Numeta g16e

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Numeta G16E (Numeta G16E)

Composition:

Active substances: L-alanine; L-arginine; L-aspartic acid; L-cysteine; L-glutamic acid; glycine; L-histidine; L-isoleucine; L-leucine; L-lysine monohydrate (equivalent to lysine); L-methionine; L-ornithine hydrochloride (equivalent to ornithine); L-phenylalanine; L-proline; L-serine; taurine; L-threonine; L-tryptophan; L-tyrosine; L-valine; sodium chloride; potassium acetate; calcium chloride dihydrate; magnesium acetate tetrahydrate; sodium glycerophosphate hydrate; glucose monohydrate (equivalent to anhydrous glucose); refined olive oil and refined soybean oil;

One 500 ml bag contains:

• Proportional content of olive oil (approximately 80% by weight) and soybean oil (approximately 20% by weight).

After mixing, 1 sachet contains:

• The proportional content of olive oil (approximately 80% by weight) and soybean oil (approximately 20% by weight) is calculated to achieve a content of 20% essential fatty acids (linoleic acid plus α-linolenic acid) of the total amount of fatty acids.

After reconstitution, the solution contains:

* Phosphate for 3-in-1 mixture includes phosphorus from the lipid emulsion (egg phospholipids).

Excipients: amino acid solution: L-malic acid, water for injections;

glucose solution: concentrated hydrochloric acid, water for injections;

lipid emulsion: egg phospholipids for injections, glycerin, sodium oleate, sodium hydroxide, water for injections.

Pharmaceutical form. Infusion emulsion.

Main physicochemical characteristics: amino acid solution – clear, colorless or slightly yellow, practically free from particles; glucose solution – clear, colorless or slightly yellow, practically free from particles; lipid emulsion – homogeneous milky-colored liquid.

Pharmacotherapeutic group.

Solutions for parenteral nutrition. Combinations.

ATC code B05B A10.

Pharmacological properties

Pharmacodynamics

The nitrogen content (20 L-amino acids, including 8 essential amino acids) in Numeta G16E, along with energy sources (glucose and triglycerides), allows maintaining an adequate nitrogen/energy balance. Nitrogen and energy are essential for normal functioning of all cells in the body and are important for protein synthesis, growth, wound healing, immune system function, muscle function, and many other cellular processes.

Numeta G16E also contains electrolytes.

The amino acid profile is as follows:

• Essential amino acids/total amino acid content – 47.5%;
• Branched-chain amino acids/total amino acid content – 24.0%.

The lipid emulsion component of Numeta G16E consists of a mixture of refined olive oil and refined soybean oil (in an approximate ratio of 80/20), with the following fatty acid distribution:

• 15% saturated fatty acids (SFA);
• 65% monounsaturated fatty acids (MUFA);
• 20% polyunsaturated fatty acids (PUFA).

The phospholipid/triglyceride ratio is 0.06. The moderate content of essential fatty acids (EFA) helps maintain adequate levels of their derivatives while correcting EFA deficiency.

Olive oil contains significant amounts of alpha-tocopherol, which, in combination with moderate PUFA intake, contributes to normalization of vitamin E levels and is important for limiting lipid peroxidation.

Glucose is the source of carbohydrates. Glucose is the primary energy source in the body.

Pharmacokinetics

The components of the infusion emulsion (amino acids, electrolytes, glucose, lipids) are distributed, metabolized, and eliminated via the same pathways as each individual component. The preparation is administered intravenously; therefore, its bioavailability is 100%, and its components are distributed into all body cells and metabolized.

Clinical characteristics.

Indications.

For parenteral nutrition of full-term newborns and children up to 2 years of age when oral or enteral nutrition is impossible, inadequate, or contraindicated.

Contraindications.

General contraindications for the use of Numeta G16E as an activated two-chamber bag (without lipid emulsion) for intravenous infusion:

• hypersensitivity to egg or soy proteins, peanuts, or to any of the active substances, excipients, or components of the bag material;
• congenital disorders of amino acid metabolism;
• pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus;
• as with other calcium-containing infusion solutions – concomitant treatment with ceftriaxone in neonates (age ≤ 28 days), even when using a separate infusion system (risk of fatal precipitation of calcium-ceftriaxone salt in the infant’s bloodstream) (see sections "Interaction with other medicinal products and other types of interactions", "Special instructions", and "Incompatibility");
• severe hyperglycemia.

