Your doctor will check and review the fluids in your child's body, the levels of chemicals in the blood, and other blood levels as sometimes, refeeding someone who is severely malnourished may lead to changes in blood chemistry levels.Fluid accumulation in tissues and swelling may also occur.It is recommended to start parenteral nutrition slowly and under supervision.

Monitoring and adjustment

Your doctor will monitor and adjust the dose of Numeta G19%E to meet your child's individual needs if they experience the following states:

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

Use with caution:

Numeta 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 eliminate substances normally),
• blood clotting disorders.

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

Use ofNumeta G19%E with other medications

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

Numeta G19%E should not be administered at the same time as:

• ceftriaxona(an 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).
• ampicilina, fosfenitoina, and furosemidathrough 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.The olive and soy oils contain vitamin K1.Vitamin K1 may interfere with the action of medications such as coumarin and warfarin.These medications are anticoagulants used to prevent blood clotting.

Laboratory tests

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

Interaction of Numeta G19%E with medications that may affect potassium levels:

Numeta G19%E contains potassium.High levels of potassium in the blood may cause abnormal heart rhythm.Special attention should be paid to patients taking diuretics (medications that reduce fluid retention), ACE inhibitors, or angiotensin II receptor antagonists (all used to treat high blood pressure) or immunosuppressants (medications that may decrease the body's natural defenses).These types of medications may increase potassium levels.

Pregnancy, lactation, and fertility

There are insufficient data on the use of Numeta in pregnant women or breastfeeding women.Your doctor should carefully evaluate the benefits and potential risks in each patient before prescribing Numeta.

Your child must always be givenNumetaG19%Eexactly as directed by their doctor. Consult their doctor if you have any doubts.

Age range

NumetaG19%Ehas been designed to meet the nutritional needs of childrenover two years old and adolescents up to 18 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 mayopt not toadministerlipidsto your child.The design of theNumetaG19%Ebottle allows thenon-permanent seal of the compartment between the amino acid/electrolyte chambers 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.

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 will depend 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 NumetaG19%E.Additional proteins or oral or intestinal nutrition may also be administered.

If your child is given moreNumetaG19%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 G19%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 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 imbalances (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.
  • Coagulation disorders, which affect the blood's ability to clot.
  • Respiratory disorders that reduce oxygen levels in the body.
  • Conditions that cause increased blood acidity (acidosis).
  • Coma requiring hospitalization.
• Formation of small particles that may cause blockage of the blood vessels in the lungs (pulmonary vascular precipitates) or difficulty breathing.

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.

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 outer packaging.

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

NumetaG19%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 solutions 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" perfusion emulsion has a uniform milky and white appearance.

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

To prevent air contact, Numetais packaged inside an oxygen barrier overpouchcontaining adesiccant withan oxygen indicatorandan oxygen indicator.

Pouch Sizes

1000 ml pouch: 6 units per carton

1 1000 ml pouch

Only certain pouch sizes may be marketed.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder

Baxter, S.L.

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

Responsible Person for Manufacturing

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

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

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This information is intended solely for healthcare professionals:*

(*) Please note that in some 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 bag without first checking its compatibility.Particulates may form or the lipid emulsion may break down, which could block blood vessels.

NumetaG19%Emust be at room temperature before use.

Before administeringNumetaG19%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 this appearance:

• The non-permanent seals are intact. This is observed because there is no mixing of the three chambers.
• The amino acid and glucose solutions are transparent, colorless, or slightly yellowish and without visible particles.
• The lipid emulsion is a milky and white liquid.

Before opening the overpouch, examine the color of the desiccant.

• 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 desiccant 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 desiccant.

Figure 1Figure 2

Preparing the Mix

• 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-chambered 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 and milky emulsion.

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

Activating the 2-chambered 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 and glucose, start rolling the bag from the D-hanger corner of the seal separating the amino acid and glucose chambers and press to open the seal separating the two 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: Next, reverse the direction and roll the bag towards the D-hanger, pressing with the other hand until the seal separating 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 hourand adjusted according to the following factors:

The dose to be administered

The daily fluid intake

The duration of the infusion.

Administration Form

The emulsion (in the bag and in the administration equipment) must be protected from exposure to light from the administration point of the mix and throughout administration.

It is recommended to use a 1.2-micron filter for the administration of Numeta G19%E.

Due to its high osmolarity, Numeta G19%E can only be administered undiluted through a central vein; however, a suitable dilution of Numeta G19%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 3-chambered bag activated (B3C) after adding injectable water:

Adding Medication

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

Medicaments compatiblecan be added to the reconstituted mix (after opening the non-permanent seals and mixing the contents of the two or three chambers)through the administration point.

Vitamins can also be added to the glucose chamber before reconstituting the mix (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 asTE1, TE2, and TE4), vitamins (identified asliophilized V1 and emulsified 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)

* Fosfato orgánico

2Compatibility with TE1, V1, and V2

Table 3: Compatibility of 3-in-1 (B3C activated)

* Fosfato orgánico

Table 4: Compatibility of 2-in-1 (B2C activated)

* Fosfato orgánico

3Compatibility with TE2, V1, and V2

Table 5: Compatibility of 2-in-1 (B2C activated)

* Fosfato orgánico

Table 6: Compatibility of 3-in-1 (B3C activated)

* Fosfato orgánico

The composition of the commercially available oligoelement preparations used is shown below in Tables 7 and 8:

Table 7: Composition of the commercially available oligoelement preparations used:

Composition per 10 ml	TE1	TE2	TE4
Iron (µmol or mg)	-	8.9 µmol or 0.5 mg	-
Zinc (µmol or mg)	38.2 µmol or 2.5 mg	15.3 µmol or 1 mg	15.3 µmol or 1 mg
Selenium (µmol or mg)	0.253 µmol or 0.02 mg	0.6 µmol or 0.05 mg	0.253 µmol or 0.02 mg
Copper (µmol or mg)	3.15 µmol or 0.2 mg	4.7 µmol or 0.3 mg	3.15 µmol or 0.2 mg
Iodine (µmol or mg)	0.0788 µmol or 0.01 mg	0.4 µmol or 0.05 mg	Країна реєстрації Spain Активна речовина AlaninaArgininaAspartico acidoCisteinaGlutamico acidoGlicinaHistidinaIsoleucinaLeucinaLisina monohidratoLisinaMetioninaOrnitina hidrocloruroOrnitinaFenilalaninaProlinaSerinaTaurinaTreoninaL-triptofanoTirosinaValinaAceite de soja aceite de olivaSodio cloruroAcetato potasioCalcio cloruro dihidratoAcetato magnesio tetrahidratoGlicerofosfato sodioGlucosa monohidratoGlucosa anhidra Потрібен рецепт Так Виробник Baxter S.L. Склад Glicerol (e 422) (14,10 g mg), Oleato de sodio (0,19 g mg), Hidroxido de sodio (e 524) (C.S. - mg) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Поговоріть з лікарем онлайн Маєте питання щодо цього лікування або ваших симптомів? 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