Composition of NUTRYELT expressed in quantities of salts per ampoule (10 mL) and per litre. (See Table 1.)
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Content per ampoule of 10 mL: (See Table 2.)
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This product contains 0.052 mmol of sodium (1.2 mg) per dose, i.e., essentially "sodium-free".
This product contains 0.001 mmol of potassium (0.039 mg) per dose, i.e., essentially "potassium-free".
2.6 to 3.2.
60 to 100 mOsm/kg.
60 to 100 mOsm/L.
Hydrochloric acid (for pH adjustment); Water for Injections.
Pharmacotherapeutic group: Electrolyte solutions. ATC code: B05XA31.
Pharmacology: Pharmacodynamics: NUTRYELT is a balanced solution composed of nine essential trace elements, which are necessary to maintain the metabolic equilibrium.
Trace elements are normally derived from a balanced diet, but the need increases in cases of insufficient supply or abnormal loss, hypercatabolism (surgery, major trauma, burns), and in cases of poor absorption (short bowel disease or Crohn's disease).
During artificial nutrition, the supply of trace elements is necessary because a deficiency of any one of them can generate important metabolic and clinical disturbances.
Pharmacokinetics: The various pathways of trace element metabolism can be summarised as follows: Blood transport by proteins: albumin (Mn, Cu, Zn, Se), transferrin (Fe, Cr), ceruloplasmin (Cu), selenomethionine (Se), or non-protein carriers (F, I, Mo).
Storage involving specific proteins: ferritin (Fe), thyroid hormones (I), selenoproteins (Se), or non-specific proteins: metallothioneins (Cu, Zn, Mn, Mo) or fluoroapatite (F).
Elimination: The cationic trace elements (Fe, Cu, Mn, Zn) are eliminated mainly through biliary excretion. The anionic trace elements (I, F) and some oxygenated forms of minerals (Mo, Se, Cr) are primarily excreted in the urine.
Elimination through the lungs and the skin is possible.
Toxicology: Preclinical safety data: Since trace element solutions for intravenous injection are well-known products that have been used for medical purposes for many decades, no preclinical studies have been specifically performed with NUTRYELT.
NUTRYELT is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition.
NUTRYELT is indicated in adults only.
Posology: For adults only.
The recommended daily dose in patients with basal to moderately increased requirements is one ampoule (10 mL) of NUTRYELT.
In cases of significantly increased trace element requirements (such as extensive burns, patients in severe hypercatabolic state due to major trauma) two ampoules (20 mL) of NUTRYELT may be given per day, and monitoring of serum trace element level is recommended.
In patients with renal, hepatic impairments or mild cholestasis the posology should be adapted (see Precautions).
Paediatric population: NUTRYELT is contraindicated in children (see Contraindications and Precautions).
Method of administration: NUTRYELT is not intended to be administered in its current presentation. It should be diluted according to the final desired osmolarity. The osmolarity value of the final preparation allows either administration through a peripheral vein, or only central venous catheter.
For incompatibilities and instructions for use see Incompatibilities and Special precautions under Cautions for Usage.
If overdose is suspected, treatment with NUTRYELT should be discontinued. Overdose should be confirmed by appropriate laboratory tests.
Hypersensitivity to the active substances or to any of the excipients listed in Description.
Pronounced cholestasis (serum bilirubin > 140 μmol/L).
In cases of Wilson's disease and hemochromatosis.
If serum concentrations of any of the trace elements contained in NUTRYELT are elevated.
Hypersensitivity including Anaphylactic/Anaphylactoid Reactions: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies including drug allergies.
Risk of Iron Overload: Serum ferritin should be monitored regularly, particularly in case of impaired renal function and for patients receiving repeated blood transfusions.
Monitoring Blood Manganese Levels: Blood manganese levels should be regularly monitored in case of prolonged artificial nutrition. Dose reduction may be necessary. Stop NUTRYELT infusion if manganese levels rise into the potentially toxic range. The occurrence of neurological signs may represent manganese toxicity.
Use in Patients with Reduced Biliary Excretion: Use with caution in patients with reduced biliary excretion, as elimination of manganese, copper and zinc may be significantly decreased, leading to accumulation and overdose.
Use in Special Populations: Use with caution in patients with renal impairment, hepatic impairment, or mild cholestasis, as excretion of some trace elements (selenium, fluoride, chromium, molybdenum and zinc) may be significantly decreased.
Use in Patients Undergoing Medium to Long-Term Parenteral Nutrition: In patients undergoing medium to long-term parenteral nutrition, there is an increased occurrence of iron, zinc and selenium deficiency. In this circumstance, administration of supplemental iron, zinc, and/or selenium may be required.
General Monitoring: Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Chromium deficiency leads to a decrease in glucose tolerance, which improves after chromium supplementation. As a consequence, in diabetic patients on insulin medication, relative overdose of insulin and consecutive hypoglycemia may occur. Therefore controls of the blood glucose levels are recommended and re-adjustment of the insulin doses may become necessary.
NUTRYELT should be given with caution in cases of manifest hyperthyroidism or sensitivity to iodine if other iodine containing medicinal products (e.g., iodine antiseptic) are administered concomitantly.
Effects on ability to drive and use machines: There is no information of the effects of NUTRYELT on the ability to drive or operate an automobile or other heavy machinery.
Use in Children: Safety and effectiveness in the pediatric population have not been established.
There are no adequate data from the use of NUTRYELT in pregnant or lactating women.
Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing NUTRYELT.
The following adverse reaction(s) have been reported during post-marketing experience of other IV iron-containing products. The frequency is not known (cannot be estimated from the available data).
General Disorders and Administration Conditions:
Pain at application site.
Immune System Disorders:
Hypersensitivity reactions including fatal anaphylactic reactions.
No interaction studies have been performed with NUTRYELT.
Iron salts (oral route): Fainting or shock attributed to the rapid release of iron from its complex shape and transferrin saturation.
Special precautions: Before use, check that the concentrate for solution for infusion is homogeneous and that the bottle is not damaged and is free of particles.
NUTRYELT is not intended to be administered in its current presentation.
NUTRYELT must be diluted or mixed with gentle agitation during preparation under strict aseptic conditions, before infusion.
NUTRYELT must be diluted with respect to the final appropriate osmolarity. For example: 10 to 20 mL of NUTRYELT can be diluted in at least 250 mL of Sodium Chloride 0.9 % solution for infusion, 10 to 20 mL of NUTRYELT can be diluted in at least 250 mL of Glucose 5% solution for infusion.
The pH after reconstitution of 20 mL of NUTRYELT with 250 mL Sodium Chloride 0.9% will be 3.3, or 3.3-3.4 with Glucose 5%.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear.
For single use only. Do not store partially used containers and discard all unused solution.
Ensure compatibility with solutions administered simultaneously via a common inlet cannula.
Incompatibilities: NUTRYELT must not be used as a vehicle for other drugs.
NUTRYELT, as with other trace element solution, cannot be added directly to inorganic phosphate (Additive) solutions.
Degradation of ascorbic acid in parenteral nutrition mix is accelerated by trace elements.
This medical product must not be mixed with other medicinal products except those mentioned previously.
Do not freeze.
Keep the container in the outer carton in order to protect from light.
Shelf life: 24 months.
After dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 25°C protected from light.
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
A12CX - Other mineral products ; Used as dietary supplements.
Conc for soln for infusion (amp) (clear and slightly yellow solution) 10 mL x 10's.