Nutriflex Plus

Package Leaflet: Information for the User

Nutriflex peri, a set of two solutions for preparing an infusion solution

Amino Acids / Glucose / Electrolytes

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

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

1. What is Nutriflex peri 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 peri 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 you use Nutriflex peri

When not to use Nutriflex peri:

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

As with other medicines of this type, Nutriflex peri should not be used in the following cases:

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

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

Warnings and precautions

Before starting treatment with Nutriflex peri, discuss it with your doctor. You should inform your doctor if:

• you have heart or kidney problems;
• you 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;
• you have high blood sugar levels.

The dose of the medicine should be carefully adjusted and monitored 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. Ensure adequate electrolyte supply, especially potassium, magnesium, and phosphate. This medicine contains glucose (a type of sugar), which may affect the patient's blood sugar levels. Blood samples may be necessary to check this. Abrupt discontinuation 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 discontinuation of the infusion. Electrolyte levels, fluid balance, and acid-base balance should also be monitored, as well as red blood cell count, coagulation 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 peri. During peripheral vein infusions, vein inflammation causing blood clots may occur. The attending physician will check the infusion site daily. As with all intravenous solutions, strict asepsis should be observed during infusion of Nutriflex peri.

Children and adolescents

Regarding the sudden drop in blood sugar levels in children and adolescents after abrupt discontinuation of the infusion, see "Warnings and precautions". Nutriflex peri should not be given to newborns, infants, and children under 2 years of age.

Nutriflex peri and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Nutriflex peri may interact with some other medicines. Tell your doctor if you 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]);
• 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. PregnancyIf you are pregnant, you will only receive this medicine if your doctor considers it absolutely necessary for your recovery. BreastfeedingBreastfeeding is not recommended for mothers receiving parenteral nutrition. FertilityThere are 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 using machines. However, the medicine itself does not affect the ability to drive and use machines.

3. How to use Nutriflex peri

This medicine is administered by intravenous infusion (drip), i.e., through a thin tube directly into a vein. This medicine will be administered into one of the smaller (peripheral) or larger (central) veins. Before starting the infusion, the medicine should be warmed to room temperature. The doctor will decide how much of this medicine you need and how long you 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 more than the recommended dose of Nutriflex peri

If you receive too much of this medicine, you may experience an overload syndrome and the following symptoms may occur:

• excess fluid (overhydration);
• increased urine production (polyuria);
• electrolyte imbalance;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in the urine and amino acid imbalance;
• accumulation of acidic substances in the blood (metabolic acidosis);
• vomiting, nausea, chills, headache;
• high 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 you have any further questions, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Nutriflex peri 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. Frequent(occurring in 1 to 10 patients)

• Vein irritation, inflammation of the vein wall at the infusion site (phlebitis, thrombophlebitis).

Rare(occurring in 1 to 1,000 patients)

• Nausea, vomiting, and loss of appetite.

If side effects occur, the infusion should be stopped or, if necessary, continued at a lower dose. If symptoms of vein irritation or inflammation occur, the doctor will consider changing the infusion site.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.plSide effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nutriflex peri

Keep the medicine out of the sight and reach of 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 month stated.

6. Contents of the pack and other information

What Nutriflex peri contains

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

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

What Nutriflex peri looks like and contents of the pack

This medicine is an infusion solution, i.e., it is administered through a thin tube directly into a vein. Nutriflex peri 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. 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)

Package sizes: 5 × 1000 ml, 5 × 2000 ml Not all package 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:

Nutriflex peri can only be used if the solution is clear and the packaging is not damaged. Preparing the mixed solution:Remove the bag from the protective packaging and follow the instructions below:

• 1. Open the bag and lay it flat on a stable surface.
• 2. Open the inner partition using both hands. Briefly mix the contents of the bag.
• 3. The homogeneous mixture is ready for use. The infusion can be started using standard methods.

Any unused solution should be discarded. Nutriflex peri should be opened immediately before administration. When mixing the contents of the chambers and during infusion, strict asepsis should be observed. Maximum infusion rates:The maximum infusion rate for adult patients, children, and adolescents aged 2 to 17 years is 2.8 ml per kg of body weight per hour. Storage after mixing the contents of the bagThe ready-to-use infusion solution, after mixing the contents of the chambers, can be stored at room temperature for no longer than 24 hours.