Addition of lipids (administration of Numeta G16E as an activated three-chamber bag with emulsion for intravenous infusion) is additionally contraindicated in the following clinical situations:

• severe hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia.

Interaction with other medicinal products and other types of interactions.

Pharmacodynamic interaction studies with Numeta G16E have not been conducted.

Numeta G16E must not be administered simultaneously with blood transfusion through the same infusion system due to the risk of pseudoagglutination.

As with other calcium-containing infusion solutions, concomitant use of Numeta G16E with ceftriaxone in full-term neonates (age ≤ 28 days) is contraindicated, even when using a separate infusion system (risk of fatal precipitation of calcium-ceftriaxone salt in the infant’s bloodstream).

When administering ceftriaxone to patients of any age (including adults), it must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, including Numeta G16E, even through different infusion systems or at different infusion sites, due to the risk of precipitation of calcium-ceftriaxone salt (see section "Special instructions").

However, in patients older than 28 days, ceftriaxone and calcium-containing solutions may be administered sequentially, provided different infusion systems or different infusion sites are used, or the infusion system is replaced or thoroughly flushed with saline solution between infusions to prevent precipitation.

Olive and soy oils contain natural vitamin K1, which is an antagonist of the anticoagulant activity of coumarin (or coumarin derivatives, including warfarin).

Since Numeta G16E contains potassium, particular attention should be paid to patients who are concurrently receiving potassium-sparing diuretics (such as amiloride, spironolactone, triamterene) or angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine, due to the risk of hyperkalemia.

The lipids contained in this emulsion may affect the results of certain laboratory tests (such as bilirubin, lactate dehydrogenase, blood oxygen saturation, hemoglobin) if blood samples are taken before lipid clearance. Lipids are generally cleared within 5–6 hours, unless additional administration is ongoing.

See also section "Incompatibility".

Special precautions for use.

Infusion should be stopped immediately if any signs or symptoms of an allergic reaction occur (such as fever, sweating, shivering, headache, skin rash, or dyspnea).

Numeta G16E contains glucose derived from corn starch. Therefore, this product should be used with caution in patients with known allergy to corn or corn products.

Fatal cases due to precipitation of ceftriaxone calcium salt in the lungs and kidneys have been reported in full-term neonates under 1 month of age receiving ceftriaxone.

Ceftriaxone must not be mixed or co-administered simultaneously with any calcium-containing intravenous solutions, including Numeta G16E, even via different infusion systems or at different infusion sites, due to the risk of precipitation of ceftriaxone calcium salt.

However, in patients older than 28 days, ceftriaxone and calcium-containing solutions may be administered sequentially if different infusion systems or different infusion sites are used, or if the infusion system is replaced or thoroughly flushed with physiological saline solution between infusions to prevent precipitation.

Pulmonary embolism and respiratory distress due to precipitation in pulmonary vessels have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphates increases the risk of calcium phosphate precipitation (see section "Incompatibilities"). There have also been reports of suspected precipitate formation in the bloodstream.

In addition to checking the solution, the infusion set and catheter should be periodically inspected for precipitate formation.

If symptoms of respiratory distress occur, the infusion should be stopped and appropriate medical evaluation initiated.

No additives should be introduced into the infusion bag without prior verification of ingredient compatibility, as precipitate formation or destabilization of the lipid emulsion may lead to vascular occlusion (see sections "Incompatibilities" and "Dosage and administration").

Infection and sepsis may occur due to the use of intravenous catheters for parenteral drug administration or poor catheter care. Immunosuppressive effects of disease or medications may predispose to infection and sepsis. Close monitoring for clinical symptoms and laboratory signs—such as fever/chills, leukocytosis, technical complications related to the medical device access system, and hyperglycemia—can help detect infection at an early stage. Patients requiring parenteral nutrition are often prone to infectious complications due to malnutrition and/or underlying disease. Strict adherence to aseptic techniques during catheter insertion, care, and preparation of parenteral nutrition formulations is essential to reduce the risk of septic complications.

