Nutriflex Peri

Leaflet accompanying the packaging: information for the user

Nutriflex peri set of two solutions for preparing an infusion solution

Amino acids / Glucose / Electrolytes

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 peri, and what is it used for
• 2. Before using Nutriflex peri
• 3. How to use Nutriflex peri
• 4. Possible side effects
• 5. How to store Nutriflex peri
• 6. Contents of the packaging 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 using Nutriflex peri

When not to use Nutriflex peri:

Similar to other medicines of this type, Nutriflex peri 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 oxygenation, 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 administered to newborns, infants, and children under 2 years of age.

Warnings and precautions

Before starting treatment with Nutriflex peri, 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 monitored in patients with kidney, liver, adrenal, heart, or lung failure. The doctor will exercise particular caution in patients with a compromised 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 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. It is necessary to closely monitor blood sugar levels, especially after discontinuation of the infusion. It is also necessary to monitor electrolyte levels, fluid balance, and acid-base balance, red blood cell count, clotting factors, and liver function. The doctor will ensure that the patient receives adequate fluids and 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 doctor will check the infusion site daily. As with all intravenous solutions, strict aseptic rules must be followed during Nutriflex peri infusion.

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 administered to newborns, infants, and children under 2 years of age.

Nutriflex peri 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 peri 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]);
• 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 receive this medicine only if the 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 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 the patient needs and how long they will require treatment with this medicine. The recommended dose for adult patients is up to 40 ml of the 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 2-17 years. The doctor knows what dosage to use for patients in this age group.

Using a higher dose of Nutriflex peri 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 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;
• 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. In case of any doubts, the patient should consult their 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.

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

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, 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 peri

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 peri 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 injection.

What Nutriflex peri 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 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 update of the leaflet:2023-04-18 .
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Information intended for healthcare professionals only:

Nutriflex peri can only be used if the solution is clear and the packaging is not damaged. Preparation of 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 aseptic rules should be followed. Maximum infusion rates:The maximum infusion rate for adult patients, children, and adolescents aged 2-17 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.