Nutrielt Pediatric

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

NUTRYELT PEDIATRIC, concentrate for solution for infusion

(for preterm infants, newborns, infants, and children)

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 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 one person. 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 inform their doctor or pharmacist, or nurse. See section 4.

The full name of this medicinal product is N P, concentrate for solution for infusion, but in the rest of the leaflet, it will be referred to as N P.

Table of contents of the leaflet

• 1. What is N P and what is it used for
• 2. Important information before using N P
• 3. How to use N P
• 4. Possible side effects
• 5. How to store N P
• 6. Contents of the pack and other information

1. What is N P and what is it used for

N P is a concentrate for solution for infusion, specifically designed for preterm infants, newborns, infants, and children.
It contains five essential trace elements (zinc, copper, manganese, iodine, and selenium) that are considered essential because the body cannot produce them, but they are needed in very small amounts for its proper functioning.
Trace elements are usually provided in a balanced diet.
N P is intended to provide trace elements to preterm infants and newborns, infants, and children who cannot eat normally and need intravenous nutrition.

2. Important information before using N P

When the child should not receive N P:

• if they are allergic (hypersensitive) to any component of N P (see section 6 of this leaflet);
• if they have Wilson's disease (a congenital disease characterized by an excessive amount of copper in the body);
• if they have an abnormally high concentration of any of the components of the medicine in their blood. (In case of any doubts, consult a doctor.)

Warnings and precautions

Before using N P, you should discuss it with your doctor or pharmacist if the child:

• has liver or kidney function disorders;
• has thyroid function disorders.

During treatment, the doctor will regularly check the levels of trace elements in the blood and adjust the dosage of N P accordingly.

N P and other medicines

You should tell your doctor about all medicines the child is currently taking or has recently taken, as well as any medicines the child is going to take in the future, including those available without a prescription.

N P contains sodium and potassium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free". The medicine contains less than 1 mmol (39 mg) of potassium per ampoule, which means the medicine is considered "potassium-free".

3. How to use N P

N P will be administered to the child intravenously (into a vein) in the form of an infusion (drip) by a nurse or doctor. They will decide what dose is suitable for the child.

Dosage

Preterm infants, newborns, infants, and children (with a body weight of 20 kg or less):

A dose of 1 ml of N P per kg of body weight per day, up to a maximum daily dose of 20 ml, covers the basic requirement for the trace elements contained in the product.

Children (with a body weight over 20 kg):

A daily dose of 20 ml of N P should cover the basic requirement for trace elements.
In the case of treating preterm infants, N P should be supplemented with a solution for injection containing only zinc, to achieve a total parenteral zinc intake of 450-500 µg/kg/day.
In the case of long-term (lasting more than 3 weeks) parenteral nutrition of preterm infants, it is recommended to administer a daily infusion containing iron, and to add molybdenum in the case of parenteral nutrition lasting more than 4 weeks.
N P must be diluted before use; it must not be administered to the patient undiluted.

Using a higher dose of N P in a child than recommended

It is very unlikely that a child will receive a larger amount of the medicine in an infusion than they should, because during treatment, they will be monitored by a doctor or nurse. However, if it is suspected that the child has received a larger dose of N P than they should, you should immediately inform the doctor or nurse.
The doctor will stop the administration of N P and perform the necessary laboratory tests in case of suspected overdose.
In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, N P can cause side effects, although not everybody gets them.
If any of the following symptoms occur, you should immediately inform your doctor:
frequency not known (cannot be estimated from the available data): pain at the injection site.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.
Side effects can be reported directly to the marketing authorization holder.

5. How to store N P

It has been demonstrated that after dilution, the product retains its chemical and physical stability for 48 hours at a temperature of 25°C.
From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the user is responsible for the storage time and conditions before use.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXPIRY DATE. The expiry date refers to the last day of the month stated.
Do not freeze.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What N P contains

The active substances of N P are:
in 10 ml (1 ampoule)
zinc (Zn)
1000 µg
(as zinc gluconate)
copper (Cu)
200 µg
(as copper gluconate)
manganese (Mn)
5 µg
(as manganese gluconate)
iodine (I)
10 µg
(as potassium iodide)
selenuim (Se)
20 µg
(as sodium selenite)
Other ingredients are: hydrochloric acid (to adjust pH) and water for injections.

What N P looks like and what the pack contains

A clear, colorless concentrate for solution for infusion in 10 ml ampoules, packaged in cardboard boxes of 10 or 50 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer

Laboratoire AGUETTANT
Lieu-dit Chantecaille
07340 CHAMPAGNE
France

Date of last revision of the leaflet: 03.2019. ------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Pharmaceutical form:

Density 1.0
pH
2.7 to 3.3
Osmolality 15 mosmol/kg
Osmolarity 15 mosmol/l

Incompatibilities:

Do not use the medicinal product N P as a vehicle for other medicines.
Do not mix the medicinal product with other medicinal products, except for sodium chloride 0.9% and glucose 5%.

Shelf life:

3 years
It has been demonstrated that after dilution, the product retains its chemical and physical stability for 48 hours at a temperature of 25°C.
From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the user is responsible for the storage time and conditions before use.

Special precautions for storage:

Do not freeze.

Instructions for use and handling:

Before use, you should ensure that the concentrate for solution for infusion is homogeneous, the ampoule is not damaged, and the solution does not contain solid particles.
The medicinal product N P is not intended for administration in its undiluted form.
The medicinal product N P should be diluted or added to other solutions by gently mixing, under strictly aseptic conditions, immediately before administration in an infusion.
The medicinal product N P should be diluted taking into account the final osmolality of the solution.
For example:

• 5 or 10 ml of the medicinal product N P can be diluted by adding at least 50 ml of sodium chloride infusion solution 0.9% or glucose infusion solution 5%;
• 10 or 20 ml of the medicinal product N P can be diluted by adding at least 100 ml of sodium chloride infusion solution 0.9% or glucose infusion solution 5%.
• After dilution, the pH value is approximately 3.5 to 4.5.

The reconstituted infusion solution should be inspected before use. Only a clear solution without solid particles should be used.
Do not store partially used containers and dispose of all equipment after use.
You should check the compatibility with solutions administered simultaneously through a common cannula.

More information on dosing can be found in section 3 of this leaflet.