Fat overload syndrome has been reported during administration of other parenteral nutrition products. Reduced or limited ability to metabolize the fats contained in Numeta G16E, or overdose, may lead to fat overload syndrome (see sections "Overdose" and "Side effects").

Refeeding severely malnourished patients may lead to refeeding syndrome, characterized by intracellular depletion of potassium, phosphate, and magnesium due to anabolic processes in the patient. Thiamine deficiency and fluid retention may also occur. Parenteral nutrition should be initiated cautiously and gradually, with careful monitoring of fluid, electrolyte, trace element, and vitamin levels.

Numeta G16E should be administered only via central veins, except when appropriate dilution has been performed (see section "Dosage and administration"). When adding other substances to the product, the final osmolarity of the mixture must be calculated before administration via peripheral vein to avoid venous irritation or tissue damage in case of extravasation. Peripheral administration of Numeta G16E has led to extravasation and, consequently, soft tissue damage and skin necrosis.

Bags must not be connected in series to avoid potential air embolism from residual gas in the first bag.

If needed, fats, vitamins, additional electrolytes, and trace elements should be supplemented.

Precautionary measures

No additional medicinal products or substances should be added to any of the three chambers of the bag or to the reconstituted solution/emulsion without prior confirmation of compatibility and final product stability (especially lipid emulsion stability) (see sections "Incompatibilities" and "Dosage and administration").

After adding trace elements and/or vitamins to intravenous parenteral nutrition solutions, exposure to light may lead to the formation of peroxides and other degradation products, which may adversely affect clinical outcomes in neonates. When administering Numeta G16E to neonates and children under 2 years of age, the product should be protected from light exposure until the end of the infusion (see sections "Dosage and administration" and "Shelf life").

Fluid and electrolyte balance should be monitored regularly throughout the treatment period, including serum osmolarity, serum triglyceride concentration, acid-base balance, blood glucose levels, liver and kidney function, blood cell counts (including platelets), and coagulation parameters.

Administration of Numeta G16E in unstable clinical conditions (e.g., after severe post-traumatic states, in decompensated diabetes mellitus, during acute circulatory shock, acute myocardial infarction, severe metabolic acidosis, severe sepsis, or hyperosmolar coma) should be carefully monitored and adjusted according to the patient's clinical needs.

Cardiovascular system

Use with caution in patients with pulmonary edema or heart failure. Fluid balance should be closely monitored.

Kidneys

Use with caution in patients with renal insufficiency. Fluid and electrolyte balance, including magnesium levels, should be closely monitored in such patients (see "Hypermagnesemia" below).

Severe fluid and electrolyte imbalances, severe fluid overload, and severe metabolic disturbances should be corrected before initiating infusion.

Liver/Gastrointestinal system

Use with caution in patients with severe hepatic insufficiency, including cholestasis, or elevated liver enzymes. Liver function parameters should be closely monitored.

Endocrine system and metabolism

Metabolic complications may occur if nutrient intake is not adapted to patient needs or if metabolic capacity for any dietary component is inaccurately assessed. Undesirable metabolic effects may result from inappropriate or excessive nutrient administration or from inadequate formulation of the mixture relative to the individual patient's needs.

Serum triglyceride levels and fat metabolism capacity should be regularly assessed. Monitoring of serum triglycerides is recommended when clinically necessary or if fat metabolism impairment is suspected.

In case of hyperglycemia, the infusion rate of Numeta G16E should be adjusted and/or insulin administered (see section "Overdose").

Blood

Use with caution in patients with severe coagulation disorders. Blood cell counts and coagulation parameters should be closely monitored.

Hypermagnesemia

Numeta G16E provides 0.3 mmol/kg/day of magnesium when administered at the maximum dose (see section "Dosage and administration"). There is a risk of hypermagnesemia, which may manifest as generalized weakness, hyporeflexia, nausea, vomiting, hypocalcemia, respiratory depression, arterial hypotension, and arrhythmia. Since signs of hypermagnesemia may be subtle, monitoring of magnesium levels is recommended at the beginning of treatment and at appropriate intervals thereafter, in accordance with standard clinical practice and individual patient needs. This is particularly important for patients at increased risk of hypermagnesemia, including those with impaired renal function, those receiving other medications that increase the risk of hypermagnesemia, or those receiving magnesium from other sources—e.g., neonates whose mothers recently received magnesium before delivery.

