Nutriflex Basal

Leaflet attached to the packaging: information for the user

Nutriflex basal set of two solutions for preparing an infusion solution

Amino acids / Glucose / Electrolytes

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents:

• 1. What is Nutriflex basal and what is it used for
• 2. Before using Nutriflex basal
• 3. How to use Nutriflex basal
• 4. Possible side effects
• 5. How to store Nutriflex basal
• 6. Contents of the packaging and other information

1. What is Nutriflex basal and what is it used for

This medicine contains fluids and substances called amino acids, salts (electrolytes), and carbohydrates (glucose) that are necessary for the growth of the body or for recovery, as well as calories in the form of carbohydrates. Since the patient is unable to eat properly or cannot be fed through a tube, this medicine will be administered directly into a vein (infusion). Nutriflex basal is particularly indicated for adults and children and adolescents aged 2-17 years with mild or moderate catabolism, a condition in which the patient consumes energy resources, protein, etc. faster than they can be replenished.

2. Before using Nutriflex basal

When not to use Nutriflex basal:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has congenital disorders of amino acid metabolism, which requires the use of a special protein diet;
• if the patient has elevated blood sugar levels, requiring the administration of insulin in doses above 6 units per hour;
• if the patient has elevated acid content in the blood (acidosis);
• if the patient has bleeding in the skull or spinal cord;
• if the patient has severe liver failure;
• if the patient has severe kidney failure without access to renal replacement therapy (hemofiltration or dialysis).

Similarly to other medicines of this type, Nutriflex basal should not be used in the following cases:

• acute phase of a heart attack (myocardial infarction) or shock;
• any untreated metabolic disorders, such as loss of consciousness (coma) of unknown origin or insufficient tissue oxygen supply, or uncontrolled diabetes;
• life-threatening circulatory disorders that may occur, for example, during collapse or shock, fluid accumulation in the lungs (pulmonary edema), or fluid balance disorders.

Nutriflex basal should not be administered to newborns, infants, and children under 2 years of age.

Warnings and precautions

Before starting treatment with Nutriflex basal, the patient should discuss it with their doctor. The patient should inform their doctor if:

• they have heart or kidney problems;
• they have fluid, electrolyte, or acid-base disorders, such as low fluid and electrolyte levels (hypotonic dehydration) or low sodium or potassium levels in the blood;
• they have elevated blood sugar levels.

The dose of the medicine should be carefully adjusted and controlled in patients with kidney, liver, adrenal, heart, or lung failure. The doctor will exercise particular caution in patients with a damaged blood-brain barrier, as this medicine may increase pressure in the skull or spinal cord. In patients with severe malnutrition, parenteral nutrition should be introduced gradually, with great caution. It is necessary to ensure adequate electrolyte supply, particularly potassium, magnesium, and phosphate. This medicine contains glucose (a type of sugar), which may affect the patient's blood sugar levels. Blood samples may need to be taken to check this. Sudden interruption of the infusion may lead to a sudden drop in blood sugar levels. The doctor will take this into account, especially in patients with impaired glucose metabolism (e.g., diabetic patients) and in children under 3 years of age. Therefore, blood sugar levels should be closely monitored, especially after interruption of the infusion. Electrolyte levels, fluid balance, and acid-base balance should also be monitored, as well as red blood cell count, clotting factors, and liver function. The doctor will ensure that the patient is properly hydrated and receives adequate electrolytes. To meet the patient's nutritional needs, other nutritional substances will be administered with Nutriflex basal. As with all intravenous solutions, strict aseptic rules must be followed during infusion of Nutriflex basal.

Children and adolescents

Regarding the sudden drop in blood sugar levels in children and adolescents after sudden interruption of the infusion, see the "Warnings and precautions" section. Nutriflex basal should not be administered to newborns, infants, and children under 2 years of age.

Nutriflex basal and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Nutriflex basal may interact with some other medicines. The patient should tell their doctor if they are taking or receiving any of the following medicines:

• medicines used to treat inflammatory conditions (corticosteroids);
• hormonal preparations that affect fluid balance (adrenocorticotropic hormone [ACTH]);
• medicines that increase urine production (diuretics), such as spironolactone, triamterene, or amiloride;
• medicines used to treat high blood pressure (ACE inhibitors), such as captopril and enalapril;
• medicines used to treat high blood pressure or heart disease (angiotensin II receptor antagonists), such as losartan and valsartan;
• medicines used in organ transplants, such as cyclosporine and tacrolimus.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. PregnancyIf the patient is pregnant, they will only receive this medicine if their doctor considers it absolutely necessary for their recovery. BreastfeedingBreastfeeding is not recommended for mothers receiving parenteral nutrition. FertilityThere is no available data.

