Nutriflex plus

Package leaflet: Information for the user

Nutriflex Peri set of two solutions for infusion concentrate
Amino acids / Glucose / Electrolytes
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents:

1. What Nutriflex Peri is and what it is used for
2. Before you are given 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 Nutriflex Peri is and what it is used for

This medicine contains fluids and substances called amino acids, salts (electrolytes), and carbohydrates (glucose), which are essential for body growth or recovery, as well as calories in the form of carbohydrates.
Since the patient is unable to eat properly or be fed via a feeding tube, this medicine will be administered directly into a vein (intravenous infusion).
Nutriflex Peri is particularly indicated for adults and children and adolescents aged 2–17 years with mild to moderate catabolism, a condition in which the patient uses up energy and protein reserves faster than they can be replenished.

2. Before using Nutriflex peri

When not to use Nutriflex peri:

• if the patient is allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if the patient has congenital amino acid metabolism disorders requiring a special protein diet;
• if the patient has high blood sugar levels requiring insulin administration at doses exceeding 6 units per hour;
• if the patient has increased levels of acidic substances in the blood (acidosis);
• if the patient has bleeding within 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).

As with other similar medicines, Nutriflex peri must not be used in the following cases:

• acute phase of heart attack (myocardial infarction) or shock;
• any untreated or inadequately treated metabolic disorders, e.g. loss of consciousness (coma) of unknown origin, inadequate tissue oxygenation, or uncontrolled diabetes;
• life-threatening circulatory disorders, such as those occurring during collapse or shock, fluid accumulation in the lungs (pulmonary edema), or disturbances in water balance.

Nutriflex peri must not be administered to newborns, infants, or children under 2 years of age.
Warnings and precautions
Before starting treatment with Nutriflex peri plus, discuss this with your doctor.
Inform your doctor if:

• the patient has heart or kidney disorders;
• the patient has fluid, electrolyte, or acid-base imbalances, for example low levels of fluids and electrolytes (hypotonic dehydration) or low levels of sodium or potassium in the blood;
• the patient has high blood sugar levels.

Dosage must be carefully adjusted and monitored in patients with kidney, liver, adrenal, heart, or lung failure.
The doctor will exercise particular caution in patients with impaired blood-brain barrier, as this medicine may increase intracranial or intraspinal pressure.
In patients with severe malnutrition, parenteral nutrition should be introduced gradually and with great caution. Adequate supply of electrolytes, particularly potassium, magnesium, and phosphate, must be ensured.
This medicine contains glucose (a type of sugar), which may affect the patient's blood sugar levels. Blood samples may therefore need to be taken to monitor this.
Sudden interruption of the infusion may lead to a rapid drop in blood sugar levels. The doctor will take this into account, especially in patients with impaired glucose metabolism (e.g. patients with diabetes) and in children under 3 years of age. Therefore, blood sugar levels should be closely monitored, particularly after stopping the infusion.
Electrolyte levels in the blood, fluid balance, acid-base balance, red blood cell count, coagulation factors, and liver function should also be monitored.
The doctor will ensure appropriate fluid and electrolyte replacement. To meet the patient's nutritional requirements, other nutritional substances will be administered alongside Nutriflex peri.
When administered via peripheral veins, phlebitis with thrombus formation may occur. The attending physician will check the venous access site daily.
As with all intravenous solutions, strict aseptic techniques must be observed during infusion of Nutriflex peri.
Children and adolescents
Regarding sudden drop in blood sugar levels in children and adolescents after abrupt interruption of infusion, see section “Warnings and precautions”.
Nutriflex peri must not be administered to newborns, infants, or children under 2 years of age.
Nutriflex peri and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Nutriflex peri may interact with certain other medicines. Inform your doctor if the patient is taking or receiving any of the following medicines:

• medicines used to treat inflammatory conditions (corticosteroids);
• hormonal preparations affecting 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 conditions (angiotensin II receptor antagonists), such as losartan and valsartan;
• medicines used in organ transplantation, such as cyclosporine and tacrolimus.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
The patient will receive this medicine during pregnancy only if the doctor considers it absolutely necessary for her recovery.
Breastfeeding
Breastfeeding is not recommended for mothers receiving parenteral nutrition.
Effect on fertility
No data are available.
Driving and using machines
This medicine is usually administered to immobilized patients, for example in hospital or clinic settings, which excludes driving and operating machinery. However, the medicine itself does not affect the ability to drive or operate machinery.

3. How to use Nutriflex peri

This medicine is administered by intravenous infusion (drip infusion), meaning through a thin tube directly into a vein.
This medicine will be given into one of the smaller (peripheral) or larger (central) veins.
Before starting the infusion, the medicine should be warmed to room temperature.
Your doctor will decide how much of this medicine you need and how long you will require treatment with this medicine.
The recommended dose for adult patients is up to 40 ml of infusion solution per kg of body weight.
Your doctor will determine the appropriate dose.

Use in children and adolescents
The dose should be adjusted for children and adolescents aged 2 to 17 years. Your doctor knows the appropriate dosage for patients in this age group.

Administration of a higher than recommended dose of Nutriflex peri
If too high a dose of this medicine is administered, the patient may develop so-called overhydration syndrome and the following symptoms may occur:

• excess fluid (fluid overload);
• increased urine output (polyuria);
• electrolyte imbalances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in urine and amino acid imbalances;
• accumulation of acidic substances in the blood (metabolic acidosis);
• vomiting, nausea, chills, headache;
• elevated blood sugar levels (hyperglycemia);
• glucose in the urine (glucosuria);
• lack of fluids (dehydration);
• significantly higher blood component concentrations than normal (hyperosmolality);
• disturbances or loss of consciousness due to extremely high blood sugar levels (hyperglycemic-hyperosmolar coma).

If any of these symptoms occur, the infusion must be stopped immediately. The doctor will decide whether further treatment is necessary. Any imbalances should be corrected before resuming the infusion.
If you have any doubts, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are usually the result of overdose or infusion administered too rapidly, and typically resolve after
stopping the infusion.
Common (occur in 1 to 10 patients):

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

Rare (occur in 1 to 1,000 patients):

• Nausea, vomiting, and loss of appetite.

If adverse reactions occur, the infusion should be discontinued or, if appropriate, continued at a reduced rate.
If symptoms of irritation or phlebitis occur, the physician will consider changing the infusion site.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine’s safety and helps provide more information on its safe use.

5. How to store Nutriflex Peri

Keep this medicine out of the reach and sight of children.
Do not store above 25°C.
Store the bag in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

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 after mixing contains:

The 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 infusion bags. The lower chamber contains glucose, and the upper chamber contains an amino acid solution. The glucose and amino acid solutions are clear, colourless 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)

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

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Correspondence address:
34209 Melsungen
Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

Information intended exclusively for medical professionals:

Nutriflex Peri may only be used if the solution is clear and the packaging is undamaged.
Preparation of the mixed solution:
Remove the bag from its protective packaging and proceed as follows:

1. Open the bag and place it on a stable surface.
2. Open the internal compartment using both hands. Gently mix the contents of the bag.
3. The homogeneous mixture is ready for use. Infusion can be started using standard methods.

Any unused portions of the solution must be discarded.
Nutriflex Peri should be opened immediately before administration.
Aseptic techniques must be strictly followed when mixing the contents of the compartments and during infusion.
Maximum infusion rates:
The maximum infusion rate for adult patients, children, and adolescents aged 2 to 17 years is 2.8 ml per kg body weight per hour.
Storage after mixing the bag contents:
The ready-to-use infusion solution, after mixing the compartment contents, may be stored at room temperature for no longer than 24 hours.