If serum magnesium levels are elevated (above the upper limit of the normal reference range), infusion of Numeta G16E should be discontinued or its rate reduced, taking into account clinical needs and safety considerations.

Use during pregnancy or breastfeeding.

Pregnancy

The medicinal product is intended only for full-term neonates and children up to 2 years of age.

Breastfeeding

The medicinal product is intended only for full-term neonates and children up to 2 years of age.

Reproductive function

The medicinal product contains glucose, pediatric amino acid solution, electrolytes, and lipid emulsion, which are unlikely to affect reproductive function.

Effect on ability to drive or operate machinery.

Not applicable.

Method of administration and dosage.

Dosage

Dosage depends on energy expenditure, body weight, age, clinical condition of the patient, and their ability to metabolize the components of Numeta G16E, as well as on the amount of additional energy or protein entering the body orally/enterally. The overall composition of electrolytes and macronutrients depends on the number of activated chambers (see section "Composition").

The maximum daily dose should not be exceeded. Due to the fixed composition of the multi-chamber bag, it may be impossible to simultaneously meet all of the patient's nutritional requirements. There may be clinical situations in which patients require nutrients in amounts different from those contained in the multi-chamber bag.

The maximum recommended infusion rate per hour and daily volume depend on the components of the medicinal product. If the limits of infusion rate or volume are reached, this determines the maximum daily dose. Table 1 provides the maximum recommended hourly infusion rates and daily volumes.

Table 1

a Restrictive parameter according to the methodological guidelines of the European Society for Parenteral and Enteral Nutrition – European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPEN-ESPGHAN).

Method of administration

When administered to newborns and children under 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until the end of infusion (see sections "Special precautions for use" and "Shelf life").

Due to its high osmolarity, undiluted Numeta G16E must be administered only through a central vein. However, adequate dilution of Numeta G16E with water for injections reduces osmolarity and allows administration via peripheral vein infusion. The following formula shows how dilution affects the osmolarity of the bag contents:

Final osmolarity = (bag volume × initial osmolarity) / (volume of added water + bag volume).

Examples of osmolarity of mixtures from activated 2-chamber and 3-chamber bags after addition of water for injections are given in Table 2.

Table 2

The infusion rate should be gradually increased during the first hour. At the end of the infusion, the administration rate should be gradually decreased over the last hour. The infusion rate should be adjusted according to the administered dose, daily volume, and duration of infusion (see section "Overdose").

The contents of a single bag should not be used for longer than 24 hours. Cyclic infusions should be prescribed according to the patient's metabolic tolerance.

Parenteral nutrition treatment may be continued as long as the patient's clinical condition requires it.

This medicinal product contains electrolytes, and other electrolyte preparations may be added at the physician's discretion depending on the patient's clinical needs.

Vitamins and trace elements may be added at the physician's discretion depending on the patient's clinical needs.

Instructions for use of the bags

For single use only.

Do not use damaged bags.

Check the integrity of the bag and the non-removable partitions. Use only undamaged bags with intact non-removable partitions (i.e., no mixing of the contents of the three chambers) and provided that the solutions in the amino acid and glucose chambers are clear, colorless or slightly yellowish, practically free from particles, and the lipid emulsion appears as a homogeneous milky liquid (see Figure 1).

A 1.2 µm filter is recommended for the administration of Numeta G16E.

Figure 1

Before opening the outer pouch, check the color of the oxygen indicator. Compare it with the reference color printed next to the "OK" mark and shown in the printed area of the indicator label. Do not use the product if the color of the oxygen indicator does not match the reference color printed next to the "OK" mark.

Opening: remove the protective outer pouch (see Figure 2). Dispose of the outer pouch and the sachet containing the oxygen absorber/indicator.

Figure 2

Mixing: ensure the product is at room temperature before breaking the non-removable partitions. Place the bag on a clean, flat surface.

Activation of 3 chambers (breaking two non-removable partitions)

Begin twisting the bag from the side of holder D (see Figure 3).

Figure 3

Apply pressure until the inter-chamber partitions open (see Figure 4).