Driving and using machines

This medicine is usually administered to immobilized patients, e.g., in a hospital or clinic, which excludes driving and operating machines. However, the medicine itself does not affect the ability to drive or operate machines.

3. How to use Nutriflex basal

This medicine is administered by intravenous infusion (drip), i.e., through a thin tube directly into a vein. Before starting the infusion, the medicine should be warmed to room temperature. The doctor will decide how much of this medicine the patient needs and how long they will need treatment with it. The recommended dose for adult patients is up to 40 ml of infusion solution per kg of body weight. The doctor will determine the dose.

Use in children and adolescents

The dose should be adjusted for children and adolescents aged 2 to 17 years. The doctor knows what dosage to use for patients in this age group.

Using a higher dose of Nutriflex basal than recommended

If the patient receives too much of this medicine, they may experience an overload syndrome, and the following symptoms may occur:

• excess fluid (overhydration);
• increased urine production (polyuria);
• electrolyte balance disorders;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in the urine and amino acid balance disorders;
• accumulation of acidic substances in the blood (metabolic acidosis);
• vomiting, nausea, chills, headache;
• elevated blood sugar levels (hyperglycemia);
• glucose in the urine (glycosuria);
• fluid deficiency (dehydration);
• significantly higher blood component levels than normal (hyperosmolality)
• disorders or loss of consciousness due to extremely high blood sugar levels (hyperglycemic-hyperosmolar coma).

If any of these symptoms occur, the infusion should be stopped immediately. The doctor will decide whether further treatment is necessary. Before resuming the infusion, any disorders should be corrected. If there are any doubts, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Nutriflex basal can cause side effects, although not everybody gets them. Side effects are usually the result of overdose or too rapid infusion and usually disappear after the infusion is stopped. Rarely (occurring in 1 to 1,000 patients)

• Nausea, vomiting, and loss of appetite.

If side effects occur, the infusion should be stopped or, if appropriate, continued at a lower dose.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: website: https://smz.ezdrowie.gov.plSide effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nutriflex basal

The medicine should be stored in a place inaccessible to children. Do not store above 25°C. The bag should be stored in the outer packaging to protect it from light. Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.

6. Contents of the packaging and other information

What Nutriflex basal contains

The active substances of the medicine are amino acids, glucose, and electrolytes. Each bag contains:

Other ingredients of the medicine are citric acid and water for injections.

What Nutriflex basal looks like and what the packaging contains

This medicine is an infusion solution, i.e., it is administered through a thin tube directly into a vein. Nutriflex basal is supplied in dual-chamber bags for infusion. The lower chamber contains glucose, and the upper chamber contains an amino acid solution. The glucose and amino acid solutions are clear, colorless, or slightly yellowish in color. The medicine is supplied in dual-chamber plastic bags containing:

• 1000 ml (400 ml amino acids + 600 ml glucose)
• 2000 ml (800 ml amino acids + 1200 ml glucose)

Pack sizes: 5 × 1000 ml, 5 × 2000 ml Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany

Address for correspondence 34209 Melsungen, Germany Tel.: +49-5661-71-0 Fax: +49-5661-71-4567 Date of last revision of the leaflet:2023-04-18 .__________________________________________________________________________

Information intended for healthcare professionals only:

Before starting the infusion, the medicine should be warmed to room temperature. Nutriflex basal can only be used if the solution is clear and the packaging is not damaged. Any unused solution should be discarded. Preparing the mixed solution:The partition between the chambers should be broken immediately before use, and the contents of the chambers should be mixed under aseptic conditions. Remove the bag from the protective packaging and follow the instructions below:

• Unfold the bag and place it on a stable surface.
• Open the breakable partition using both hands.
• Briefly mix the contents of the chambers.

An additional port allows for the addition of other substances to Nutriflex basal. When adding other solutions or fat emulsions to Nutriflex basal, aseptic rules should be followed. A special infusion set can be used to easily add fat emulsions to the solution. Maximum infusion rates:The maximum infusion rate for adult patients, children, and adolescents aged 2 to 17 years is 2.0 ml per kg of body weight per hour. Storage after mixing the contents of the bagNutriflex basal should be used immediately after mixing the contents of both chambers. If the medicine cannot be used immediately after mixing the chambers, it can be stored for up to 7 days at room temperature and up to 14 days at a temperature of 2 – 8°C (including administration time). Partially used containers should not be reconnected.