Nutriflex basal

Package leaflet: Information for the user

Nutriflex Basal set of two solutions for infusion solution
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 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents:

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

1. What Nutriflex Basal 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.
Because the patient is unable to feed normally or via a feeding 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 to moderate catabolism, a condition in which the patient consumes energy and protein reserves 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has inherited disorders of amino acid metabolism requiring a special protein-restricted diet;
• if the patient has elevated blood glucose 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 intracranial or spinal hemorrhage;
• if the patient has severe liver failure;
• if the patient has severe renal failure without access to renal replacement therapy (hemofiltration or dialysis).

As with other similar medicinal products, Nutriflex Basal must not be used in the following conditions:

• acute phase of myocardial infarction (heart attack) 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, pulmonary edema (fluid accumulation in the lungs), or disturbances in fluid balance.

Nutriflex Basal must not be administered to newborns, infants, or children under 2 years of age.
Warnings and precautions
Before starting treatment with Nutriflex Basal 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, such as reduced fluid and electrolyte levels (hypotonic dehydration) or low levels of sodium or potassium in the blood;
• the patient has elevated blood glucose levels.

Dosage must be carefully adjusted and monitored in patients with renal, hepatic, adrenal, cardiac, or pulmonary insufficiency.
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, especially potassium, magnesium, and phosphate, must be ensured.
This medicine contains glucose (a type of sugar), which may affect the patient's blood glucose concentration. Blood sampling may therefore be necessary to monitor glucose levels.
Sudden interruption of the infusion may lead to a rapid drop in blood glucose concentration. 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 glucose levels must be closely monitored, particularly after stopping the infusion.
Blood electrolyte levels, 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, additional nutrients will be administered alongside Nutriflex Basal.
As with all intravenous solutions, strict aseptic techniques must be observed during infusion of Nutriflex Basal.
Children and adolescents
Regarding sudden drop in blood glucose levels in children and adolescents after abrupt interruption of infusion, see section “Warnings and precautions”.
Nutriflex Basal must not be administered to newborns, infants, or children under 2 years of age.
Nutriflex Basal and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Nutriflex Basal may interact with certain other medicines. Inform the doctor if the patient is taking or receiving any of the following medicines:

• drugs used to treat inflammatory conditions (corticosteroids);
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone [ACTH]);
• diuretics (water pills), such as spironolactone, triamterene, or amiloride;
• drugs used to treat high blood pressure (ACE inhibitors), such as captopril and enalapril;
• drugs used to treat high blood pressure or heart disease (angiotensin II receptor antagonists), such as losartan and valsartan;
• drugs 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 operating machines
This medicine is usually administered to immobilized patients, e.g. 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 Basal

This medicine is administered by intravenous infusion (drip), meaning through a thin tube directly into a vein.
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 it.
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
Dosage should be adjusted for children and adolescents aged 2 to 17 years. Your doctor knows the appropriate dosing for patients in this age group.

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

• fluid overload (overhydration);
• increased urine production (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 urine (glucosuria);
• fluid deficiency (dehydration);
• significantly higher concentration of blood components 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 disturbances 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 everybody gets them.
Adverse reactions are usually the result of overdose or infusion that is too rapid, and typically resolve after
stopping the infusion.
Rare (affects 1 to 1,000 patients):

• Nausea, vomiting and loss of appetite.

If adverse reactions occur, the infusion should be stopped or, if appropriate, continued at a reduced rate.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the 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, e-mail:
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Nutriflex Basal

Keep this medicine out of the sight and reach 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 container. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Nutriflex Basal 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 Basal looks like and contents of the pack
This medicine is a solution for infusion, meaning it is administered through a thin tube directly into a vein.
Nutriflex Basal 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:

Before starting the infusion, the medicinal product should be warmed to room temperature.
Nutriflex Basal may be used only if the solution is clear and the packaging is undamaged. Any unused portions of the solution must be discarded.
Preparation of the mixed solution:
The partition between the chambers should be ruptured immediately before use, and the contents of the chambers should be mixed under aseptic conditions.
Remove the bag from the protective overwrap and proceed as follows:

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

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