Figure 4

Then change direction and twist the bag toward holder D; continue until the partition is fully opened.

Continue in the same direction to complete opening of the second inter-chamber partition (see Figure 5).

Figure 5

Turn the bag upside down at least three times to thoroughly mix the contents (see Figure 6). The mixed solution should appear as a milk-like emulsion.

Figure 6

Remove the protective cap from the administration port (see Figure 7) and connect the intravenous administration set.

Figure 7

Activation of 2 chambers (breaking the non-removable partition between the amino acid and glucose chambers)

To break only the partition between the amino acid and glucose chambers, begin twisting from the corner of the partition near holder D (see Figure 8) that separates the amino acid and glucose chambers, and apply pressure to open the partition between these two chambers.

Figure 8

Orient the bag so that the compartment containing the lipid emulsion is closest to the operator, and twist the bag while protecting the lipid emulsion compartment from breaking the partition with the palms (see Figure 9).

Figure 9

Apply pressure with one hand, twisting the bag toward the tubes (see Figure 10).

Figure 10

Then begin twisting the bag toward holder D, pressing with the other hand, and continue until the partition between the amino acid and glucose compartments is fully opened (see Figure 11).

Figure 11

Turn the bag upside down at least three times to thoroughly mix the contents (see Figure 12). The mixed solution should appear as a clear, colorless or slightly yellow liquid.

Figure 12

Remove the protective cap from the administration port (see Figure 13) and connect the intravenous administration set.

Figure 13

Addition of additives

When used in newborns and children under 2 years of age, the solution should be protected from light exposure until administration is complete.

Exposure of Numeta G16E to ambient light, especially after addition of trace elements and vitamins, may promote the formation of peroxides and other degradation products, which can be prevented by protecting from light (see sections "Special precautions for use" and "Shelf life"). Any additions may be made to the reconstituted mixture (after opening the non-removable partitions and mixing the contents of two or three chambers). Vitamins may also be added to the glucose chamber prior to reconstitution (before opening the non-removable partitions and mixing the solutions and emulsion).

To perform additions

Aseptic technique must be followed.

Prepare the injection site on the bag.

Puncture the bag and add the additional substances using an injection needle or reconstitution device.

Mix the contents of the bag and the added substances.

Preparation for infusion

Aseptic technique must be followed.

Hang the bag.

Remove the protective cap from the administration port.

Firmly insert the infusion set needle into the administration port.

Performing the infusion

Administer the product only after opening the non-removable partitions between two or three chambers and mixing the contents of two or three chambers.

Ensure the absence of signs of phase separation in the ready-to-use, activated 3-chamber emulsion for infusion, or the absence of particles in the prepared 2-chamber infusion solution.

After opening, the contents must be used immediately. Storage for subsequent infusion is prohibited.

Under no circumstances should a partially used bag be connected.

Do not connect bags in series, to avoid air embolism due to possible residual gas in the first bag.

Any unused medicinal products or waste, as well as all necessary disposable materials, must be disposed of and must not be reused.

Children

The product is indicated for use in term newborns and children under 2 years of age for parenteral nutrition.

Overdose

In case of improper use (overdose and/or exceeding the recommended infusion rate), symptoms such as nausea, vomiting, tremor, electrolyte imbalance, and signs of hypervolemia or acidosis with potentially fatal outcome may occur. In such cases, the infusion must be stopped immediately. Additional interventions may be required if medically indicated.

If the glucose infusion rate exceeds its clearance, hyperglycemia, glucosuria, and hyperosmolar syndrome may develop.

Overdose or reduced or limited ability to metabolize lipids may lead to fat overload syndrome, the consequences of which usually resolve after discontinuation of lipid administration (see section "Adverse reactions").

In newborns and infants, fat overload syndrome has been associated with metabolic acidosis and respiratory distress.

There is no specific antidote for overdose. Emergency procedures usually consist of supportive measures, with particular attention to the respiratory and cardiovascular systems. In some severe cases, hemodialysis, hemofiltration, or hemodiafiltration may be required.

Severe cases of fat overload syndrome have been reported in the scientific literature and were treated with exchange transfusion.

Careful monitoring of blood biochemistry is extremely important; any detected deviations from normal values require appropriate treatment.

Adverse reactions.

Adverse reactions observed in clinical trials and during the post-marketing period

The safety of Numeta G16E was evaluated in one phase III clinical trial. The study included one hundred and fifty-nine (159) children who received Numeta G16E.

Table 3 lists the adverse reactions observed in this study and during the post-marketing period.

Table 3

1 Blood samples were taken during infusion (not in the fasting state).

2 Frequency was determined according to the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data).

3 These adverse reactions were reported only with peripheral administration of Numeta G13E and G16E formulations when insufficiently diluted (see section "Special precautions for use").

Other reactions

Below are adverse reactions observed after administration of other parenteral nutrition mixtures.

• Fat overload syndrome may develop due to improper use of the product (e.g. overdose and/or exceeding the recommended infusion rate, see section "Overdose"); however, signs of this syndrome may also occur when the product is administered according to instructions. Impaired or limited ability to metabolize lipids contained in Numeta G16E is associated with prolonged plasma clearance and may lead to the development of fat overload syndrome. This syndrome is associated with sudden deterioration in the patient's clinical condition and is characterized by pathological changes such as hyperlipidemia, elevated body temperature, fatty infiltration of the liver (hepatomegaly), impaired liver function, anemia, leukopenia, thrombocytopenia, coagulation disorders, acute respiratory distress, metabolic acidosis, and manifestations from the central nervous system (e.g. coma). The syndrome usually resolves after discontinuation of lipid emulsion infusion.
• Pulmonary vascular precipitates (pulmonary embolism and respiratory distress) (see section "Special precautions for use").

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

18 months.

When administered to newborns and children under 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until the end of administration.

Shelf life after reconstitution

The product should be used immediately after opening the non-permanent partitions between two or three chambers. However, stability data for reconstituted mixtures indicate that the product remains stable for 7 days when stored at 2–8 °C, followed by storage for up to 48 hours at 30 °C.

Shelf life after supplementation (with electrolytes, trace elements, vitamins, water)

Stability of individual mixtures of Numeta G16E has been demonstrated during use for 7 days when stored at 2–8 °C, followed by storage for up to 48 hours at 30 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage duration and conditions during use lies with the user; storage should generally not exceed 24 hours at 2–8 °C, except when reconstitution/dilution/supplementation is performed under controlled and validated aseptic conditions.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Incompatibilities.

This medicinal product should not be mixed with other medicinal products unless compatibility studies are available (see section "Method of administration and dosage").

As with other parenteral nutrition mixtures, the calcium-phosphate ratio must be considered. Excessive addition of calcium and phosphate, especially in the form of mineral salts, may lead to calcium phosphate precipitate formation.

As with other calcium-containing infusion solutions, concomitant treatment with ceftriaxone and Numeta G16E is contraindicated in neonates (≤ 28 days of age), even when using separate infusion lines (risk of fatal precipitation of ceftriaxone calcium salt in the infant's bloodstream, see section "Interaction with other medicinal products and other forms of interaction").

For patients of any age, ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, including Numeta G16E, even via different infusion systems or at different infusion sites, due to the risk of ceftriaxone calcium salt precipitation.

Due to the risk of precipitate formation, Numeta G16E should not be administered through the same infusion line together with ampicillin, phenytoin, or furosemide.

Numeta G16E must not be administered simultaneously with blood through the same infusion line (see section "Interaction with other medicinal products and other forms of interaction").

Numeta G16E contains calcium ions, which may pose an additional risk of coagulation of precipitated blood or blood components to which citrate has been added as an anticoagulant/preservative.

Packaging.

500 ml (50 % glucose solution – 155 ml; 5.9 % amino acid solution with electrolytes – 221 ml; 12.5 % lipid emulsion – 124 ml) in a three-chamber plastic bag. The three-chamber plastic bag is enclosed in a protective film wrapper containing an oxygen absorber and an oxygen indicator. Packs of 6 bags in a cardboard box.

Prescription category.

Prescription only.

Manufacturer.

Baxter S.A. / Baxter SA

Manufacturer's location and address of place of business.

Boulevard Rene Branquart 80, Lessines, 7860, Belgium / Boulevard Rene Branquart 80, Lessines, 7860, Belgium